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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 3:39 PM

Ignite Modification Date: 2025-12-26 @ 3:56 PM

Study NCT ID: NCT01681992

Status: COMPLETED

Last Update Posted: 2021-01-07

First Post: 2012-09-06

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}], 'ancestors': [{'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D010309', 'term': 'Parotitis'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022542', 'term': 'Measles-Mumps-Rubella Vaccine'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}, {'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022362', 'term': 'Hepatitis A Vaccines'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'C028581', 'term': 'CRM197 (non-toxic variant of diphtheria toxin)'}], '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': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}]}}, '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 & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).', 'eventGroups': [{'id': 'EG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.', 'otherNumAtRisk': 1493, 'deathsNumAtRisk': 1493, 'otherNumAffected': 1299, 'seriousNumAtRisk': 1493, 'deathsNumAffected': 1, 'seriousNumAffected': 91}, {'id': 'EG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.', 'otherNumAtRisk': 1497, 'deathsNumAtRisk': 1497, 'otherNumAffected': 1311, 'seriousNumAtRisk': 1497, 'deathsNumAffected': 0, 'seriousNumAffected': 102}, {'id': 'EG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.', 'otherNumAtRisk': 1526, 'deathsNumAtRisk': 1526, 'otherNumAffected': 1330, 'seriousNumAtRisk': 1526, 'deathsNumAffected': 1, 'seriousNumAffected': 92}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Accidental exposure to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Adenoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Adenoviral conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Allergy to animal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angular cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Application site hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 92, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 115, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 95, 'numAffected': 77}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bullous impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Burn infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1493, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1497, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1361', 'groupId': 'OG000'}, {'value': '1366', 'groupId': 'OG001'}, {'value': '1378', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Anti-measles ≥ 150 mIU/mL', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '89.0', 'upperLimit': '92.6'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '95.6'}, {'value': '96.5', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '97.5'}]}]}, {'title': 'Anti-measles ≥ 200 mIU/mL', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000', 'lowerLimit': '88.9', 'upperLimit': '92.5'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '92.6', 'upperLimit': '95.5'}, {'value': '96.3', 'groupId': 'OG002', 'lowerLimit': '95.0', 'upperLimit': '97.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in seroresponse rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-5.48', 'ciLowerLimit': '-7.65', 'ciUpperLimit': '-3.43', 'estimateComment': 'Asymptotic standardized 97.5% CI for the difference in seroresponse rate.', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Min vaccine compared to Com\\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\\_MMR\\_Min minus Com\\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in seroresponse rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-2.08', 'ciLowerLimit': '-3.96', 'ciUpperLimit': '-0.27', 'estimateComment': 'Asymptotic standardized 97.5% CI for the difference in seroresponse rate.', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Med vaccine compared to Com\\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\\_MMR\\_Med minus Com\\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 42', 'description': 'For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above \\[≥\\] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than \\[\\<\\] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med was to be ≥ 90% for antibodies to measles virus.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'According-to-protocol (ATP) cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \\& post-dose 1 serology results \\& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \\& complied with post-dose 1 blood sample schedule.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1161', 'groupId': 'OG000'}, {'value': '1131', 'groupId': 'OG001'}, {'value': '1155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Anti-mumps ≥ 5 EU/mL', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '98.2', 'upperLimit': '99.6'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '98.1', 'upperLimit': '99.6'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '99.7'}]}]}, {'title': 'Anti-mumps ≥ 10 EU/mL', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '98.3'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '98.2'}, {'value': '97.8', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '98.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in seroresponse rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.42', 'ciLowerLimit': '-1.91', 'ciUpperLimit': '1.04', 'estimateComment': 'Asymptotic standardized 97.5% CI for the difference in seroresponse rate.', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Min vaccine compared to Com\\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group difference (Inv\\_MMR\\_Min minus Com\\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in seroresponse rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.58', 'ciLowerLimit': '-2.11', 'ciUpperLimit': '0.91', 'estimateComment': 'Asymptotic standardized 97.5% CI for the difference in seroresponse rate.', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Med vaccine compared to Com\\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group difference (Inv\\_MMR\\_Med minus Com\\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 42', 'description': 'For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med was to be ≥ 90% for antibodies to mumps virus.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \\& post-dose 1 serology results \\& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \\& complied with post-dose 1 blood sample schedule.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1252', 'groupId': 'OG000'}, {'value': '1265', 'groupId': 'OG001'}, {'value': '1287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': '≥ 2.5 ED50', 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '81.3'}, {'value': '81.6', 'groupId': 'OG001', 'lowerLimit': '79.3', 'upperLimit': '83.7'}, {'value': '87.5', 'groupId': 'OG002', 'lowerLimit': '85.6', 'upperLimit': '89.2'}]}]}, {'title': '≥ 4 ED50', 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '73.7'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '75.8'}, {'value': '80.6', 'groupId': 'OG002', 'lowerLimit': '78.3', 'upperLimit': '82.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in seroresponse rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-9.41', 'ciLowerLimit': '-13.20', 'ciUpperLimit': '-5.62', 'estimateComment': 'Asymptotic standardized 97.5% CI for the difference in seroresponse rate.', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Min vaccine compared to Com\\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group difference (Inv\\_MMR\\_Min minus Com\\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in seroresponse rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-7.22', 'ciLowerLimit': '-10.94', 'ciUpperLimit': '-3.49', 'estimateComment': 'Asymptotic standardized 97.5% CI for the difference in seroresponse rate.', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Med vaccine compared to Com\\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group difference (Inv\\_MMR\\_Med minus Com\\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 42', 'description': 'For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration \\< 2.5 ED50) before dose 1.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \\& post-dose 1 serology results \\& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \\& complied with post-dose 1 blood sample schedule.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1359', 'groupId': 'OG000'}, {'value': '1366', 'groupId': 'OG001'}, {'value': '1376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': '≥ 4 IU/mL', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '99.7'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '98.9', 'upperLimit': '99.8'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '98.9', 'upperLimit': '99.8'}]}]}, {'title': '≥ 10 IU/mL', 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '97.7'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '98.2'}, {'value': '98.5', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '99.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in seroresponse rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.71', 'ciLowerLimit': '-3.11', 'ciUpperLimit': '-0.42', 'estimateComment': 'Asymptotic standardized 97.5% CI for the difference in seroresponse rate.', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Min vaccine compared to Com\\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group difference (Inv\\_MMR\\_Min minus Com\\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in seroresponse rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.18', 'ciLowerLimit': '-2.50', 'ciUpperLimit': '0.05', 'estimateComment': 'Asymptotic standardized 97.5% CI for the difference in seroresponse rate.', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Med vaccine compared to Com\\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group difference (Inv\\_MMR\\_Med minus Com\\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 42', 'description': 'For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med was to be ≥ 90% for antibodies to mumps virus.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \\& post-dose 1 serology results \\& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \\& complied with post-dose 1 blood sample schedule.'}, {'type': 'PRIMARY', 'title': 'Anti-measles Virus Antibody Concentrations (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1361', 'groupId': 'OG000'}, {'value': '1366', 'groupId': 'OG001'}, {'value': '1378', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2209.9', 'groupId': 'OG000', 'lowerLimit': '2041.3', 'upperLimit': '2392.4'}, {'value': '2540.9', 'groupId': 'OG001', 'lowerLimit': '2368.8', 'upperLimit': '2725.5'}, {'value': '2787.7', 'groupId': 'OG002', 'lowerLimit': '2619.5', 'upperLimit': '2966.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.79', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.88', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Min vaccine compared to COM\\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': '97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\\_MMR\\_Min over pooled Com\\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.91', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.01', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Med vaccine compared to COM\\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': '97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\\_MMR\\_Med over pooled Com\\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \\& post-dose 1 serology results \\& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \\& complied with post-dose 1 blood sample schedule.'}, {'type': 'PRIMARY', 'title': 'Anti-mumps Virus Antibody Concentrations (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1161', 'groupId': 'OG000'}, {'value': '1131', 'groupId': 'OG001'}, {'value': '1155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '62.1'}, {'value': '60.2', 'groupId': 'OG001', 'lowerLimit': '56.8', 'upperLimit': '63.7'}, {'value': '71.6', 'groupId': 'OG002', 'lowerLimit': '67.7', 'upperLimit': '75.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.82', 'ciLowerLimit': '0.76', 'ciUpperLimit': '0.89', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Min vaccine compared to COM\\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': '97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\\_MMR\\_Min over pooled Com\\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.84', 'ciLowerLimit': '0.78', 'ciUpperLimit': '0.91', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Med vaccine compared to COM\\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': '97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\\_MMR\\_Med over pooled Com\\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'Antibody concentrations were expressed as GMCs in EU/mL.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \\& post-dose 1 serology results \\& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \\& complied with post-dose 1 blood sample schedule.'}, {'type': 'PRIMARY', 'title': 'Anti-mumps Virus Antibody Concentrations (by PRNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1252', 'groupId': 'OG000'}, {'value': '1265', 'groupId': 'OG001'}, {'value': '1287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '10.6'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '11.5'}, {'value': '16.3', 'groupId': 'OG002', 'lowerLimit': '15.1', 'upperLimit': '17.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.60', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.68', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Min vaccine compared to COM\\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': '97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\\_MMR\\_Min over pooled Com\\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.65', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.74', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Med vaccine compared to COM\\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': '97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\\_MMR\\_Med over pooled Com\\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'Antibody concentrations were expressed as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \\& post-dose 1 serology results \\& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \\& complied with post-dose 1 blood sample schedule.'}, {'type': 'PRIMARY', 'title': 'Anti-rubella Virus Antibody Concentrations (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1359', 'groupId': 'OG000'}, {'value': '1366', 'groupId': 'OG001'}, {'value': '1376', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '54.1', 'upperLimit': '60.0'}, {'value': '56.9', 'groupId': 'OG001', 'lowerLimit': '54.2', 'upperLimit': '59.8'}, {'value': '64.4', 'groupId': 'OG002', 'lowerLimit': '61.4', 'upperLimit': '67.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.89', 'ciLowerLimit': '0.83', 'ciUpperLimit': '0.95', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Min vaccine compared to COM\\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': '97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\\_MMR\\_Min over pooled Com\\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMC ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.88', 'ciLowerLimit': '0.83', 'ciUpperLimit': '0.95', 'groupDescription': 'Non-inferiority of Inv\\_MMR\\_Med vaccine compared to COM\\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': '97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.', 'nonInferiorityComment': 'The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\\_MMR\\_Med over pooled Com\\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'Antibody concentrations were expressed as GMCs in IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \\& post-dose 1 serology results \\& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \\& complied with post-dose 1 blood sample schedule.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': '≥ 150 mIU/mL', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '99.8'}, {'value': '98.8', 'groupId': 'OG002', 'lowerLimit': '96.6', 'upperLimit': '99.8'}]}]}, {'title': '≥ 200 mIU/mL', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '99.6'}, {'value': '98.4', 'groupId': 'OG002', 'lowerLimit': '96.1', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 84', 'description': 'For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 150 mIU/mL) before dose 1.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\\_MMR/Com\\_MMR vaccine, with pre- \\& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \\& complied with post-dose 2 blood sample schedule.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': '≥ 5 EU/mL', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '100'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '96.6', 'upperLimit': '99.9'}]}]}, {'title': '≥ 10 EU/mL', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '100'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 84', 'description': 'For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 5 EU/mL) before dose 1.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\\_MMR/Com\\_MMR vaccine, with pre- \\& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \\& complied with post-dose 2 blood sample schedule.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '255', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': '≥ 4 IU/mL', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100'}]}]}, {'title': '≥ 10 IU/mL', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}, {'value': '99.6', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 84', 'description': 'For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 4 IU/mL) before dose 1.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\\_MMR/Com\\_MMR vaccine, with pre- \\& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \\& complied with post-dose 2 blood sample schedule.'}, {'type': 'SECONDARY', 'title': 'Anti-measles Virus Antibody Concentrations (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '4803.5', 'groupId': 'OG000', 'lowerLimit': '4290.4', 'upperLimit': '5378.0'}, {'value': '4557.7', 'groupId': 'OG001', 'lowerLimit': '4061.5', 'upperLimit': '5114.4'}, {'value': '4453.9', 'groupId': 'OG002', 'lowerLimit': '3951.9', 'upperLimit': '5019.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 84', 'description': 'Antibody concentrations were expressed as GMCs in mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\\_MMR/Com\\_MMR vaccine, with pre- \\& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \\& complied with post-dose 2 blood sample schedule.'}, {'type': 'SECONDARY', 'title': 'Anti-mumps Virus Antibody Concentrations (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '98.3'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '103.8'}, {'value': '86.4', 'groupId': 'OG002', 'lowerLimit': '77.4', 'upperLimit': '96.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 84', 'description': 'Antibody concentrations were expressed as GMCs in EU/mL.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\\_MMR/Com\\_MMR vaccine, with pre- \\& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \\& complied with post-dose 2 blood sample schedule.'}, {'type': 'SECONDARY', 'title': 'Anti-rubella Virus Antibody Concentrations (by ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '255', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '112.7', 'groupId': 'OG000', 'lowerLimit': '104.1', 'upperLimit': '122.0'}, {'value': '110.7', 'groupId': 'OG001', 'lowerLimit': '102.9', 'upperLimit': '119.1'}, {'value': '110.9', 'groupId': 'OG002', 'lowerLimit': '101.8', 'upperLimit': '120.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 84', 'description': 'Antibody concentrations were expressed as GMCs in IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\\_MMR/Com\\_MMR vaccine, with pre- \\& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \\& complied with post-dose 2 blood sample schedule.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1453', 'groupId': 'OG000'}, {'value': '1464', 'groupId': 'OG001'}, {'value': '1482', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Any pain', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}]}]}, {'title': 'Any redness', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}]}, {'title': 'Any swelling', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total Vaccinated cohort (TVC) included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited Local AEs Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1427', 'groupId': 'OG000'}, {'value': '1440', 'groupId': 'OG001'}, {'value': '1456', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Any pain', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}]}, {'title': 'Any redness', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}]}, {'title': 'Any swelling', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited General AEs Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1454', 'groupId': 'OG000'}, {'value': '1466', 'groupId': 'OG001'}, {'value': '1486', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Any drowsiness', 'categories': [{'measurements': [{'value': '551', 'groupId': 'OG000'}, {'value': '565', 'groupId': 'OG001'}, {'value': '582', 'groupId': 'OG002'}]}]}, {'title': 'Any irritability / fussiness', 'categories': [{'measurements': [{'value': '749', 'groupId': 'OG000'}, {'value': '792', 'groupId': 'OG001'}, {'value': '788', 'groupId': 'OG002'}]}]}, {'title': 'Any loss of appetite', 'categories': [{'measurements': [{'value': '570', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}, {'value': '591', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 15-day (Days 0-14) post-vaccination period', 'description': 'Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Fever Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1454', 'groupId': 'OG000'}, {'value': '1466', 'groupId': 'OG001'}, {'value': '1486', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '582', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}, {'value': '618', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Any fever = Fever (axillary) ≥ 38°C.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Fever Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1426', 'groupId': 'OG000'}, {'value': '1443', 'groupId': 'OG001'}, {'value': '1455', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '458', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}, {'value': '499', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Any fever = Fever (axillary) ≥ 38°C.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Rash Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1454', 'groupId': 'OG000'}, {'value': '1466', 'groupId': 'OG001'}, {'value': '1486', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Any localized or generalized', 'categories': [{'measurements': [{'value': '328', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}]}]}, {'title': 'Any with fever', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}]}, {'title': 'Any varicella like', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Any measles/rubella like', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Rash Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1426', 'groupId': 'OG000'}, {'value': '1443', 'groupId': 'OG001'}, {'value': '1455', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Any localized or generalized', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}]}, {'title': 'Any with fever', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Any varicella like', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any measles/rubella like', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1454', 'groupId': 'OG000'}, {'value': '1466', 'groupId': 'OG001'}, {'value': '1486', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Any parotid gland swelling', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Any febrile convulsion', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1426', 'groupId': 'OG000'}, {'value': '1443', 'groupId': 'OG001'}, {'value': '1455', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Any parotid gland swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any febrile convulsion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Unsolicited AES Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '1497', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '762', 'groupId': 'OG000'}, {'value': '794', 'groupId': 'OG001'}, {'value': '777', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Unsolicited AES Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1449', 'groupId': 'OG000'}, {'value': '1464', 'groupId': 'OG001'}, {'value': '1483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '667', 'groupId': 'OG000'}, {'value': '703', 'groupId': 'OG001'}, {'value': '690', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any AEs of Specific Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '1497', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'title': 'Any NOCD', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Any AE prompting ER visit', 'categories': [{'measurements': [{'value': '348', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 through the end of the study (Day 222)', 'description': 'AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '1497', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'OG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 through the end of the study (Day 222)', 'description': 'SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TVC included all vaccinated subjects with at least one vaccine administration of either Inv\\_MMR lots or Com\\_MMR lots documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inv_MMR_Min Group', 'description': "Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\\_MMR), from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively."}, {'id': 'FG001', 'title': 'Inv_MMR_Med Group', 'description': "Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\\_MMR), from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively."}, {'id': 'FG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of M-M-R II (Com\\_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1493'}, {'groupId': 'FG001', 'numSubjects': '1497'}, {'groupId': 'FG002', 'numSubjects': '1526'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1427'}, {'groupId': 'FG001', 'numSubjects': '1427'}, {'groupId': 'FG002', 'numSubjects': '1443'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '83'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'As Per Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'US sub-cohort: Subjects recruited in US and received Inv\\_MMR\\_Min or Inv\\_MMR\\_Med or Com\\_MMR (Lot 1 or 2) co-administered with Varivax (VV), Havrix (HAV) and Prevnar 13 (PCV-13) at Day 0. Non-US sub-cohort: Subjects recruited outside US and received Inv\\_MMR\\_Min or Inv\\_MMR\\_Med or Com\\_MMR (Lot 1 or 2) co-administered with VV and HAV at Day 0.', 'preAssignmentDetails': '4538 subjects were registered in the study. 3 subjects were excluded because of invalid Informed Consent Forms and 19 subjects received a subject number but were not vaccinated. Therefore, the number of subjects started is 4516.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'BG000'}, {'value': '1497', 'groupId': 'BG001'}, {'value': '1526', 'groupId': 'BG002'}, {'value': '4516', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Inv_MMR_Min Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'BG001', 'title': 'Inv_MMR_Med Group', 'description': 'Subjects received one dose of Inv\\_MMR, from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'BG002', 'title': 'Com_MMR Group', 'description': 'Subjects received one dose of Com\\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '12.6', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '12.6', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '12.6', 'spread': '0.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '704', 'groupId': 'BG000'}, {'value': '718', 'groupId': 'BG001'}, {'value': '758', 'groupId': 'BG002'}, {'value': '2180', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '789', 'groupId': 'BG000'}, {'value': '779', 'groupId': 'BG001'}, {'value': '768', 'groupId': 'BG002'}, {'value': '2336', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Heritage / African American', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '362', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}, {'value': '1095', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White - Arabic / North African Heritage', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'White - Caucasian / European Heritage', 'categories': [{'measurements': [{'value': '1017', 'groupId': 'BG000'}, {'value': '1022', 'groupId': 'BG001'}, {'value': '1052', 'groupId': 'BG002'}, {'value': '3091', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4538}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'dispFirstSubmitDate': '2016-04-07', 'completionDateStruct': {'date': '2015-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2012-09-06', 'dispFirstSubmitQcDate': '2016-04-07', 'resultsFirstSubmitDate': '2016-12-30', 'studyFirstSubmitQcDate': '2012-09-06', 'dispFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-19', 'studyFirstPostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])', 'timeFrame': 'At Day 42', 'description': 'For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above \\[≥\\] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than \\[\\<\\] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med was to be ≥ 90% for antibodies to measles virus.'}, {'measure': 'Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'timeFrame': 'At Day 42', 'description': 'For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med was to be ≥ 90% for antibodies to mumps virus.'}, {'measure': 'Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])', 'timeFrame': 'At Day 42', 'description': 'For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration \\< 2.5 ED50) before dose 1.'}, {'measure': 'Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'timeFrame': 'At Day 42', 'description': 'For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\\_MMR\\_Min/Inv\\_MMR\\_Med was to be ≥ 90% for antibodies to mumps virus.'}, {'measure': 'Anti-measles Virus Antibody Concentrations (by ELISA)', 'timeFrame': 'At Day 42', 'description': 'Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.'}, {'measure': 'Anti-mumps Virus Antibody Concentrations (by ELISA)', 'timeFrame': 'At Day 42', 'description': 'Antibody concentrations were expressed as GMCs in EU/mL.'}, {'measure': 'Anti-mumps Virus Antibody Concentrations (by PRNT)', 'timeFrame': 'At Day 42', 'description': 'Antibody concentrations were expressed as Geometric Mean Titers (GMTs).'}, {'measure': 'Anti-rubella Virus Antibody Concentrations (by ELISA)', 'timeFrame': 'At Day 42', 'description': 'Antibody concentrations were expressed as GMCs in IU/mL.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'timeFrame': 'At Day 84', 'description': 'For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 150 mIU/mL) before dose 1.'}, {'measure': 'Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'timeFrame': 'At Day 84', 'description': 'For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 5 EU/mL) before dose 1.'}, {'measure': 'Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)', 'timeFrame': 'At Day 84', 'description': 'For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration \\< 4 IU/mL) before dose 1.'}, {'measure': 'Anti-measles Virus Antibody Concentrations (by ELISA)', 'timeFrame': 'At Day 84', 'description': 'Antibody concentrations were expressed as GMCs in mIU/mL.'}, {'measure': 'Anti-mumps Virus Antibody Concentrations (by ELISA)', 'timeFrame': 'At Day 84', 'description': 'Antibody concentrations were expressed as GMCs in EU/mL.'}, {'measure': 'Anti-rubella Virus Antibody Concentrations (by ELISA)', 'timeFrame': 'At Day 84', 'description': 'Antibody concentrations were expressed as GMCs in IU/mL.'}, {'measure': 'Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Any Solicited Local AEs Post Dose 2', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination period', 'description': 'Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Any Solicited General AEs Post Dose 1', 'timeFrame': 'During the 15-day (Days 0-14) post-vaccination period', 'description': 'Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects Reporting Any Fever Post Dose 1', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Any fever = Fever (axillary) ≥ 38°C.'}, {'measure': 'Number of Subjects Reporting Any Fever Post Dose 2', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Any fever = Fever (axillary) ≥ 38°C.'}, {'measure': 'Number of Subjects Reporting Any Rash Post Dose 1', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects Reporting Any Rash Post Dose 2', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects Reporting Any Unsolicited AES Post Dose 1', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects Reporting Any Unsolicited AES Post Dose 2', 'timeFrame': 'During the 43-day (Days 0-42) post-vaccination period', 'description': 'Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects Reporting Any AEs of Specific Interest', 'timeFrame': 'From Day 0 through the end of the study (Day 222)', 'description': 'AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.'}, {'measure': 'Number of Subjects Reporting Any Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 through the end of the study (Day 222)', 'description': 'SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.'}]}, 'conditionsModule': {'keywords': ['Safety', 'Measles, mumps and rubella diseases', 'Immunogenicity'], 'conditions': ['Measles', 'Mumps', 'Rubella', 'Measles-Mumps-Rubella Vaccine']}, 'referencesModule': {'references': [{'pmid': '30104117', 'type': 'BACKGROUND', 'citation': 'MMR-161 Study Group. Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial. Vaccine. 2018 Sep 11;36(38):5781-5788. doi: 10.1016/j.vaccine.2018.07.076. Epub 2018 Aug 10.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \\& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).", 'detailedDescription': "This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center, multi-country study with four parallel groups. This study will evaluate the immunogenicity and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv\\_MMR vaccine, throughout this document) in contrast to the US standard of care comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as Com\\_MMR throughout this document) in children during their second year of life. The first dose of this two-dose study is designed to establish the end of shelf-life potency of Inv\\_MMR vaccine. The Inv\\_MMR vaccine will be given as one of two lots; one of a minimum potency, designated Inv\\_MMR\\_Min; and the other at a mid-range or medium potency designated Inv\\_MMR\\_Med to two groups. The second dose for both of these Inv\\_MMR groups will have a potency within the release range of the marketed vaccine. The Com\\_MMR vaccine will consist of two lots designated Com\\_MMR\\_L1 and Com\\_MMR\\_L2 and will be analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely administered to children of this age in the US."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female child between 12 and 15 months of age at the time of vaccination.\n* The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol.\n* Written informed consent obtained from the parent(s)/LAR(s) of the child.\n* Child is in stable health as determined by investigator's clinical examination and assessment of child's medical history.\n\nFor US children only:\n\n• Child that previously received a 3-dose series of Prevnar 13 with last dose at least 60 days prior to study entry.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination or planned use during the entire study period.\n* Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product. Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.\n\n * Inhaled and topical steroids are allowed.\n* Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please Note:\n\n * Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).\n * Any age appropriate vaccine may be given starting at Visit 2 (or starting at Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.\n* Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the US post-dose 2 sub-cohort.\n* History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.\n* Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the first study vaccination.\n* Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* A family history of congenital or hereditary immunodeficiency.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex 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 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 based on medical history.\n* Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.\n\nFor US children only:\n\n• A child that previously received a fourth dose of any pneumococcal conjugate vaccine."}, 'identificationModule': {'nctId': 'NCT01681992', 'briefTitle': "Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety Study of GSK Biologicals' Priorix Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s Measles-mumps-rubella (MMR) Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life", 'orgStudyIdInfo': {'id': '115649'}, 'secondaryIdInfos': [{'id': '2011-004905-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inv_MMR_Min Group', 'description': "Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\\_MMR), from a minimum potency lot (Inv\\_MMR\\_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.", 'interventionNames': ['Biological: Priorix', 'Biological: Varivax', 'Biological: Havrix', 'Biological: Prevnar 13']}, {'type': 'EXPERIMENTAL', 'label': 'Inv_MMR_Med Group', 'description': "Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\\_MMR), from a mid-range or medium potency lot (Inv\\_MMR\\_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv\\_MMR vaccine (Inv\\_MMR\\_Release), for the second dose. Inv\\_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.", 'interventionNames': ['Biological: Priorix', 'Biological: Varivax', 'Biological: Havrix', 'Biological: Prevnar 13']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Com_MMR Group', 'description': 'Subjects receive one dose of M-M-R II (Com\\_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose of Com\\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\\_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.', 'interventionNames': ['Biological: M-M-R II', 'Biological: Varivax', 'Biological: Havrix', 'Biological: Prevnar 13']}], 'interventions': [{'name': 'Priorix', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' live attenuated measles", 'mumps', 'rubella vaccine'], 'description': 'Subjects receive one dose of either minimum (Inv\\_MMR\\_Min) or medium (Inv\\_MMR\\_Med) potency lot at Day 0 and a dose of separate potency lot (Inv\\_MMR\\_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.', 'armGroupLabels': ['Inv_MMR_Med Group', 'Inv_MMR_Min Group']}, {'name': 'M-M-R II', 'type': 'BIOLOGICAL', 'otherNames': ['Merck & Co.', "Inc.'s measles", 'mumps', 'rubella virus vaccine', 'live'], 'description': 'Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.', 'armGroupLabels': ['Com_MMR Group']}, {'name': 'Varivax', 'type': 'BIOLOGICAL', 'otherNames': ['Merck & Co.', "Inc.'s varicella virus vaccine", 'live'], 'description': 'Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.', 'armGroupLabels': ['Com_MMR Group', 'Inv_MMR_Med Group', 'Inv_MMR_Min Group']}, {'name': 'Havrix', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' hepatitis A vaccine", 'inactivated'], 'description': 'Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.', 'armGroupLabels': ['Com_MMR Group', 'Inv_MMR_Med Group', 'Inv_MMR_Min Group']}, {'name': 'Prevnar 13', 'type': 'BIOLOGICAL', 'otherNames': ["Pfizer Inc.'s pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)"], 'description': 'US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.', 'armGroupLabels': ['Com_MMR Group', 'Inv_MMR_Med Group', 'Inv_MMR_Min Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 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