Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-29 @ 7:35 PM
Study NCT ID:
NCT05507450
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2022-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Clinical Trials Disclosure', 'organization': 'Merck Sharp & Dohme LLC'}, '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination', 'description': 'All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received', 'eventGroups': [{'id': 'EG000', 'title': 'V181 High-Potency Level', 'description': 'Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.', 'otherNumAtRisk': 231, 'deathsNumAtRisk': 231, 'otherNumAffected': 200, 'seriousNumAtRisk': 231, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'V181 Mid-Potency Level', 'description': 'Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.', 'otherNumAtRisk': 461, 'deathsNumAtRisk': 463, 'otherNumAffected': 402, 'seriousNumAtRisk': 461, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'V181 Low-Potency Level', 'description': 'Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.', 'otherNumAtRisk': 459, 'deathsNumAtRisk': 461, 'otherNumAffected': 406, 'seriousNumAtRisk': 459, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received a single 0.5 mL SC dose of placebo', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 116, 'otherNumAffected': 79, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 125, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 231, 'numAffected': 224}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 212, 'numAffected': 202}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 43, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 89, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 108, 'numAffected': 107}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 76, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 80, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 92, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 69, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 50, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 58, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 60, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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[{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 131, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 295, 'numAffected': 295}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 315, 'numAffected': 315}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tooth impacted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Herpes simplex encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Biochemical pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Self-destructive behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V181 High-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.'}, {'id': 'OG001', 'title': 'V181 Mid-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.'}, {'id': 'OG002', 'title': 'V181 Low-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single SC 0.5 mL dose of placebo.'}], 'classes': [{'title': 'DENV1 Serotype', 'categories': [{'measurements': [{'value': '326.31', 'groupId': 'OG000', 'lowerLimit': '256.52', 'upperLimit': '415.08'}, {'value': '261.10', 'groupId': 'OG001', 'lowerLimit': '220.90', 'upperLimit': '308.61'}, {'value': '184.85', 'groupId': 'OG002', 'lowerLimit': '153.89', 'upperLimit': '222.03'}, {'value': '10.33', 'groupId': 'OG003', 'lowerLimit': '8.79', 'upperLimit': '12.14'}]}]}, {'title': 'DENV2 Serotype', 'categories': [{'measurements': [{'value': '815.79', 'groupId': 'OG000', 'lowerLimit': '674.69', 'upperLimit': '986.40'}, {'value': '766.98', 'groupId': 'OG001', 'lowerLimit': '683.66', 'upperLimit': '860.45'}, {'value': '854.59', 'groupId': 'OG002', 'lowerLimit': '755.07', 'upperLimit': '967.22'}, {'value': '7.50', 'groupId': 'OG003', 'lowerLimit': '7.50', 'upperLimit': '7.50'}]}]}, {'title': 'DENV3 Serotype', 'categories': [{'measurements': [{'value': '203.04', 'groupId': 'OG000', 'lowerLimit': '162.87', 'upperLimit': '253.12'}, {'value': '135.19', 'groupId': 'OG001', 'lowerLimit': '115.70', 'upperLimit': '157.97'}, {'value': '94.69', 'groupId': 'OG002', 'lowerLimit': '78.92', 'upperLimit': '113.61'}, {'value': '7.20', 'groupId': 'OG003', 'lowerLimit': '6.11', 'upperLimit': '8.48'}]}]}, {'title': 'DENV4 Serotype', 'categories': [{'measurements': [{'value': '102.13', 'groupId': 'OG000', 'lowerLimit': '77.08', 'upperLimit': '135.33'}, {'value': '68.33', 'groupId': 'OG001', 'lowerLimit': '55.80', 'upperLimit': '83.67'}, {'value': '64.43', 'groupId': 'OG002', 'lowerLimit': '52.42', 'upperLimit': '79.19'}, {'value': '6.50', 'groupId': 'OG003', 'lowerLimit': '6.50', 'upperLimit': '6.50'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 post-vaccination', 'description': 'A dengue VRNT was conducted to assess neutralizing antibody Geometric Mean Titers (GMTs) for each of the 4 dengue vaccine serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. These deviations include participant was seropositive at baseline as assessed by VRNT and missing serology results.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V181 High-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.'}, {'id': 'OG001', 'title': 'V181 Mid-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.'}, {'id': 'OG002', 'title': 'V181 Low-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single SC 0.5 mL dose of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days post-vaccination', 'description': 'An SAE is an AE that results in death, 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 will be determined by the investigator.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V181 High-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.'}, {'id': 'OG001', 'title': 'V181 Mid-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.'}, {'id': 'OG002', 'title': 'V181 Low-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single SC 0.5 mL dose of placebo.'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}, {'value': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '19.7', 'groupId': 'OG001'}, {'value': '13.5', 'groupId': 'OG002'}, {'value': '14.8', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}, {'value': '2.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days post-vaccination', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs include pain, erythema (redness), and swelling.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}, {'value': '459', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V181 High-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.'}, {'id': 'OG001', 'title': 'V181 Mid-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.'}, {'id': 'OG002', 'title': 'V181 Low-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a single SC 0.5 mL dose of placebo.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '48.6', 'groupId': 'OG001'}, {'value': '44.0', 'groupId': 'OG002'}, {'value': '33.9', 'groupId': 'OG003'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '5.7', 'groupId': 'OG002'}, {'value': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '12.6', 'groupId': 'OG001'}, {'value': '13.1', 'groupId': 'OG002'}, {'value': '7.8', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000'}, {'value': '26.5', 'groupId': 'OG001'}, {'value': '24.0', 'groupId': 'OG002'}, {'value': '18.3', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '49.9', 'groupId': 'OG001'}, {'value': '46.2', 'groupId': 'OG002'}, {'value': '47.0', 'groupId': 'OG003'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}, {'value': '64.0', 'groupId': 'OG001'}, {'value': '68.6', 'groupId': 'OG002'}, {'value': '8.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days post-vaccination', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include rash, headache, fatigue (tiredness), pyrexia (oral temperature ≥100.4 °F or 38.0 °C), myalgia (muscle pain), and arthralgia (joint pain).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V181 High-Potency Level Group', 'description': 'Participants received a single 0.5 mL subcutaneous (SC) dose of V181 High-Potency vaccine.'}, {'id': 'FG001', 'title': 'V181 Mid-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.'}, {'id': 'FG002', 'title': 'V181 Low-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received a single SC 0.5 mL dose of placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '463'}, {'groupId': 'FG002', 'numSubjects': '461'}, {'groupId': 'FG003', 'numSubjects': '116'}]}, {'type': 'Vaccinated at Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '461'}, {'groupId': 'FG002', 'numSubjects': '459'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '430'}, {'groupId': 'FG002', 'numSubjects': '431'}, {'groupId': 'FG003', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', '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': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Randomized By Mistake Without Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Participant left the country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Adult males or females, in generally good health, between 18 to 50 years of age, and without a history of dengue or Zika natural infection or prior receipt of any other dengue vaccine were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '1271', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'V181 High-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.'}, {'id': 'BG001', 'title': 'V181 Mid-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.'}, {'id': 'BG002', 'title': 'V181 Low-Potency Level Group', 'description': 'Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received a single SC 0.5 mL dose of placebo.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '33.1', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '33.3', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '33.2', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '33.3', 'spread': '9.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '262', 'groupId': 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'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '1074', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '6', 'groupId': 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{'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'dispFirstSubmitDate': '2024-03-15', 'completionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2022-08-17', 'resultsFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2022-08-17', 'dispFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-23', 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)', 'timeFrame': 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Relatedness of an SAE to the study vaccine will be determined by the investigator.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)', 'timeFrame': 'Up to 5 days post-vaccination', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs include pain, erythema (redness), and swelling.'}, {'measure': 'Percentage of Participants With Solicited Systemic AEs', 'timeFrame': 'Up to 28 days post-vaccination', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include rash, headache, fatigue (tiredness), pyrexia (oral temperature ≥100.4 °F or 38.0 °C), myalgia (muscle pain), and arthralgia (joint pain).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dengue Disease', 'Dengue Virus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male participants are eligible to participate if they agree to the following for at least 90 days after administration of study intervention: Abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is NOT women of child-bearing potential; or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\<1% per year), or is abstinent from heterosexual intercourse as her preferred and usual lifestyle (abstinent on a long term and persistent basis), for at least 90 days after administration of study intervention. (Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.)\n\nExclusion Criteria:\n\n* Has known history of dengue or zika natural infection.\n* Has an acute febrile illness (temperature ≥38.0°C \\[≥100.4°F\\] oral or equivalent) occurring within 72 hours before receipt of study vaccine or placebo.\n* Has a serious or progressive disease, including but not limited to cancer; uncontrolled diabetes; severe cardiac, renal, or hepatic insufficiency; or systemic autoimmune or neurologic disorder.\n* Has known or suspected impairment of immunological function, including but not limited to congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, hematologic malignancy, or treatment for autoimmune diseases.\n* Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access.\n* Has a known hypersensitivity to any component of the study vaccine or placebo, or history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.\n* Has received a dose of any dengue vaccine (investigational or approved) before study entry, or plans to receive any dengue vaccine (investigational or approved) for the duration of the trial.\n* Has received other licensed non-live vaccines within 14 days before receipt of study vaccine or placebo, or is scheduled to receive any licensed non-live vaccine within 28 days following receipt of study vaccine or placebo. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or placebo, or at least 28 days after receipt of study vaccine or placebo.\n* Has received a licensed live vaccine within 28 days before receipt of study vaccine or placebo, or is scheduled to receive any live vaccine within 28 days following receipt of study vaccine or placebo.\n* Has received systemic corticosteroids (equivalent of ≥2 mg/kg/day of prednisone or ≥20 mg/d for persons weighing \\>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days before study entry or is expected to receive systemic corticosteroids at aforementioned dose and duration within 28 days following receipt of study vaccine or placebo. 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