Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00092456
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2004-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Consistency Lots Vaccine Study (V260-009)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022243', 'term': 'Rotavirus Vaccines'}, {'id': 'C492535', 'term': 'RotaTeq'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.', 'description': 'The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - Placebo) is the number of patients who received study treatment.\n\nAlthough a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.', 'eventGroups': [{'id': 'EG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.', 'otherNumAtRisk': 226, 'otherNumAffected': 206, 'seriousNumAtRisk': 226, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.', 'otherNumAtRisk': 224, 'otherNumAffected': 212, 'seriousNumAtRisk': 224, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.', 'otherNumAtRisk': 229, 'otherNumAffected': 211, 'seriousNumAtRisk': 229, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.', 'otherNumAtRisk': 111, 'otherNumAffected': 101, 'seriousNumAtRisk': 111, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 122}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 103}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Infantile colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Infrequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Regurgitation of food', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 77}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Injection site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 122}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 115}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Candida nappy rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, 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'numAtRisk': 226, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}], 'seriousEvents': [{'term': 'Congenital ventricular septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'G1 SNA (dilution units)', 'categories': [{'measurements': [{'value': '167.9', 'groupId': 'OG000', 'lowerLimit': '135.7', 'upperLimit': '207.7'}, {'value': '193.2', 'groupId': 'OG001', 'lowerLimit': '157.6', 'upperLimit': '236.8'}, {'value': '171.0', 'groupId': 'OG002', 'lowerLimit': '140.6', 'upperLimit': '208.1'}, {'value': '9.3', 'groupId': 'OG003', 'lowerLimit': '7.2', 'upperLimit': '11.9'}]}]}, {'title': 'G2 SNA (dilution units)', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '24.7'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '26.8'}, {'value': '17.8', 'groupId': 'OG002', 'lowerLimit': '15.1', 'upperLimit': '20.9'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '5.3', 'upperLimit': '6.6'}]}]}, {'title': 'G3 SNA (dilution units)', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '21.2'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '21.9'}, {'value': '14.6', 'groupId': 'OG002', 'lowerLimit': '12.4', 'upperLimit': '17.2'}, {'value': '9.6', 'groupId': 'OG003', 'lowerLimit': '7.4', 'upperLimit': '12.5'}]}]}, {'title': 'G4 SNA (dilution units)', 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '57.0', 'upperLimit': '76.4'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '64.4', 'upperLimit': '85.7'}, {'value': '65.7', 'groupId': 'OG002', 'lowerLimit': '55.6', 'upperLimit': '77.5'}, {'value': '7.8', 'groupId': 'OG003', 'lowerLimit': '6.5', 'upperLimit': '9.4'}]}]}, {'title': 'P1A[8] SNA (dilution units)', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '84.2'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '61.4', 'upperLimit': '85.3'}, {'value': '65.6', 'groupId': 'OG002', 'lowerLimit': '55.0', 'upperLimit': '78.2'}, {'value': '10.2', 'groupId': 'OG003', 'lowerLimit': '7.6', 'upperLimit': '13.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.', 'groupDescription': 'A pairwise comparison of lots was made for each serotype, for each pair of lots.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.', 'groupDescription': 'A pairwise comparison of lots was made for each serotype, for each pair of lots.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2)'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.', 'groupDescription': 'A pairwise comparison of lots was made for each serotype, for each pair of lots.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days following the 3rd vaccination', 'description': 'Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\\[8\\]', 'unitOfMeasure': 'dilution units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '292.7', 'groupId': 'OG000', 'lowerLimit': '241.0', 'upperLimit': '355.5'}, {'value': '272.5', 'groupId': 'OG001', 'lowerLimit': '227.9', 'upperLimit': '325.7'}, {'value': '266.2', 'groupId': 'OG002', 'lowerLimit': '220.1', 'upperLimit': '321.8'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '0.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days following the 3rd vaccination', 'description': 'Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA', 'unitOfMeasure': 'units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects With Clinical Adverse Experiences (CAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'With CAEs', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}]}, {'title': 'Without CAEs', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': "Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: All subjects who were vaccinated and followed up'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'With Serious CAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Without Serious CAEs', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': 'Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were vaccinated and followed up'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects With Vaccine-Related Clinical AEs (CAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'With vaccine-related CAEs', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}]}, {'title': 'Without vaccine-related CAEs', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': "CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were vaccinated and followed up'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'With serious vaccine-related CAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Without serious vaccine-related CAEs', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': 'Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were vaccinated and followed up'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects Discontinued Due to Clinical Adverse Experiences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'Discontinued due to CAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Not discontinued due to CAEs', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': "A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were vaccinated and followed up'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'Discontinued due to vaccine-related CAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Not discontinued due to vaccine-related CAEs', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': "CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were vaccinated and followed up'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'Discontinued due to serious CAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Not discontinued due to serious CAEs', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': 'SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were vaccinated and followed up'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}], 'classes': [{'title': 'Discontinued due to serious vaccine-related CAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'NOTdiscontinued dueto serious vaccine-related CAEs', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': 'Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were vaccinated and followed up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'FG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses (\\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'FG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses (\\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subject assigned to \\~8.81 X 10\\^7 IU/Dose of RotaTeq™ - Lot 1', 'groupId': 'FG000', 'numSubjects': '226'}, {'comment': 'Subject assigned to \\~8.01 X 10\\^7 IU/Dose of RotaTeq™ - Lot 2', 'groupId': 'FG001', 'numSubjects': '225'}, {'comment': 'Subject assigned to \\~6.91 X 10\\^7 IU/Dose of RotaTeq™ - Lot 3', 'groupId': 'FG002', 'numSubjects': '229'}, {'comment': 'Subjects assigned to Placebo-matching RotaTeq™', 'groupId': 'FG003', 'numSubjects': '113'}]}, {'type': 'Vaccinated at Visit 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '225'}, {'groupId': 'FG002', 'numSubjects': '229'}, {'groupId': 'FG003', 'numSubjects': '113'}]}, {'type': 'Vaccinated at Visit 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '217'}, {'groupId': 'FG002', 'numSubjects': '210'}, {'groupId': 'FG003', 'numSubjects': '104'}]}, {'type': 'Vaccinated at Visit 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '210'}, {'groupId': 'FG002', 'numSubjects': '200'}, {'groupId': 'FG003', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects who received 3 scheduled vaccinations; with up to 42 days safety follow-up after each dose', 'groupId': 'FG000', 'numSubjects': '201'}, {'comment': 'Subjects who received 3 scheduled vaccinations; with up to 42 days safety follow-up after each dose', 'groupId': 'FG001', 'numSubjects': '208'}, {'comment': 'Subjects who received 3 scheduled vaccinations; with up to 42 days safety follow-up after each dose', 'groupId': 'FG002', 'numSubjects': '200'}, {'comment': 'Subjects who received 3 scheduled vaccinations; with up to 42 days safety follow-up after each dose', 'groupId': 'FG003', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 10 sites in the United States from 09-May-2003 (first patient in) to 02-Jul-2004\n\n(last dose given).\n\nLast subject completed follow-up: 13-Aug-2004.\n\nAll data corrections applied (Frozen File) date: 30-Sep-2004', 'preAssignmentDetails': 'Subjects with prior rotavirus disease, chronic diarrhea, and fever at time of immunization were excluded\n\nfrom the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '793', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'RotaTeq™ Lot 1', 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'BG001', 'title': 'RotaTeq™ Lot 2', 'description': 'Three oral doses ( \\~8.01 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'BG002', 'title': 'RotaTeq™ Lot 3', 'description': 'Three oral doses ( \\~6.91 X 10\\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6 to 12 Weeks', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '790', 'groupId': 'BG004'}]}]}, {'title': 'Over 12 Weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '367', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '426', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '498', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic American', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '186', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 793}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-18', 'studyFirstSubmitDate': '2004-09-22', 'resultsFirstSubmitDate': '2009-06-19', 'studyFirstSubmitQcDate': '2004-09-24', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-11', 'studyFirstPostDateStruct': {'date': '2004-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).', 'timeFrame': '42 days following the 3rd vaccination', 'description': 'Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA'}, {'measure': 'Number of Subjects With Clinical Adverse Experiences (CAEs)', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': "Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product"}, {'measure': 'Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': 'Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.'}, {'measure': 'Number of Subjects With Vaccine-Related Clinical AEs (CAEs)', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': "CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment."}, {'measure': 'Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': 'Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose'}, {'measure': 'Number of Subjects Discontinued Due to Clinical Adverse Experiences', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': "A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product."}, {'measure': 'Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': "CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment."}, {'measure': 'Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': 'SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.'}, {'measure': 'Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)', 'timeFrame': 'Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first', 'description': 'Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.'}], 'primaryOutcomes': [{'measure': 'Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]', 'timeFrame': '42 days following the 3rd vaccination', 'description': 'Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\\[8\\]'}]}, 'conditionsModule': {'conditions': ['Rotavirus Infections']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants\n\nExclusion Criteria:\n\n* History of abdominal disorders from a birth defect, intussusception, or abdominal surgery\n* Known or suspected problems with the immune system\n* Fever at time of immunization\n* Prior administration of a rotavirus vaccine\n* History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.'}, 'identificationModule': {'nctId': 'NCT00092456', 'briefTitle': 'Consistency Lots Vaccine Study (V260-009)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants', 'orgStudyIdInfo': {'id': 'V260-009'}, 'secondaryIdInfos': [{'id': '2004_078'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RotaTeq™ Lot 1', 'description': '\\~8.81 X 10\\^7 IU/Dose of RotaTeq™', 'interventionNames': ['Biological: rotavirus vaccine, live, oral, pentavalent']}, {'type': 'EXPERIMENTAL', 'label': 'RotaTeq™ Lot 2', 'description': '\\~8.01 X 10\\^7 IU/Dose of RotaTeq™', 'interventionNames': ['Biological: rotavirus vaccine, live, oral, pentavalent']}, {'type': 'EXPERIMENTAL', 'label': 'RotaTeq™ Lot 3', 'description': '\\~6.91 X 10\\^7 IU/Dose of RotaTeq™', 'interventionNames': ['Biological: rotavirus vaccine, live, oral, pentavalent']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'rotavirus vaccine, live, oral, pentavalent', 'type': 'BIOLOGICAL', 'otherNames': ['V260', 'RotaTeq™'], 'description': 'Three oral doses (\\~8.81 X 10\\^7 IU/Dose for Lot 1; \\~8.01 X 10\\^7 IU/Dose for Lot 2; and \\~6.91 X 10\\^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination', 'armGroupLabels': ['RotaTeq™ Lot 1', 'RotaTeq™ Lot 2', 'RotaTeq™ Lot 3']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10\n\nweeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}