Viewing Study NCT02503202

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Ignite Creation Date: 2025-12-25 @ 3:45 AM
Ignite Modification Date: 2026-02-21 @ 4:41 PM
Study NCT ID: NCT02503202
Status: COMPLETED
Last Update Posted: 2018-10-12
First Post: 2015-07-17
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Spain', 'United States']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Month 24', 'description': 'The at-risk population was randomized participants who received vaccination and had follow-up safety data available.', 'eventGroups': [{'id': 'EG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1', 'otherNumAtRisk': 265, 'deathsNumAtRisk': 265, 'otherNumAffected': 211, 'seriousNumAtRisk': 265, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 263, 'otherNumAffected': 211, 'seriousNumAtRisk': 263, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 263, 'otherNumAffected': 208, 'seriousNumAtRisk': 263, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 208, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 35, 'seriousNumAtRisk': 133, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 43, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 42, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 198, 'numAffected': 179}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 215, 'numAffected': 192}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 212, 'numAffected': 185}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 192, 'numAffected': 176}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 51, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 40, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 52, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 42, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 66, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 70, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 83, 'numAffected': 76}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 72, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 74, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 75, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 79, 'numAffected': 53}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 72, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 56, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 68, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 83, 'numAffected': 67}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}], 'seriousEvents': [{'term': 'Conductive deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Abdominal incarcerated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Incarcerated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 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[{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '219', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'OG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'OG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'OG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '1183.9', 'groupId': 'OG000', 'lowerLimit': '1038.7', 'upperLimit': '1349.4'}, {'value': '1266.0', 'groupId': 'OG001', 'lowerLimit': '1108.2', 'upperLimit': '1446.2'}, {'value': '1346.0', 'groupId': 'OG002', 'lowerLimit': '1176.6', 'upperLimit': '1539.9'}, {'value': '1291.9', 'groupId': 'OG003', 'lowerLimit': '1126.9', 'upperLimit': '1481.2'}, {'value': 'NA', 'comment': 'Geometric Mean and CIs are \\<36.11 EU/mL', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (Lot A / Lot B)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.14', 'pValueComment': 'Primary analysis: a p-value \\<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot consistency requires the 95% confidence interval of the GMT ratio of \\>0.5 and ≤2.0 for the primary analysis and \\>0.67 and ≤1.5 for the secondary analysis.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (Lot A / Lot C)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.09', 'pValueComment': 'Primary analysis: a p-value \\<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot consistency requires the 95% confidence interval of the GMT ratio of \\>0.5 and ≤2.0 for the primary analysis and \\>0.67 and ≤1.5 for the secondary analysis.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT ratio (Lot B / Lot C)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.15', 'pValueComment': 'Primary analysis: a p-value \\<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot consistency requires the 95% confidence interval of the GMT ratio of \\>0.5 and ≤2.0 for the primary analysis and \\>0.67 and ≤1.5 for the secondary analysis.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 postvaccination', 'description': 'Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample collected within the acceptable day range'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'OG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'OG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'OG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}, {'value': '1.2', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '4.0', 'estimateComment': 'Risk difference is Lot A - Lot B', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.989', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '3.0', 'estimateComment': 'Risk difference is Lot A - Lot C', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.361', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '1.5', 'estimateComment': 'Risk difference is Lot B - Lot C', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.214', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.3', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 6 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received vaccination and had follow-up data for the outcome measure'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'OG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'OG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'OG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}], 'classes': [{'title': 'Injection-site erythema', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}, {'value': '14.8', 'groupId': 'OG002'}, {'value': '7.3', 'groupId': 'OG003'}, {'value': '1.5', 'groupId': 'OG004'}]}]}, {'title': 'Injection-site pain', 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}, {'value': '73.0', 'groupId': 'OG001'}, {'value': '70.3', 'groupId': 'OG002'}, {'value': '67.7', 'groupId': 'OG003'}, {'value': '12.8', 'groupId': 'OG004'}]}]}, {'title': 'Injection-site swelling', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '13.7', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}, {'value': '16.2', 'groupId': 'OG003'}, {'value': '3.0', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.160', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '9.9', 'estimateComment': 'Risk difference is Lot A - Lot B', 'groupDescription': 'Injection site erythema', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.971', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '6.0', 'estimateComment': 'Risk difference is Lot A - Lot C', 'groupDescription': 'Injection site erythema', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.151', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '1.5', 'estimateComment': 'Risk difference is Lot B - Lot C', 'groupDescription': 'Injection site erythema', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.016', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '1.4', 'ciUpperLimit': '9.9', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'groupDescription': 'Injection site erythema', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-14.0', 'ciUpperLimit': '1.6', 'estimateComment': 'Risk difference is Lot A - Lot B', 'groupDescription': 'Injection site pain', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.380', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '94', 'paramValue': '-3.5', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '4.4', 'estimateComment': 'Risk difference is Lot A - Lot C', 'groupDescription': 'Injection site pain', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.499', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '10.4', 'estimateComment': 'Risk difference is Lot B - Lot C', 'groupDescription': 'Injection site pain', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.9', 'ciLowerLimit': '46.2', 'ciUpperLimit': '62.3', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'groupDescription': 'Injection site pain', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '10.3', 'estimateComment': 'Risk difference is Lot A - Lot B', 'groupDescription': 'Injection site swelling', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.878', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '6.1', 'estimateComment': 'Risk difference is Lot A - Lot C', 'groupDescription': 'Injection site swelling', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.154', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-10.9', 'ciUpperLimit': '1.7', 'estimateComment': 'Risk difference is Lot B - Lot C', 'groupDescription': 'Injection site swelling', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '7.4', 'ciUpperLimit': '18.6', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'groupDescription': 'Injection site swelling', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 5 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received vaccination and had follow-up data for the outcome measure'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Elevated Maximum Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}, {'value': '258', 'groupId': 'OG003'}, {'value': '132', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'OG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'OG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'OG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '22.4', 'groupId': 'OG002'}, {'value': '32.2', 'groupId': 'OG003'}, {'value': '0.8', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.176', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '11.4', 'estimateComment': 'Risk difference is Lot A - Lot B', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.769', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '6.0', 'estimateComment': 'Risk difference is Lot A - Lot C', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.100', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-12.5', 'ciUpperLimit': '1.1', 'estimateComment': 'Risk difference is Lot B - Lot C', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.4', 'ciLowerLimit': '25.6', 'ciUpperLimit': '37.5', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 42 postvaccination', 'description': 'Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received vaccination and had follow-up data for the outcome measure'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'OG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'OG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'OG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}], 'classes': [{'title': 'Arthralgia AEs', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}, {'value': '6.5', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}, {'value': '1.5', 'groupId': 'OG004'}]}]}, {'title': 'Arthritis AEs', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}, {'value': '3.1', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.983', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '4.1', 'estimateComment': 'Risk difference is Lot A - Lot B', 'groupDescription': 'Arthralgia', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.699', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '3.4', 'estimateComment': 'Risk difference is Lot A - Lot C', 'groupDescription': 'Arthralgia', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.716', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '3.5', 'estimateComment': 'Risk difference is Lot B - Lot C', 'groupDescription': 'Arthralgia', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.012', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.2', 'ciLowerLimit': '1.8', 'ciUpperLimit': '10.4', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'groupDescription': 'Arthralgia', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.677', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '4.4', 'estimateComment': 'Risk difference is Lot A - Lot B', 'groupDescription': 'Arthritis', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.250', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '5.4', 'estimateComment': 'Risk difference is Lot A - Lot C', 'groupDescription': 'Arthritis', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.460', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '4.5', 'estimateComment': 'Risk difference is Lot B - Lot C', 'groupDescription': 'Arthritis', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.041', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '0.2', 'ciUpperLimit': '6.0', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'groupDescription': 'Arthritis', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 5 to Day 42 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received vaccination and had follow-up data for the outcome measure'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'OG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'OG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'OG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '3.8', 'groupId': 'OG003'}, {'value': '1.5', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.353', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '1.9', 'estimateComment': 'Risk difference is Lot A - Lot B', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.620', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '2.5', 'estimateComment': 'Risk difference is Lot A - Lot C', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.663', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '4.5', 'estimateComment': 'Risk difference is Lot B - Lot C', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.202', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '5.7', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 42 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received vaccination and had follow-up data for the outcome measure'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}, {'value': '260', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'OG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'OG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'OG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '1.5', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.483', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '3.3', 'estimateComment': 'Risk difference is Lot A - Lot B', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.746', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '3.0', 'estimateComment': 'Risk difference is Lot A - Lot C', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.704', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '2.0', 'estimateComment': 'Risk difference is Lot B - Lot C', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.151', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '3.9', 'estimateComment': 'Risk difference is High-dose Lot - Placebo', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 42 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received vaccination and had follow-up data for the outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'FG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'FG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'FG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}], 'periods': [{'title': 'Base Study: Up to Month 6', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '266'}, {'groupId': 'FG001', 'numSubjects': '265'}, {'groupId': 'FG002', 'numSubjects': '267'}, {'groupId': 'FG003', 'numSubjects': '266'}, {'groupId': 'FG004', 'numSubjects': '133'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '266'}, {'groupId': 'FG001', 'numSubjects': '265'}, {'groupId': 'FG002', 'numSubjects': '266'}, {'groupId': 'FG003', 'numSubjects': '264'}, {'groupId': 'FG004', 'numSubjects': '133'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '253'}, {'groupId': 'FG002', 'numSubjects': '252'}, {'groupId': 'FG003', 'numSubjects': '255'}, {'groupId': 'FG004', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Randomized not vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extension: Month 6 to 24', 'milestones': [{'type': 'STARTED', 'comment': 'A subset of US participants enrolled in Extension Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '112'}, {'groupId': 'FG003', 'numSubjects': '137'}, {'groupId': 'FG004', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '119'}, {'groupId': 'FG004', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 1261 participants were screened and 1197 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}, {'value': '266', 'groupId': 'BG003'}, {'value': '133', 'groupId': 'BG004'}, {'value': '1197', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1'}, {'id': 'BG001', 'title': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1'}, {'id': 'BG002', 'title': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1'}, {'id': 'BG003', 'title': 'V920 High-dose Lot', 'description': 'Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Participants received a 1.0-mL intramuscular injection of placebo on Day 1'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '41.5', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '40.9', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '41.7', 'spread': '13.4', 'groupId': 'BG003'}, {'value': '41.1', 'spread': '13.7', 'groupId': 'BG004'}, {'value': '41.3', 'spread': '13.1', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}, {'value': '637', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '560', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2015-07-17', 'resultsFirstSubmitDate': '2018-09-07', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-09', 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody', 'timeFrame': 'Day 28 postvaccination', 'description': 'Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.'}, {'measure': 'Percentage of Participants Reporting Serious Adverse Events', 'timeFrame': 'Up to Month 6 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.'}, {'measure': 'Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card', 'timeFrame': 'Up to Day 5 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.'}, {'measure': 'Percentage of Participants With Elevated Maximum Temperature', 'timeFrame': 'Up to Day 42 postvaccination', 'description': 'Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).'}, {'measure': 'Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card', 'timeFrame': 'From Day 5 to Day 42 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.'}, {'measure': 'Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card', 'timeFrame': 'Up to Day 42 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.'}, {'measure': 'Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card', 'timeFrame': 'Up to Day 42 postvaccination', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prevention of Ebola Infection']}, 'referencesModule': {'references': [{'pmid': '28549145', 'type': 'RESULT', 'citation': 'Halperin SA, Arribas JR, Rupp R, Andrews CP, Chu L, Das R, Simon JK, Onorato MT, Liu K, Martin J, Helmond FA; V920-012 Study Team. Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. J Infect Dis. 2017 Jun 15;215(12):1789-1798. doi: 10.1093/infdis/jix189.'}, {'pmid': '33782211', 'type': 'DERIVED', 'citation': 'Grant-Klein RJ, Antonello J, Nichols R, Dubey S, Simon JK. Effects of Gamma Irradiation of Human Serum Samples from rVSVDeltaG-ZEBOV-GP (V920) Ebola Virus Vaccine Recipients on Plaque-Reduction Neutralization Assays. Am J Trop Med Hyg. 2021 Mar 29;104(5):1751-1754. doi: 10.4269/ajtmh.20-1055.'}, {'pmid': '31505665', 'type': 'DERIVED', 'citation': 'Halperin SA, Das R, Onorato MT, Liu K, Martin J, Grant-Klein RJ, Nichols R, Coller BA, Helmond FA, Simon JK; V920-012 Study Team. Immunogenicity, Lot Consistency, and Extended Safety of rVSVDeltaG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults. J Infect Dis. 2019 Aug 30;220(7):1127-1135. doi: 10.1093/infdis/jiz241.'}, {'pmid': '28647166', 'type': 'DERIVED', 'citation': 'Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination.\n\nExclusion Criteria:\n\n* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial.\n* Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine.\n* Has been exposed to Ebola virus at any time prior to study entry.\n* Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination.\n* Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial.\n* Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry.\n* Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing \\>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry.\n* Has received systemic corticosteroids exceeding physiologic replacement doses (\\~5 mg/day prednisone equivalent) within 14 days prior to study entry.\n* Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry.\n* Has known or suspected impairment of immunological function (e.g., HIV positive).\n* Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).\n* Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry.\n* Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin).\n* Has a history of malignancy \\<=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.'}, 'identificationModule': {'nctId': 'NCT02503202', 'briefTitle': 'Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults', 'orgStudyIdInfo': {'id': 'V920-012'}, 'secondaryIdInfos': [{'id': '2015-001658-14', 'type': 'EUDRACT_NUMBER'}, {'id': 'V920-012', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V920 Consistency Lot A', 'description': 'Participants received a 1.0 mL intramuscular injection of V920 on Day 1', 'interventionNames': ['Biological: V920 Consistency Lot A']}, {'type': 'EXPERIMENTAL', 'label': 'V920 Consistency Lot B', 'description': 'Participants received a 1.0 mL intramuscular injection of V920 on Day 1', 'interventionNames': ['Biological: V920 Consistency Lot B']}, {'type': 'EXPERIMENTAL', 'label': 'V920 Consistency Lot C', 'description': 'Participants received a 1.0 mL intramuscular injection of V920 on Day 1', 'interventionNames': ['Biological: V920 Consistency Lot C']}, {'type': 'EXPERIMENTAL', 'label': 'V920 High-dose Lot', 'description': 'Participants received a 1.0 mL intramuscular injection of V920 on Day 1', 'interventionNames': ['Biological: V920 High-dose Lot']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to V920', 'description': 'Participants received a 1.0 mL intramuscular injection of placebo on Day 1', 'interventionNames': ['Biological: Placebo to V920']}], 'interventions': [{'name': 'V920 Consistency Lot A', 'type': 'BIOLOGICAL', 'description': 'V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection', 'armGroupLabels': ['V920 Consistency Lot A']}, {'name': 'V920 Consistency Lot B', 'type': 'BIOLOGICAL', 'description': 'V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection', 'armGroupLabels': ['V920 Consistency Lot B']}, {'name': 'V920 Consistency Lot C', 'type': 'BIOLOGICAL', 'description': 'V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection', 'armGroupLabels': ['V920 Consistency Lot C']}, {'name': 'V920 High-dose Lot', 'type': 'BIOLOGICAL', 'description': 'V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection', 'armGroupLabels': ['V920 High-dose Lot']}, {'name': 'Placebo to V920', 'type': 'BIOLOGICAL', 'description': 'Sodium chloride 0.9%, sterile solution for intramuscular injection', 'armGroupLabels': ['Placebo to V920']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}