Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-09 @ 7:17 AM
Study NCT ID:
NCT02509494
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2015-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019142', 'term': 'Hemorrhagic Fever, Ebola'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}], 'ancestors': [{'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018702', 'term': 'Filoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525703', 'term': 'MenACWY'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Director Clinical Franchise Lead', '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 with hold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months', 'description': 'The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 22, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 194, 'seriousNumAtRisk': 298, 'deathsNumAffected': 1, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 63, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 56, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 18, 'seriousNumAtRisk': 48, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 69, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 21, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 108, 'seriousNumAtRisk': 144, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG008', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 38, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 13}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Peptic Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 123}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 50}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 81}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 17}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Tinea Capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Typhoid Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 26}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pruritus Generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Anaemia of Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 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21.1'}, {'term': 'Abortion Threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Haemorrhage in Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Placenta Praevia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Premature Labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Renal Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Hypovolaemic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '143', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '144', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '144', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG005', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG006', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG007', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG008', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post dose 1 (Day 8)', 'description': 'Number of participants with solicited local AEs were reported. 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 diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '143', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '143', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG005', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG006', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG007', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG008', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post dose 2 (Day 64)', 'description': 'Number of participants with solicited local AEs were reported. 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 diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Solicited Local AEs (Day 738)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post dose 3 (Day 738)', 'description': 'Number of participants with solicited local AEs were reported. 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 diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations. This outcome measure was only planned for participants who received booster vaccination with Ad26.ZEBOV hence other arms are not reported.'}, {'type': 'PRIMARY', 'title': 'Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '143', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '144', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '144', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG005', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG006', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG007', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG008', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '36', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post dose 1 (Day 8)', 'description': 'Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '143', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '143', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG005', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG006', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG007', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG008', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post dose 2 (Day 64)', 'description': 'Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Solicited Systemic AEs (Day 738)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post dose 3 (Up to Day 738)', 'description': 'Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations. This outcome measure was only planned for participants who received booster vaccination with Ad26.ZEBOV hence other arms are not reported.'}, {'type': 'PRIMARY', 'title': 'Stages 1: Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 months', 'description': 'Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stages 2: Number of Participants With SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '144', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '144', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG005', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG006', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG007', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Unsolicited AEs (Day 759)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days post booster dose (Day 759)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Unsolicited AEs (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days post dose 1 (Day 29)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Number of Participants With Unsolicited AEs (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '144', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '144', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG005', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG006', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG007', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '88', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days post dose 1 (Day 29)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Unsolicited AEs (Day 85)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days post dose 2 (Day 85)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Number of Participants With Unsolicited AEs (Day 85)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '143', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '143', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG005', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG006', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG007', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '92', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days post dose 2 (Day 85)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 months', 'description': 'Number of participants with deaths were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Number of Participants With Deaths (Children and Adolescents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '144', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG001', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG005', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Number of participants (children and adolescents) with deaths were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Number of Participants With Deaths (Adults)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'Number of participants (adults) with deaths were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Number of Participants With Immediate Reportable Event (IREs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 36 months', 'description': 'Number of participants with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\\>) 7 days duration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Number of Participants With IREs (Children and Adolescents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '144', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG001', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG005', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Number of participants (children and adolescents) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\\>) 7 days duration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Number of Participants With IREs (Adults)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'Number of participants (adults) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\\>) 7 days duration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '124', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '124', 'groupId': 'OG007'}, {'value': '38', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}, {'id': 'OG001', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG002', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG003', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'OG004', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG005', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'OG006', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'OG007', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'OG008', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'classes': [{'categories': [{'measurements': [{'value': '4784', 'groupId': 'OG000', 'lowerLimit': '3736', 'upperLimit': '6125'}, {'value': '3810', 'groupId': 'OG001', 'lowerLimit': '3312', 'upperLimit': '4383'}, {'value': '50', 'comment': "Here, 'NA' signifies that lower limit of calculated 95% CI was less than LLOQ.", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '70'}, {'value': '9929', 'groupId': 'OG003', 'lowerLimit': '8172', 'upperLimit': '12064'}, {'value': '74', 'groupId': 'OG004', 'lowerLimit': '48', 'upperLimit': '114'}, {'value': '10212', 'groupId': 'OG005', 'lowerLimit': '8419', 'upperLimit': '12388'}, {'value': '42', 'comment': "Here, 'NA' signifies that lower limit of calculated 95% CI was less than LLOQ.", 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': '60'}, {'value': '22568', 'groupId': 'OG007', 'lowerLimit': '18426', 'upperLimit': '27642'}, {'value': 'NA', 'comment': "Here, 'NA' signifies that geometric mean and lower limit of calculated 95% CI was less than LLOQ.", 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': '38'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '21 days post-dose 2 (Day 78)', 'description': 'GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL).', 'unitOfMeasure': 'ELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The per protocol analysis set included all randomized and vaccinated participants, who received both the prime and boost vaccinations had at least 1 post-vaccination evaluable immunogenicity sample, and had no major protocol violations influencing the immune response. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}, {'id': 'FG001', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'FG002', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'FG003', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'FG004', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'FG005', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'FG006', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'FG007', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'FG008', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '298'}, {'groupId': 'FG002', 'numSubjects': '102'}, {'groupId': 'FG003', 'numSubjects': '143'}, {'groupId': 'FG004', 'numSubjects': '48'}, {'groupId': 'FG005', 'numSubjects': '144'}, {'groupId': 'FG006', 'numSubjects': '48'}, {'groupId': 'FG007', 'numSubjects': '144'}, {'groupId': 'FG008', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '217'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '132'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '133'}, {'groupId': 'FG006', 'numSubjects': '45'}, {'groupId': 'FG007', 'numSubjects': '137'}, {'groupId': 'FG008', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'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'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Out of 1023 participants who signed informed consent form, only 1018 participants were randomized and received study treatment and were included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '144', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}, {'value': '144', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}, {'value': '1018', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\\*10\\^10 vp as a booster dose 2 years post dose 1 (Day 731).'}, {'id': 'BG001', 'title': 'Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with \\>=18 years of age (adults) received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'BG002', 'title': 'Stage 2 (>=18 Years): MenACWY, Placebo', 'description': 'Participants with \\>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'BG003', 'title': 'Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 12-17 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 Inf.U as dose 2 on Day 57.'}, {'id': 'BG004', 'title': 'Stage 2 (12-17 Years): MenACWY, Placebo', 'description': 'Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'BG005', 'title': 'Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 4-11 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\\*10\\^8 Inf.U as Dose 2 on Day 57.'}, {'id': 'BG006', 'title': 'Stage 2 (4-11 Years): MenACWY, Placebo', 'description': 'Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.'}, {'id': 'BG007', 'title': 'Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo', 'description': 'Participants with 1-3 years of age received Ad26.ZEBOV 5\\*10\\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\\*10\\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.'}, {'id': 'BG008', 'title': 'Stage 2 (1-3 Years): MenACWY, Placebo', 'description': 'Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '9.87', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '10.46', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '14.2', 'spread': '1.58', 'groupId': 'BG003'}, {'value': '14', 'spread': '1.58', 'groupId': 'BG004'}, {'value': '7.7', 'spread': '1.88', 'groupId': 'BG005'}, {'value': '7.9', 'spread': '1.96', 'groupId': 'BG006'}, {'value': '1.9', 'spread': '0.79', 'groupId': 'BG007'}, {'value': '1.9', 'spread': '0.76', 'groupId': 'BG008'}, {'value': '16.6', 'spread': '12.79', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '67', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}, {'value': '350', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}, {'value': '77', 'groupId': 'BG007'}, {'value': '27', 'groupId': 'BG008'}, {'value': '668', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', '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': '1', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '144', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}, {'value': '144', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}, {'value': '1017', 'groupId': 'BG009'}]}, {'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'}]}]}], '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'}]}, {'title': 'Asian', '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'}]}, {'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': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '144', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}, {'value': '144', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}, {'value': '1014', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}, {'title': 'More than one race', '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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'SIERRA LEONE', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '144', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}, {'value': '144', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}, {'value': '1018', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-02', 'size': 4198148, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-22T04:43', 'hasProtocol': True}, {'date': '2018-06-22', 'size': 2394226, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-22T04:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1023}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2020-06-25', 'completionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2015-06-24', 'dispFirstSubmitQcDate': '2020-06-25', 'resultsFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2015-07-27', 'dispFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-22', 'studyFirstPostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8)', 'timeFrame': '7 days post dose 1 (Day 8)', 'description': 'Number of participants with solicited local AEs were reported. 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 diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.'}, {'measure': 'Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64)', 'timeFrame': '7 days post dose 2 (Day 64)', 'description': 'Number of participants with solicited local AEs were reported. 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 diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.'}, {'measure': 'Stage 1: Number of Participants With Solicited Local AEs (Day 738)', 'timeFrame': '7 days post dose 3 (Day 738)', 'description': 'Number of participants with solicited local AEs were reported. 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 diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.'}, {'measure': 'Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8)', 'timeFrame': '7 days post dose 1 (Day 8)', 'description': 'Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).'}, {'measure': 'Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64)', 'timeFrame': '7 days post dose 2 (Day 64)', 'description': 'Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).'}, {'measure': 'Stage 1: Number of Participants With Solicited Systemic AEs (Day 738)', 'timeFrame': '7 days post dose 3 (Up to Day 738)', 'description': 'Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).'}, {'measure': 'Stages 1: Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 36 months', 'description': 'Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.'}, {'measure': 'Stages 2: Number of Participants With SAEs', 'timeFrame': 'Up to 24 months', 'description': 'Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.'}, {'measure': 'Stage 1: Number of Participants With Unsolicited AEs (Day 759)', 'timeFrame': '28 days post booster dose (Day 759)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.'}, {'measure': 'Stage 1: Number of Participants With Unsolicited AEs (Day 29)', 'timeFrame': '28 days post dose 1 (Day 29)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.'}, {'measure': 'Stage 2: Number of Participants With Unsolicited AEs (Day 29)', 'timeFrame': '28 days post dose 1 (Day 29)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.'}, {'measure': 'Stage 1: Number of Participants With Unsolicited AEs (Day 85)', 'timeFrame': '28 days post dose 2 (Day 85)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.'}, {'measure': 'Stage 2: Number of Participants With Unsolicited AEs (Day 85)', 'timeFrame': '28 days post dose 2 (Day 85)', 'description': 'Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.'}, {'measure': 'Stage 1: Number of Participants With Deaths', 'timeFrame': 'Up to 36 months', 'description': 'Number of participants with deaths were reported.'}, {'measure': 'Stage 2: Number of Participants With Deaths (Children and Adolescents)', 'timeFrame': 'Up to 12 months', 'description': 'Number of participants (children and adolescents) with deaths were reported.'}, {'measure': 'Stage 2: Number of Participants With Deaths (Adults)', 'timeFrame': 'Up to 24 months', 'description': 'Number of participants (adults) with deaths were reported.'}, {'measure': 'Stage 1: Number of Participants With Immediate Reportable Event (IREs)', 'timeFrame': 'Up to 36 months', 'description': 'Number of participants with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\\>) 7 days duration.'}, {'measure': 'Stage 2: Number of Participants With IREs (Children and Adolescents)', 'timeFrame': 'Up to 12 months', 'description': 'Number of participants (children and adolescents) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\\>) 7 days duration.'}, {'measure': 'Stage 2: Number of Participants With IREs (Adults)', 'timeFrame': 'Up to 24 months', 'description': 'Number of participants (adults) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\\>) 7 days duration.'}], 'secondaryOutcomes': [{'measure': 'Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA)', 'timeFrame': '21 days post-dose 2 (Day 78)', 'description': 'GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccine', 'Ebola', 'Ebola virus disease', 'EVD', 'Hemorrhagic fever', 'Sierra Leone', 'Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)', 'Safety', 'Immunogenicity', 'Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector', '(MVA-BN Filo)'], 'conditions': ['Ebola Virus Disease']}, 'referencesModule': {'references': [{'pmid': '38603720', 'type': 'DERIVED', 'citation': 'Barry H, Lhomme E, Surenaud M, Nouctara M, Robinson C, Bockstal V, Valea I, Somda S, Tinto H, Meda N, Greenwood B, Thiebaut R, Lacabaratz C. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. PLoS Negl Trop Dis. 2024 Apr 11;18(4):e0011500. doi: 10.1371/journal.pntd.0011500. eCollection 2024 Apr.'}, {'pmid': '37631885', 'type': 'DERIVED', 'citation': 'Manno D, Patterson C, Drammeh A, Tetteh K, Kroma MT, Otieno GT, Lawal BJ, Soremekun S, Ayieko P, Gaddah A, Kamara AB, Baiden F, Afolabi MO, Tindanbil D, Owusu-Kyei K, Ishola D, Deen GF, Keshinro B, Njie Y, Samai M, Lowe B, Robinson C, Leigh B, Drakeley C, Greenwood B, Watson-Jones D. The Effect of Previous Exposure to Malaria Infection and Clinical Malaria Episodes on the Immune Response to the Two-Dose Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen. Vaccines (Basel). 2023 Aug 2;11(8):1317. doi: 10.3390/vaccines11081317.'}, {'pmid': '34529963', 'type': 'DERIVED', 'citation': 'Ishola D, Manno D, Afolabi MO, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Kohn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Leyssen M, Greenwood B, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial. Lancet Infect Dis. 2022 Jan;22(1):97-109. doi: 10.1016/S1473-3099(21)00125-0. Epub 2021 Sep 13.'}, {'pmid': '34529962', 'type': 'DERIVED', 'citation': 'Afolabi MO, Ishola D, Manno D, Keshinro B, Bockstal V, Rogers B, Owusu-Kyei K, Serry-Bangura A, Swaray I, Lowe B, Kowuor D, Baiden F, Mooney T, Smout E, Kohn B, Otieno GT, Jusu M, Foster J, Samai M, Deen GF, Larson H, Lees S, Goldstein N, Gallagher KE, Gaddah A, Heerwegh D, Callendret B, Luhn K, Robinson C, Greenwood B, Leyssen M, Douoguih M, Leigh B, Watson-Jones D; EBL3001 study group. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial. Lancet Infect Dis. 2022 Jan;22(1):110-122. doi: 10.1016/S1473-3099(21)00128-6. Epub 2021 Sep 13.'}, {'pmid': '29895178', 'type': 'DERIVED', 'citation': 'Mooney T, Smout E, Leigh B, Greenwood B, Enria L, Ishola D, Manno D, Samai M, Douoguih M, Watson-Jones D. EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country. Clin Trials. 2018 Oct;15(5):436-443. doi: 10.1177/1740774518780678. Epub 2018 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen.', 'detailedDescription': 'This is staged Phase 3 study to gather information on the safety and immunogenicity of a 2-dose heterologous regimen. In this regimen, Ad26.ZEBOV will be administered as a Dose 1 vaccination followed by the candidate vaccine MVA-BN-Filo (Dose 2 56 days later) and a booster dose of A26.ZEBOV will be administered 2 years post Dose 1 vaccination to participants in Stage 1 who consent to this. The study will take place in Sierra Leone and will consist of a screening phase, an active phase (vaccination) and a follow-up phase. The active phase of the study will be conducted initially in two stages. In the first stage approximately 40 adults aged 18 years or older will be vaccinated to gain information about the safety and immunogenicity of the 2-dose heterologous vaccine regimen. In stage 2 a larger group of approximately 976 individuals will be vaccinated to further evaluate the safety and immunogenicity of the 2 dose heterologous vaccine regimen across different age groups. In this stage, children aged 1 year or older, adolescents and adults will be included. Solicited local and systemic adverse events will be collected until 7 days after the Dose 1 and Dose 2 vaccination. Unsolicited adverse events will be collected from signing of the informed consent form (ICF) onwards until 56 days after the Dose 2 vaccination in Stage 1 and then again from the day of the booster vaccination until 28 days after the booster vaccination, and until 28 days after each vaccination in stage 2. Serious adverse events will be collected from signing of the ICF onwards until 12 and 36 months after the Dose 1 vaccination in Stage 2 and Stage 1, respectively. These data will be reviewed by an independent data monitoring committee (IDMC) to assess whether initiation of vaccination in the next stage or age group can be provided. Safety evaluations will include assessment of adverse events, which will be monitored throughout the study. Participants in Stage 2 will be followed up for safety and immunogenicity until 12 months (children and adolescents) or 24 months (adults) after the Dose 1 vaccination. Participants in Stage 1 will be followed up for safety and immunogenicity until 36 months after the Dose 1 vaccination or until 1 year after the booster vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Stage 1 and 2:\n\n* Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available\n* Participant Stage 1 must be 18 years or older at screening and be resident in selected study community with no intention to move from study area within the next 5 months\n* Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before Dose 1 vaccination\n* Female participants of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination\n* Participant must pass the test of understanding (TOU)\n\nAdditional Inclusion criteria Stage 2:\n\n* One year or older at screening (children of enrolled parents are eligible)\n* Parent/legal guardian (for children) must pass the TOU before signing the ICF\n* Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness\n\nExclusion Criteria:\n\n* Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of \\>= 38 degree Celsius (fever)\n* Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia)\n* Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine\n* Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before Dose 1 vaccination\n* Treated with an immunosuppressive drug at the time of screening\n\nAdditional exclusion criteria:\n\n\\- Children up to 5 years of age with severe malnutrition (underweight or Z-score weight \\<2)'}, 'identificationModule': {'nctId': 'NCT02509494', 'acronym': 'EBOVAC-Salone', 'briefTitle': 'Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Vaccines & Prevention B.V.'}, 'officialTitle': 'A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola', 'orgStudyIdInfo': {'id': 'CR107372'}, 'secondaryIdInfos': [{'id': 'VAC52150EBL3001', 'type': 'OTHER', 'domain': 'Janssen Vaccines & Prevention B.V.'}, {'id': '115854 EBOVAC1', 'type': 'OTHER_GRANT', 'domain': 'The Trial is financed within the IMI-2 Ebola program'}, {'id': '2019-000691-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1: Active vaccination', 'description': 'Ad26.ZEBOV will be administered as a 0.5 milliliter (mL) intramuscular (IM) injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2). The booster vaccination using Ad26.ZEBOV will be administered as a 0.5 mL IM injection (2 years post Dose 1).', 'interventionNames': ['Biological: Ad26.ZEBOV', 'Biological: MVA-BN-Filo']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Active vaccination', 'description': 'Ad26.ZEBOV will be administered as a 0.5 mL IM injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2).', 'interventionNames': ['Biological: Ad26.ZEBOV', 'Biological: MVA-BN-Filo']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Active vaccination for children', 'description': 'Ad26.ZEBOV will be administered as a 0.5 mL IM injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2). Children aged less than 2 years at randomization will receive a booster dose of vaccination at 3 months post Dose 2 with Placebo.', 'interventionNames': ['Biological: Ad26.ZEBOV', 'Biological: MVA-BN-Filo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2: Control vaccination', 'description': 'MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2).', 'interventionNames': ['Biological: MenACWY', 'Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2: Control vaccination for children', 'description': 'MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2). Children aged less than 2 years at randomization will receive a booster dose of MenACWY vaccination at 3 months post Dose 2 with MenACWY.', 'interventionNames': ['Biological: MenACWY', 'Biological: Placebo']}], 'interventions': [{'name': 'Ad26.ZEBOV', 'type': 'BIOLOGICAL', 'description': 'Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\\*10\\^10 viral particles.', 'armGroupLabels': ['Stage 1: Active vaccination', 'Stage 2: Active vaccination', 'Stage 2: Active vaccination for children']}, {'name': 'MVA-BN-Filo', 'type': 'BIOLOGICAL', 'description': 'MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1\\*10\\^8 Infectious Unit (Inf. U.).', 'armGroupLabels': ['Stage 1: Active vaccination', 'Stage 2: Active vaccination', 'Stage 2: Active vaccination for children']}, {'name': 'MenACWY', 'type': 'BIOLOGICAL', 'description': 'MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.', 'armGroupLabels': ['Stage 2: Control vaccination', 'Stage 2: Control vaccination for children']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% saline for injection.', 'armGroupLabels': ['Stage 2: Control vaccination', 'Stage 2: Control vaccination for children']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freetown', 'country': 'Sierra Leone', 'geoPoint': {'lat': 8.48714, 'lon': -13.2356}}], 'overallOfficials': [{'name': 'Janssen Vaccines & Prevention B.V. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Vaccines & Prevention B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Vaccines & Prevention B.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'Ministry of Health and Sanitation, Sierra Leone', 'class': 'OTHER_GOV'}, {'name': 'University of Sierra Leone', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Grameen Foundation', 'class': 'OTHER'}, {'name': 'World Vision, Ireland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}