Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT03486834
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination.', 'description': 'The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.', 'eventGroups': [{'id': 'EG000', 'title': 'V160 3-Dose Group', 'description': 'Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.', 'otherNumAtRisk': 728, 'deathsNumAtRisk': 733, 'otherNumAffected': 697, 'seriousNumAtRisk': 728, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'V160 2-Dose Group', 'description': 'Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.', 'otherNumAtRisk': 729, 'deathsNumAtRisk': 733, 'otherNumAffected': 700, 'seriousNumAtRisk': 729, 'deathsNumAffected': 0, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'Placebo Group', 'description': 'Participants received placebo by IM injection on Day 1, Month 2, and Month 6.', 'otherNumAtRisk': 732, 'deathsNumAtRisk': 734, 'otherNumAffected': 557, 'seriousNumAtRisk': 732, 'deathsNumAffected': 0, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 50, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 68, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 54, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1128, 'numAffected': 457}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1077, 'numAffected': 461}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 843, 'numAffected': 357}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 400, 'numAffected': 254}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 273, 'numAffected': 208}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 39, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1943, 'numAffected': 680}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1524, 'numAffected': 664}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 374, 'numAffected': 239}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 54, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 404, 'numAffected': 248}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 311, 'numAffected': 233}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 93, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 112, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 42, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 59, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 56, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 226, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 249, 'numAffected': 162}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 121, 'numAffected': 76}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 996, 'numAffected': 455}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 818, 'numAffected': 424}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 336, 'numAffected': 200}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 988, 'numAffected': 434}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 976, 'numAffected': 450}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 795, 'numAffected': 368}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 81, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 80, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 80, 'numAffected': 69}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Salivary gland calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pelvic bone injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Splenic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Traumatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Enchondromatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Idiopathic intracranial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anembryonic gestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, 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'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Threatened labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Adnexal torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intermenstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 728, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 729, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V160 3-Dose Regimen', 'description': 'Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by IM injection on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '1.6', 'ciUpperLimit': '4.9', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% confidence interval (CI).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '3.3', 'ciUpperLimit': '7.6', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.4', 'ciLowerLimit': '-13.5', 'ciUpperLimit': '71.1', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post last vaccination (Month 7) up to ~Month 24', 'description': 'Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 3 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injection-site Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'OG000'}, {'value': '729', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V160 3-Dose Regimen', 'description': 'Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'V160 2-Dose Regimen', 'description': 'Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo by IM injection on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '683', 'groupId': 'OG000'}, {'value': '668', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.8', 'ciLowerLimit': '55.8', 'ciUpperLimit': '63.5', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.6', 'ciLowerLimit': '53.5', 'ciUpperLimit': '61.5', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 days after each vaccination', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'OG000'}, {'value': '729', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V160 3-Dose Regimen', 'description': 'Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'V160 2-Dose Regimen', 'description': 'Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo by IM injection on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '621', 'groupId': 'OG000'}, {'value': '633', 'groupId': 'OG001'}, {'value': '508', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.9', 'ciLowerLimit': '11.7', 'ciUpperLimit': '20.1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.4', 'ciLowerLimit': '13.3', 'ciUpperLimit': '21.6', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 14 days after each vaccination', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vaccine-related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'OG000'}, {'value': '729', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'V160 3-Dose Regimen', 'description': 'Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.'}, {'id': 'OG001', 'title': 'V160 2-Dose Regimen', 'description': 'Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo by IM injection on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 14 days after each vaccination', 'description': 'A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '546', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V160 2-Dose Regimen', 'description': 'Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by IM injection on Day 1, Month 2, and Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Incidence Rate Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '4.6', 'ciUpperLimit': '9.5', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.'}, {'groupIds': ['OG001'], 'paramType': 'Incidence Rate Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '3.3', 'ciUpperLimit': '7.6', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.'}, {'groupIds': ['OG000'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.0', 'ciLowerLimit': '-135.0', 'ciUpperLimit': '25.0', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks post last vaccination (Month 7) up to ~Month 24', 'description': 'CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 2 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V160 3-Dose Regimen', 'description': 'Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.'}, {'id': 'FG001', 'title': 'V160 2-Dose Regimen', 'description': 'Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received placebo by IM injection on Day 1, Month 2, and Month 6.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '733'}, {'groupId': 'FG001', 'numSubjects': '733'}, {'groupId': 'FG002', 'numSubjects': '734'}]}, {'type': 'Treatment 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '729'}, {'groupId': 'FG001', 'numSubjects': '729'}, {'groupId': 'FG002', 'numSubjects': '733'}]}, {'type': 'Treatment 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '680'}, {'groupId': 'FG001', 'numSubjects': '680'}, {'groupId': 'FG002', 'numSubjects': '679'}]}, {'type': 'Treatment 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '614'}, {'groupId': 'FG001', 'numSubjects': '631'}, {'groupId': 'FG002', 'numSubjects': '622'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '614'}, {'groupId': 'FG001', 'numSubjects': '631'}, {'groupId': 'FG002', 'numSubjects': '622'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '112'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'Non-compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of approximately 2100 participants were planned to be enrolled with 2200 participants actually randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '733', 'groupId': 'BG000'}, {'value': '733', 'groupId': 'BG001'}, {'value': '734', 'groupId': 'BG002'}, {'value': '2200', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'V160 3-Dose Regimen', 'description': 'Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.'}, {'id': 'BG001', 'title': 'V160 2-Dose Regimen', 'description': 'Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received placebo by IM injection on Day 1, Month 2, and Month 6.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '26.1', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '26.0', 'spread': '4.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '733', 'groupId': 'BG000'}, {'value': '733', 'groupId': 'BG001'}, {'value': '734', 'groupId': 'BG002'}, {'value': '2200', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '432', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '588', 'groupId': 'BG000'}, {'value': '585', 'groupId': 'BG001'}, {'value': '587', 'groupId': 'BG002'}, {'value': '1760', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '657', 'groupId': 'BG000'}, {'value': '652', 'groupId': 'BG001'}, {'value': '665', 'groupId': 'BG002'}, {'value': '1974', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-07', 'size': 3128088, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-01T09:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2018-03-28', 'resultsFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2018-03-28', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-13', 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)', 'timeFrame': '4 weeks post last vaccination (Month 7) up to ~Month 24', 'description': 'Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.'}, {'measure': 'Number of Participants With Solicited Injection-site Adverse Events', 'timeFrame': 'Up to 5 days after each vaccination', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.'}, {'measure': 'Number of Participants With Solicited Systemic AEs', 'timeFrame': 'Up to 14 days after each vaccination', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.'}, {'measure': 'Number of Participants With Vaccine-related Serious Adverse Events', 'timeFrame': 'Up to 14 days after each vaccination', 'description': 'A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)', 'timeFrame': '4 weeks post last vaccination (Month 7) up to ~Month 24', 'description': 'CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prevention of cytomegalovirus infection (CMVi)'], 'conditions': ['Cytomegalovirus (CMV) Infections']}, 'referencesModule': {'references': [{'pmid': '37660711', 'type': 'RESULT', 'citation': 'Das R, Blazquez-Gamero D, Bernstein DI, Gantt S, Bautista O, Beck K, Conlon A, Rosenbloom DIS, Wang D, Ritter M, Arnold B, Annunziato P, Russell KL; V160-002 study group. Safety, efficacy, and immunogenicity of a replication-defective human cytomegalovirus vaccine, V160, in cytomegalovirus-seronegative women: a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2023 Dec;23(12):1383-1394. doi: 10.1016/S1473-3099(23)00343-2. Epub 2023 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy based on medical history and physical examination.\n* Serologically confirmed to be CMV seronegative prior to receiving the first dose of V160/placebo\n* Have direct exposure to young children (≤5 years of age) at home or occupationally\n* Of childbearing potential\n* Agrees to avoid becoming pregnant during the 6-month treatment period and for at least 4 weeks after the last dose of study drug by either 1) practicing abstinence from heterosexual activity, or 2) use a highly-effective method of birth control (as specified in the protocol) during heterosexual activity.\n\nExclusion Criteria:\n\n* Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might expose the participant to risk by participating in the trial, confound the results of the trial, or interfere with participation for the full duration of the trial, as assessed by the investigator\n* Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention or of any severe allergic reaction to any vaccine component that required medical intervention.\n* Has a recent (\\<72 hours) history of febrile illness (temperature ≥100.4°F/38.0°C, oral equivalent)\n* Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition that requires immunosuppressive medication.\n* Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant.\n* A woman of childbearing potential (WOCBP) who has a positive pregnancy test at screening or within 24 hours before the first dose of study treatment.\n* Has previously received a CMV vaccine.\n* Had any live virus vaccine administered or scheduled to be administered in the period from 4 weeks prior to, and 4 weeks following receipt of any dose of trial vaccine.\n* Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following, any dose of trial vaccine.\n* Had administration of any immune globulin or blood product within 90 days prior to injection with V160/placebo or scheduled within 30 days thereafter.\n* Received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/d for persons weighing \\>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to trial entry.\n* Received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d prednisone equivalent) within 14 days prior to the first vaccination (participants using inhaled, nasal, or topical steroids are considered eligible for the trial).\n* Received any anti-viral agent with proven or potential activity against CMV two weeks prior to vaccination or is likely to receive such an agent within 2 weeks after vaccination.\n* Receiving or has received in the year prior to enrollment immunosuppressive therapies or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic immunotherapy, chemotherapy and other immunosuppressive therapies known to interfere with the immune response. Topical tacrolimus is allowed provided that it is not used within 2 weeks prior to, or 2 weeks following a V160 dose.\n* Participated in another clinical trial in the past 4 weeks, or plans to participate in a treatment-based trial or a trial in which an invasive procedure is to be performed while enrolled in this trial.\n* Plans donation of eggs at any time from signing the informed consent through 1 month after receiving the last dose of the trial V160/placebo.'}, 'identificationModule': {'nctId': 'NCT03486834', 'briefTitle': 'V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3-Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age', 'orgStudyIdInfo': {'id': 'V160-002'}, 'secondaryIdInfos': [{'id': '2017-004233-86', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V160 3-Dose Regimen', 'description': 'Participants received 3 doses of vaccine V160 (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant \\[MAPA\\], 4°C stable formulation) administered by intramuscular (IM) injection on Day 1, Month 2, and Month 6.', 'interventionNames': ['Biological: V160']}, {'type': 'EXPERIMENTAL', 'label': 'V160 2-Dose Regimen', 'description': 'Participants received 2 doses of vaccine V160 (100 Units/0.5 mL dose with MAPA, 4°C stable formulation) administered IM on Day 1 and Month 6 and a placebo-saline solution at Month 2.', 'interventionNames': ['Biological: V160', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo (saline solution) by IM injection on Day 1, Month 2, and Month 6.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'V160', 'type': 'BIOLOGICAL', 'otherNames': ['Human cytomegalovirus vaccine'], 'description': 'V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant \\[MAPA\\], 4°C stable formulation) IM injection.', 'armGroupLabels': ['V160 2-Dose Regimen', 'V160 3-Dose Regimen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline solution administered as a 0.5 mL IM injection', 'armGroupLabels': ['Placebo', 'V160 2-Dose Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics ( Site 0025)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC ( Site 0055)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus US Phoenix Southeast ( Site 0057)', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92377', 'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Inland Empire Liver Foundation ( Site 0026)', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Integrated Research of Inland, Inc. 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