Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-06 @ 3:09 AM
Study NCT ID:
NCT02492958
Status:
COMPLETED
Last Update Posted:
2018-07-30
First Post:
2015-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.', 'otherNumAtRisk': 34, 'otherNumAffected': 11, 'seriousNumAtRisk': 34, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.', 'otherNumAtRisk': 34, 'otherNumAffected': 13, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.', 'otherNumAtRisk': 34, 'otherNumAffected': 8, 'seriousNumAtRisk': 34, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.', 'otherNumAtRisk': 34, 'otherNumAffected': 17, 'seriousNumAtRisk': 34, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Benign prostatic hyperplasia', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyalosis asteroid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Carotid artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostatitis', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vocal cord disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '29.4', 'groupId': 'OG003', 'lowerLimit': '15.1', 'upperLimit': '47.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 14', 'description': 'Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were defined as mild (2.5 to 5.0 centimeters \\[cm\\]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to \\[\\>=\\] 10.5 cm). Pain at injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). In this outcome measure percentage of participants with any local reaction was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '15.3'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '8.8', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '23.7'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Pain: Mild', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '17.6', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '34.5'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '14.7', 'groupId': 'OG003', 'lowerLimit': '5.0', 'upperLimit': '31.1'}]}]}, {'title': 'Pain: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Pain: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 14', 'description': 'Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (5.5 to 10.0 cm) and, severe (\\>=10.5 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '47.5'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '47.5'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '34.5'}, {'value': '35.3', 'groupId': 'OG003', 'lowerLimit': '19.7', 'upperLimit': '53.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 14', 'description': 'Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (\\>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). In this outcome measure percentage of participants with any systemic event was reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Fever: 37.5 degree C-38.4 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Fever: 38.5 degree C-38.9 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Fever: 39.0 degree C-40.0 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Fever: >40.0 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '11.8', 'groupId': 'OG003', 'lowerLimit': '3.3', 'upperLimit': '27.5'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '27.5'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '15.3'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '31.1'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Muscle Pain: Mild', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '8.8', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '23.7'}]}]}, {'title': 'Muscle Pain: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Muscle Pain: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Joint Pain: Mild', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}]}]}, {'title': 'Joint Pain: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '15.3'}]}]}, {'title': 'Joint Pain: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 14', 'description': 'Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}, {'value': '5.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 29', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious AEs. Treatment-emergent AEs were events between the administration of investigational product and up to Day 29 that were absent before vaccination or that worsened relative to pre-administration state.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}, {'value': '11.8', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}, {'value': '8.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Day 29 up to Month 12', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or deemed medically significant for any other reason. A treatment emergent AE was defined as an event that emerged during the study that was absent before administration of investigational product, or worsened relative to the pre-administration state. AEs reported during this time period included both SAEs and newly diagnosed chronic medical disorders (NDCMD). A NDCMD was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hematology Abnormalities at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'White Blood Cells', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5', 'description': 'Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here 'number of participants analyzed (N)' signifies number of participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hematology Abnormalities at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}, {'title': 'White Blood Cells', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Coagulation Abnormalities at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'PT', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'APTT', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet AGG: ADP', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet AGG: Arachidonic acid', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet AGG: Collagen', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Fibrinogen Activity', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5', 'description': 'Coagulation analysis included the following parameters: prothrombin time (PT), activated partial thromboplastin time (APTT), platelet aggregation (AGG) (with adenosine diphosphate \\[ADP\\], with arachidonic acid, and with collagen) and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Coagulation Abnormalities at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'PT', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'APTT', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet AGG: ADP', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet AGG: Arachidonic acid', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}, {'title': 'Platelet AGG: Collagen', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Fibrinogen Activity', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'Coagulation analysis included the following parameters: PT, APTT, platelet AGG with ADP, platelet AGG with arachidonic acid, platelet AGG with collagen and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Blood Chemistry Abnormalities at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Creatine Kinase', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Lactate Dehydrogenase', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5', 'description': 'Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Blood Chemistry Abnormalities at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Creatine Kinase', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Lactate Dehydrogenase', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '44.6'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '15.6', 'groupId': 'OG002', 'lowerLimit': '5.3', 'upperLimit': '32.8'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '89.7', 'upperLimit': '100.0'}]}]}, {'title': 'CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '34.5'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '20.6', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '94.1', 'groupId': 'OG003', 'lowerLimit': '80.3', 'upperLimit': '99.3'}]}]}, {'title': 'ClfA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '80.3', 'upperLimit': '99.3'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '88.2', 'groupId': 'OG003', 'lowerLimit': '72.5', 'upperLimit': '96.7'}]}]}, {'title': 'MntC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '76.3', 'upperLimit': '98.1'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '94.1', 'groupId': 'OG003', 'lowerLimit': '80.3', 'upperLimit': '99.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Percentage of participants achieving predefined antibody response to capsular polysaccharide serotype 5 (CP5), capsular polysaccharide serotype 8 (CP8), clumping factor A (ClfA) and manganese transporter C (MntC) at Day 29 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on opsonophagocytic activity (OPA) assay for CP5 and CP8, respectively; was 121 based on fibrinogen-binding inhibition (FBI) assay for ClfA and 512 based on competitive Luminex immunoassay (cLIA) for MntC.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population included all participants who received investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here "n" signifies the number of participants who were evaluable for specific antigens for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Baseline: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '41.2'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': '27.5'}, {'value': '14.7', 'groupId': 'OG003', 'lowerLimit': '5.0', 'upperLimit': '31.1'}]}]}, {'title': 'Baseline: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '31.9'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '51.8'}, {'value': '20.6', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '26.5', 'groupId': 'OG003', 'lowerLimit': '12.9', 'upperLimit': '44.4'}]}]}, {'title': 'Baseline: ClfA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '27.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}, {'title': 'Baseline: MntC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '41.2'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '11.8', 'groupId': 'OG003', 'lowerLimit': '3.3', 'upperLimit': '27.5'}]}]}, {'title': 'Day 11: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '100.0'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '35.5'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '89.7', 'upperLimit': '100.0'}]}]}, {'title': 'Day 11: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '35.5'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '20.6', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '94.1', 'groupId': 'OG003', 'lowerLimit': '80.3', 'upperLimit': '99.3'}]}]}, {'title': 'Day 11: ClfA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '27.5'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '84.7', 'upperLimit': '99.9'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '82.4', 'groupId': 'OG003', 'lowerLimit': '65.5', 'upperLimit': '93.2'}]}]}, {'title': 'Day 11: MntC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '80.3', 'upperLimit': '99.3'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '97.1', 'groupId': 'OG003', 'lowerLimit': '84.7', 'upperLimit': '99.9'}]}]}, {'title': 'Day 15: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '38.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '24.3'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '89.7', 'upperLimit': '100.0'}]}]}, {'title': 'Day 15: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '36.4'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '20.6', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '97.1', 'groupId': 'OG003', 'lowerLimit': '84.7', 'upperLimit': '99.9'}]}]}, {'title': 'Day 15: ClfA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '27.5'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '84.7', 'upperLimit': '99.9'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '88.2', 'groupId': 'OG003', 'lowerLimit': '72.5', 'upperLimit': '96.7'}]}]}, {'title': 'Day 15: MntC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '80.3', 'upperLimit': '99.3'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '34.5'}, {'value': '97.1', 'groupId': 'OG003', 'lowerLimit': '84.7', 'upperLimit': '99.9'}]}]}, {'title': 'Month 3: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '36.4'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '20.6', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '89.7', 'upperLimit': '100.0'}]}]}, {'title': 'Month 3: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '37.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '14.7', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '31.1'}, {'value': '88.2', 'groupId': 'OG003', 'lowerLimit': '72.5', 'upperLimit': '96.7'}]}]}, {'title': 'Month 3: ClfA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '88.2', 'groupId': 'OG001', 'lowerLimit': '72.5', 'upperLimit': '96.7'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '82.4', 'groupId': 'OG003', 'lowerLimit': '65.5', 'upperLimit': '93.2'}]}]}, {'title': 'Month 3: MntC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '58.8', 'upperLimit': '89.3'}, {'value': '14.7', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '31.1'}, {'value': '82.4', 'groupId': 'OG003', 'lowerLimit': '65.5', 'upperLimit': '93.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 11, 15 and Month3', 'description': 'Percentage of participants achieving predefined antibody response to CP5, CP8, ClfA and MntC at Baseline, Day 11, 15 and Month 3 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on OPA assay for CP5 and CP8, respectively; was 121 based on FBI assay for ClfA, 512 based on cLIA for MntC.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population included all participants who received investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here "n" signifies the number of participants who were evaluable for specific antigens for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Baseline: ClfA', 'categories': [{'measurements': [{'value': '200.7', 'groupId': 'OG000', 'lowerLimit': '177.6', 'upperLimit': '226.8'}, {'value': '218.1', 'groupId': 'OG001', 'lowerLimit': '196.7', 'upperLimit': '241.7'}, {'value': '216.6', 'groupId': 'OG002', 'lowerLimit': '179.7', 'upperLimit': '261.0'}, {'value': '174.0', 'groupId': 'OG003', 'lowerLimit': '150.3', 'upperLimit': '201.4'}]}]}, {'title': 'Baseline: MntC', 'categories': [{'measurements': [{'value': '349.4', 'groupId': 'OG000', 'lowerLimit': '306.8', 'upperLimit': '398.0'}, {'value': '376.8', 'groupId': 'OG001', 'lowerLimit': '316.5', 'upperLimit': '448.5'}, {'value': '321.4', 'groupId': 'OG002', 'lowerLimit': '270.6', 'upperLimit': '381.7'}, {'value': '334.8', 'groupId': 'OG003', 'lowerLimit': '291.6', 'upperLimit': '384.3'}]}]}, {'title': 'Day 11: ClfA', 'categories': [{'measurements': [{'value': '190.7', 'groupId': 'OG000', 'lowerLimit': '166.1', 'upperLimit': '218.9'}, {'value': '4105.2', 'groupId': 'OG001', 'lowerLimit': '2389.4', 'upperLimit': '7053.0'}, {'value': '203.7', 'groupId': 'OG002', 'lowerLimit': '172.2', 'upperLimit': '241.0'}, {'value': '3394.1', 'groupId': 'OG003', 'lowerLimit': '2029.3', 'upperLimit': '5676.8'}]}]}, {'title': 'Day 11: MntC', 'categories': [{'measurements': [{'value': '358.5', 'groupId': 'OG000', 'lowerLimit': '312.2', 'upperLimit': '411.6'}, {'value': '5019.6', 'groupId': 'OG001', 'lowerLimit': '3207.2', 'upperLimit': '7856.2'}, {'value': '313.6', 'groupId': 'OG002', 'lowerLimit': '260.9', 'upperLimit': '377.0'}, {'value': '6712.9', 'groupId': 'OG003', 'lowerLimit': '4385.4', 'upperLimit': '10275.6'}]}]}, {'title': 'Day 15: ClfA', 'categories': [{'measurements': [{'value': '198.7', 'groupId': 'OG000', 'lowerLimit': '172.2', 'upperLimit': '229.2'}, {'value': '4706.0', 'groupId': 'OG001', 'lowerLimit': '2802.7', 'upperLimit': '7902.1'}, {'value': '231.9', 'groupId': 'OG002', 'lowerLimit': '199.1', 'upperLimit': '270.1'}, {'value': '4571.3', 'groupId': 'OG003', 'lowerLimit': '2883.1', 'upperLimit': '7248.1'}]}]}, {'title': 'Day 15: MntC', 'categories': [{'measurements': [{'value': '351.4', 'groupId': 'OG000', 'lowerLimit': '312.2', 'upperLimit': '395.6'}, {'value': '4431.7', 'groupId': 'OG001', 'lowerLimit': '2896.0', 'upperLimit': '6781.7'}, {'value': '356.0', 'groupId': 'OG002', 'lowerLimit': '297.8', 'upperLimit': '425.5'}, {'value': '5710.0', 'groupId': 'OG003', 'lowerLimit': '3816.9', 'upperLimit': '8541.9'}]}]}, {'title': 'Day 29: ClfA', 'categories': [{'measurements': [{'value': '198.4', 'groupId': 'OG000', 'lowerLimit': '173.7', 'upperLimit': '226.6'}, {'value': '3815.0', 'groupId': 'OG001', 'lowerLimit': '2288.8', 'upperLimit': '6359.0'}, {'value': '182.5', 'groupId': 'OG002', 'lowerLimit': '149.4', 'upperLimit': '223.1'}, {'value': '3313.6', 'groupId': 'OG003', 'lowerLimit': '2155.0', 'upperLimit': '5095.3'}]}]}, {'title': 'Day 29: MntC', 'categories': [{'measurements': [{'value': '326.9', 'groupId': 'OG000', 'lowerLimit': '287.2', 'upperLimit': '371.9'}, {'value': '2920.8', 'groupId': 'OG001', 'lowerLimit': '1947.4', 'upperLimit': '4380.8'}, {'value': '281.4', 'groupId': 'OG002', 'lowerLimit': '235.8', 'upperLimit': '335.7'}, {'value': '3471.0', 'groupId': 'OG003', 'lowerLimit': '2397.3', 'upperLimit': '5025.5'}]}]}, {'title': 'Month 3: ClfA', 'categories': [{'measurements': [{'value': '201.6', 'groupId': 'OG000', 'lowerLimit': '177.3', 'upperLimit': '229.2'}, {'value': '2309.3', 'groupId': 'OG001', 'lowerLimit': '1492.9', 'upperLimit': '3572.3'}, {'value': '224.8', 'groupId': 'OG002', 'lowerLimit': '190.8', 'upperLimit': '264.8'}, {'value': '2054.8', 'groupId': 'OG003', 'lowerLimit': '1348.3', 'upperLimit': '3131.6'}]}]}, {'title': 'Month 3: MntC', 'categories': [{'measurements': [{'value': '316.3', 'groupId': 'OG000', 'lowerLimit': '275.6', 'upperLimit': '363.0'}, {'value': '1273.5', 'groupId': 'OG001', 'lowerLimit': '912.1', 'upperLimit': '1778.0'}, {'value': '384.1', 'groupId': 'OG002', 'lowerLimit': '329.9', 'upperLimit': '447.2'}, {'value': '1528.7', 'groupId': 'OG003', 'lowerLimit': '1112.2', 'upperLimit': '2101.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by cLIA for ClfA and MntC and corresponding 2-sided 95 percent (%) confidence intervals (CIs) were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.'}, {'type': 'SECONDARY', 'title': 'Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Baseline: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '355.1', 'groupId': 'OG000', 'lowerLimit': '227.7', 'upperLimit': '553.8'}, {'value': '301.7', 'groupId': 'OG001', 'lowerLimit': '197.4', 'upperLimit': '461.0'}, {'value': '349.0', 'groupId': 'OG002', 'lowerLimit': '249.2', 'upperLimit': '488.9'}, {'value': '332.9', 'groupId': 'OG003', 'lowerLimit': '223.9', 'upperLimit': '495.1'}]}]}, {'title': 'Baseline: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '512.9', 'groupId': 'OG000', 'lowerLimit': '338.4', 'upperLimit': '777.5'}, {'value': '702.5', 'groupId': 'OG001', 'lowerLimit': '407.8', 'upperLimit': '1210.1'}, {'value': '337.3', 'groupId': 'OG002', 'lowerLimit': '195.7', 'upperLimit': '581.3'}, {'value': '388.6', 'groupId': 'OG003', 'lowerLimit': '222.6', 'upperLimit': '678.3'}]}]}, {'title': 'Day 11: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '360.6', 'groupId': 'OG000', 'lowerLimit': '231.7', 'upperLimit': '561.1'}, {'value': '37617.8', 'groupId': 'OG001', 'lowerLimit': '27863.0', 'upperLimit': '50787.8'}, {'value': '342.0', 'groupId': 'OG002', 'lowerLimit': '231.1', 'upperLimit': '506.2'}, {'value': '31066.0', 'groupId': 'OG003', 'lowerLimit': '20279.0', 'upperLimit': '47591.1'}]}]}, {'title': 'Day 11: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '567.9', 'groupId': 'OG000', 'lowerLimit': '372.3', 'upperLimit': '866.3'}, {'value': '27501.3', 'groupId': 'OG001', 'lowerLimit': '19669.7', 'upperLimit': '38451.2'}, {'value': '351.2', 'groupId': 'OG002', 'lowerLimit': '205.9', 'upperLimit': '598.9'}, {'value': '16214.6', 'groupId': 'OG003', 'lowerLimit': '8218.2', 'upperLimit': '31991.7'}]}]}, {'title': 'Day 15: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '354.9', 'groupId': 'OG000', 'lowerLimit': '236.9', 'upperLimit': '531.9'}, {'value': '26677.0', 'groupId': 'OG001', 'lowerLimit': '20149.0', 'upperLimit': '35319.9'}, {'value': '331.3', 'groupId': 'OG002', 'lowerLimit': '231.2', 'upperLimit': '474.9'}, {'value': '31706.4', 'groupId': 'OG003', 'lowerLimit': '21585.9', 'upperLimit': '46571.8'}]}]}, {'title': 'Day 15: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '514.7', 'groupId': 'OG000', 'lowerLimit': '333.8', 'upperLimit': '793.5'}, {'value': '25403.8', 'groupId': 'OG001', 'lowerLimit': '18448.2', 'upperLimit': '34981.9'}, {'value': '326.6', 'groupId': 'OG002', 'lowerLimit': '193.6', 'upperLimit': '551.1'}, {'value': '24039.8', 'groupId': 'OG003', 'lowerLimit': '13014.0', 'upperLimit': '44407.0'}]}]}, {'title': 'Day 29: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '432.6', 'groupId': 'OG000', 'lowerLimit': '275.3', 'upperLimit': '679.8'}, {'value': '25026.5', 'groupId': 'OG001', 'lowerLimit': '18911.3', 'upperLimit': '33119.1'}, {'value': '350.1', 'groupId': 'OG002', 'lowerLimit': '241.8', 'upperLimit': '506.9'}, {'value': '29639.2', 'groupId': 'OG003', 'lowerLimit': '20983.3', 'upperLimit': '41865.7'}]}]}, {'title': 'Day 29: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '544.5', 'groupId': 'OG000', 'lowerLimit': '362.0', 'upperLimit': '819.1'}, {'value': '23453.9', 'groupId': 'OG001', 'lowerLimit': '16904.7', 'upperLimit': '32540.3'}, {'value': '336.4', 'groupId': 'OG002', 'lowerLimit': '195.7', 'upperLimit': '578.3'}, {'value': '16542.0', 'groupId': 'OG003', 'lowerLimit': '9489.2', 'upperLimit': '28836.7'}]}]}, {'title': 'Month 3: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '410.0', 'groupId': 'OG000', 'lowerLimit': '266.1', 'upperLimit': '631.8'}, {'value': '14679.2', 'groupId': 'OG001', 'lowerLimit': '11032.9', 'upperLimit': '19530.7'}, {'value': '339.8', 'groupId': 'OG002', 'lowerLimit': '238.9', 'upperLimit': '483.4'}, {'value': '16000.3', 'groupId': 'OG003', 'lowerLimit': '11448.0', 'upperLimit': '22362.8'}]}]}, {'title': 'Month 3: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '504.1', 'groupId': 'OG000', 'lowerLimit': '327.4', 'upperLimit': '776.2'}, {'value': '11856.2', 'groupId': 'OG001', 'lowerLimit': '8663.2', 'upperLimit': '16226.1'}, {'value': '308.5', 'groupId': 'OG002', 'lowerLimit': '187.1', 'upperLimit': '508.7'}, {'value': '7881.5', 'groupId': 'OG003', 'lowerLimit': '4521.6', 'upperLimit': '13738.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by OPA for CP5 and CP8 and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here "n" signifies number of participants who were evaluable for specific antigens for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '74.7'}, {'value': '60.5', 'comment': 'CI was not estimated due to the lack of variability of GMT.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '63.3', 'groupId': 'OG002', 'lowerLimit': '57.7', 'upperLimit': '69.4'}, {'value': '60.5', 'comment': 'CI was not estimated due to the lack of variability of GMT.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '59.7', 'upperLimit': '78.3'}, {'value': '755.5', 'groupId': 'OG001', 'lowerLimit': '468.1', 'upperLimit': '1219.2'}, {'value': '63.3', 'groupId': 'OG002', 'lowerLimit': '57.7', 'upperLimit': '69.4'}, {'value': '620.1', 'groupId': 'OG003', 'lowerLimit': '367.8', 'upperLimit': '1045.6'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '60.2', 'upperLimit': '81.2'}, {'value': '868.5', 'groupId': 'OG001', 'lowerLimit': '544.1', 'upperLimit': '1386.3'}, {'value': '64.6', 'groupId': 'OG002', 'lowerLimit': '58.7', 'upperLimit': '71.1'}, {'value': '706.8', 'groupId': 'OG003', 'lowerLimit': '421.2', 'upperLimit': '1185.9'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '59.1', 'upperLimit': '78.5'}, {'value': '748.4', 'groupId': 'OG001', 'lowerLimit': '473.0', 'upperLimit': '1184.4'}, {'value': '65.2', 'groupId': 'OG002', 'lowerLimit': '58.6', 'upperLimit': '72.5'}, {'value': '620.7', 'groupId': 'OG003', 'lowerLimit': '396.5', 'upperLimit': '971.8'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000', 'lowerLimit': '57.1', 'upperLimit': '71.8'}, {'value': '474.5', 'groupId': 'OG001', 'lowerLimit': '309.7', 'upperLimit': '726.9'}, {'value': '63.1', 'groupId': 'OG002', 'lowerLimit': '57.9', 'upperLimit': '68.8'}, {'value': '384.8', 'groupId': 'OG003', 'lowerLimit': '256.1', 'upperLimit': '578.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by FBI for ClfA and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Day 11: ClfA', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '32.1'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '19.5', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '31.8'}]}]}, {'title': 'Day 11: MntC', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '19.8'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '20.1', 'groupId': 'OG003', 'lowerLimit': '13.2', 'upperLimit': '30.5'}]}]}, {'title': 'Day 15: ClfA', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '21.6', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '35.7'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.2'}, {'value': '26.3', 'groupId': 'OG003', 'lowerLimit': '17.0', 'upperLimit': '40.5'}]}]}, {'title': 'Day 15: MntC', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '17.1'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.3'}, {'value': '17.1', 'groupId': 'OG003', 'lowerLimit': '11.5', 'upperLimit': '25.3'}]}]}, {'title': 'Day 29: ClfA', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '28.7'}, {'value': '0.8', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '0.9'}, {'value': '19.0', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '28.4'}]}]}, {'title': 'Day 29: MntC', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.1'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '10.9'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '10.4', 'groupId': 'OG003', 'lowerLimit': '7.3', 'upperLimit': '14.7'}]}]}, {'title': 'Month 3: ClfA', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '16.1'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.1'}, {'value': '11.8', 'groupId': 'OG003', 'lowerLimit': '8.0', 'upperLimit': '17.5'}]}]}, {'title': 'Month 3: MntC', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.4'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '1.4'}, {'value': '4.6', 'groupId': 'OG003', 'lowerLimit': '3.4', 'upperLimit': '6.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'GMFRs of anti-Staphylococcus aureus cLIA for ClfA and MntC were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Day 11: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.2'}, {'value': '125.0', 'groupId': 'OG001', 'lowerLimit': '78.5', 'upperLimit': '198.9'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '93.3', 'groupId': 'OG003', 'lowerLimit': '56.7', 'upperLimit': '153.5'}]}]}, {'title': 'Day 11: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.3'}, {'value': '38.7', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '71.3'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '41.7', 'groupId': 'OG003', 'lowerLimit': '20.6', 'upperLimit': '84.6'}]}]}, {'title': 'Day 15: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.2'}, {'value': '88.4', 'groupId': 'OG001', 'lowerLimit': '59.4', 'upperLimit': '131.6'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '95.2', 'groupId': 'OG003', 'lowerLimit': '61.5', 'upperLimit': '147.5'}]}]}, {'title': 'Day 15: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '35.2', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '64.8'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '61.9', 'groupId': 'OG003', 'lowerLimit': '30.8', 'upperLimit': '124.4'}]}]}, {'title': 'Day 29: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.2'}, {'value': '83.0', 'groupId': 'OG001', 'lowerLimit': '54.2', 'upperLimit': '126.9'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.1'}, {'value': '89.0', 'groupId': 'OG003', 'lowerLimit': '58.6', 'upperLimit': '135.2'}]}]}, {'title': 'Day 29: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.2'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '59.5'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '42.6', 'groupId': 'OG003', 'lowerLimit': '22.6', 'upperLimit': '80.4'}]}]}, {'title': 'Month 3: CP5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.3'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '34.2', 'upperLimit': '69.2'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '48.1', 'groupId': 'OG003', 'lowerLimit': '32.1', 'upperLimit': '71.9'}]}]}, {'title': 'Month 3: CP8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.2'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '27.6'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '20.3', 'groupId': 'OG003', 'lowerLimit': '11.5', 'upperLimit': '35.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'GMFRs of anti-Staphylococcus aureus OPA for CP5 and CP8 were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here "n" signifies number of participants who were evaluable for specific antigens for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'OG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'classes': [{'title': 'Day 11', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '20.2'}, {'value': '1.0', 'comment': 'CI was not estimated due to the lack of variability of GMFR.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '17.3'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.2'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '22.9'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.1'}, {'value': '11.7', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '19.6'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '19.6'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.1'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '6.6', 'upperLimit': '16.1'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '12.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '6.4', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '9.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'GMFR of anti-Staphylococcus aureus FBI for ClfA was computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'FG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'FG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'FG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (20 to <65 Years)', 'description': 'Participants aged from 20 years to less than (\\<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'BG001', 'title': 'SA4Ag (20 to <65 Years)', 'description': 'Participants aged from 20 years to \\<65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'BG002', 'title': 'Placebo (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'BG003', 'title': 'SA4Ag (65 to <86 Years)', 'description': 'Participants aged from 65 years to \\<86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '0', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '0', 'spread': '4.2', 'groupId': 'BG002'}, {'value': '0', 'spread': '3.6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2015-05-29', 'resultsFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2015-07-06', 'lastUpdatePostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-27', 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination', 'timeFrame': 'Day 1 up to Day 14', 'description': 'Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were defined as mild (2.5 to 5.0 centimeters \\[cm\\]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to \\[\\>=\\] 10.5 cm). Pain at injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). In this outcome measure percentage of participants with any local reaction was reported.'}, {'measure': 'Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination', 'timeFrame': 'Day 1 up to Day 14', 'description': 'Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (5.5 to 10.0 cm) and, severe (\\>=10.5 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).'}, {'measure': 'Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination', 'timeFrame': 'Day 1 up to Day 14', 'description': 'Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (\\>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). In this outcome measure percentage of participants with any systemic event was reported.'}, {'measure': 'Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination', 'timeFrame': 'Day 1 up to Day 14', 'description': 'Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).'}, {'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit', 'timeFrame': 'Day 1 up to Day 29', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious AEs. Treatment-emergent AEs were events between the administration of investigational product and up to Day 29 that were absent before vaccination or that worsened relative to pre-administration state.'}, {'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12', 'timeFrame': 'After Day 29 up to Month 12', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or deemed medically significant for any other reason. A treatment emergent AE was defined as an event that emerged during the study that was absent before administration of investigational product, or worsened relative to the pre-administration state. AEs reported during this time period included both SAEs and newly diagnosed chronic medical disorders (NDCMD). A NDCMD was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Percentage of Participants With Hematology Abnormalities at Day 5', 'timeFrame': 'Day 5', 'description': 'Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Hematology Abnormalities at Day 15', 'timeFrame': 'Day 15', 'description': 'Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Coagulation Abnormalities at Day 5', 'timeFrame': 'Day 5', 'description': 'Coagulation analysis included the following parameters: prothrombin time (PT), activated partial thromboplastin time (APTT), platelet aggregation (AGG) (with adenosine diphosphate \\[ADP\\], with arachidonic acid, and with collagen) and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Coagulation Abnormalities at Day 15', 'timeFrame': 'Day 15', 'description': 'Coagulation analysis included the following parameters: PT, APTT, platelet AGG with ADP, platelet AGG with arachidonic acid, platelet AGG with collagen and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Blood Chemistry Abnormalities at Day 5', 'timeFrame': 'Day 5', 'description': 'Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Blood Chemistry Abnormalities at Day 15', 'timeFrame': 'Day 15', 'description': 'Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.'}, {'measure': 'Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29', 'timeFrame': 'Day 29', 'description': 'Percentage of participants achieving predefined antibody response to capsular polysaccharide serotype 5 (CP5), capsular polysaccharide serotype 8 (CP8), clumping factor A (ClfA) and manganese transporter C (MntC) at Day 29 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on opsonophagocytic activity (OPA) assay for CP5 and CP8, respectively; was 121 based on fibrinogen-binding inhibition (FBI) assay for ClfA and 512 based on competitive Luminex immunoassay (cLIA) for MntC.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3', 'timeFrame': 'Baseline, Day 11, 15 and Month3', 'description': 'Percentage of participants achieving predefined antibody response to CP5, CP8, ClfA and MntC at Baseline, Day 11, 15 and Month 3 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on OPA assay for CP5 and CP8, respectively; was 121 based on FBI assay for ClfA, 512 based on cLIA for MntC.'}, {'measure': 'Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by cLIA for ClfA and MntC and corresponding 2-sided 95 percent (%) confidence intervals (CIs) were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.'}, {'measure': 'Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by OPA for CP5 and CP8 and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.'}, {'measure': 'Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by FBI for ClfA and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'GMFRs of anti-Staphylococcus aureus cLIA for ClfA and MntC were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'GMFRs of anti-Staphylococcus aureus OPA for CP5 and CP8 were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3', 'timeFrame': 'Baseline, Day 11, 15, 29 and Month 3', 'description': 'GMFR of anti-Staphylococcus aureus FBI for ClfA was computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Staphylococcal Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3451003&StudyName=A%20Phase%201%2F2a%20Placebo-controlled%2C%20Randomized%2C%20Double-blind%2C%20Sponsor-unblinded%20Trial%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20And%20Immunogenicity%20Of%20Staphylococcus%20Aureus%204-antigen%20Vaccine%20%28sa4ag%29%20In%20Japanese%20Adults', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to \\<86 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Japanese male and female adults aged 20 to \\<86 years,\n2. Determined as healthy by the investigator (Subjects with preexisting chronic medical conditions determined to be stable may be included),\n3. Must be available for the 12 month duration of the study,\n4. Subjects must agree to use an acceptable method of birth control for 3 months after study vaccination (if the subject or the subject's partner are/is capable of having children).\n\nExclusion Criteria:\n\n1. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components,\n2. Unstable or serious chronic medical condition that would increase the subject's risk of participation,\n3. Immune system suppression or treatment with medications that suppress the immune system,\n4. Receipt of blood products or immunoglobulins within the past 12 months,\n5. Any infection proven or suspected to be caused by S.aureus within the past 6 months,\n6. A staff member at this site nor a relative of those site staff members, nor a sponsor's employee directly involved in the conduct of this research study,\n7. Living in a nursing home, long-term care facility or other institution or requiring any types of nursing care,\n8. A pregnant or a breast feeding woman."}, 'identificationModule': {'nctId': 'NCT02492958', 'briefTitle': 'SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1/2a Placebo-controlled, Randomized, Double-blind, Sponsor-unblinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of Staphylococcus Aureus 4-antigen Vaccine (sa4ag) In Japanese Adults', 'orgStudyIdInfo': {'id': 'B3451003'}, 'secondaryIdInfos': [{'id': '6123K1-1006', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SA4Ag', 'description': 'Staphylococcus aureus 4-antigen vaccine', 'interventionNames': ['Biological: Staphylococcus aureus 4-antigen vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'a lyophile match to the vaccine, consisting of excipients of SA4Ag formulation minus the active ingredients', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Staphylococcus aureus 4-antigen vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['SA4Ag'], 'description': 'a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm', 'armGroupLabels': ['SA4Ag']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-0004', 'city': 'Sumida-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)'}, {'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}