Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 1:54 AM
Study NCT ID:
NCT04033068
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071243', 'term': 'Zika Virus Infection'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Clinical Trials Disclosure', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigators may not submit the results for publication or presentation without prior written permission of the sponsor. Authorship for any publication will be determined in mutual agreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 182 Days', 'description': 'The analysis population included all randomized participants who received at least one dose of study treatment. Per protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 31, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '92.9', 'groupId': 'OG001'}, {'value': '91.7', 'groupId': 'OG002'}, {'value': '62.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '= 0.2003', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher-Freeman-Halton Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 56', 'description': 'An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. As specified by the protocol, the percentage of participants who experience an AE up to study Day 56 was presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced a Solicited AE up to Day 182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '78.6', 'groupId': 'OG001'}, {'value': '83.3', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '= 0.1448', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher-Freeman-Halton Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 182', 'description': 'An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Solicited AEs include local solicited AEs (e.g. injection site pain, tenderness, erythema/redness, swelling, itching and induration) and systemic solicited AEs (e.g. nausea, vomiting, arthralgia, headache, fatigue, myalgia, fever, pain in limb, rash and flu-like symptoms). Solicited AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experience a solicited AE up to study Day 182 was presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced an Unsolicited AE up to Day 182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '58.3', 'groupId': 'OG002'}, {'value': '62.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '= 0.9111', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher-Freeman-Halton Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 182', 'description': 'An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Unsolicited or spontaneous AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experienced an unsolicited AE up to study Day 182 was presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '= 1.0000', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher-Freeman-Halton Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 182', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect or is another important medical event deemed as much by medical or scientific judgement. As specified by the protocol, the percentage of participants who experience an SAE up to study Day 182 was presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '10.0', 'spread': '10.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG002', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG003', 'lowerLimit': '10.0', 'upperLimit': '10.0'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '10.0', 'spread': '10.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG002', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG003', 'lowerLimit': '10.0', 'upperLimit': '10.0'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '10.0', 'spread': '10.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG002', 'lowerLimit': '10.0', 'upperLimit': '10.0'}, {'value': '10.0', 'spread': '10.0', 'groupId': 'OG003', 'lowerLimit': '10.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0, Day 28 and Day 56', 'description': 'The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of a VNT, an immunoassay that detects and quantifies antibodies in serum samples that can neutralize infectious Zika virions. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by the VNT on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the lower limit of quantification (LLOQ) were set to the half of the true LLOQ value and values above the upper limit of quantification (ULOQ) were set to the true ULOQ value for calculations.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could impact immune response, who had anti-ZIKA-RSP antibody VNT data available.'}, {'type': 'SECONDARY', 'title': 'GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '2107.0', 'spread': '579.6', 'groupId': 'OG000', 'lowerLimit': '579.6', 'upperLimit': '7659.7'}, {'value': '2310.9', 'spread': '829.1', 'groupId': 'OG001', 'lowerLimit': '829.1', 'upperLimit': '6440.8'}, {'value': '2780.8', 'spread': '1269.3', 'groupId': 'OG002', 'lowerLimit': '1269.3', 'upperLimit': '6092.5'}, {'value': '1759.2', 'spread': '408.9', 'groupId': 'OG003', 'lowerLimit': '408.9', 'upperLimit': '7568.2'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '4084.2', 'spread': '1348.4', 'groupId': 'OG000', 'lowerLimit': '1348.4', 'upperLimit': '12370.5'}, {'value': '3529.3', 'spread': '1570.9', 'groupId': 'OG001', 'lowerLimit': '1570.9', 'upperLimit': '7929.5'}, {'value': '4219.7', 'spread': '2008.3', 'groupId': 'OG002', 'lowerLimit': '2008.3', 'upperLimit': '8866.3'}, {'value': '1821.1', 'spread': '421.3', 'groupId': 'OG003', 'lowerLimit': '421.3', 'upperLimit': '7872.4'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '5908.4', 'spread': '2210.4', 'groupId': 'OG000', 'lowerLimit': '2210.4', 'upperLimit': '15792.8'}, {'value': '4600.6', 'spread': '2386.1', 'groupId': 'OG001', 'lowerLimit': '2386.1', 'upperLimit': '8870.4'}, {'value': '3485.9', 'spread': '1783.3', 'groupId': 'OG002', 'lowerLimit': '1783.3', 'upperLimit': '6813.9'}, {'value': '2059.0', 'spread': '435.5', 'groupId': 'OG003', 'lowerLimit': '435.5', 'upperLimit': '9734.7'}]}]}], 'analyses': [{'pValue': '= 0.9990', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.2', 'ciUpperLimit': '5.5', 'groupDescription': 'Day 0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9798', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.1', 'ciUpperLimit': '5.2', 'groupDescription': 'Day 0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9958', 'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.1', 'ciUpperLimit': '10.1', 'groupDescription': 'Day 0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9935', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.1', 'ciUpperLimit': '5.5', 'groupDescription': 'Day 0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9852', 'groupIds': ['OG001', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.2', 'ciUpperLimit': '10.7', 'groupDescription': 'Day 0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9440', 'groupIds': ['OG002', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '0.2', 'ciUpperLimit': '14.4', 'groupDescription': 'Day 0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9943', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.2', 'ciUpperLimit': '5.5', 'groupDescription': 'Day 28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9999', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.2', 'ciUpperLimit': '5.1', 'groupDescription': 'Day 28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.6476', 'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.4', 'ciUpperLimit': '14.3', 'groupDescription': 'Day 28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9911', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.2', 'ciUpperLimit': '4.3', 'groupDescription': 'Day 28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.7647', 'groupIds': ['OG001', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '0.3', 'ciUpperLimit': '12.0', 'groupDescription': 'Day 28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.6447', 'groupIds': ['OG002', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '15.8', 'groupDescription': 'Day 28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9638', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '5.3', 'groupDescription': 'Day 56', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.7837', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.4', 'ciUpperLimit': '7.7', 'groupDescription': 'Day 56', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.3427', 'groupIds': ['OG000', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '0.5', 'ciUpperLimit': '15.3', 'groupDescription': 'Day 56', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9578', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '5.8', 'groupDescription': 'Day 56', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.5637', 'groupIds': ['OG001', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.4', 'ciUpperLimit': '11.7', 'groupDescription': 'Day 56', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.8471', 'groupIds': ['OG002', 'OG003'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '9.6', 'groupDescription': 'Day 56', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0, Day 28 and Day 56', 'description': 'The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of Immunoglobulin G (IgG) ELISA, an immunoassay that quantifies anti-ZIKA-RSP IgG. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by ELISA on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could impact immune response, who had anti-ZIKA-RSP antibody ELISA data available.'}, {'type': 'SECONDARY', 'title': 'T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '10.0', 'spread': '3.0', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '30.0'}, {'value': '2.5', 'spread': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '10.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 56', 'description': 'Immune response mediated by functional T-cells was investigated using an IFNγ enzyme-linked immune adsorbent spot (ELISpot) assay. This is an immunoassay that quantifies IFNγ producing cells by assessing the number of SFCs per 10\\^6 PBMCs stimulated with a peptide pool containing the viral protein prM\\*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IFNγ SFCs per 10\\^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.', 'unitOfMeasure': 'SFC/10^6 PBMC', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could impact immune response, who had IFNγ SFC data available.'}, {'type': 'SECONDARY', 'title': 'T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.5'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '18.0'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 56', 'description': 'Immune response mediated by functional T-cells was investigated using an IL-2 ELISpot assay. This is an immunoassay that quantifies IL-2 producing cells by assessing the number of SFCs per 10\\^6 PBMCs stimulated with a peptide pool containing the viral protein prM\\*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IL-2 SFCs per 10\\^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.', 'unitOfMeasure': 'SFC/10^6 PBMC', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could impact immune response, who had IL-2 SFC data available.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Basophils Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '0.06', 'spread': '0.05', 'groupId': 'OG003'}]}]}, {'title': 'Basophils Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.05', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.17', 'spread': '0.14', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '0.16', 'spread': '0.08', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.11', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '7.47', 'spread': '3.82', 'groupId': 'OG001'}, {'value': '5.51', 'spread': '1.58', 'groupId': 'OG002'}, {'value': '7.49', 'spread': '2.96', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.81', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '7.21', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '5.55', 'spread': '1.48', 'groupId': 'OG002'}, {'value': '7.83', 'spread': '3.53', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.01', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '1.74', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '2.03', 'spread': '0.93', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '1.76', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '1.85', 'spread': '1.02', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '0.49', 'spread': '0.22', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.52', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.29', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '4.74', 'spread': '3.09', 'groupId': 'OG001'}, {'value': '3.15', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '4.73', 'spread': '2.22', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.11', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '3.20', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '5.28', 'spread': '2.68', 'groupId': 'OG003'}]}]}, {'title': 'Platelets Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '275.0', 'spread': '82.43', 'groupId': 'OG000'}, {'value': '290.93', 'spread': '74.22', 'groupId': 'OG001'}, {'value': '236.45', 'spread': '45.65', 'groupId': 'OG002'}, {'value': '274.86', 'spread': '60.78', 'groupId': 'OG003'}]}]}, {'title': 'Platelets Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '273.21', 'spread': '73.62', 'groupId': 'OG000'}, {'value': '286.93', 'spread': '75.68', 'groupId': 'OG001'}, {'value': '229.55', 'spread': '47.98', 'groupId': 'OG002'}, {'value': '281.17', 'spread': '60.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'Giga cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available hematology data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.73', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '4.59', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '4.80', 'spread': '0.42', 'groupId': 'OG003'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.67', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '4.63', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '4.83', 'spread': '0.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of erythrocytes on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'Trillions of cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available hematology data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.43', 'spread': '0.03', 'groupId': 'OG003'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.43', 'spread': '0.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hematocrit on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'Liter of cells per liter of blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available hematology data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.06', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '13.57', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '13.82', 'spread': '0.70', 'groupId': 'OG002'}, {'value': '14.63', 'spread': '1.19', 'groupId': 'OG003'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.89', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '13.64', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '13.79', 'spread': '0.74', 'groupId': 'OG002'}, {'value': '14.63', 'spread': '1.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hemoglobin on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available hematology data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Alanine Aminotransferase Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.00', 'spread': '21.91', 'groupId': 'OG000'}, {'value': '20.14', 'spread': '8.79', 'groupId': 'OG001'}, {'value': '21.09', 'spread': '7.38', 'groupId': 'OG002'}, {'value': '26.00', 'spread': '13.66', 'groupId': 'OG003'}]}]}, {'title': 'Alanine Aminotransferase Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.21', 'spread': '19.86', 'groupId': 'OG000'}, {'value': '22.29', 'spread': '13.75', 'groupId': 'OG001'}, {'value': '22.18', 'spread': '8.32', 'groupId': 'OG002'}, {'value': '22.14', 'spread': '8.36', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '65.29', 'spread': '14.62', 'groupId': 'OG000'}, {'value': '63.43', 'spread': '20.63', 'groupId': 'OG001'}, {'value': '63.18', 'spread': '16.14', 'groupId': 'OG002'}, {'value': '79.86', 'spread': '23.36', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '65.50', 'spread': '15.81', 'groupId': 'OG000'}, {'value': '65.14', 'spread': '20.72', 'groupId': 'OG001'}, {'value': '59.73', 'spread': '16.63', 'groupId': 'OG002'}, {'value': '77.43', 'spread': '23.78', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.21', 'spread': '19.26', 'groupId': 'OG000'}, {'value': '21.64', 'spread': '6.45', 'groupId': 'OG001'}, {'value': '22.36', 'spread': '3.29', 'groupId': 'OG002'}, {'value': '24.57', 'spread': '8.04', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.43', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '19.36', 'spread': '5.47', 'groupId': 'OG001'}, {'value': '22.55', 'spread': '4.32', 'groupId': 'OG002'}, {'value': '23.71', 'spread': '6.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Sodium Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '139.57', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '139.5', 'spread': '1.95', 'groupId': 'OG001'}, {'value': '139.82', 'spread': '1.78', 'groupId': 'OG002'}, {'value': '141.43', 'spread': '1.62', 'groupId': 'OG003'}]}]}, {'title': 'Sodium Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '139.64', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '139.86', 'spread': '2.07', 'groupId': 'OG001'}, {'value': '139.45', 'spread': '2.02', 'groupId': 'OG002'}, {'value': '140.29', 'spread': '1.80', 'groupId': 'OG003'}]}]}, {'title': 'Calcium Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '2.36', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '2.40', 'spread': '0.08', 'groupId': 'OG003'}]}]}, {'title': 'Calcium Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '2.36', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '2.34', 'spread': '0.08', 'groupId': 'OG003'}]}]}, {'title': 'Potassium Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.72', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '4.35', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '4.53', 'spread': '0.26', 'groupId': 'OG003'}]}]}, {'title': 'Potassium Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.61', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '4.58', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '4.67', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '4.70', 'spread': '0.30', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of sodium, calcium and potassium on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Bilirubin Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '0.50', 'spread': '0.35', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '0.46', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '0.84', 'spread': '0.13', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.79', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.81', 'spread': '0.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of bilirubin and creatinine on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'milligrams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available clinical chemistry data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter (Urinalysis): pH on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.79', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '5.43', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '5.82', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '5.57', 'spread': '0.79', 'groupId': 'OG003'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.71', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '5.79', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '5.82', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '5.14', 'spread': '0.38', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the pH on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available urinalysis data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.014', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '1.011', 'spread': '0.007', 'groupId': 'OG001'}, {'value': '1.010', 'spread': '0.008', 'groupId': 'OG002'}, {'value': '1.011', 'spread': '0.009', 'groupId': 'OG003'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.013', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '1.012', 'spread': '0.007', 'groupId': 'OG001'}, {'value': '1.013', 'spread': '0.004', 'groupId': 'OG002'}, {'value': '1.009', 'spread': '0.005', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 and Day 56', 'description': 'Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the specific gravity on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'grams per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available urinalysis data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Bilirubin Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocytes Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '90.9', 'groupId': 'OG002'}, {'value': '71.4', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocytes Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '85.7', 'groupId': 'OG003'}]}]}, {'title': 'Ketones Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Ketones Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Nitrite Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Nitrite Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Protein Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '92.9', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Protein Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '81.8', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 and Day 56', 'description': 'Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein levels were defined as negative by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants negative for bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available urinalysis data.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'OG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'OG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'OG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'classes': [{'title': 'Glucose Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Glucose Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Urobilinogen Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Urobilinogen Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 and Day 56', 'description': 'Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Glucose and urobilinogen were defined as normal by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants normal for glucose and urobilinogen on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had available urinalysis data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'FG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'FG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'FG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'First Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Second Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Inclusion / exclusion criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants were screened within two weeks prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: V187 (High Dose) - V187 (High Dose)', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 Tissue Culture Infective Dose 50% (TCID50) on Day 0 (first dose) and Day 28 (second dose) via intramuscular (IM) injection.'}, {'id': 'BG001', 'title': 'Group B: V187 (Low Dose) - V187 (Low Dose)', 'description': 'Participants receive V187 at a low dose of 2.5x10\\^4 TCID50 on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'BG002', 'title': 'Group C: V187 (High Dose) - Placebo', 'description': 'Participants receive V187 at a high dose of 1x10\\^5 TCID50 on Day 0 (first dose) and V187-matching placebo on Day 28 (second dose) via IM injection.'}, {'id': 'BG003', 'title': 'Group D: Placebo - Placebo', 'description': 'Participants receive V187-matching placebo on Day 0 (first dose) and Day 28 (second dose) via IM injection.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '9.15', 'groupId': 'BG000'}, {'value': '35.5', 'spread': '10.09', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '10.74', 'groupId': 'BG002'}, {'value': '39.3', 'spread': '12.41', 'groupId': 'BG003'}, {'value': '36.5', 'spread': '10.32', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-28', 'size': 2224673, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-28T12:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2019-07-08', 'resultsFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2019-07-24', 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-28', 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56', 'timeFrame': 'Up to Day 56', 'description': 'An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. As specified by the protocol, the percentage of participants who experience an AE up to study Day 56 was presented.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced a Solicited AE up to Day 182', 'timeFrame': 'Up to Day 182', 'description': 'An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Solicited AEs include local solicited AEs (e.g. injection site pain, tenderness, erythema/redness, swelling, itching and induration) and systemic solicited AEs (e.g. nausea, vomiting, arthralgia, headache, fatigue, myalgia, fever, pain in limb, rash and flu-like symptoms). Solicited AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experience a solicited AE up to study Day 182 was presented.'}, {'measure': 'Percentage of Participants Who Experienced an Unsolicited AE up to Day 182', 'timeFrame': 'Up to Day 182', 'description': 'An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Unsolicited or spontaneous AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experienced an unsolicited AE up to study Day 182 was presented.'}, {'measure': 'Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182', 'timeFrame': 'Up to Day 182', 'description': 'An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect or is another important medical event deemed as much by medical or scientific judgement. As specified by the protocol, the percentage of participants who experience an SAE up to study Day 182 was presented.'}, {'measure': 'Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56', 'timeFrame': 'Day 0, Day 28 and Day 56', 'description': 'The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of a VNT, an immunoassay that detects and quantifies antibodies in serum samples that can neutralize infectious Zika virions. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by the VNT on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the lower limit of quantification (LLOQ) were set to the half of the true LLOQ value and values above the upper limit of quantification (ULOQ) were set to the true ULOQ value for calculations.'}, {'measure': 'GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56', 'timeFrame': 'Day 0, Day 28 and Day 56', 'description': 'The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of Immunoglobulin G (IgG) ELISA, an immunoassay that quantifies anti-ZIKA-RSP IgG. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by ELISA on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.'}, {'measure': 'T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56', 'timeFrame': 'Day 56', 'description': 'Immune response mediated by functional T-cells was investigated using an IFNγ enzyme-linked immune adsorbent spot (ELISpot) assay. This is an immunoassay that quantifies IFNγ producing cells by assessing the number of SFCs per 10\\^6 PBMCs stimulated with a peptide pool containing the viral protein prM\\*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IFNγ SFCs per 10\\^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.'}, {'measure': 'T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56', 'timeFrame': 'Day 56', 'description': 'Immune response mediated by functional T-cells was investigated using an IL-2 ELISpot assay. This is an immunoassay that quantifies IL-2 producing cells by assessing the number of SFCs per 10\\^6 PBMCs stimulated with a peptide pool containing the viral protein prM\\*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IL-2 SFCs per 10\\^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.'}, {'measure': 'Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of erythrocytes on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hematocrit on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hemoglobin on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of sodium, calcium and potassium on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of bilirubin and creatinine on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameter (Urinalysis): pH on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the pH on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the specific gravity on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein levels were defined as negative by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants negative for bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}, {'measure': 'Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56', 'timeFrame': 'Day 28 and Day 56', 'description': 'Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Glucose and urobilinogen were defined as normal by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants normal for glucose and urobilinogen on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Zika virus', 'mosquito-borne pathogen', 'Zika fever'], 'conditions': ['Zika Virus Infection']}, 'referencesModule': {'references': [{'pmid': '31053842', 'type': 'RESULT', 'citation': 'Rossi SL, Comer JE, Wang E, Azar SR, Lawrence WS, Plante JA, Ramsauer K, Schrauf S, Weaver SC. Immunogenicity and Efficacy of a Measles Virus-Vectored Chikungunya Vaccine in Nonhuman Primates. J Infect Dis. 2019 Jul 31;220(5):735-742. doi: 10.1093/infdis/jiz202.'}], 'seeAlsoLinks': [{'url': 'http://www.themis.com', 'label': 'Sponsor Web Page'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate, at first, safety and tolerability of a novel liquid vaccine formulation named MV-ZIKA-RSP, in healthy adults aged 18 to 55 years', 'detailedDescription': "This is an observer-blinded, block-randomized, dose-finding, phase I trial, comparing different dose levels of MV-ZIKA-RSP to evaluate the safety, tolerability, and immunogenicity, of this novel ZIKA-RSP vaccine. Placebo (physiological saline solution) will be applied to blind the different treatment schedules.\n\nAfter the screening procedures, 48 healthy male and female volunteers aged 18-55 years will be randomly assigned to one of four treatment groups (A, B, C or D). Participants will be assessed for immunogenicity on days 0, 28 and 56 (treatment period), as confirmed by the presence of functional anti-zika-rsp antibodies determined by (PRNT50) and by ELISA, at the same time safety will be also assessed. After the treatment period, participants will be called by phone (day 182) for evaluation of safety follow-up.\n\nThe investigator and site personnel assessing AEs, all participants, as well as one of the sponsor's representatives involved in the monitoring and conduct of the study will be blinded to which vaccine was administered. Only the unblinded monitor, site personnel performing randomization, preparation and administration of IMP will be unblinded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent obtained before any trial-related activities\n2. Healthy men or women aged 18 to 55 years on the day of consenting\n3. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study\n4. All female participants must have a negative urine pregnancy serum pregnancy test at screening\n5. Willingness not to become pregnant or to father a child during the entire study period by practising reliable methods of contraception as specified in protocol section 8.11.4\n6. Availability during the duration of the trial\n7. Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant\n8. Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)\n\nExclusion Criteria:\n\n1. Participation in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period (day 56)\n2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection\n3. Strong anamnestic evidence for or confirmed the history of or current infection with Zika- or Dengue-virus\n4. History of drug addiction including alcohol dependence within the last 2 years\n5. Inability or unwillingness to avoid intake of more than around 20g alcohol per day during 48 hours after each vaccination (equals roughly 0.5 L beer or 0.25 L of wine)\n6. Vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until the end of the treatment period (day 56)\n7. Prior receipt of any Zika or Chikungunya vaccine\n8. History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit\n9. Recent infection within 1 week prior to Screening Visit (possibility of deferral)\n10. Blood donations including plasma donations, 90 days prior to Screening Visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until the end of the treatment period (day 56)\n11. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study\n12. History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any haematological malignancy\n13. Behavioural, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol\n14. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine\n15. History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer\n16. Abnormal laboratory values which, at the discretion of the investigator should lead to the exclusion of the subject\n17. Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants. (Prior to taking any medication within 72 h before study vaccination, the subject should consult the investigator)\n18. Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to first IMP administration, or anticipated use until completion of the end of treatment visit Receipt of blood products or immunoglobulins within 120 days prior to the Screening Visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period (day 56)\n19. Pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period\n20. Unreliable contraception methods (for details please refer to protocol section 8.11.4)\n21. Persons in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor'}, 'identificationModule': {'nctId': 'NCT04033068', 'acronym': 'MV-ZIKA-RSP', 'briefTitle': 'Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Themis Bioscience GmbH'}, 'officialTitle': 'Observer Blinded, Randomized Trial to Evaluate Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP', 'orgStudyIdInfo': {'id': 'V187-001'}, 'secondaryIdInfos': [{'id': '2019-000840-93', 'type': 'EUDRACT_NUMBER'}, {'id': 'MV-ZIKA-RSP', 'type': 'OTHER', 'domain': 'Themisbio'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Two MV-ZIKA-RSP vaccinations (high dose)', 'description': '14 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and day 28', 'interventionNames': ['Biological: Two MV-ZIKA-RSP vaccinations (high dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Two MV-ZIKA-RSP vaccination (low dose)', 'description': '14 Participants will receive MV-ZIKA-RSP 2,5 x10E4 /dose on day 0 and day 28', 'interventionNames': ['Biological: Two MV-ZIKA-RSP vaccination (low dose)']}, {'type': 'EXPERIMENTAL', 'label': 'One MV-ZIKA-RSP vaccination (high dose) and one placebo', 'description': '12 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and placebo on day 28', 'interventionNames': ['Biological: One MV-ZIKA-RSP vaccination (high dose) and one placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Two placebo injection', 'description': '8 Participants will receive placebo on day 0 and placebo on day 28', 'interventionNames': ['Other: Two placebo injection']}], 'interventions': [{'name': 'Two MV-ZIKA-RSP vaccinations (high dose)', 'type': 'BIOLOGICAL', 'description': 'In this arm of the study, 14 participants will receive:\n\n1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).\n2. V2= day 28; dose vaccination with MV-ZIKA-RSP (high dose).\n\nDescription:\n\nVisit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (high dose)', 'armGroupLabels': ['Two MV-ZIKA-RSP vaccinations (high dose)']}, {'name': 'Two MV-ZIKA-RSP vaccination (low dose)', 'type': 'BIOLOGICAL', 'description': 'In this arm of the study, 14 participants will receive:\n\n1. V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose).\n2. V2= day 28; dose vaccination with MV-ZIKA-RSP (low dose).\n\nDescription:\n\nVisit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (low dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (low dose)', 'armGroupLabels': ['Two MV-ZIKA-RSP vaccination (low dose)']}, {'name': 'One MV-ZIKA-RSP vaccination (high dose) and one placebo', 'type': 'BIOLOGICAL', 'description': 'In this arm of the study, 12 participants will receive:\n\n1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).\n2. V2= day 28; treatment with placebo\n\nDescription:\n\nVisit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second treatment with placebo', 'armGroupLabels': ['One MV-ZIKA-RSP vaccination (high dose) and one placebo']}, {'name': 'Two placebo injection', 'type': 'OTHER', 'otherNames': ['Placebo arm'], 'description': 'In this arm of the study, 8 participants will receive:\n\n1. V1= day 0; placebo treatment\n2. V2= day 28; placebo treatment\n\nDescription:\n\nVisit 1: Participants will receive their first treatment with placebo Visit 2: Participants will receive their second treatment with placebo', 'armGroupLabels': ['Two placebo injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Institute of Specific Prophylaxis and Tropical Medicine', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Themis Bioscience GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}