Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT01536405
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2012-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}, {'id': 'D000249', 'term': 'Adenosine Monophosphate'}], 'ancestors': [{'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months (180 days) after vaccination 2', 'description': 'The All Subjects as Treated population included randomized participants who received \\>=1 dose of study vaccine and had safety follow-up results', 'eventGroups': [{'id': 'EG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)', 'otherNumAtRisk': 682, 'otherNumAffected': 574, 'seriousNumAtRisk': 682, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process', 'otherNumAtRisk': 683, 'otherNumAffected': 572, 'seriousNumAtRisk': 683, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 52, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 47, 'numAffected': 46}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 98, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 107, 'numAffected': 91}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 77, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 72, 'numAffected': 61}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 344, 'numAffected': 254}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 258, 'numAffected': 199}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 267, 'numAffected': 208}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 243, 'numAffected': 187}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 190, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 146, 'numAffected': 123}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 349, 'numAffected': 225}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 360, 'numAffected': 235}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 43, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 65, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 76, 'numAffected': 66}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 177, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 179, 'numAffected': 128}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 72, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 57, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 47, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 43, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 210, 'numAffected': 159}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 212, 'numAffected': 163}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 52, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 64, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 113, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 118, 'numAffected': 101}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 78, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 64, 'numAffected': 53}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 76, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 106, 'numAffected': 77}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 50, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 55, 'numAffected': 47}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16'}], 'seriousEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Cellulitis staphylcoccal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Staphylococcal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Exposure via direct contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Exposure via ingestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Foreign body aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Juvenile idiopathic arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 682, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 683, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 16'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)'}, {'id': 'OG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process'}], 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '98.4'}, {'value': '93.0', 'groupId': 'OG001', 'lowerLimit': '90.7', 'upperLimit': '95.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '1.8', 'ciUpperLimit': '6.8', 'estimateComment': 'RD = MMRV (AMP) - MMRV (2006 process)', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease \\>= the prespecified criterion of 10 percentage points'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '97.3', 'ciLowerLimit': '95.6', 'ciUpperLimit': '98.4', 'groupDescription': 'Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \\>76%', 'statisticalMethod': 'One-sample binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol population included participants who received \\>=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)'}, {'id': 'OG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process'}], 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '97.9'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '99.5'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '-0.6', 'estimateComment': 'RD = MMRV (AMP) - MMRV (2006 process)', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \\>= the prespecified criterion of 5 percentage points'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '96.7', 'ciLowerLimit': '94.9', 'ciUpperLimit': '97.9', 'groupDescription': 'Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \\>90%', 'statisticalMethod': 'One-sample binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for measles virus IgG antibody levels by an ELISA', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol population included participants who received \\>=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '618', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)'}, {'id': 'OG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '99.1'}, {'value': '97.2', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '98.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': 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'nonInferiorityComment': 'The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \\>=1.5 fold'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for VZV IgG antibody levels by gpELISA', 'unitOfMeasure': 'ELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol population included participants who received \\>=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Measles Virus Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, 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'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who received \\>=1 study vaccination and had follow-up safety data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Zoster-like Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)'}, {'id': 'OG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process'}], 'classes': [{'title': 'Vaccination 1; n=682, n=682', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Vaccination 2; n=634, 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'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)'}, {'id': 'OG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process'}], 'classes': [{'title': 'Vaccination 1; n=682, n=682', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Vaccination 2; n=634, n=632', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days after each vaccination', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who received \\>=1 study vaccination and had follow-up safety data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Varicella-like Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)'}, {'id': 'OG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process'}], 'classes': [{'title': 'Vaccination 1; n=682, n=682', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Vaccination 2; 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Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who received \\>=1 study vaccination and had follow-up safety data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)'}, {'id': 'FG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process'}], 'periods': [{'title': 'Randomization to Visit 1 (Vaccination 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '706'}, {'groupId': 'FG001', 'numSubjects': '706'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '698'}, {'groupId': 'FG001', 'numSubjects': '702'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Not vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Visit 1 (Vaccination 1) to Visit 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '698'}, {'groupId': 'FG001', 'numSubjects': '702'}]}, {'type': 'Received Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '698'}, {'groupId': 'FG001', 'numSubjects': '702'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '666'}, {'groupId': 'FG001', 'numSubjects': '662'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}, {'title': 'Visit 2 to Visit 3 (Vaccination 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '666'}, {'groupId': 'FG001', 'numSubjects': '662'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '635'}, {'groupId': 'FG001', 'numSubjects': '634'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Visit 3 (Vaccination 2) to Visit 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '635'}, {'groupId': 'FG001', 'numSubjects': '634'}]}, {'type': 'Received Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '634'}, {'groupId': 'FG001', 'numSubjects': '632'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '615'}, {'groupId': 'FG001', 'numSubjects': '618'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}, {'title': 'Visit 4 to Extended Study Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '615'}, {'groupId': 'FG001', 'numSubjects': '618'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '595'}, {'groupId': 'FG001', 'numSubjects': '595'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': 'One participant was inadvertently randomized twice, for a total of 1413 randomizations. The Participant Flow reported below includes this participant only once.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '706', 'groupId': 'BG000'}, {'value': '706', 'groupId': 'BG001'}, {'value': '1412', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MMRV (AMP)', 'description': 'Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)'}, {'id': 'BG001', 'title': 'MMRV (2006 Process)', 'description': 'Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '13.6', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '13.5', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '344', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '668', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '362', 'groupId': 'BG000'}, {'value': '382', 'groupId': 'BG001'}, {'value': '744', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1412}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2014-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2012-02-16', 'resultsFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-30', 'studyFirstPostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)'}, {'measure': 'Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for measles virus IgG antibody levels by an ELISA'}, {'measure': 'Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)'}, {'measure': 'Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for rubella virus IgG antibody levels by an ELISA'}, {'measure': 'Geometric Mean Titer (GMT) of VZV Antibodies', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for VZV IgG antibody levels by gpELISA'}, {'measure': 'Geometric Mean Titer (GMT) of Measles Virus Antibodies', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for measles virus IgG antibody levels by ELISA'}, {'measure': 'Geometric Mean Titer (GMT) of Mumps Virus Antibodies', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for mumps virus IgG antibody levels by ELISA'}, {'measure': 'Geometric Mean Titer (GMT) of Rubella Virus Antibodies', 'timeFrame': 'Six weeks after vaccination 1', 'description': 'Sera were tested for rubella virus IgG antibody levels by ELISA'}, {'measure': 'Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)', 'timeFrame': 'Up to 5 days after vaccination 1'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)', 'timeFrame': 'Up to 42 days after each vaccination'}, {'measure': 'Percentage of Participants With Zoster-like Rash', 'timeFrame': 'Up to 42 days after each vaccination'}, {'measure': 'Percentage of Participants With Mumps-like Symptoms', 'timeFrame': 'Up to 42 days after each vaccination'}, {'measure': 'Percentage of Participants With Measles-like Rash', 'timeFrame': 'Up to 42 days after each vaccination'}, {'measure': 'Percentage of Participants With Rubella-like Rash', 'timeFrame': 'Up to 42 days after each vaccination'}, {'measure': 'Percentage of Participants With Varicella-like Rash', 'timeFrame': 'Up to 42 days after each vaccination'}, {'measure': 'Percentage of Participants With an Injection-site Adverse Event', 'timeFrame': 'Up to 5 days after each vaccination', 'description': 'An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Measles', 'Mumps', 'Rubella', 'Varicella']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=V221-027&kw=V221-027&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '27149048', 'type': 'RESULT', 'citation': 'Marshall GS, Senders SD, Shepard J, Twiggs JD, Gardner J, Hille D, Hartzel J, Valenzuela R, Stek JE, Helmond FA. A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. Hum Vaccin Immunother. 2016 Aug 2;12(8):2188-2196. doi: 10.1080/21645515.2016.1165374. Epub 2016 May 5.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Negative clinical history for measles, mumps, rubella, varicella, and zoster\n\nExclusion Criteria:\n\n* Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study\n* Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study\n* Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination\n* Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy\n* Received 1) systemic immunomodulatory steroids \\[greater than the\n\nequivalent of 2 mg/kg total daily dose of prednisone\\] within 3 months prior to\n\nentering the study, or 2) any dose of systemic immunomodulatory steroids within\n\n7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study\n\n* History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines\n* Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination\n* Diagnosis of an active neurological disorder. Enrollment may be considered\n\nwhen the disease process has been stabilized\n\n* History of seizure disorder, including single febrile seizure\n* Diagnosis of active untreated tuberculosis\n* History of thrombocytopenia\n* Born to a human immunodeficiency virus (HIV) infected mother'}, 'identificationModule': {'nctId': 'NCT01536405', 'briefTitle': 'Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)', 'orgStudyIdInfo': {'id': 'V221-027'}, 'secondaryIdInfos': [{'id': 'P20930'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MMRV (AMP)', 'description': 'Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)', 'interventionNames': ['Biological: MMRV (AMP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MMRV (2006 process)', 'description': 'Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process', 'interventionNames': ['Biological: MMRV (2006 process)']}], 'interventions': [{'name': 'MMRV (AMP)', 'type': 'BIOLOGICAL', 'description': 'Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.', 'armGroupLabels': ['MMRV (AMP)']}, {'name': 'MMRV (2006 process)', 'type': 'BIOLOGICAL', 'otherNames': ['ProQuad™'], 'description': 'Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.', 'armGroupLabels': ['MMRV (2006 process)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}