Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT01621802
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2012-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022542', 'term': 'Measles-Mumps-Rubella Vaccine'}, {'id': 'C051021', 'term': 'DTPP vaccine'}, {'id': 'C050102', 'term': 'measles, mumps, rubella, varicella vaccine'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D008458', 'term': 'Measles Vaccine'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D009108', 'term': 'Mumps Vaccine'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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}}, 'adverseEventsModule': {'timeFrame': 'Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).', 'eventGroups': [{'id': 'EG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).', 'otherNumAtRisk': 802, 'deathsNumAtRisk': 802, 'otherNumAffected': 544, 'seriousNumAtRisk': 802, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 198, 'seriousNumAtRisk': 298, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).', 'otherNumAtRisk': 796, 'deathsNumAtRisk': 796, 'otherNumAffected': 410, 'seriousNumAtRisk': 796, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).', 'otherNumAtRisk': 303, 'deathsNumAtRisk': 303, 'otherNumAffected': 156, 'seriousNumAtRisk': 303, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).', 'otherNumAtRisk': 1319, 'deathsNumAtRisk': 1319, 'otherNumAffected': 702, 'seriousNumAtRisk': 1319, 'deathsNumAffected': 0, 'seriousNumAffected': 25}, {'id': 'EG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).', 'otherNumAtRisk': 489, 'deathsNumAtRisk': 489, 'otherNumAffected': 279, 'seriousNumAtRisk': 489, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 41, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 41, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 50, 'numAffected': 47}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 159, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 61, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 173, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 75, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 147, 'numAffected': 147}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 53, 'numAffected': 53}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 242, 'numAffected': 242}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 90, 'numAffected': 90}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 321, 'numAffected': 309}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 125, 'numAffected': 118}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 153, 'numAffected': 153}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 278, 'numAffected': 278}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 123, 'numAffected': 123}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 97, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 32, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 108, 'numAffected': 108}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 100, 'numAffected': 77}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 143, 'numAffected': 112}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 57, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 177, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 67, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 146, 'numAffected': 146}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 58, 'numAffected': 58}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 257, 'numAffected': 257}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 96, 'numAffected': 96}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 61, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 56, 'numAffected': 56}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 199, 'numAffected': 199}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 73, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 66, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 35, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 107, 'numAffected': 92}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cyclic vomiting syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Accidental exposure to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adenoidal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eczema vesicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 802, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 796, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 489, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '697', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '281', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in seroresponse rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.00', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '1.98', 'estimateComment': 'Difference in percentage (Inv\\_MMR\\_CO Group minus Com\\_MMR\\_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.', 'groupDescription': 'Power obtained using PASS 2005 (Likelihood Score \\[Miettienen and Nurminen approach\\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \\& alpha=1.25%.\n\nThe global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv\\_MMR\\_CO Group minus pooled Com\\_MMR\\_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Seroresponse rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.71', 'ciLowerLimit': '0.02', 'ciUpperLimit': '2.97', 'estimateComment': 'Difference in percentage (Inv\\_MMR\\_I Group minus Com\\_MMR\\_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.', 'groupDescription': 'Power obtained using PASS 2005 (Likelihood Score \\[Miettienen and Nurminen approach\\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \\& alpha=1.25%.\n\nThe global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\\_MMR\\_I group minus pooled Com\\_MMR\\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on According to Protocol (ATP) cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '698', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in seroresponse rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.00', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '1.97', 'estimateComment': 'Difference in percentage (Inv\\_MMR\\_CO Group minus Com\\_MMR\\_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.', 'groupDescription': 'Power obtained using PASS 2005 (Likelihood Score \\[Miettienen and Nurminen approach\\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \\& alpha=1.25%.\n\nThe global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\\_MMR\\_CO Group minus pooled Com\\_MMR\\_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Seroresponse rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.00', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '1.75', 'estimateComment': 'Difference in percentage (Inv\\_MMR\\_I Group minus Com\\_MMR\\_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.', 'groupDescription': 'Power obtained using PASS 2005 (Likelihood Score \\[Miettienen and Nurminen approach\\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \\& alpha=1.25%.\n\nThe global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\\_MMR\\_I group minus pooled Com\\_MMR\\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '696', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in seroresponse rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.14', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '1.84', 'estimateComment': 'Difference in percentage (Inv\\_MMR\\_CO Group minus Com\\_MMR\\_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.', 'groupDescription': 'Power obtained using PASS 2005 (Likelihood Score \\[Miettienen and Nurminen approach\\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \\& alpha=1.25%.\n\nThe global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\\_MMR\\_CO group minus pooled Com\\_MMR\\_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in seroresponse rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.00', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '1.75', 'estimateComment': 'Difference in percentage (Inv\\_MMR\\_I Group minus Com\\_MMR\\_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.', 'groupDescription': 'Power obtained using PASS 2005 (Likelihood Score \\[Miettienen and Nurminen approach\\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \\& alpha=1.25%.\n\nThe global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\\_MMR\\_I group minus pooled Com\\_MMR\\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '4335.0', 'groupId': 'OG000', 'lowerLimit': '4089.7', 'upperLimit': '4594.9'}, {'value': '4215.6', 'groupId': 'OG001', 'lowerLimit': '3806.7', 'upperLimit': '4668.4'}, {'value': '3646.6', 'groupId': 'OG002', 'lowerLimit': '3453.5', 'upperLimit': '3850.4'}, {'value': '3503.9', 'groupId': 'OG003', 'lowerLimit': '3174.6', 'upperLimit': '3867.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.99', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.06', 'estimateComment': 'The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': 'Ancova model: adjustment for baseline concentration - pooled variance', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\\_MMR\\_CO group divided by pooled Com\\_MMR\\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.03', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.10', 'estimateComment': 'The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': 'Ancova model: adjustment for baseline concentration country - pooled variance', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\\_MMR\\_I group divided by pooled Com\\_MMR\\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '170.5', 'groupId': 'OG000', 'lowerLimit': '161.6', 'upperLimit': '179.9'}, {'value': '190.1', 'groupId': 'OG001', 'lowerLimit': '174.7', 'upperLimit': '206.8'}, {'value': '167.2', 'groupId': 'OG002', 'lowerLimit': '158.6', 'upperLimit': '176.3'}, {'value': '176.2', 'groupId': 'OG003', 'lowerLimit': '161.5', 'upperLimit': '192.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.91', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.00', 'estimateComment': 'The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': 'Ancova model: adjustment for baseline concentration - pooled variance', 'nonInferiorityComment': 'The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\\_MMR\\_CO group divided by pooled Com\\_MMR\\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.96', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.06', 'estimateComment': 'The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': 'Ancova model: adjustment for baseline concentration - pooled variance.', 'nonInferiorityComment': 'The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\\_MMR\\_I group divided by pooled Com\\_MMR\\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'PRIMARY', 'title': 'Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100.4'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '103.0'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '95.3', 'upperLimit': '102.8'}, {'value': '98.7', 'groupId': 'OG003', 'lowerLimit': '93.2', 'upperLimit': '104.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.03', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.09', 'estimateComment': 'The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.', 'groupDescription': 'Adjusted geometric mean concentration (GMC) ratio (Inv\\_MMR\\_CO group divided by Com\\_MMR\\_CO group) for antibodies to rubella virus.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': 'Ancova model: adjustment for baseline concentration - pooled variance.', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\\_MMR\\_CO group divided by pooled Com\\_MMR\\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.01', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.07', 'estimateComment': 'The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': 'Ancova model: adjustment for baseline concentration - pooled variance.', 'nonInferiorityComment': 'Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\\_MMR\\_I group divided by pooled Com\\_MMR\\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '693', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '887.7', 'groupId': 'OG000', 'lowerLimit': '834.3', 'upperLimit': '944.4'}, {'value': '820.4', 'groupId': 'OG001', 'lowerLimit': '749.3', 'upperLimit': '898.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'title': 'Anti-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '659', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '657', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}]}, {'title': 'Anti-T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '621', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Booster response was defined as:\n\nFor subjects with pre-vaccination antibody concentration less than (\\<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.\n\nFor subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.\n\nAnalysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '659', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '643', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Booster response was defined as:\n\nFor initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration \\< 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.\n\nAnalysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '659', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '620', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Booster response was defined as:\n\nFor initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration \\< 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.\n\nAnalysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Booster Response to Pertactin (PRN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '660', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '657', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Booster response was defined as:\n\nFor initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration \\< 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.\n\nAnalysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '18.1'}, {'value': '17.8', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '19.6'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '7.8'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '9.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000', 'lowerLimit': '71.6', 'upperLimit': '82.0'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '66.2', 'upperLimit': '82.4'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '316.2', 'groupId': 'OG000', 'lowerLimit': '299.4', 'upperLimit': '334.0'}, {'value': '319.3', 'groupId': 'OG001', 'lowerLimit': '293.1', 'upperLimit': '347.9'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '402.2', 'groupId': 'OG000', 'lowerLimit': '370.4', 'upperLimit': '436.8'}, {'value': '427.3', 'groupId': 'OG001', 'lowerLimit': '377.6', 'upperLimit': '483.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '684', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '684', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Analysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '683', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '678', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Analysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'title': 'Anti-Polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1618.7', 'groupId': 'OG000', 'lowerLimit': '1499.8', 'upperLimit': '1747.0'}, {'value': '1587.3', 'groupId': 'OG001', 'lowerLimit': '1387.3', 'upperLimit': '1816.1'}]}]}, {'title': 'Anti-Polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2026.4', 'groupId': 'OG000', 'lowerLimit': '1881.2', 'upperLimit': '2182.7'}, {'value': '2206.1', 'groupId': 'OG001', 'lowerLimit': '1955.2', 'upperLimit': '2489.3'}]}]}, {'title': 'Anti-Polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2753.5', 'groupId': 'OG000', 'lowerLimit': '2512.4', 'upperLimit': '3017.6'}, {'value': '3040.6', 'groupId': 'OG001', 'lowerLimit': '2613.0', 'upperLimit': '3538.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.', 'unitOfMeasure': 'ED50', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \\& complied with protocol procedures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '766', 'groupId': 'OG002'}, {'value': '289', 'groupId': 'OG003'}, {'value': '1289', 'groupId': 'OG004'}, {'value': '480', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'OG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '278', 'groupId': 'OG004'}, {'value': '123', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '242', 'groupId': 'OG004'}, {'value': '90', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . \\> 50mm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '731', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.\n\nAnalysis was done for sub-cohort 1 only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '731', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '767', 'groupId': 'OG002'}, {'value': '291', 'groupId': 'OG003'}, {'value': '1291', 'groupId': 'OG004'}, {'value': '481', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'OG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'title': 'Any fever', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '257', 'groupId': 'OG004'}, {'value': '96', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3 fever', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Related fever', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Any fever = fever ≥ 38°C; Grade 3 fever = fever \\> 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting MMR Specific Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '731', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '767', 'groupId': 'OG002'}, {'value': '291', 'groupId': 'OG003'}, {'value': '1291', 'groupId': 'OG004'}, {'value': '481', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'OG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'title': 'Any Sign of meningism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3 Sign of meningism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Related Sign of meningism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any Parotid gland swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3 Parotid gland swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Related Parotid gland swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Investigator-confirmed Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '731', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '767', 'groupId': 'OG002'}, {'value': '291', 'groupId': 'OG003'}, {'value': '1291', 'groupId': 'OG004'}, {'value': '481', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'OG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'title': 'Any localized or generalized', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Any with fever', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Any Varicella like', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any Measles/Rubella like', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Any grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any related', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Localized any', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'Localized administration site', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Localized other site', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'Localized with fever', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Localized Varicella like', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Localized Measles/Rubella like', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Localized Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Localized related', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Generalized any', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Generalized with fever', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Generalized Varicella like', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Generalized Measles/Rubella like', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Generalized Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Generalized Related', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With New Onset Chronic Diseases (NOCDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '802', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '796', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '1319', 'groupId': 'OG004'}, {'value': '489', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'OG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Day 180)', 'description': 'NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '802', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '796', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '1319', 'groupId': 'OG004'}, {'value': '489', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'OG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Day 180)', 'description': 'The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '802', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '796', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '1319', 'groupId': 'OG004'}, {'value': '489', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'OG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}, {'value': '508', 'groupId': 'OG004'}, {'value': '186', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '802', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '796', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}, {'value': '1319', 'groupId': 'OG004'}, {'value': '489', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-RII (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'OG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'OG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'OG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Day 180)', 'description': 'Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'FG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'FG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'FG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'FG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'FG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '802'}, {'groupId': 'FG001', 'numSubjects': '298'}, {'groupId': 'FG002', 'numSubjects': '796'}, {'groupId': 'FG003', 'numSubjects': '303'}, {'groupId': 'FG004', 'numSubjects': '1319'}, {'groupId': 'FG005', 'numSubjects': '489'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '755'}, {'groupId': 'FG001', 'numSubjects': '275'}, {'groupId': 'FG002', 'numSubjects': '763'}, {'groupId': 'FG003', 'numSubjects': '292'}, {'groupId': 'FG004', 'numSubjects': '1284'}, {'groupId': 'FG005', 'numSubjects': '477'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '35'}, {'groupId': 'FG005', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Subjects were enrolled in 3 sub-cohorts. Sub-cohort 1: Inv\\_MMR\\_CO and Com\\_MMR\\_CO (Lot 1 or Lot 2), Sub-cohort 2: Inv\\_MMR\\_I and Com\\_MMR\\_I (Lot 1 or Lot 2) and Sub-cohort 3: Inv\\_MMR\\_S and Com\\_MMR\\_S (Lot 1 or Lot 2).', 'preAssignmentDetails': '4011 subjects were enrolled in the study with 4007 eligible subjects receiving a study vaccination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '802', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '796', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}, {'value': '1319', 'groupId': 'BG004'}, {'value': '489', 'groupId': 'BG005'}, {'value': '4007', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Inv_MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'BG001', 'title': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).'}, {'id': 'BG002', 'title': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'BG003', 'title': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'BG004', 'title': 'Inv_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).'}, {'id': 'BG005', 'title': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '4.1', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'BG002'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'BG003'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'BG004'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'BG005'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '398', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}, {'value': '632', 'groupId': 'BG004'}, {'value': '225', 'groupId': 'BG005'}, {'value': '1903', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '404', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '687', 'groupId': 'BG004'}, {'value': '264', 'groupId': 'BG005'}, {'value': '2104', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'African Heritage / African American', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '328', 'groupId': 'BG006'}]}, {'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '190', 'groupId': 'BG006'}]}, {'title': 'Asian - Central/South Asian Heritage', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}, {'title': 'Asian - East Asian Heritage', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}, {'value': '565', 'groupId': 'BG004'}, {'value': '209', 'groupId': 'BG005'}, {'value': '1338', 'groupId': 'BG006'}]}, {'title': 'Asian - Japanese Heritage', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Asian - South East Asian Heritage', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '113', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '275', 'groupId': 'BG006'}]}, {'title': 'White - Arabic / North African Heritage', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}, {'title': 'White - Caucasian / European Heritage', 'measurements': [{'value': '363', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '575', 'groupId': 'BG004'}, {'value': '218', 'groupId': 'BG005'}, {'value': '1699', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4011}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'dispFirstSubmitDate': '2016-07-06', 'completionDateStruct': {'date': '2015-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2012-06-14', 'dispFirstSubmitQcDate': '2016-07-06', 'resultsFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2012-06-14', 'dispFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-14', 'studyFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.'}, {'measure': 'Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.'}, {'measure': 'Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.'}, {'measure': 'Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations', 'timeFrame': '42 days after vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.'}, {'measure': 'Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.'}, {'measure': 'Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.'}, {'measure': 'Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.'}, {'measure': 'Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Booster response was defined as:\n\nFor subjects with pre-vaccination antibody concentration less than (\\<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.\n\nFor subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.\n\nAnalysis was done in sub-cohort 1 only.'}, {'measure': 'Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Booster response was defined as:\n\nFor initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration \\< 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.\n\nAnalysis was done in sub-cohort 1 only.'}, {'measure': 'Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Booster response was defined as:\n\nFor initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration \\< 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.\n\nAnalysis was done in sub-cohort 1 only.'}, {'measure': 'Number of Subjects With Antibody Booster Response to Pertactin (PRN)', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Booster response was defined as:\n\nFor initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration \\< 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.\n\nFor initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.\n\nAnalysis was done in sub-cohort 1 only.'}, {'measure': 'Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.'}, {'measure': 'Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.'}, {'measure': 'Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Analysis was done in sub-cohort 1 only.'}, {'measure': 'Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Analysis was done in sub-cohort 1 only.'}, {'measure': 'Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers', 'timeFrame': '42 days post vaccination (At Day 42)', 'description': 'Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.'}, {'measure': 'Number of Subjects With Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . \\> 50mm.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.\n\nAnalysis was done for sub-cohort 1 only.'}, {'measure': 'Number of Subjects Reporting Fever', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Any fever = fever ≥ 38°C; Grade 3 fever = fever \\> 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.'}, {'measure': 'Number of Subjects Reporting MMR Specific Solicited General Symptoms', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.'}, {'measure': 'Number of Subjects Reporting Investigator-confirmed Rash', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.'}, {'measure': 'Number of Subjects With New Onset Chronic Diseases (NOCDs)', 'timeFrame': 'During the entire study period (from Day 0 up to Day 180)', 'description': 'NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.'}, {'measure': 'Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits', 'timeFrame': 'During the entire study period (from Day 0 up to Day 180)', 'description': 'The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period (from Day 0 up to Day 180)', 'description': 'Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safety', 'Measles, mumps and rubella diseases', 'Immunogenicity'], 'conditions': ['Measles-Mumps-Rubella']}, 'referencesModule': {'references': [{'pmid': '30785357', 'type': 'BACKGROUND', 'citation': 'MMR-158 Study Group. A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration. Hum Vaccin Immunother. 2019;15(4):786-799. doi: 10.1080/21645515.2018.1554971. Epub 2019 Feb 20.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.", 'detailedDescription': "The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv\\_MMR vaccine and Com\\_MMR vaccine respectively. 2 lots of the comparator vaccine (Com\\_MMR\\_L1 and Com\\_MMR\\_L2) will be used, but the 2 lots will be analysed as a pool.\n\nThe Inv\\_MMR vaccine will be administered as a second dose to children who already received a first dose Com\\_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.\n* Male or female subjects 4 to 6 years of age at the time of vaccination.\n* Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).\n* Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.\n* Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.\n* For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:\n\n * subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.\n * subjects received a first dose of VV in the second year of life.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.\n* Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.\n* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.\n* Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.\n* History of measles, mumps, and/or rubella disease.\n* Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin or gelatin.\n* Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.\n* Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C (100.4°F) measured by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.\n* Active untreated tuberculosis according to the subject's medical history.\n* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.\n\nIn addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:\n\n* Previous vaccination with a second dose of varicella-containing vaccine.\n* Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination.\n* History of varicella/zoster disease.\n* Known exposure to varicella/zoster during the period starting 30 days prior to enrollment.\n* History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.\n* Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life.\n* Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids.\n* Following a previous administration of DTP vaccine: temperature ≥40.6°C (\\>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine.\n* Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines."}, 'identificationModule': {'nctId': 'NCT01621802', 'briefTitle': "Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)", 'orgStudyIdInfo': {'id': '115158'}, 'secondaryIdInfos': [{'id': '2011-004638-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inv _MMR_CO Group', 'description': 'Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).', 'interventionNames': ['Biological: Priorix', 'Biological: Kinrix', 'Biological: ProQuad']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Com_MMR_CO Group', 'description': 'Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).', 'interventionNames': ['Biological: M-M-R II', 'Biological: Kinrix', 'Biological: ProQuad']}, {'type': 'EXPERIMENTAL', 'label': 'Inv_MMR_I Group', 'description': 'Subjects received one dose of Priorix at Visit 1 (Day 0).', 'interventionNames': ['Biological: Priorix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Com_MMR_I Group', 'description': 'Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).', 'interventionNames': ['Biological: M-M-R II']}, {'type': 'EXPERIMENTAL', 'label': 'Inv _MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).', 'interventionNames': ['Biological: Priorix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Com_MMR_S Group', 'description': 'Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).', 'interventionNames': ['Biological: M-M-R II']}], 'interventions': [{'name': 'Priorix', 'type': 'BIOLOGICAL', 'description': 'One dose administered subcutaneously in the triceps region of the right arm.', 'armGroupLabels': ['Inv _MMR_CO Group', 'Inv _MMR_S Group', 'Inv_MMR_I Group']}, {'name': 'M-M-R II', 'type': 'BIOLOGICAL', 'description': 'One dose administered subcutaneously in the triceps region of the right arm.', 'armGroupLabels': ['Com_MMR_CO Group', 'Com_MMR_I Group', 'Com_MMR_S Group']}, {'name': 'Kinrix', 'type': 'BIOLOGICAL', 'description': 'One dose administered by deep intramuscular injection in the upper left deltoid.', 'armGroupLabels': ['Com_MMR_CO Group', 'Inv _MMR_CO Group']}, {'name': 'ProQuad', 'type': 'BIOLOGICAL', 'description': 'One dose administered subcutaneously in the triceps region of the left arm.', 'armGroupLabels': ['Com_MMR_CO Group', 'Inv _MMR_CO Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 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24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=19838', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}