Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-01-05 @ 5:59 PM
Study NCT ID:
NCT00986232
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2009-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ProQuad Dose Selection Study (V221-011)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}, {'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D010309', 'term': 'Parotitis'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C050102', 'term': 'measles, mumps, rubella, varicella vaccine'}]}}, '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': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Seven (7) participants received unknown clinical material and 1 participant received diluent only; they were considered to be protocol violators and weren't included in the efficacy/safety analyses."}}, 'adverseEventsModule': {'timeFrame': 'Participants were followed for safety for 42 days after each scheduled vaccination.', 'description': 'Number of participants reported as "At Risk" is the number of participants with follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'ProQuad (Low Dose) After Injection 1', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.', 'otherNumAtRisk': 378, 'otherNumAffected': 286, 'seriousNumAtRisk': 378, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'ProQuad (Middle Dose) After Injection 1', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.', 'otherNumAtRisk': 387, 'otherNumAffected': 286, 'seriousNumAtRisk': 387, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'ProQuad (High Dose) After Injection 1', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.', 'otherNumAtRisk': 377, 'otherNumAffected': 289, 'seriousNumAtRisk': 377, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)', 'description': 'One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.', 'otherNumAtRisk': 381, 'otherNumAffected': 297, 'seriousNumAtRisk': 381, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'ProQuad (Low Dose) After Injection 2', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.', 'otherNumAtRisk': 353, 'otherNumAffected': 253, 'seriousNumAtRisk': 353, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'ProQuad (Middle Dose) After Injection 2', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.', 'otherNumAtRisk': 361, 'otherNumAffected': 258, 'seriousNumAtRisk': 361, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'ProQuad (High Dose) After Injection 2', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.', 'otherNumAtRisk': 358, 'otherNumAffected': 254, 'seriousNumAtRisk': 358, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Asthenia/Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 128}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 145}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 136}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 81}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 98}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 99}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Infection, Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Candidiasis, Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 26}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Gastroenteritis, Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 29}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 28}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 29}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Congestion, Nasal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Congestion, Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 20}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 33}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Infection, Respiratory, Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 67}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 64}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 82}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 110}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 93}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Laryngotracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 41}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 29}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 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'sourceVocabulary': 'Merck CRISP'}, {'term': 'Seizure, febrile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Laryngotracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Respiratory distress, newborn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 378, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 377, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 381, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '307', 'groupId': 'OG004'}, {'value': '309', 'groupId': 'OG005'}, {'value': '320', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ (Low Dose) After 1 Injection', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG001', 'title': 'ProQuad™ (Low Dose) After 2 Injections', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG002', 'title': 'ProQuad™ (Middle Dose) After 1 Injection', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG003', 'title': 'ProQuad™ (Middle Dose) After 2 Injections', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG004', 'title': 'ProQuad™ (High Dose) After 1 Injection', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG005', 'title': 'ProQuad™ (High Dose) After 2 Injections', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG006', 'title': 'M-M-R™ II + PUVV After 1 Injection', 'description': 'One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '272', 'groupId': 'OG004'}, {'value': '306', 'groupId': 'OG005'}, {'value': '298', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks postvaccination', 'description': 'Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \\<1.25 gpELISA units', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}, {'value': '328', 'groupId': 'OG003'}, {'value': '323', 'groupId': 'OG004'}, {'value': '326', 'groupId': 'OG005'}, {'value': '350', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ (Low Dose) After 1 Injection', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG001', 'title': 'ProQuad™ (Low Dose) After 2 Injections', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG002', 'title': 'ProQuad™ (Middle Dose) After 1 Injection', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG003', 'title': 'ProQuad™ (Middle Dose) After 2 Injections', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG004', 'title': 'ProQuad™ (High Dose) After 1 Injection', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG005', 'title': 'ProQuad™ (High Dose) After 2 Injections', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG006', 'title': 'M-M-R™ II + PUVV After 1 Injection', 'description': 'One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '321', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}, {'value': '327', 'groupId': 'OG003'}, {'value': '321', 'groupId': 'OG004'}, {'value': '326', 'groupId': 'OG005'}, {'value': '349', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks postvaccination', 'description': 'Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer \\<207.5 mIU/mL) to measles at baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}, {'value': '331', 'groupId': 'OG003'}, {'value': '331', 'groupId': 'OG004'}, {'value': '335', 'groupId': 'OG005'}, {'value': '351', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ (Low Dose) After 1 Injection', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG001', 'title': 'ProQuad™ (Low Dose) After 2 Injections', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG002', 'title': 'ProQuad™ (Middle Dose) After 1 Injection', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG003', 'title': 'ProQuad™ (Middle Dose) After 2 Injections', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG004', 'title': 'ProQuad™ (High Dose) After 1 Injection', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG005', 'title': 'ProQuad™ (High Dose) After 2 Injections', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG006', 'title': 'M-M-R™ II + PUVV After 1 Injection', 'description': 'One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '333', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '344', 'groupId': 'OG002'}, {'value': '330', 'groupId': 'OG003'}, {'value': '325', 'groupId': 'OG004'}, {'value': '335', 'groupId': 'OG005'}, {'value': '350', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer \\< 2.0 Ab units/mL) to Mumps at baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}, {'value': '333', 'groupId': 'OG003'}, {'value': '333', 'groupId': 'OG004'}, {'value': '335', 'groupId': 'OG005'}, {'value': '357', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ (Low Dose) After 1 Injection', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG001', 'title': 'ProQuad™ (Low Dose) After 2 Injections', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG002', 'title': 'ProQuad™ (Middle Dose) After 1 Injection', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG003', 'title': 'ProQuad™ (Middle Dose) After 2 Injections', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG004', 'title': 'ProQuad™ (High Dose) After 1 Injection', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG005', 'title': 'ProQuad™ (High Dose) After 2 Injections', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG006', 'title': 'M-M-R™ II + PUVV After 1 Injection', 'description': 'One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '343', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}, {'value': '326', 'groupId': 'OG004'}, {'value': '335', 'groupId': 'OG005'}, {'value': '352', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer \\<10 IU/mL) to Rubella at baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '387', 'groupId': 'OG002'}, {'value': '361', 'groupId': 'OG003'}, {'value': '377', 'groupId': 'OG004'}, {'value': '358', 'groupId': 'OG005'}, {'value': '381', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ (Low Dose) After 1 Injection', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG001', 'title': 'ProQuad™ (Low Dose) After 2 Injections', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG002', 'title': 'ProQuad™ (Middle Dose) After 1 Injection', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG003', 'title': 'ProQuad™ (Middle Dose) After 2 Injections', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG004', 'title': 'ProQuad™ (High Dose) After 1 Injection', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG005', 'title': 'ProQuad™ (High Dose) After 2 Injections', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG006', 'title': 'M-M-R™ II + PUVV After 1 Injection', 'description': 'One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.'}], 'classes': [{'title': 'With Serious Vaccine-Related CAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Without Serious Vaccine-Related CAEs', 'categories': [{'measurements': [{'value': '378', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '361', 'groupId': 'OG003'}, {'value': '377', 'groupId': 'OG004'}, {'value': '358', 'groupId': 'OG005'}, {'value': '381', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination Visit 1 or Visit 2', 'description': 'Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with follow-up for safety were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '307', 'groupId': 'OG004'}, {'value': '309', 'groupId': 'OG005'}, {'value': '320', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ (Low Dose) After 1 Injection', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG001', 'title': 'ProQuad™ (Low Dose) After 2 Injections', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG002', 'title': 'ProQuad™ (Middle Dose) After 1 Injection', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG003', 'title': 'ProQuad™ (Middle Dose) After 2 Injections', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG004', 'title': 'ProQuad™ (High Dose) After 1 Injection', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG005', 'title': 'ProQuad™ (High Dose) After 2 Injections', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'OG006', 'title': 'M-M-R™ II + PUVV After 1 Injection', 'description': 'One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '6.5'}, {'value': '167.7', 'groupId': 'OG001', 'lowerLimit': '145.6', 'upperLimit': '193.2'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '11.7'}, {'value': '381.0', 'groupId': 'OG003', 'lowerLimit': '335.8', 'upperLimit': '432.4'}, {'value': '11.9', 'groupId': 'OG004', 'lowerLimit': '10.8', 'upperLimit': '13.1'}, {'value': '469.4', 'groupId': 'OG005', 'lowerLimit': '405.5', 'upperLimit': '543.4'}, {'value': '16.5', 'groupId': 'OG006', 'lowerLimit': '15.1', 'upperLimit': '18.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. 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[{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Missed one or more bleeds', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Incomplete safety follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '18 clinical sites in the United States\n\nDate first participant visit: 08-Apr-1999\n\nDate last participant visit: 03-Apr-2000'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}, {'value': '390', 'groupId': 'BG003'}, {'value': '1551', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'ProQuad™ (Low Dose)', 'description': 'One ProQuad™ (3.48 log10 plaque-forming units \\[PFU\\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'BG001', 'title': 'ProQuad™ (Middle Dose)', 'description': 'One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'BG002', 'title': 'ProQuad™ (High Dose)', 'description': 'One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.'}, {'id': 'BG003', 'title': 'M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)', 'description': 'One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '12.9', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '12.9', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '13.0', 'spread': '1.7', 'groupId': 'BG003'}, {'value': '12.9', 'spread': '1.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}, {'value': '720', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}, {'value': '831', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '238', 'groupId': 'BG004'}]}]}, {'title': 'Asian/Pacific', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '262', 'groupId': 'BG003'}, {'value': '1021', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1551}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2000-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-23', 'studyFirstSubmitDate': '2009-09-25', 'resultsFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2009-09-25', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-25', 'studyFirstPostDateStruct': {'date': '2009-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units', 'timeFrame': '6 weeks postvaccination', 'description': 'Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \\<1.25 gpELISA units'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL', 'timeFrame': '6 weeks postvaccination', 'description': 'Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer \\<207.5 mIU/mL) to measles at baseline'}, {'measure': 'Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer \\< 2.0 Ab units/mL) to Mumps at baseline'}, {'measure': 'Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer \\<10 IU/mL) to Rubella at baseline'}, {'measure': 'Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)', 'timeFrame': '6 weeks Postvaccination Visit 1 or Visit 2', 'description': 'Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).'}, {'measure': 'Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)'}, {'measure': 'Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)'}, {'measure': 'Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)'}, {'measure': 'Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)', 'timeFrame': '6 weeks postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Measles', 'Mumps', 'Rubella', 'Varicella']}, 'referencesModule': {'references': [{'pmid': '16094218', 'type': 'RESULT', 'citation': 'Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schodel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):670-5. doi: 10.1097/01.inf.0000172901.29621.e9.'}]}, 'descriptionModule': {'briefSummary': 'A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good health\n* Negative clinical history of measles, mumps, rubella, varicella, and zoster\n\nExclusion Criteria:\n\n* Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination\n* Any immune impairment or deficiency\n* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination\n* Vaccination with an inactive vaccine with in the past 14 days\n* Vaccination with a live vaccine within the past 30 days\n* Immune globulin or any blood product administered in the past 3 months'}, 'identificationModule': {'nctId': 'NCT00986232', 'briefTitle': 'ProQuad Dose Selection Study (V221-011)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections', 'orgStudyIdInfo': {'id': 'V221-011'}, 'secondaryIdInfos': [{'id': '2009_667'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ProQuad (low dose)', 'interventionNames': ['Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'ProQuad (middle dose)', 'interventionNames': ['Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'ProQuad (high dose)', 'interventionNames': ['Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'M-M-R II + PUVV', 'interventionNames': ['Biological: Comparator: M-M-R II', 'Biological: Comparator: PUVV']}], 'interventions': [{'name': 'Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live', 'type': 'BIOLOGICAL', 'otherNames': ['ProQuad'], 'description': 'a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Comparator: M-M-R II', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL subcutaneous injection at Day 0', 'armGroupLabels': ['4']}, {'name': 'Comparator: PUVV', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL subcutaneous injection at Day 0', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}