Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-04-04 @ 9:25 PM
Study NCT ID:
NCT00985166
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
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': 'GMTs (adjusted for prevaccination titer, study center, and primary vaccination history status) have been reported in the literature. One subject received diluent only at visit 1 and was excluded from all immunogenicity/safety summaries.'}}, 'adverseEventsModule': {'description': 'The number of participants listed as "at risk" is the number of participants with follow-up.\n\n0/0 indicates that subjects in this treatment group did not receive the indicated vaccine.', 'eventGroups': [{'id': 'EG000', 'title': 'ProQuad™ + Placebo', 'description': 'ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.', 'otherNumAtRisk': 397, 'otherNumAffected': 292, 'seriousNumAtRisk': 397, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'M-M-R™ II + Placebo', 'description': 'M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.', 'otherNumAtRisk': 205, 'otherNumAffected': 150, 'seriousNumAtRisk': 205, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'M-M-R™ II + VARIVAX™', 'description': 'VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.', 'otherNumAtRisk': 193, 'otherNumAffected': 140, 'seriousNumAtRisk': 193, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Abdominal pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Diarrhoea NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Vomiting NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Venipuncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Ear infection NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Gastroenteritis viral NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Otitis media NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pneumonia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Sinusitis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Upper respiratory tract infection NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Viral infection NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Appetite decreased NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Asthma NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Bronchospasm NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Rash NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site bruising (M-M-R II Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site erythema (M-M-R II Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site pain (M-M-R II Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site swelling (M-M-R II Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site bruising (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site erythema (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site pain (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site pruritus (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site rash (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site swelling (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site bruising (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site erythema (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site nodule (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site pain (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 71}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site pruritus (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injection site swelling (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'seriousEvents': [{'term': 'Pyelonephritis - Not other wise Specified (NOS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ + Placebo', 'description': 'ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.'}, {'id': 'OG001', 'title': 'M-M-R™ II + VARIVAX™', 'description': 'VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '322.2', 'groupId': 'OG000', 'lowerLimit': '278.9', 'upperLimit': '372.2'}, {'value': '209.3', 'groupId': 'OG001', 'lowerLimit': '171.2', 'upperLimit': '255.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer of antibody to Varicella', 'unitOfMeasure': 'gpELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '171', 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antibody to Measles', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ + Placebo', 'description': 'ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.'}, {'id': 'OG001', 'title': 'M-M-R™ II + Placebo', 'description': 'M-M-R™ II + placebo administered concomitantly at 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procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ProQuad™ + Placebo', 'description': 'ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.'}, {'id': 'OG001', 'title': 'M-M-R™ II + Placebo', 'description': 'M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.'}, {'id': 'OG002', 'title': 'M-M-R™ II + VARIVAX™', 'description': 'VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '217.3', 'groupId': 'OG000', 'lowerLimit': '200.1', 'upperLimit': '236.0'}, {'value': '174.0', 'groupId': 'OG001', 'lowerLimit': '157.3', 'upperLimit': '192.6'}, {'value': '154.1', 'groupId': 'OG002', 'lowerLimit': '138.9', 'upperLimit': '170.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer of antibody to Rubella', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ProQuad™ + Placebo', 'description': 'ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.'}, {'id': 'FG001', 'title': 'M-M-R™ II + Placebo', 'description': 'M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.'}, {'id': 'FG002', 'title': 'M-M-R™ II + VARIVAX™', 'description': 'VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Two randomized subjects withdrew consent before vaccination: no demographic information available.', 'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '195'}]}, {'type': 'Vaccinated at Visit 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '399'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '195'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '201'}, {'groupId': 'FG002', 'numSubjects': '188'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Test not done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '17 clinical sites in the United States\n\nDate of first participant visit: 24-Aug-2000\n\nDate of last participant visit: 06-May-2002', 'preAssignmentDetails': 'Prior to entering study, all subjects received primary dose of M-M-R II™ and Varivax™ at less than or equal to 12 months of age.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}, {'value': '799', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ProQuad™ + Placebo', 'description': 'ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.'}, {'id': 'BG001', 'title': 'M-M-R™ II + Placebo', 'description': 'M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.'}, {'id': 'BG002', 'title': 'M-M-R™ II + VARIVAX™', 'description': 'VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '373', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '426', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}, {'title': 'Asian/Pacific', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '313', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '628', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 801}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2009-09-24', 'resultsFirstSubmitDate': '2009-12-23', 'studyFirstSubmitQcDate': '2009-09-25', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-23', 'studyFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer of antibody to Varicella'}, {'measure': 'Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer of antibody to Measles'}, {'measure': 'Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer of antibody to Mumps'}, {'measure': 'Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed Geometric Mean Titer of antibody to Rubella'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Measles', 'Mumps', 'Rubella', 'Varicella']}, 'referencesModule': {'references': [{'pmid': '16452343', 'type': 'RESULT', 'citation': 'Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. doi: 10.1542/peds.2005-0092.'}]}, 'descriptionModule': {'briefSummary': 'The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good health\n* Received primary dose of M-M-R II at less than or equal to 12 months of age\n* Received primary dose of Varivax at less than or equal to 12 months of age\n* Negative history of varicella, zoster, measles, mumps, and rubella\n\nExclusion Criteria:\n\n* history of receiving more than once dose of M-M-R II or Varivax\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* Receipt of immune globulin, or blood product in the past 5 months'}, 'identificationModule': {'nctId': 'NCT00985166', 'briefTitle': 'A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age', 'orgStudyIdInfo': {'id': 'V221-014'}, 'secondaryIdInfos': [{'id': '2009_668'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ProQuad + Placebo', 'interventionNames': ['Biological: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)', 'Biological: Comparator: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'M-M-R II + Placebo', 'interventionNames': ['Biological: Comparator: M-M-R II', 'Biological: Comparator: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'M-M-R II + Varivax', 'interventionNames': ['Biological: Comparator: M-M-R II', 'Biological: Comparator: Varivax']}], 'interventions': [{'name': 'ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)', 'type': 'BIOLOGICAL', 'otherNames': ['ProQuad'], 'description': 'A Single 0.5 mL subcutaneous injection at Day 1', 'armGroupLabels': ['1']}, {'name': 'Comparator: M-M-R II', 'type': 'BIOLOGICAL', 'description': 'A Single 0.5 mL subcutaneous injection at Day 1', 'armGroupLabels': ['2', '3']}, {'name': 'Comparator: Varivax', 'type': 'BIOLOGICAL', 'description': 'A Single 0.5 mL subcutaneous injection at Day 1', 'armGroupLabels': ['3']}, {'name': 'Comparator: Placebo', 'type': 'BIOLOGICAL', 'description': 'A Single 0.5 mL subcutaneous placebo injection at Day 1', 'armGroupLabels': ['1', '2']}]}, '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'}}}}