Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT00984295
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2009-09-23
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, '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': 'Two participants were incorrectly vaccinated and are not included in the efficacy/safety analyses. One received M-M-R™II+TRIPEDIA™+COMVAX™ and 1 received VARIVAX™+TRIPEDIA™+COMVAX™ instead of ProQuad™+TRIPEDIA™+COMVAX™'}}, 'adverseEventsModule': {'timeFrame': 'Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).', 'description': 'Number of participants reported as "At Risk" is the number of participants with follow-up.\n\nAlthough a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.', 'eventGroups': [{'id': 'EG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.', 'otherNumAtRisk': 929, 'otherNumAffected': 831, 'seriousNumAtRisk': 929, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.', 'otherNumAtRisk': 479, 'otherNumAffected': 435, 'seriousNumAtRisk': 479, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.', 'otherNumAtRisk': 467, 'otherNumAffected': 411, 'seriousNumAtRisk': 467, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 295}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 142}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 136}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Infection, Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Gastroenteritis, Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 67}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Congestion, Nasal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Congestion, Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Infection, Respiratory, Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 258}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 131}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 108}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Laryngotracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 10}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 41}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Bite/Sting, Non-Venomous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Dermatitis, Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Miliaria Rubra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rash, Diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 43}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rash, Measles/Rubella-Like', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rash, Varicella-Like', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Viral Exanthema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Otitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 13}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 77}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pain, Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Ecchymosis (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Erythema (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pain/Tenderness/Soreness (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 308}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 121}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Rash (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Swelling (ProQuad Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Erythema (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 56}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pain/Tenderness/Soreness (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 121}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Swelling (Varivax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Erythema (M-M-R II Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 64}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pain/Tenderness/Soreness (M-M-R II Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 125}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Swelling (M-M-R II Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Ecchymosis (Tripedia Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Erythema (Tripedia Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 244}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 113}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 110}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pain/Tenderness/Soreness (Tripedia Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 327}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 134}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 140}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Swelling (Tripedia Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 78}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Ecchymosis (Comvax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Erythema (Comvax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 266}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 118}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 113}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Induration (Comvax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pain/Tenderness/Soreness (Comvax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 327}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 143}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 139}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Swelling (Comvax Injection-site)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 204}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 82}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}], 'seriousEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Hernia, inguinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Infection, viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Allergy, food', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Afebrile seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Seizure, febrile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Laryngotracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Cellulitis, orbital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}, {'term': 'Necrosis, testicle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 479, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Merck CRISP'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '741', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Weeks Postvaccination', 'description': 'Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \\<120 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': 'PRIMARY', 'title': 'Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '774', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \\<10 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': 'PRIMARY', 'title': 'Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '829', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '817', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody Response to Rubella at 6 Weeks Postvaccination for 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': 'PRIMARY', 'title': 'Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '757', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '679', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \\<0.6 gpELISA units/mL) to VZV at Baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants\n\nwho had pre- and post-randomization blood samples within predefined day ranges, were seronegative to\n\nvaricella at baseline, and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '667', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Diphtheria at 6 weeks postvaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '803', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '796', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '748', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '554', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '748', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and 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EIA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '825', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '791', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) 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'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '3504.9', 'groupId': 'OG000', 'lowerLimit': '3269.7', 'upperLimit': '3757.2'}, {'value': '3506.2', 'groupId': 'OG001', 'lowerLimit': '3195.7', 'upperLimit': '3846.9'}, {'value': '2562.1', 'groupId': 'OG002', 'lowerLimit': '2172.2', 'upperLimit': '3022.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)', '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, were seronegative to measles at baseline, and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '811', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '95.7'}, {'value': '84.1', 'groupId': 'OG001', 'lowerLimit': '76.2', 'upperLimit': '92.8'}, {'value': '98.1', 'groupId': 'OG002', 'lowerLimit': '85.7', 'upperLimit': '112.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)', 'unitOfMeasure': 'ELISA Ab 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, were seronegative to mumps at baseline, and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '829', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '105.0'}, {'value': '99.9', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '108.7'}, {'value': '126.3', 'groupId': 'OG002', 'lowerLimit': '111.9', 'upperLimit': '142.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)', '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, were seronegative to rubella at baseline, and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '757', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '14.8'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '17.0'}, {'value': '15.8', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '18.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)', 'unitOfMeasure': 'gpELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '1.43'}, {'value': '1.72', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '1.89'}, {'value': '1.59', 'groupId': 'OG002', 'lowerLimit': '1.29', 'upperLimit': '1.97'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '748', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '46.5'}, {'value': '55.7', 'groupId': 'OG001', 'lowerLimit': '49.7', 'upperLimit': '62.4'}, {'value': '46.3', 'groupId': 'OG002', 'lowerLimit': '35.0', 'upperLimit': '61.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).', 'unitOfMeasure': 'units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '748', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000', 'lowerLimit': '53.7', 'upperLimit': '62.9'}, {'value': '81.2', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '89.7'}, {'value': '65.0', 'groupId': 'OG002', 'lowerLimit': '49.6', 'upperLimit': '85.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)', 'unitOfMeasure': 'units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '825', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '758', 'groupId': 'OG000', 'lowerLimit': '658', 'upperLimit': '874'}, {'value': '996', 'groupId': 'OG001', 'lowerLimit': '828', 'upperLimit': '1199'}, {'value': '1135', 'groupId': 'OG002', 'lowerLimit': '836', 'upperLimit': '1541'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '12.3'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '13.7'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '16.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '803', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'OG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.93', 'groupId': 'OG000', 'lowerLimit': '3.59', 'upperLimit': '4.31'}, {'value': '5.74', 'groupId': 'OG001', 'lowerLimit': '5.13', 'upperLimit': '6.42'}, {'value': '4.36', 'groupId': 'OG002', 'lowerLimit': '3.67', 'upperLimit': '5.17'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'FG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 patients were incorrectly vaccinated and are excluded from this table.', 'groupId': 'FG000', 'numSubjects': '949'}, {'groupId': 'FG001', 'numSubjects': '485'}, {'groupId': 'FG002', 'numSubjects': '479'}]}, {'type': 'Visit 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '949'}, {'groupId': 'FG001', 'numSubjects': '485'}, {'groupId': 'FG002', 'numSubjects': '479'}]}, {'type': 'Visit 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '909'}, {'groupId': 'FG001', 'numSubjects': '468'}, {'groupId': 'FG002', 'numSubjects': '453'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '884'}, {'groupId': 'FG001', 'numSubjects': '453'}, {'groupId': 'FG002', 'numSubjects': '442'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'CAE - discontinued test vaccine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Missed one or more blood samplings', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Incomplete safety follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '48 clinical sites in the United States\n\nDate first participant visit: 27-Jun-2000\n\nDate last participant visit: 23-Oct-2001'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '949', 'groupId': 'BG000'}, {'value': '485', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}, {'value': '1913', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Concomitant Group', 'description': 'Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.'}, {'id': 'BG001', 'title': 'Nonconcomitant Group', 'description': 'Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '12.3', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '12.4', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '12.4', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '442', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '911', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '507', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}, {'value': '1002', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}]}, {'title': 'Asian/Pacific', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '678', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}, {'value': '1356', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1913}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2001-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2009-09-23', 'resultsFirstSubmitDate': '2010-02-03', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-03', 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL', 'timeFrame': '6 Weeks Postvaccination', 'description': 'Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \\<120 mIU/mL) to Measles at Baseline'}, {'measure': 'Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \\<10 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 for Participants Initially Seronegative (a titer \\<10 IU/mL) to Rubella at Baseline'}, {'measure': 'Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \\<0.6 gpELISA units/mL) to VZV at Baseline'}, {'measure': 'Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Diphtheria at 6 weeks postvaccination'}, {'measure': 'Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.'}, {'measure': 'Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).'}, {'measure': 'Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).'}, {'measure': 'Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).'}, {'measure': 'Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL', 'timeFrame': '6 weeks Postvaccination', 'description': 'Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)'}, {'measure': 'Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)'}, {'measure': 'Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)'}, {'measure': 'Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)'}, {'measure': 'Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)'}, {'measure': 'Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)'}, {'measure': 'Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).'}, {'measure': 'Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)'}, {'measure': 'Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)'}, {'measure': 'Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)'}, {'measure': 'Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT', 'timeFrame': '6 weeks Postvaccination', 'description': 'Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Measles', 'Mumps', 'Rubella', 'Varicella']}, 'referencesModule': {'references': [{'pmid': '16567978', 'type': 'RESULT', 'citation': 'Shinefield H, Black S, Thear M, Coury D, Reisinger K, Rothstein E, Xu J, Hartzel J, Evans B, Digilio L, Schodel F, Brown ML, Kuter B; 013 Study Group for ProQuad. Safety and immunogenicity of a measles, mumps, rubella and varicella vaccine given with combined Haemophilus influenzae type b conjugate/hepatitis B vaccines and combined diphtheria-tetanus-acellular pertussis vaccines. Pediatr Infect Dis J. 2006 Apr;25(4):287-92. doi: 10.1097/01.inf.0000207857.10947.1f.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good health\n* Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B\n* Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib vaccine\n* Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into trial\n\nExclusion Criteria:\n\n* Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination\n* Any immune impairment or deficiency\n* Recent household, daycare or school exposure to invasive Hib disease or hepatitis B\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, blood transfusion or blood-derived product in the past 3 months\n* Recent history of fever or underlying medical problems'}, 'identificationModule': {'nctId': 'NCT00984295', 'briefTitle': 'Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Frozen MMRV Given Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines in Healthy Children 12 to 15 Months of Age', 'orgStudyIdInfo': {'id': 'V221-013'}, 'secondaryIdInfos': [{'id': '2009_666'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ProQuad + Tripedia + Comvax at Day 0 (Concomitant)', 'interventionNames': ['Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live', 'Biological: Comparator: Tripedia', 'Biological: Comparator: Comvax']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)', 'interventionNames': ['Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live', 'Biological: Comparator: Tripedia', 'Biological: Comparator: Comvax']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control)', 'interventionNames': ['Biological: Comparator: Tripedia', 'Biological: Comparator: Comvax', 'Biological: Comparator: Varivax', 'Biological: Comparator: M-M-R II']}], 'interventions': [{'name': 'Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live', 'type': 'BIOLOGICAL', 'otherNames': ['ProQuad'], 'description': 'A single 0.5 mL subcutaneous injection at Day 0', 'armGroupLabels': ['1', '2']}, {'name': 'Comparator: Tripedia', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL intramuscular injection (at Day 0 or Day 42)', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Comparator: Comvax', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL intramuscular injection (at Day 0 or Day 42)', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Comparator: Varivax', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL subcutaneous injection at Day 0', 'armGroupLabels': ['3']}, {'name': 'Comparator: M-M-R II', 'type': 'BIOLOGICAL', 'description': 'A single 0.5 mL subcutaneous injection at Day 0', 'armGroupLabels': ['3']}]}, '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'}}}}