Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04453202
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2020-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D022261', 'term': 'Respiratory Syncytial Virus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'CLINICAL FRANCHISE LEADER', 'organization': 'Janssen Vaccines & Prevention B.V.'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline (Day 1) up to 6 months', 'description': 'FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 42, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 36, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 25, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 23, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 7, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 44, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 48, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 13, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 25, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 44, 'seriousNumAtRisk': 51, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 8, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 13}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 10}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 32}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 37}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 16}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 34}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Influenza Like Illness', 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{'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}], 'seriousEvents': [{'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Covid-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Escherichia Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'B-Cell Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Neuropathy Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4907', 'groupId': 'OG000', 'lowerLimit': '4030', 'upperLimit': '5976'}, {'value': '4681', 'groupId': 'OG001', 'lowerLimit': '3696', 'upperLimit': '5928'}, {'value': '4038', 'groupId': 'OG002', 'lowerLimit': '3042', 'upperLimit': '5361'}, {'value': '5238', 'groupId': 'OG003', 'lowerLimit': '4070', 'upperLimit': '6743'}, {'value': '272', 'groupId': 'OG004', 'lowerLimit': '212', 'upperLimit': '350'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '14 days after vaccination on Day 1 (Day 15)', 'description': 'Geometric mean antibody titers (ELISA units per liter \\[EU/L\\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.', 'unitOfMeasure': 'EU/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Per-protocol Immunogenicity (PPI) set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until 7 days after Vaccination on Day 1 (Day 8)', 'description': 'Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set (FAS) included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until 7 days after Vaccination on Day 1 (Day 8)', 'description': 'Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \\[\\>=\\] 38 degree celsius).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until 28 days after Vaccination on Day 1 (Day 29)', 'description': 'Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'title': '3 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2550', 'groupId': 'OG000', 'lowerLimit': '2134', 'upperLimit': '3047'}, {'value': '2790', 'groupId': 'OG001', 'lowerLimit': '2251', 'upperLimit': '3459'}, {'value': '1940', 'groupId': 'OG002', 'lowerLimit': '1565', 'upperLimit': '2405'}, {'value': '2997', 'groupId': 'OG003', 'lowerLimit': '2335', 'upperLimit': '3846'}, {'value': '315', 'groupId': 'OG004', 'lowerLimit': '251', 'upperLimit': '394'}]}]}, {'title': '6 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1568', 'groupId': 'OG000', 'lowerLimit': '1351', 'upperLimit': '1819'}, {'value': '1424', 'groupId': 'OG001', 'lowerLimit': '1126', 'upperLimit': '1800'}, {'value': '1247', 'groupId': 'OG002', 'lowerLimit': '1053', 'upperLimit': '1478'}, {'value': '1834', 'groupId': 'OG003', 'lowerLimit': '1478', 'upperLimit': '2277'}, {'value': '326', 'groupId': 'OG004', 'lowerLimit': '256', 'upperLimit': '414'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 3 and 6 months after vaccination on Day 1', 'description': 'Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported.', 'unitOfMeasure': 'EU/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies participants who were evaluable at specified time points."}, {'type': 'SECONDARY', 'title': 'Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'title': '14 days after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6314', 'groupId': 'OG000', 'lowerLimit': '4800', 'upperLimit': '8307'}, {'value': '5140', 'groupId': 'OG001', 'lowerLimit': '3909', 'upperLimit': '6758'}, {'value': '4725', 'groupId': 'OG002', 'lowerLimit': '3407', 'upperLimit': '6554'}, {'value': '6194', 'groupId': 'OG003', 'lowerLimit': '4641', 'upperLimit': '8265'}, {'value': '294', 'groupId': 'OG004', 'lowerLimit': '239', 'upperLimit': '363'}]}]}, {'title': '3 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3760', 'groupId': 'OG000', 'lowerLimit': '2957', 'upperLimit': '4780'}, {'value': '3799', 'groupId': 'OG001', 'lowerLimit': '2995', 'upperLimit': '4820'}, {'value': '2777', 'groupId': 'OG002', 'lowerLimit': '2169', 'upperLimit': '3556'}, {'value': '4413', 'groupId': 'OG003', 'lowerLimit': '3409', 'upperLimit': '5713'}, {'value': '357', 'groupId': 'OG004', 'lowerLimit': '282', 'upperLimit': '452'}]}]}, {'title': '6 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1760', 'groupId': 'OG000', 'lowerLimit': '1372', 'upperLimit': '2260'}, {'value': '1883', 'groupId': 'OG001', 'lowerLimit': '1456', 'upperLimit': '2435'}, {'value': '1473', 'groupId': 'OG002', 'lowerLimit': '1188', 'upperLimit': '1827'}, {'value': '2523', 'groupId': 'OG003', 'lowerLimit': '1901', 'upperLimit': '3348'}, {'value': '301', 'groupId': 'OG004', 'lowerLimit': '241', 'upperLimit': '377'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points."}, {'type': 'SECONDARY', 'title': 'Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'title': '14 days after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '547', 'comment': 'Lower limit of full range could not be calculated as it was below the lower limit of quantification (LLOQ) (68)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '1426'}, {'value': '458', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '1721'}, {'value': '397', 'groupId': 'OG002', 'lowerLimit': '79', 'upperLimit': '1570'}, {'value': '404', 'groupId': 'OG003', 'lowerLimit': '87', 'upperLimit': '1579'}, {'value': 'NA', 'comment': 'Median lower limit of full range could not be calculated as it was below the LLOQ (68)', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': '387'}]}]}, {'title': '3 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '180', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '1462'}, {'value': '241', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '906'}, {'value': '168', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '649'}, {'value': '184', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': '737'}, {'value': 'NA', 'comment': 'Median and lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': '359'}]}]}, {'title': '6 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '129', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '1631'}, {'value': '189', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '991'}, {'value': '146', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '636'}, {'value': '127', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': '439'}, {'value': 'NA', 'comment': 'Median and lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': '266'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\\^6 PBMCs).', 'unitOfMeasure': 'SFC/10^6 PBMCs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points."}, {'type': 'SECONDARY', 'title': 'Cohort 1: Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day1) up to 6 months', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until 7 days after vaccination on Day 1 (Day 8)', 'description': 'Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until 7 days after vaccination on Day 1 (Day 8)', 'description': 'Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature \\>=38 degree celsius).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until 28 days after vaccination on Day 1 (Day 29)', 'description': 'Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'title': '14 days after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3769', 'groupId': 'OG000', 'lowerLimit': '3006', 'upperLimit': '4726'}, {'value': '3893', 'groupId': 'OG001', 'lowerLimit': '3243', 'upperLimit': '4674'}, {'value': '259', 'groupId': 'OG002', 'lowerLimit': '201', 'upperLimit': '333'}, {'value': '4278', 'groupId': 'OG003', 'lowerLimit': '3336', 'upperLimit': '5486'}, {'value': '3856', 'groupId': 'OG004', 'lowerLimit': '3177', 'upperLimit': '4682'}, {'value': '298', 'groupId': 'OG005', 'lowerLimit': '236', 'upperLimit': '376'}]}]}, {'title': '3 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1982', 'groupId': 'OG000', 'lowerLimit': '1627', 'upperLimit': '2415'}, {'value': '1665', 'groupId': 'OG001', 'lowerLimit': '1162', 'upperLimit': '2385'}, {'value': '300', 'groupId': 'OG002', 'lowerLimit': '244', 'upperLimit': '369'}, {'value': '2696', 'groupId': 'OG003', 'lowerLimit': '1991', 'upperLimit': '3651'}, {'value': '1864', 'groupId': 'OG004', 'lowerLimit': '1304', 'upperLimit': '2664'}, {'value': '339', 'groupId': 'OG005', 'lowerLimit': '256', 'upperLimit': '450'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported.', 'unitOfMeasure': 'EU/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PPI set was analyzed. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points. Due to change in planned analysis, data at 6-month was not collected and analyzed because of discontinuation of the development of the vaccine and hence, there was no scientific value to analyze the responses at Month 6."}, {'type': 'SECONDARY', 'title': 'Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'title': '14 days after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4102', 'groupId': 'OG000', 'lowerLimit': '3064', 'upperLimit': '5491'}, {'value': '3552', 'groupId': 'OG001', 'lowerLimit': '2635', 'upperLimit': '4789'}, {'value': '336', 'groupId': 'OG002', 'lowerLimit': '262', 'upperLimit': '432'}, {'value': '4085', 'groupId': 'OG003', 'lowerLimit': '3092', 'upperLimit': '5398'}, {'value': '3707', 'groupId': 'OG004', 'lowerLimit': '2841', 'upperLimit': '4839'}, {'value': '342', 'groupId': 'OG005', 'lowerLimit': '261', 'upperLimit': '448'}]}]}, {'title': '3 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3144', 'groupId': 'OG000', 'lowerLimit': '2537', 'upperLimit': '3895'}, {'value': '2556', 'groupId': 'OG001', 'lowerLimit': '1828', 'upperLimit': '3575'}, {'value': '371', 'groupId': 'OG002', 'lowerLimit': '282', 'upperLimit': '488'}, {'value': '3435', 'groupId': 'OG003', 'lowerLimit': '2714', 'upperLimit': '4348'}, {'value': '2671', 'groupId': 'OG004', 'lowerLimit': '1945', 'upperLimit': '3669'}, {'value': '490', 'groupId': 'OG005', 'lowerLimit': '344', 'upperLimit': '698'}]}]}, {'title': '6 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1983', 'groupId': 'OG000', 'lowerLimit': '1352', 'upperLimit': '2909'}, {'value': '1890', 'groupId': 'OG001', 'lowerLimit': '1460', 'upperLimit': '2447'}, {'value': '356', 'groupId': 'OG002', 'lowerLimit': '270', 'upperLimit': '470'}, {'value': '2168', 'groupId': 'OG003', 'lowerLimit': '1682', 'upperLimit': '2794'}, {'value': '1856', 'groupId': 'OG004', 'lowerLimit': '1509', 'upperLimit': '2283'}, {'value': '356', 'groupId': 'OG005', 'lowerLimit': '274', 'upperLimit': '464'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points."}, {'type': 'SECONDARY', 'title': 'Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'title': '14 days after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '361', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '1686'}, {'value': '435', 'groupId': 'OG001', 'lowerLimit': '88', 'upperLimit': '2088'}, {'value': 'NA', 'comment': 'Median and lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '942'}, {'value': '236', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': '1764'}, {'value': '204', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': '1888'}, {'value': 'NA', 'comment': 'Median and lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': '216'}]}]}, {'title': '3 months after vaccination on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '331', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '1287'}, {'value': '274', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '1831'}, {'value': 'NA', 'comment': 'Median and lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '376'}, {'value': '131', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': '851'}, {'value': '172', 'comment': 'Lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': '2737'}, {'value': 'NA', 'comment': 'Median and lower limit of full range could not be calculated as it was below the LLOQ (68).', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': '212'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\\^6 PBMCs).', 'unitOfMeasure': 'SFC/10^6 PBMCs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PPI set was analyzed. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. Due to change in planned analysis, data at 6-month was not collected and analyzed because of discontinuation of the development of the vaccine and hence, there was no scientific value to analyze the responses at Month 6."}, {'type': 'SECONDARY', 'title': 'Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG004', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day1 ) up to 6 months', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'FG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'FG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'FG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'FG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'FG005', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'FG006', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'FG007', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'FG008', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'FG009', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'FG010', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '49'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '51'}, {'groupId': 'FG010', 'numSubjects': '26'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '49'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '51'}, {'groupId': 'FG010', 'numSubjects': '26'}]}, {'type': 'Per-protocol Immunogenicity (PPI) Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '47'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '50'}, {'groupId': 'FG010', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '47'}, {'groupId': 'FG006', 'numSubjects': '48'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '48'}, {'groupId': 'FG010', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 459 participants were enrolled, of which 454 were randomized and vaccinated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '49', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}, {'value': '27', 'groupId': 'BG008'}, {'value': '51', 'groupId': 'BG009'}, {'value': '26', 'groupId': 'BG010'}, {'value': '454', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.'}, {'id': 'BG001', 'title': 'Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'BG002', 'title': 'Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\\*10\\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'BG003', 'title': 'Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\\*10\\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'BG004', 'title': 'Cohort 1: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'BG005', 'title': 'Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'BG006', 'title': 'Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'BG007', 'title': 'Cohort 2: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'BG008', 'title': 'Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'BG009', 'title': 'Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)', 'description': 'Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\\*10\\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.'}, {'id': 'BG010', 'title': 'Cohort 3: Placebo', 'description': 'Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '6.97', 'groupId': 'BG000'}, {'value': '68.7', 'spread': '7.08', 'groupId': 'BG001'}, {'value': '69.4', 'spread': '6.56', 'groupId': 'BG002'}, {'value': '70.3', 'spread': '6.82', 'groupId': 'BG003'}, {'value': '70', 'spread': '6.44', 'groupId': 'BG004'}, {'value': '68.6', 'spread': '6.69', 'groupId': 'BG005'}, {'value': '68.6', 'spread': '5.68', 'groupId': 'BG006'}, {'value': '67.6', 'spread': '5.34', 'groupId': 'BG007'}, {'value': '67.9', 'spread': '4.51', 'groupId': 'BG008'}, {'value': '68.7', 'spread': '5.41', 'groupId': 'BG009'}, {'value': '66.5', 'spread': '5.09', 'groupId': 'BG010'}, {'value': '68.8', 'spread': '6.25', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '28', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '247', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}, {'value': '23', 'groupId': 'BG009'}, {'value': '16', 'groupId': 'BG010'}, {'value': '207', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '62', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '46', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '48', 'groupId': 'BG009'}, {'value': '26', 'groupId': 'BG010'}, {'value': '390', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '21', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}, {'value': '49', 'groupId': 'BG009'}, {'value': '26', 'groupId': 'BG010'}, {'value': '425', 'groupId': 'BG011'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '49', 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'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 459}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'dispFirstSubmitDate': '2021-09-23', 'completionDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2020-06-29', 'resultsFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2020-06-29', 'dispFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-02', 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination', 'timeFrame': '14 days after vaccination on Day 1 (Day 15)', 'description': 'Geometric mean antibody titers (ELISA units per liter \\[EU/L\\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.'}, {'measure': 'Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1', 'timeFrame': 'Until 7 days after Vaccination on Day 1 (Day 8)', 'description': 'Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.'}, {'measure': 'Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1', 'timeFrame': 'Until 7 days after Vaccination on Day 1 (Day 8)', 'description': 'Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \\[\\>=\\] 38 degree celsius).'}, {'measure': 'Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1', 'timeFrame': 'Until 28 days after Vaccination on Day 1 (Day 29)', 'description': 'Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).'}], 'secondaryOutcomes': [{'measure': 'Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1', 'timeFrame': 'At 3 and 6 months after vaccination on Day 1', 'description': 'Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported.'}, {'measure': 'Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units.'}, {'measure': 'Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\\^6 PBMCs).'}, {'measure': 'Cohort 1: Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline (Day1) up to 6 months', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.'}, {'measure': 'Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1', 'timeFrame': 'Until 7 days after vaccination on Day 1 (Day 8)', 'description': 'Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.'}, {'measure': 'Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1', 'timeFrame': 'Until 7 days after vaccination on Day 1 (Day 8)', 'description': 'Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature \\>=38 degree celsius).'}, {'measure': 'Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1', 'timeFrame': 'Until 28 days after vaccination on Day 1 (Day 29)', 'description': 'Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).'}, {'measure': 'Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported.'}, {'measure': 'Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units.'}, {'measure': 'Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1', 'timeFrame': 'At 14 days and 3 and 6 months after vaccination on Day 1', 'description': 'T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\\^6 PBMCs).'}, {'measure': 'Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline (Day1 ) up to 6 months', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '39276619', 'type': 'DERIVED', 'citation': 'van Heesbeen R, Bastian AR, Omoruyi E, Rosen J, Comeaux CA, Callendret B, Heijnen E. Immunogenicity and safety of different dose levels of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 years and older: A randomized, double-blind, placebo-controlled, phase 2a study. Vaccine. 2024 Dec 2;42(26):126273. doi: 10.1016/j.vaccine.2024.126273. Epub 2024 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)\n* A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods\n* Agree to not donate blood from the time of vaccination until 3 months after vaccination\n* Have a body mass index (BMI) less than (\\<) 40 kilogram per meter square (kg/m\\^2)\n* Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study\n\nExclusion Criteria:\n\n* Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)\n* Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)\n* History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis\n* Has hepatitis B or C infection, including history of treated hepatitis C infection\n* Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization"}, 'identificationModule': {'nctId': 'NCT04453202', 'briefTitle': 'A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Vaccines & Prevention B.V.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older', 'orgStudyIdInfo': {'id': 'CR108835'}, 'secondaryIdInfos': [{'id': 'VAC18193RSV2005', 'type': 'OTHER', 'domain': 'Janssen Vaccines & Prevention B.V.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 Group 1: RSV Vaccine', 'description': 'Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.', 'interventionNames': ['Biological: RSV Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1 Group 2: RSV Vaccine', 'description': 'Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.', 'interventionNames': ['Biological: RSV Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1 Group 3: RSV Vaccine', 'description': 'Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.', 'interventionNames': ['Biological: RSV Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1 Group 4: RSV Vaccine', 'description': 'Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.', 'interventionNames': ['Biological: RSV Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 1 Group 5: Placebo', 'description': 'Participants will receive IM injection of placebo on Day 1.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 Group 6: RSV Vaccine', 'description': 'Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.', 'interventionNames': ['Biological: RSV Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 Group 7: RSV Vaccine', 'description': 'Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.', 'interventionNames': ['Biological: RSV Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 2 Group 8: Placebo', 'description': 'Participants will receive IM injection of placebo on Day 1.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 Group 9: RSV Vaccine', 'description': 'Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.', 'interventionNames': ['Biological: RSV Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 Group 10: RSV Vaccine', 'description': 'Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.', 'interventionNames': ['Biological: RSV Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 Group 11: Placebo', 'description': 'Participants will receive IM injection of placebo on Day 1.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'RSV Vaccine', 'type': 'BIOLOGICAL', 'description': 'Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.', 'armGroupLabels': ['Cohort 1 Group 1: RSV Vaccine', 'Cohort 1 Group 2: RSV Vaccine', 'Cohort 1 Group 3: RSV Vaccine', 'Cohort 1 Group 4: RSV Vaccine', 'Cohort 2 Group 6: RSV Vaccine', 'Cohort 2 Group 7: RSV Vaccine', 'Cohort 3 Group 10: RSV Vaccine', 'Cohort 3 Group 9: RSV Vaccine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive a single IM injection of placebo on Day 1.', 'armGroupLabels': ['Cohort 1 Group 5: Placebo', 'Cohort 2 Group 8: Placebo', 'Cohort 3 Group 11: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Optimal Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of South Florida, an AMR Company', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '67042', 'city': 'El Dorado', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, an AMR Company', 'geoPoint': {'lat': 37.81724, 'lon': -96.86225}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Optimal Research', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Center for Pharmaceutical Research (CPR)', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research - Omaha', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '73099', 'city': 'Yukon', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Tekton Research Inc.', 'geoPoint': {'lat': 35.50672, 'lon': -97.76254}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Janssen Vaccines & Prevention B.V. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Vaccines & Prevention B.V.'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Vaccines & Prevention B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}