Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-02 @ 8:23 AM
Study NCT ID:
NCT00474266
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2007-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577557', 'term': 'Priorix-Tetra vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs: Day 0 up to Month 6. Solicited local and general symptoms: 4-day after vaccination (Day 0-Day 3). Unsolicited symptoms: 43-day after vaccination (Days 0-42).', 'description': 'The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.', 'eventGroups': [{'id': 'EG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.', 'otherNumAtRisk': 375, 'deathsNumAtRisk': 375, 'otherNumAffected': 340, 'seriousNumAtRisk': 375, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 103, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.', 'otherNumAtRisk': 374, 'deathsNumAtRisk': 374, 'otherNumAffected': 313, 'seriousNumAtRisk': 374, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, one dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 108, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 104}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 161}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 58}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decrease appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 171}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 136}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 48}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 111}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 70}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Medical observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Henoch-schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 374, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'rSBA-MenA, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenC, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenW-135, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenY, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '359', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.29', 'ciUpperLimit': '6.78', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥-10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '1.58', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥ -10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '1.58', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥ -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '1.07', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥ -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '3.17', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥ -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '306', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.06', 'ciLowerLimit': '-2.82', 'ciUpperLimit': '12.46', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥-10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '3.18', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥ -10%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.36', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '9.5', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criterion: Lower limit \\[LL\\] of the 2-sided standardized asymptotic 95% confidence interval \\[CI\\] ≥-10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'rSBA-MenA ≥ 1:8, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenA ≥ 1:128, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenA ≥ 1:128, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '359', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenC ≥ 1:8, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenC ≥ 1:128, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenC ≥ 1:128, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '337', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenW-135 ≥ 1:8, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenW-135 ≥ 1:128, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenW-135 ≥ 1:128, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenY ≥ 1:8, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenY ≥ 1:128, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenY ≥ 1:128, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)', 'description': 'The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'rSBA-MenA, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '19.4'}, {'value': '22.8', 'groupId': 'OG001', 'lowerLimit': '16.8', 'upperLimit': '31'}, {'value': '24.4', 'groupId': 'OG002', 'lowerLimit': '13.7', 'upperLimit': '43.4'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '8.5', 'upperLimit': '24'}]}]}, {'title': 'rSBA-MenA, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2085.9', 'groupId': 'OG000', 'lowerLimit': '1905.3', 'upperLimit': '2283.6'}, {'value': '2205', 'groupId': 'OG001', 'lowerLimit': '2007.8', 'upperLimit': '2421.6'}, {'value': '33.1', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '57.4'}, {'value': '24.3', 'groupId': 'OG003', 'lowerLimit': '13.4', 'upperLimit': '44.1'}]}]}, {'title': 'rSBA-MenC, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '11.4'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '12.6'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '12.2'}, {'value': '7.6', 'groupId': 'OG003', 'lowerLimit': '5.5', 'upperLimit': '10.6'}]}]}, {'title': 'rSBA-MenC, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '519', 'groupId': 'OG000', 'lowerLimit': '470.9', 'upperLimit': '571.9'}, {'value': '477.6', 'groupId': 'OG001', 'lowerLimit': '437.3', 'upperLimit': '521.6'}, {'value': '11.2', 'groupId': 'OG002', 'lowerLimit': '8.3', 'upperLimit': '15.2'}, {'value': '212.3', 'groupId': 'OG003', 'lowerLimit': '170', 'upperLimit': '265.2'}]}]}, {'title': 'rSBA-MenW-135, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '20.7'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '21.4'}, {'value': '21.9', 'groupId': 'OG002', 'lowerLimit': '13.5', 'upperLimit': '35.4'}, {'value': '20.8', 'groupId': 'OG003', 'lowerLimit': '13.1', 'upperLimit': '33.2'}]}]}, {'title': 'rSBA-MenW-135, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2055.8', 'groupId': 'OG000', 'lowerLimit': '1871', 'upperLimit': '2258.9'}, {'value': '2681.7', 'groupId': 'OG001', 'lowerLimit': '2453.1', 'upperLimit': '2931.6'}, {'value': '25.6', 'groupId': 'OG002', 'lowerLimit': '15.6', 'upperLimit': '42.1'}, {'value': '25.1', 'groupId': 'OG003', 'lowerLimit': '14.6', 'upperLimit': '43.1'}]}]}, {'title': 'rSBA-MenY, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '30.2', 'upperLimit': '56.6'}, {'value': '50.1', 'groupId': 'OG001', 'lowerLimit': '36.7', 'upperLimit': '68.2'}, {'value': '71', 'groupId': 'OG002', 'lowerLimit': '40.9', 'upperLimit': '123.2'}, {'value': '31.7', 'groupId': 'OG003', 'lowerLimit': '18.9', 'upperLimit': '53.2'}]}]}, {'title': 'rSBA-MenY, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2282.4', 'groupId': 'OG000', 'lowerLimit': '2051.3', 'upperLimit': '2539.5'}, {'value': '2729.4', 'groupId': 'OG001', 'lowerLimit': '2472.7', 'upperLimit': '3012.8'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '39.3', 'upperLimit': '124.7'}, {'value': '31.4', 'groupId': 'OG003', 'lowerLimit': '18.4', 'upperLimit': '53.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'Anti-PSA, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.19'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.16'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.18'}, {'value': '0.16', 'groupId': 'OG003', 'lowerLimit': '0.14', 'upperLimit': '0.17'}]}]}, {'title': 'Anti-PSA, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.74', 'groupId': 'OG000', 'lowerLimit': '24.01', 'upperLimit': '34.4'}, {'value': '15.71', 'groupId': 'OG001', 'lowerLimit': '12.91', 'upperLimit': '19.12'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.17'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '0.17'}]}]}, {'title': 'Anti-PSC, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.15'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.15'}, {'value': '0.15', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.15'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '0.15'}]}]}, {'title': 'Anti-PSC, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.26', 'groupId': 'OG000', 'lowerLimit': '7.73', 'upperLimit': '11.1'}, {'value': '7.44', 'groupId': 'OG001', 'lowerLimit': '6.43', 'upperLimit': '8.6'}, {'value': '0.15', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.15'}, {'value': '4.89', 'groupId': 'OG003', 'lowerLimit': '3.69', 'upperLimit': '6.47'}]}]}, {'title': 'Anti-PSW-135, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.17'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.16'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.18'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '0.15'}]}]}, {'title': 'Anti-PSW-135, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.52', 'upperLimit': '7.65'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.77', 'upperLimit': '5.37'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.17'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '0.15'}]}]}, {'title': 'Anti-PSY, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.15'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.16'}, {'value': '0.15', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.15'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '0.15'}]}]}, {'title': 'Anti-PSY, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.56', 'groupId': 'OG000', 'lowerLimit': '7.26', 'upperLimit': '10.11'}, {'value': '6.37', 'groupId': 'OG001', 'lowerLimit': '5.13', 'upperLimit': '7.92'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '0.17'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '0.15'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'Anti-PSA ≥ 0.3 μg/mL, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSA ≥ 0.3 μg/mL, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSA ≥ 2 μg/mL, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSA ≥ 2 μg/mL, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC ≥ 0.3 μg/mL, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC ≥ 0.3 μg/mL, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC ≥ 2 μg/mL, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC ≥ 2 μg/mL, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 ≥ 0.3 μg/mL, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 ≥ 0.3 μg/mL, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 ≥ 2 μg/mL, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 ≥ 2 μg/mL, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSY ≥ 0.3 μg/mL, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSY ≥ 0.3 μg/mL, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSY ≥ 2 μg/mL, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSY ≥ 2 μg/mL, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '722', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG003', 'title': 'Pooled Group', 'description': 'Subjects from Nimenrix + Priorix-Tetra Group and subjects from Nimenrix Group'}], 'classes': [{'title': 'hSBA-MenA ≥1:4, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '713', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenA ≥1:4, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '686', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '305', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '578', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenA ≥1:8, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '713', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenA ≥1:8, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '686', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '553', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenC ≥1:4, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '722', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenC ≥1:4, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '687', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '677', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenC ≥1:8, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '722', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenC ≥1:8, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '687', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '675', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenW-135 ≥1:4, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '710', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenW-135 ≥1:4, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '673', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '575', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenW-135 ≥1:8, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '710', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenW-135 ≥1:8, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '673', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '573', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenY ≥1:4, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '693', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenY ≥1:4, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '662', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '273', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '534', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenY ≥1:8, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '693', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'hSBA-MenY ≥1:8, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '662', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '532', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '722', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 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'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '2.2'}]}]}, {'title': 'hSBA- MenA, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '686', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '39.2'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '22.1'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '25.4', 'groupId': 'OG003', 'lowerLimit': '22.8', 'upperLimit': '28.4'}]}]}, {'title': 'hSBA-MenC, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '722', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '2.1'}]}]}, {'title': 'hSBA-MenC, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '687', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '209.1', 'groupId': 'OG000', 'lowerLimit': '183.8', 'upperLimit': '238'}, {'value': '196', 'groupId': 'OG001', 'lowerLimit': '175.4', 'upperLimit': '219'}, {'value': '40.3', 'groupId': 'OG002', 'lowerLimit': '29.5', 'upperLimit': '55.1'}, {'value': '202.5', 'groupId': 'OG003', 'lowerLimit': '186', 'upperLimit': '220.5'}]}]}, {'title': 'hSBA-MenW-135, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '710', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '2.1'}]}]}, {'title': 'hSBA-MenW-135, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '673', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '69.9'}, {'value': '48.9', 'groupId': 'OG001', 'lowerLimit': '41.2', 'upperLimit': '58'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '2.2'}, {'value': '52.9', 'groupId': 'OG003', 'lowerLimit': '46.4', 'upperLimit': '60.3'}]}]}, {'title': 'hSBA-MenY, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '693', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2.1'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '2.2'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '2.1'}]}]}, {'title': 'hSBA-MenY, D42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '662', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '46.7'}, {'value': '30.9', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '37.1'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '2.3'}, {'value': '34.6', 'groupId': 'OG003', 'lowerLimit': '30.4', 'upperLimit': '39.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-measles Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '4273.4', 'groupId': 'OG000', 'lowerLimit': '4018.4', 'upperLimit': '4544.6'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '75'}, {'value': '4457.3', 'groupId': 'OG002', 'lowerLimit': '3976.3', 'upperLimit': '4996.6'}, {'value': '75', 'groupId': 'OG003', 'lowerLimit': '75', 'upperLimit': '75'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-measles Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}], 'classes': [{'categories': [{'measurements': [{'value': '7113.8', 'groupId': 'OG000', 'lowerLimit': '5335.6', 'upperLimit': '9484.7'}, {'value': '8699.8', 'groupId': 'OG001', 'lowerLimit': '4865.3', 'upperLimit': '15556.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after the second Priorix-Tetra vaccine dose (Day 126)', 'description': 'Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-mumps Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '662.9', 'groupId': 'OG000', 'lowerLimit': '598.4', 'upperLimit': '734.4'}, {'value': '115.5', 'groupId': 'OG001', 'lowerLimit': '115.5', 'upperLimit': '115.5'}, {'value': '710.1', 'groupId': 'OG002', 'lowerLimit': '583.8', 'upperLimit': '863.8'}, {'value': '115.5', 'groupId': 'OG003', 'lowerLimit': '115.5', 'upperLimit': '115.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.', 'unitOfMeasure': 'U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-mumps Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}], 'classes': [{'categories': [{'measurements': [{'value': '3351.2', 'groupId': 'OG000', 'lowerLimit': '2658.2', 'upperLimit': '4224.7'}, {'value': '3334.1', 'groupId': 'OG001', 'lowerLimit': '1933.1', 'upperLimit': '5750.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after the second Priorix-Tetra vaccine dose (Day 126)', 'description': 'Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.', 'unitOfMeasure': 'U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-rubella Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '46.5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '53.2', 'groupId': 'OG002', 'lowerLimit': '46.6', 'upperLimit': '60.7'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '2.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-rubella Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000', 'lowerLimit': '74.8', 'upperLimit': '101.6'}, {'value': '117', 'groupId': 'OG001', 'lowerLimit': '73.8', 'upperLimit': '185.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after the second Priorix-Tetra vaccine dose (Day 126)', 'description': 'Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-varicella Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '152.8', 'groupId': 'OG000', 'lowerLimit': '133.5', 'upperLimit': '174.8'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2.3'}, {'value': '128.8', 'groupId': 'OG002', 'lowerLimit': '99.1', 'upperLimit': '167.4'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '2.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-varicella Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}], 'classes': [{'categories': [{'measurements': [{'value': '4175.6', 'groupId': 'OG000', 'lowerLimit': '3064', 'upperLimit': '5690.6'}, {'value': '3360.1', 'groupId': 'OG001', 'lowerLimit': '1646.5', 'upperLimit': '6857'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after the second Priorix-Tetra vaccine dose (Day 126)', 'description': 'Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0', 'description': 'Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0', 'description': 'Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Fever≥38.0˚C', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'Meningismus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Parotiditis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups', 'description': 'Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'Fever ≥ 38.0˚C', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Meningismus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Parotiditis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) after first vaccination dose', 'description': 'Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Specific Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'title': 'Rash (es)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'NOCI (s)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'ER visit (s)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 6 after first vaccine dose', 'description': 'Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC ), which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) post Dose 1 vaccination period', 'description': 'Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 43-day (Days 0-42) follow-up period after each vaccination', 'description': 'Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'OG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 6 after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'FG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'FG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'FG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}, {'groupId': 'FG001', 'numSubjects': '374'}, {'groupId': 'FG002', 'numSubjects': '126'}, {'groupId': 'FG003', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}, {'groupId': 'FG001', 'numSubjects': '354'}, {'groupId': 'FG002', 'numSubjects': '122'}, {'groupId': 'FG003', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'BG000'}, {'value': '374', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}, {'value': '1000', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'BG001', 'title': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'BG002', 'title': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.'}, {'id': 'BG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '14.6', 'spread': '1.49', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '1.41', 'groupId': 'BG002'}, {'value': '14.4', 'spread': '1.47', 'groupId': 'BG003'}, {'value': '14.61', 'spread': '1.48', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '482', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '518', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White-Caucasian/ European heritage, n (%)', 'categories': [{'measurements': [{'value': '369', 'groupId': 'BG000'}, {'value': '372', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}, {'value': '987', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'White - Arabic / North African heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'dispFirstSubmitDate': '2009-09-03', 'completionDateStruct': {'date': '2008-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2007-05-15', 'dispFirstSubmitQcDate': '2009-09-03', 'resultsFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2007-05-15', 'dispFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-17', 'studyFirstPostDateStruct': {'date': '2007-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.'}, {'measure': 'Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).'}, {'measure': 'Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).'}, {'measure': 'Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).'}, {'measure': 'Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values', 'timeFrame': 'Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)', 'description': 'The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.'}, {'measure': 'rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers', 'timeFrame': 'Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.'}, {'measure': 'Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values', 'timeFrame': 'Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.'}, {'measure': 'Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values', 'timeFrame': 'Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.'}, {'measure': 'Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values', 'timeFrame': 'Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.'}, {'measure': 'hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers', 'timeFrame': 'Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)', 'description': 'Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.'}, {'measure': 'Anti-measles Antibody Concentrations', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.'}, {'measure': 'Anti-measles Antibody Concentrations', 'timeFrame': '42 days after the second Priorix-Tetra vaccine dose (Day 126)', 'description': 'Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.'}, {'measure': 'Anti-mumps Antibody Concentrations', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.'}, {'measure': 'Anti-mumps Antibody Concentrations', 'timeFrame': '42 days after the second Priorix-Tetra vaccine dose (Day 126)', 'description': 'Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.'}, {'measure': 'Anti-rubella Antibody Concentrations', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.'}, {'measure': 'Anti-rubella Antibody Concentrations', 'timeFrame': '42 days after the second Priorix-Tetra vaccine dose (Day 126)', 'description': 'Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.'}, {'measure': 'Anti-varicella Antibody Titers', 'timeFrame': '42 days after the first vaccine dose (Day 42)', 'description': 'Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.'}, {'measure': 'Anti-varicella Antibody Titers', 'timeFrame': '42 days after the second Priorix-Tetra vaccine dose (Day 126)', 'description': 'Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.'}, {'measure': 'Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination', 'timeFrame': 'During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0', 'description': 'Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.'}, {'measure': 'Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0', 'timeFrame': 'During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0', 'description': 'Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.'}, {'measure': 'Number of Subjects Reporting Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups', 'description': 'Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.'}, {'measure': 'Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms', 'timeFrame': 'During the 43-day (Days 0-42) after first vaccination dose', 'description': 'Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.'}, {'measure': 'Number of Subjects Reporting Specific Adverse Events (AEs)', 'timeFrame': 'From Day 0 up to Month 6 after first vaccine dose', 'description': 'Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.'}, {'measure': 'Number of Subjects Reporting Unsolicited Symptoms', 'timeFrame': 'During the 43-day (Days 0-42) post Dose 1 vaccination period', 'description': 'Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.'}, {'measure': 'Number of Subjects Reporting Unsolicited Symptoms', 'timeFrame': 'During the 43-day (Days 0-42) follow-up period after each vaccination', 'description': 'Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 up to Month 6 after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.'}]}, 'conditionsModule': {'keywords': ['MMRV vaccine', 'co-administration', 'immunogenicity', 'meningococcal vaccine', 'conjugate vaccine'], 'conditions': ['Infections, Meningococcal']}, 'referencesModule': {'availIpds': [{'id': '109670', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109670', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109670', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109670', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109670', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109670', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109670', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '21443965', 'type': 'BACKGROUND', 'citation': 'Vesikari T, Karvonen A, Bianco V, Van der Wielen M, Miller J. Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial. Vaccine. 2011 Jun 6;29(25):4274-84. doi: 10.1016/j.vaccine.2011.03.043. Epub 2011 Apr 6.'}, {'pmid': '26780033', 'type': 'BACKGROUND', 'citation': 'Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Immunogenicity, Safety and Antibody Persistence of a Booster Dose of Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine Compared with Monovalent Meningococcal Serogroup C Vaccine Administered Four Years After Primary Vaccination Using the Same Vaccines. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.', 'detailedDescription': 'Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days.\n\nTwo control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days.\n\nFor all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.\n* A male or female between, and including, 12 and 23 months of age at the time of the vaccination.\n* Written informed consent obtained from the parent or guardian of the subject.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.\n* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).\n* Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.\n* History of meningococcal disease.\n* Previous vaccination against measles, mumps, rubella, and/or varicella.\n* History of measles, mumps, rubella and/or varicella.\n* Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.\n* Major congenital defects or serious chronic illness.\n* Acute disease at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period."}, 'identificationModule': {'nctId': 'NCT00474266', 'briefTitle': 'Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children", 'orgStudyIdInfo': {'id': '109670'}, 'secondaryIdInfos': [{'id': '2006-006580-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimenrix + Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine and 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84.', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612 (Nimenrix)', 'Biological: Priorix-Tetra']}, {'type': 'EXPERIMENTAL', 'label': 'Nimenrix Group', 'description': 'Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612 (Nimenrix)', 'Biological: Priorix-Tetra']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Priorix-Tetra Group', 'description': 'Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84.', 'interventionNames': ['Biological: Priorix-Tetra', 'Biological: Meningitec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.', 'interventionNames': ['Biological: Priorix-Tetra', 'Biological: Meningitec']}], 'interventions': [{'name': 'Meningococcal vaccine GSK134612 (Nimenrix)', 'type': 'BIOLOGICAL', 'description': 'Single dose intramuscular injection', 'armGroupLabels': ['Nimenrix + Priorix-Tetra Group', 'Nimenrix Group']}, {'name': 'Priorix-Tetra', 'type': 'BIOLOGICAL', 'description': '2-dose subcutaneous injection', 'armGroupLabels': ['Meningitec Group', 'Nimenrix + Priorix-Tetra Group', 'Nimenrix Group', 'Priorix-Tetra Group']}, {'name': 'Meningitec', 'type': 'BIOLOGICAL', 'description': 'Single dose intramuscular injection', 'armGroupLabels': ['Meningitec Group', 'Priorix-Tetra Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02100', 'city': 'Espoo', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00930', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '04400', 'city': 'Järvenpää', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '48600', 'city': 'Kotka', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.4664, 'lon': 26.94582}}, {'zip': '70100', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '15140', 'city': 'Lahti', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}, {'zip': '90100', 'city': 'Oulu', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '28100', 'city': 'Pori', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '60100', 'city': 'Seinäjoki', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '01300', 'city': 'Vantaa', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.29414, 'lon': 25.04099}}, {'zip': '01600', 'city': 'Vantaa', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.29414, 'lon': 25.04099}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=248', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}