Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-31 @ 1:20 AM
Study NCT ID:
NCT02177032
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2014-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011819', 'term': 'Rabies Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).', 'description': 'Solicited local,systemic AEs \\& associated medications will be recorded on diary cards for 3,4, 7 \\& 7 days post vaccination on Visits 1,2,3 \\& 5,respectively.Unsolicited AEs \\& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \\& A2 \\& from D1-50 for Groups B1 \\& B2.After D29/50, until D366 only SAEs \\& AEs leading to withdrawal \\& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.', 'eventGroups': [{'id': 'EG000', 'title': '4-sites, 1-week WITHOUT HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen', 'otherNumAtRisk': 356, 'otherNumAffected': 292, 'seriousNumAtRisk': 356, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight', 'otherNumAtRisk': 85, 'otherNumAffected': 78, 'seriousNumAtRisk': 85, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '2-sites, TRC WITHOUT HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.', 'otherNumAtRisk': 353, 'otherNumAffected': 298, 'seriousNumAtRisk': 353, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': '2-sites, TRC WITH HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly', 'otherNumAtRisk': 89, 'otherNumAffected': 82, 'seriousNumAtRisk': 89, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 195}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 168}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'INJECTION SITE INDURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 89}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'INJECTION SITE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'VACCINATION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 79}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'VACCINATION SITE INDURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'VACCINATION SITE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Appendiceal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Appendicitis Perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dengue Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'HIV Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hand-Foot-And-Mouth Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pseudomonal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Animal Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Animal Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Joint Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysfunctional Uterine Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOTAL 4-sites, 1-week', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with and without HRIG administered on day 1'}, {'id': 'OG001', 'title': 'TOTAL 2-sites, TRC', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at day 50 is \\> -0.05 (non-inferiority margin).'}], 'paramType': 'NUMBER', 'timeFrame': 'Study day 50 (D50)', 'description': 'Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.\n\nNon-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.', 'unitOfMeasure': 'Percentages of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOTAL 4-sites, 1-week', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1'}, {'id': 'OG001', 'title': 'TOTAL 2-sites, TRC', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '4.58', 'groupId': 'OG000', 'lowerLimit': '4.15', 'upperLimit': '5.06'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '9.29', 'upperLimit': '11'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Group Ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.37', 'ciUpperLimit': '0.58', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Study Day 50', 'description': 'Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.\n\nNon-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOTAL 4-sites, 1-week', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1'}, {'id': 'OG001', 'title': 'TOTAL 2-sites, TRC', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1'}], 'classes': [{'title': 'Day 8 (N= 363, 362)', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.25'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.15'}]}]}, {'title': 'Day 15 (N= 357, 361)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '20'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '13'}]}]}, {'title': 'Day 91 (N= 358, 362)', 'categories': [{'measurements': [{'value': '2.32', 'groupId': 'OG000', 'lowerLimit': '2.09', 'upperLimit': '2.56'}, {'value': '3.68', 'groupId': 'OG001', 'lowerLimit': '3.32', 'upperLimit': '4.07'}]}]}, {'title': 'Day 181 (N= 357, 360)', 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '1.78'}, {'value': '1.44', 'groupId': 'OG001', 'lowerLimit': '1.28', 'upperLimit': '1.62'}]}]}, {'title': 'Day 366 (N= 356, 352)', 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '1.79'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '1.01', 'upperLimit': '1.28'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Group Ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.29', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 8)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Group Ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.35', 'ciUpperLimit': '2.1', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 15)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Group Ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.85', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 91).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Group Ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.59', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 181)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Group Ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '1.27', 'ciUpperLimit': '2.19', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The investigational regimen 4-sites, 1-week" ID PEP will be declared as non-inferior to currently recommended "2-sites TRC" ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 366)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 8, 15, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.\n\nNon-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOTAL 4-sites, 1-week', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1'}, {'id': 'OG001', 'title': 'TOTAL 2-sites, TRC', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1'}], 'classes': [{'title': 'Day 8 (N= 363, 362)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '23'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '13'}]}]}, {'title': 'Day 15 (N= 357, 361)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'Day 91 (N= 358, 362)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '98'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'Day 181 (N= 357, 360)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '95'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '96'}]}]}, {'title': 'Day 366 (N= 356, 352)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '93'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '87'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '3.8', 'ciUpperLimit': '13.9', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \\> -0.05 (non-inferiority margin).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1', 'ciUpperLimit': '1.6', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \\> -0.05 (non-inferiority margin).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3', 'ciLowerLimit': '-6', 'ciUpperLimit': '-1.4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \\> -0.05 (non-inferiority margin).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '3.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \\> -0.05 (non-inferiority margin).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6', 'ciLowerLimit': '1.3', 'ciUpperLimit': '11.5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen compared to the currently recommended "2-sites TRC" (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \\> -0.05 (non-inferiority margin).'}], 'paramType': 'NUMBER', 'timeFrame': 'At Days 8, 15, 91, 181 and 366', 'description': 'Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.\n\nRVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population.', 'unitOfMeasure': 'Percentages of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen with HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight'}, {'id': 'OG001', 'title': '4-sites, 1-week WITHOUT HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen'}], 'classes': [{'title': 'Day 8 (N= 66, 150)', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.26'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.17'}]}]}, {'title': 'Day 15 (N= 65, 146)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '15'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '17'}]}]}, {'title': 'Day 50 (N= 65, 146)', 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.43'}, {'value': '4.47', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.13'}]}]}, {'title': 'Day 91 (N= 65, 149)', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.27'}, {'value': '2.28', 'groupId': 'OG001', 'lowerLimit': '1.96', 'upperLimit': '2.65'}]}]}, {'title': 'Day 181 (N= 65, 146)', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.14'}, {'value': '1.92', 'groupId': 'OG001', 'lowerLimit': '1.61', 'upperLimit': '2.29'}]}]}, {'title': 'Day 366 (N= 65, 145)', 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '0.88'}, {'value': '1.42', 'groupId': 'OG001', 'lowerLimit': '1.19', 'upperLimit': '1.69'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '-1', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \\> -0.05 (non-inferiority margin).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '2.6', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \\> -0.05 (non-inferiority margin).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15', 'ciLowerLimit': '-26', 'ciUpperLimit': '-7.1', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \\> -0.05 (non-inferiority margin).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17', 'ciLowerLimit': '-29', 'ciUpperLimit': '-7.1', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \\> -0.05 (non-inferiority margin).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Protection Rate Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25', 'ciLowerLimit': '-37.8', 'ciUpperLimit': '-13.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority in immune response of the "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new "4-sites, 1-week" (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \\> -0.05 (non-inferiority margin).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 8, 15, 50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.\n\nRVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight'}, {'id': 'OG001', 'title': '4-sites, 1-week WITHOUT HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen'}], 'classes': [{'title': 'Day 1 (N= 66, 151)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day 8 (N= 66, 150)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '26'}]}]}, {'title': 'Day 15 (N= 65, 146)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'Day 50 (N= 65, 146)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '99'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'Day 91 (N= 65, 149)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '91'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '100'}]}]}, {'title': 'Day 181 (N= 65, 146)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '86'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '97'}]}]}, {'title': 'Day 366 (N= 65, 145)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '77'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Days 8, 15,50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.\n\nPercentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)', 'unitOfMeasure': 'Percentages of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4-sites, 1-week Without HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen'}, {'id': 'OG001', 'title': '2-sites, TRC Without HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.'}], 'classes': [{'title': 'Day 1 (N=298, 290)', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.05'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.05'}]}]}, {'title': 'Day 8 (N= 297, 290)', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.25'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.14'}]}]}, {'title': 'Day 15 (N= 292, 289)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '21'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '13'}]}]}, {'title': 'Day 50 (N= 292, 281)', 'categories': [{'measurements': [{'value': '5.04', 'groupId': 'OG000', 'lowerLimit': '4.56', 'upperLimit': '5.57'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '9.48', 'upperLimit': '12'}]}]}, {'title': 'Day 91 (N= 293, 290)', 'categories': [{'measurements': [{'value': '2.54', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '2.82'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.42', 'upperLimit': '4.21'}]}]}, {'title': 'Day 181 (N= 292, 289)', 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '1.95'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.32', 'upperLimit': '1.69'}]}]}, {'title': 'Day 366 (N= 291, 283)', 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '1.95'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.06', 'upperLimit': '1.36'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 8, 15, 50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4-sites, 1-week Without HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen'}, {'id': 'OG001', 'title': '2-sites, TRC Without HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.'}], 'classes': [{'title': 'Day 8 (N= 297, 290)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '26'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '14'}]}]}, {'title': 'Day 15 (N= 292, 289)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '100'}]}]}, {'title': 'Day 50 (N= 292, 281)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '100'}]}]}, {'title': 'Day 91 (N= 293, 290)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'Day 181 (N= 292, 289)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '98'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '98'}]}]}, {'title': 'Day 366 (N= 291, 283)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '97'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '90'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Days 8, 15, 50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age', 'unitOfMeasure': 'Percentages of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is only applicable for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '4-sites, 1-week WITHOUT HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen'}, {'id': 'OG001', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight'}, {'id': 'OG002', 'title': '2-sites, TRC WITHOUT HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.'}, {'id': 'OG003', 'title': '2-sites, TRC WITH HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly'}], 'classes': [{'title': 'Injection site erythema(≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema(≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema(≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema(≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration(≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration(≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration(≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration(≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Sleepiness (≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Sleepiness (≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Sleepiness (≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Sleepiness (≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting (≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting (≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting (≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting (≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Irritability.( ≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Irritability.( ≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Irritability.( ≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Irritability.( ≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Chills(≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Chills(≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Chills(≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Chills(≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Nausea ( ≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Nausea ( ≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Nausea ( ≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Nausea ( ≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Headache (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Headache (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Headache (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Headache (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Rash (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Rash (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Rash (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Rash (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Vomitting (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Vomitting (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Vomitting (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Vomitting (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Chills (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Chills (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Chills (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Chills (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Nausea,( ≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Nausea,( ≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Nausea,( ≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Nausea,( ≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Myalgia (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Myalgia (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Myalgia (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Myalgia (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Arthralgia (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Arthralgia (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Arthralgia (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Generalized Arthralgia (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Headache (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Headache (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Headache (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Headache (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Rash (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Rash (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Rash (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Rash (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Vomitting (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vomitting (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Vomitting (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Vomitting (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Loss Of Appetite (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Loss Of Appetite (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Loss Of Appetite (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Loss Of Appetite (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Injection site tenderness (≥ 1 to ≤ 5 Y); Day 1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site tenderness (≥ 1 to ≤ 5 Y); Day 4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site tenderness (≥ 1 to ≤ 5 Y); Day 8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site tenderness (≥ 1 to ≤ 5 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain (≥ 6 to ≤ 17 Y); Day 1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain (≥ 6 to ≤ 17 Y); Day 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain (≥ 6 to ≤ 17 Y); Day 8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain (≥ 6 to ≤ 17 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain (≥ 18 Y); Day 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain (≥ 18 Y); Day 4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain (≥ 18 Y); Day 8', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain (≥ 18 Y); Day 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not assessed at Day 29 for this group', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)', 'description': 'Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited Safety Set- All subjects in the Exposed Population who provide post vaccination solicited adverse event data. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '4-sites, 1-week WITHOUT HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen'}, {'id': 'OG001', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight'}, {'id': 'OG002', 'title': '2-sites, TRC WITHOUT HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen'}, {'id': 'OG003', 'title': '2-sites, TRC WITH HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly'}], 'classes': [{'title': '≥ 1 to ≤ 5 Y Any AEs;D1-366', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥ 1 to ≤ 5 Y SAE;D1-366', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥ 1 to ≤ 5 Y At least possibly related SAEs;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥ 1 to ≤ 5 Y Deaths;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥1 to ≤ 5 Y Withdrawal from study due to AE;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥ 6 to ≤ 17 Y Any AEs;D1-366', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '≥ 6 to ≤ 17 Y SAE;D1-366', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥6 to ≤ 17 Y At least possibly related SAEs;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥ 6 to ≤ 17 Y Deaths;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥6 to ≤17 Y Withdrawal from study due to AE;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data as only adults to be enrolled to this group', 'groupId': 'OG003'}]}]}, {'title': '≥ 18 Y Any AEs;D1-366', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': '≥ 18 Y SAE;D1-366', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': '≥ 18 Y At least possibly related SAEs;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '≥ 18 Y Deaths;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '≥ 18 Y Withdrawal from study due to AE;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Overall population ≥ 1 Y Any AEs;D1-366', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}]}, {'title': 'Overall population ≥ 1 Y SAE;D1-366', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Overall ≥1Y Atleast possibly related SAEs;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Overall population ≥ 1 Y Deaths;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Overall population ≥1Y Withdrawal due to AE;D1-366', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Unsolicited Safety Set- All subjects in the Exposed Population who have post vaccination unsolicited adverse event records. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight'}, {'id': 'OG001', 'title': '2-sites TRC WITH HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1'}], 'classes': [{'title': 'Day 1 (N= 66, 72)', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.05'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.05'}]}]}, {'title': 'Day 8 (N= 66, 72)', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.26'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.14', 'upperLimit': '0.21'}]}]}, {'title': 'Day 15 (N= 65, 72)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '15'}, {'value': '8.37', 'groupId': 'OG001', 'lowerLimit': '6.96', 'upperLimit': '10'}]}]}, {'title': 'Day 50 (N= 65, 69)', 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.43'}, {'value': '6.37', 'groupId': 'OG001', 'lowerLimit': '5.21', 'upperLimit': '7.78'}]}]}, {'title': 'Day 91 (N= 65, 72)', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.27'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '1.81', 'upperLimit': '2.79'}]}]}, {'title': 'Day 181 (N= 65, 71)', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.14'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.81', 'upperLimit': '1.35'}]}]}, {'title': 'Day 366 (N= 65, 69)', 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '0.88'}, {'value': '0.59', 'groupId': 'OG001', 'lowerLimit': '0.46', 'upperLimit': '0.76'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 8, 15, 50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites TRC with HRIG Groups.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight'}, {'id': 'OG001', 'title': '2-sites, TRC WITH HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen, with or without HRIG administered on day 1'}], 'classes': [{'title': 'Day 1 (N= 66, 72)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day 8 (N= 66, 72)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '19'}]}]}, {'title': 'Day 15 (N= 65, 72)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '100'}]}]}, {'title': 'Day 50 (N= 65, 69)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '99'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'Day 91 (N= 65, 72)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '91'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '100'}]}]}, {'title': 'Day 181 (N= 65, 71)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '86'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '92'}]}]}, {'title': 'Day 366 (N= 65, 69)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '77'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '80'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Days 8, 15,50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age', 'unitOfMeasure': 'Percentages of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites, TRC with HRIG Groups'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '4-sites, 1-week WITHOUT HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen'}, {'id': 'FG001', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly'}, {'id': 'FG002', 'title': '2-sites, TRC WITHOUT HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen'}, {'id': 'FG003', 'title': '2-sites, TRC WITH HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '355'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '354'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '350'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '351'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'ADMINISTRATIVE REASON', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'OTHER', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All enrolled subjects were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '885', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '4-sites, 1-week WITHOUT HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen'}, {'id': 'BG001', 'title': '4-sites, 1-week WITH HRIG', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight'}, {'id': 'BG002', 'title': '2-sites, TRC WITHOUT HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen.'}, {'id': 'BG003', 'title': '2-sites, TRC WITH HRIG', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '15.0', 'groupId': 'BG000'}, {'value': '32.7', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '20.6', 'spread': '15.1', 'groupId': 'BG002'}, {'value': '34.4', 'spread': '11.2', 'groupId': 'BG003'}, {'value': '22.9', 'spread': '15.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'FEMALE', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '476', 'groupId': 'BG004'}]}, {'title': 'MALE', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '409', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 885}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2014-06-24', 'resultsFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-21', 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)', 'timeFrame': 'Study day 50 (D50)', 'description': 'Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.\n\nNon-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs', 'timeFrame': 'Study Day 50', 'description': 'Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.\n\nNon-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.'}, {'measure': 'Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age', 'timeFrame': 'At Days 8, 15, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.\n\nNon-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.'}, {'measure': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age', 'timeFrame': 'At Days 8, 15, 91, 181 and 366', 'description': 'Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.\n\nRVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population.'}, {'measure': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age', 'timeFrame': 'At Days 8, 15, 50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.\n\nRVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)'}, {'measure': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age', 'timeFrame': 'At Days 8, 15,50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.\n\nPercentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)'}, {'measure': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age', 'timeFrame': 'At Days 8, 15, 50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age'}, {'measure': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age', 'timeFrame': 'At Days 8, 15, 50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age'}, {'measure': 'Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination', 'timeFrame': 'From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)', 'description': 'Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)'}, {'measure': 'Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age', 'timeFrame': 'At Days 8, 15, 50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age'}, {'measure': 'Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age', 'timeFrame': 'At Days 8, 15,50, 91, 181 and 366', 'description': 'Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rabies vaccines', 'intradermal', 'human rabies immunoglobulins'], 'conditions': ['Rabies Infection']}, 'descriptionModule': {'briefSummary': 'Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy males and females ≥ 1 years of age\n2. Individuals/ individual\'s parents or legal guardians who have given written consent\n3. Individuals in good health\n4. Individuals who can comply with study procedures\n\nExclusion Criteria:\n\n1. Behavioral or cognitive impairment or psychiatric disease.\n2. Unable to comprehend and to follow all required study procedures for the whole period of the study.\n3. History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.\n4. Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.\n5. Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.\n6. Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).\n7. Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry.\n8. Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50.\n9. Female of childbearing potential, with a positive pregnancy test prior to enrollment.\n10. Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.\n11. Allergic to any of the vaccine components.\n12. Allergic to any of the human rabies immunoglobulin components.\n13. Contraindication or precaution against rabies vaccination.\n14. Contraindication or precaution against man rabies immunoglobulin administration.\n15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50.\n16. Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.\n17. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.\n18. Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.\n19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.\n20. Part of the study personnel or immediate family members of study personnel conducting this study.\n21. Current or history of drug or alcohol abuse within the past 2 years.'}, 'identificationModule': {'nctId': 'NCT02177032', 'briefTitle': 'Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Phase 3, Randomized, Stratified, Open Label, Multicenter, Controlled Clinical Study to Evaluate Safety and Immunogenicity of a Rabies Vaccine Administered, With and Without Human Rabies Immunoglobulin, Using the New "4-sites, 1-week" Intradermal Regimen for Postexposure Prophylaxis Compared to the Currently Recommended "2-sites, TRC" Intradermal Regimen in Children and Adults Subjects.', 'orgStudyIdInfo': {'id': 'V49_30'}, 'secondaryIdInfos': [{'id': '2013-CT0191', 'type': 'REGISTRY', 'domain': 'registry.healthresearch.ph'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4-sites, 1-week without HRIG', 'description': 'PCEC rabies vaccine, administered ID according to the "4-sites, 1-week" regimen', 'interventionNames': ['Biological: Rabies vaccine']}, {'type': 'EXPERIMENTAL', 'label': '4-sites, 1-week with HRIG', 'description': 'PCEC rabies vaccine, administered ID to adults, according to the "4-sites, 1-week" regimen plus HRIG', 'interventionNames': ['Biological: Rabies vaccines + Rabies immunoglobulins']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2-sites, TRC without HRIG', 'description': 'PCEC rabies vaccine, administered ID according to the "2-sites, TRC" regimen', 'interventionNames': ['Biological: Rabies vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2-sites, TRC with HRIG', 'description': 'PCEC rabies vaccine, administered ID to adults , according to the "2-sites, TRC" regimen plus HRIG', 'interventionNames': ['Biological: Rabies vaccines + Rabies immunoglobulins']}], 'interventions': [{'name': 'Rabies vaccine', 'type': 'BIOLOGICAL', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8).', 'armGroupLabels': ['4-sites, 1-week without HRIG']}, {'name': 'Rabies vaccines + Rabies immunoglobulins', 'type': 'BIOLOGICAL', 'description': '12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.', 'armGroupLabels': ['4-sites, 1-week with HRIG']}, {'name': 'Rabies vaccine', 'type': 'BIOLOGICAL', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29).', 'armGroupLabels': ['2-sites, TRC without HRIG']}, {'name': 'Rabies vaccines + Rabies immunoglobulins', 'type': 'BIOLOGICAL', 'description': '8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.', 'armGroupLabels': ['2-sites, TRC with HRIG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4114', 'city': 'Cavite', 'country': 'Philippines', 'facility': '4, De La Salle Health Sciences Institute', 'geoPoint': {'lat': 15.67785, 'lon': 120.76978}}, {'zip': '1781', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': '1, Research Institute for Tropical Medicine', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'zip': '1781', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': '2, Asian Hospital and Medical Center', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': '3, Research Institute for Tropical Medicine', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': '11, Infectious Diseases Unit, Department of Pediatrics, Phramongkutklao hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': '12, Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}