Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-02-27 @ 10:06 AM
Study NCT ID:
NCT00508261
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2007-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine
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'}]}}, '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 were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination.', 'description': 'The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.', 'eventGroups': [{'id': 'EG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 166, 'seriousNumAtRisk': 222, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 183, 'seriousNumAtRisk': 220, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 185, 'seriousNumAtRisk': 224, 'deathsNumAffected': 1, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 75, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 100, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 89, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 91, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 151, 'numAffected': 102}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 155, 'numAffected': 103}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 37, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 83, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 139, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 125, 'numAffected': 93}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 69, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 95, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 99, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 86, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 114, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 114, 'numAffected': 89}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 119, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 136, 'numAffected': 95}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 89, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 110, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 224, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Coxsackie viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}], 'classes': [{'title': 'rSBA-MenA, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenC, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenW-135, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}, {'title': 'rSBA-MenY, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '4.71', 'groupDescription': 'Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.73', 'ciLowerLimit': '0.73', 'ciUpperLimit': '6.24', 'groupDescription': 'Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup C, at month 1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '4.64', 'groupDescription': 'Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup W-135, at month 1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '0.71', 'ciUpperLimit': '6.18', 'groupDescription': 'Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup Y, at month 1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month after vaccination with Nimenrix vaccine (Month 1)', 'description': 'The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination 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 assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}], 'classes': [{'title': 'Anti-PT, M1', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '95'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '96'}]}]}, {'title': 'Anti-FHA, M1', 'categories': [{'measurements': [{'value': '542', 'groupId': 'OG000', 'lowerLimit': '492', 'upperLimit': '597'}, {'value': '544', 'groupId': 'OG001', 'lowerLimit': '485', 'upperLimit': '611'}]}]}, {'title': 'Anti-PRN, M1', 'categories': [{'measurements': [{'value': '470', 'groupId': 'OG000', 'lowerLimit': '411', 'upperLimit': '537'}, {'value': '450', 'groupId': 'OG001', 'lowerLimit': '387', 'upperLimit': '522'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.12', 'groupDescription': 'Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), at month 1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PT (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.13', 'groupDescription': 'Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA), at month 1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-FHA (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMC ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.1', 'groupDescription': 'Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertactin (PRN), at month 1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PRN (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the first vaccination (Month 1)', 'description': 'The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at month 1.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix and Infanrix-hexa vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa vaccine at Day 0, followed one month later by 1 dose of Nimenrix vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '4.6', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentages of subjects with anti-HBs antibody concentrations ≥10 mIU/ml is greater than or equal to the pre-defined clinical limit of -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month after vaccination with Nimenrix vaccine (Month 1)', 'description': 'The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. The analysis for the primary outcome measure was based only on subjects receiving Infanrix-hexa vaccination at Month 1.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '-1.45', 'ciUpperLimit': '4.5', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentage of subjects with anti-PRP concentrations (ELISA) ≥1.0 μg/mL is greater than or equal to the pre-defined clinical limit of -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month after vaccination with Nimenrix vaccine (Month 1)', 'description': 'The cut-off for the assay was ≥ 1μg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at Day 0.'}, {'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': '193', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'title': 'rSBA-MenA [M 0], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenA [M 1], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenA [M 2], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenA [M 0], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenA [M 1], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenA [M 2], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenC [M 0], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenC [M 1], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenC [M 2], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenC [M 0], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenC [M 1], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenC [M 2], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenW-135 [M 0], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenW-135 [M 1], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenW-135 [M 2], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenW-135 [M 0], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenW-135 [M 1] ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenW-135 [M 2], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenY [M 0], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenY [M 1], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenY [M 2], ≥1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}]}, {'title': 'rSBA-MenY [M 0], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenY [M 1], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'rSBA-MenY [M 2], ≥1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-off values for the assay were ≥ 1:8 and ≥ 1:128', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. 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'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '9.6'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '12.2'}, {'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '7.7'}, {'value': '7.6', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '11.2'}]}]}, {'title': 'rSBA-MenC [M 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '879.7', 'groupId': 'OG000', 'lowerLimit': '763.1', 'upperLimit': '1014'}, {'value': '828.7', 'groupId': 'OG001', 'lowerLimit': '672.4', 'upperLimit': '1021.4'}, {'value': '7.5', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '9.3'}, {'value': '691.4', 'groupId': 'OG003', 'lowerLimit': '520.8', 'upperLimit': '917.9'}]}]}, {'title': 'rSBA-MenC [M 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '519.6', 'groupId': 'OG001', 'lowerLimit': '391.7', 'upperLimit': '689.2'}, {'value': '386', 'groupId': 'OG002', 'lowerLimit': '333.9', 'upperLimit': '446.2'}]}]}, {'title': 'rSBA-MenW-135 [M 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '27.6'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '27.7'}, {'value': '24.8', 'groupId': 'OG002', 'lowerLimit': '16.7', 'upperLimit': '36.8'}, {'value': '15.6', 'groupId': 'OG003', 'lowerLimit': '9.8', 'upperLimit': '25'}]}]}, {'title': 'rSBA-MenW-135 [M 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4147', 'groupId': 'OG000', 'lowerLimit': '3670.1', 'upperLimit': '4685.8'}, {'value': '4022.3', 'groupId': 'OG001', 'lowerLimit': '3269.2', 'upperLimit': '4948.8'}, {'value': '25.2', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '34.2'}, {'value': '14.2', 'groupId': 'OG003', 'lowerLimit': '10.2', 'upperLimit': '19.7'}]}]}, {'title': 'rSBA-MenW-135 [M 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3630.1', 'groupId': 'OG001', 'lowerLimit': '2899.1', 'upperLimit': '4545.4'}, {'value': '2466.4', 'groupId': 'OG002', 'lowerLimit': '2175.4', 'upperLimit': '2796.4'}]}]}, {'title': 'rSBA-MenY [M 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '54.8'}, {'value': '45.4', 'groupId': 'OG001', 'lowerLimit': '29.1', 'upperLimit': '71'}, {'value': '41.2', 'groupId': 'OG002', 'lowerLimit': '26.7', 'upperLimit': '63.4'}, {'value': '32', 'groupId': 'OG003', 'lowerLimit': '18.3', 'upperLimit': '55.9'}]}]}, {'title': 'rSBA-MenY [M 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3461.8', 'groupId': 'OG000', 'lowerLimit': '2990.1', 'upperLimit': '4007.9'}, {'value': '3167.7', 'groupId': 'OG001', 'lowerLimit': '2521.9', 'upperLimit': '3978.9'}, {'value': '45.9', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '63.9'}, {'value': '47.2', 'groupId': 'OG003', 'lowerLimit': '32.1', 'upperLimit': '69.3'}]}]}, {'title': 'rSBA-MenY [M 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3010.4', 'groupId': 'OG001', 'lowerLimit': '2325.3', 'upperLimit': '3897.3'}, {'value': '2446.9', 'groupId': 'OG002', 'lowerLimit': '2088.5', 'upperLimit': '2866.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The 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Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at 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'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSA [Month 2], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSA [Month 0], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSA [Month 1], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSA [Month 2], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC [Month 0], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC [Month 1], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC [Month 2], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSC [Month 0], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC [Month 1], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSC [Month 2], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSW-135 [Month 0], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 [Month 1], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 [Month 2], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 [Month 0], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 [Month 1], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSW-135 [Month 2], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSY [Month 0], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSY [Month 1], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSY [Month 2], ≥0.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Anti-PSY [Month 0], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSY [Month 1], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anti-PSY [Month 2], ≥2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. 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Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).'}, {'type': 'SECONDARY', 'title': 'Anti-HBs Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'title': 'anti-HBS [M 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '111.6', 'groupId': 'OG000', 'lowerLimit': '90.9', 'upperLimit': '136.9'}, {'value': '92.8', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '114.4'}, {'value': '101.2', 'groupId': 'OG002', 'lowerLimit': '81.5', 'upperLimit': '125.7'}, {'value': '85.6', 'groupId': 'OG003', 'lowerLimit': '65.7', 'upperLimit': '111.5'}]}]}, {'title': 'anti-HBS [M 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2048.4', 'groupId': 'OG000', 'lowerLimit': '1589.3', 'upperLimit': '2640'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '74.8', 'upperLimit': '120.6'}, {'value': '1711.6', 'groupId': 'OG002', 'lowerLimit': '1292.7', 'upperLimit': '2266.3'}, {'value': '101.6', 'groupId': 'OG003', 'lowerLimit': '75.5', 'upperLimit': '136.7'}]}]}, {'title': 'anti-HBS [M 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2392.3', 'groupId': 'OG001', 'lowerLimit': '1841.7', 'upperLimit': '3107.4'}, {'value': '1241', 'groupId': 'OG002', 'lowerLimit': '976.2', 'upperLimit': '1577.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}], 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'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month after vaccination (Month 1)', 'description': 'Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration \\< 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination.\n\nThe analysis was based only on subjects receiving experimental vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component prior to (M0) and after vaccination (M1).'}, {'type': 'SECONDARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': 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'groupId': 'OG001', 'lowerLimit': '664', 'upperLimit': '750'}, {'value': '413', 'groupId': 'OG002', 'lowerLimit': '366', 'upperLimit': '465'}]}]}, {'title': 'Anti-PRN [M 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '31'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '31'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '24'}, {'value': '23', 'groupId': 'OG003', 'lowerLimit': '18', 'upperLimit': '28'}]}]}, {'title': 'Anti-PRN [M 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '470', 'groupId': 'OG000', 'lowerLimit': '411', 'upperLimit': '537'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '27'}, {'value': '450', 'groupId': 'OG002', 'lowerLimit': '387', 'upperLimit': '522'}, {'value': '21', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '26'}]}]}, {'title': 'Anti-PRN [M 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '583', 'groupId': 'OG001', 'lowerLimit': '502', 'upperLimit': '676'}, {'value': '336', 'groupId': 'OG002', 'lowerLimit': '286', 'upperLimit': '395'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in "Nimenrix + Infanrix-hexa Group" and "Meningitec Group" only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful.', '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 after meningococcal vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination', 'description': 'The analysis was based only on subjects receiving combined-diphtheria vaccination.', '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 after the Infanrix-hexa vaccination. Subjects in the Meningitec Group did not receive any Infanrix-hexa and hence are not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'title': 'Drowsiness, D1', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}, {'title': 'Fever, D1', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Irritability, D1', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Loss of appetite, D1', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Drowsiness, D2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fever, D2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Irritability, D2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Loss of appetite, D2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)', 'description': 'Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship.\n\nSubjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination.', '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 Any Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 - Month 7', 'description': 'Any was defined as occurrence of at least one symptom experienced.', '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 Any New Onset of Chronic Illnesses (NOCIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 - Month 7', 'description': 'Any was defined as occurrence of at least one symptom experienced.', '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 Any Conditions Prompting Emergency Room Visits (ER)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 - Month 7', 'description': 'Any was defined as occurrence of at least one symptom experienced.', '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 Any Unsolicited Adverse Events (AEs) After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Occurring within Day 0-30 following vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.', '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 Any Unsolicited Adverse Events (AEs) After the Second Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG001', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Occurring within Day 0-30 following vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.\n\nThe analysis was based only on subjects receiving a second dose of vaccination.', '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 Any Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'OG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'OG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'OG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From dose 1 (Month 0) up to study end (Month 7)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.', '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 + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'FG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'FG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'FG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '220'}, {'groupId': 'FG002', 'numSubjects': '224'}, {'groupId': 'FG003', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '212'}, {'groupId': 'FG002', 'numSubjects': '218'}, {'groupId': 'FG003', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Migrated/ moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], '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': '222', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '793', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Nimenrix + Infanrix-hexa Group', 'description': 'Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.'}, {'id': 'BG001', 'title': 'Nimenrix Group', 'description': 'Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.'}, {'id': 'BG002', 'title': 'Infanrix-Hexa Group', 'description': 'Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.'}, {'id': 'BG003', 'title': 'Meningitec Group', 'description': 'Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '3.01', 'groupId': 'BG000'}, {'value': '15', 'spread': '3.33', 'groupId': 'BG001'}, {'value': '14.9', 'spread': '3.17', 'groupId': 'BG002'}, {'value': '14.6', 'spread': '2.99', 'groupId': 'BG003'}, {'value': '14.8', 'spread': '3.14', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '395', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '398', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White - Caucasian/ European heritage, n (%)', 'categories': [{'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}, {'value': '741', 'groupId': 'BG004'}]}]}, {'title': 'African heritage / African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaskan native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Asian - Central/ South Asian heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Asian - East Asian heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Asian - South east Asian heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'White - Arabic / North African heritage', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', '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': 793}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'dispFirstSubmitDate': '2009-09-03', 'completionDateStruct': {'date': '2008-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2007-07-26', 'dispFirstSubmitQcDate': '2009-09-03', 'resultsFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2007-07-26', 'dispFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-07', 'studyFirstPostDateStruct': {'date': '2007-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.', 'timeFrame': '1 month after vaccination with Nimenrix vaccine (Month 1)', 'description': 'The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Concentrations', 'timeFrame': '1 month after the first vaccination (Month 1)', 'description': 'The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).'}, {'measure': 'Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off', 'timeFrame': '1 month after vaccination with Nimenrix vaccine (Month 1)', 'description': 'The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).'}, {'measure': 'Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off', 'timeFrame': '1 month after vaccination with Nimenrix vaccine (Month 1)', 'description': 'The cut-off for the assay was ≥ 1μg/mL.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-off values for the assay were ≥ 1:8 and ≥ 1:128'}, {'measure': 'rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results were tabulated as geometric mean expressed in titers.'}, {'measure': 'Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.'}, {'measure': 'Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).'}, {'measure': 'Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-off for the assay was ≥ 0.1'}, {'measure': 'Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).'}, {'measure': 'Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-off for the assay was ≥ 0.1'}, {'measure': 'Anti-diphtheria (Anti-D) Antibody Concentrations', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).'}, {'measure': 'Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-off for the assay was ≥ 1:8.'}, {'measure': 'Anti-polio Type 1, 2 & 3 Titers', 'timeFrame': 'At month 0, 1 and 2', 'description': 'The results for the assay were tabulated as geometric mean expressed in titers.'}, {'measure': 'Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-off for the assay was ≥ 1.0'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).'}, {'measure': 'Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The cut-offs for the assay were ≥ 10 mIU/mL and ≥ 100 mIU/mL respectively .'}, {'measure': 'Anti-HBs Antibody Concentrations', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens', 'timeFrame': '1 month after vaccination (Month 1)', 'description': 'Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration \\< 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination.\n\nThe analysis was based only on subjects receiving experimental vaccination.'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'timeFrame': 'At month 0, month 1 and month 2', 'description': 'The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful.'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination', 'description': 'The analysis was based only on subjects receiving combined-diphtheria vaccination.'}, {'measure': 'Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose', 'timeFrame': 'During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)', 'description': 'Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship.\n\nSubjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination.'}, {'measure': 'Number of Subjects Reporting Any Rash', 'timeFrame': 'Day 0 - Month 7', 'description': 'Any was defined as occurrence of at least one symptom experienced.'}, {'measure': 'Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)', 'timeFrame': 'Day 0 - Month 7', 'description': 'Any was defined as occurrence of at least one symptom experienced.'}, {'measure': 'Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)', 'timeFrame': 'Day 0 - Month 7', 'description': 'Any was defined as occurrence of at least one symptom experienced.'}, {'measure': 'Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose', 'timeFrame': 'Occurring within Day 0-30 following vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.'}, {'measure': 'Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose', 'timeFrame': 'Occurring within Day 0-30 following vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.\n\nThe analysis was based only on subjects receiving a second dose of vaccination.'}, {'measure': 'Number of Subjects Reporting Any Serious Adverse Events (SAEs)', 'timeFrame': 'From dose 1 (Month 0) up to study end (Month 7)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.'}]}, 'conditionsModule': {'keywords': ['Meningococcal vaccine', 'Immunogenicity', 'Routine infancy vaccination', 'Safety'], 'conditions': ['Infections, Meningococcal']}, 'referencesModule': {'availIpds': [{'id': '109835', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109835', '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': '109835', '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': '109835', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '109835', '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': '109835', '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': '109835', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '21420417', 'type': 'BACKGROUND', 'citation': 'Knuf M, Pantazi-Chatzikonstantinou A, Pfletschinger U, Tichmann-Schumann I, Maurer H, Maurer L, Fischbach T, Zinke H, Pankow-Culot H, Papaevangelou V, Bianco V, Van der Wielen M, Miller JM. An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children. Vaccine. 2011 Jun 6;29(25):4264-73. doi: 10.1016/j.vaccine.2011.03.009. Epub 2011 Mar 21.'}, {'type': 'BACKGROUND', 'citation': 'Maurer H et al. Co-administration of MENACWY-TT conjugate vaccine with DTPA-HBV-IPV/HIB vaccine does not impair immune response to DTPA-HBV-IPV/HIB, and has an acceptable safety profile. Abstract presented at the 28th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.'}], '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 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.', 'detailedDescription': 'Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™.\n\nFor subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination.\n\nFor subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.'}, '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 first 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* Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 first vaccine dose.\n* Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).\n* Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y.\n* Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y.\n* Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b.\n* History of meningococcal disease.\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 reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).\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.\n\nAdditional criteria for subjects receiving Infanrix hexa™\n\n* Hypersensitivity reaction due to previous vaccination with Infanrix hexa™.\n* Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.'}, 'identificationModule': {'nctId': 'NCT00508261', 'briefTitle': 'Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children", 'orgStudyIdInfo': {'id': '109835'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Meningococcal vaccine GSK134612 co-administered with Infanrix hexa™', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612', 'Biological: Infanrix™ hexa']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Meningococcal vaccine GSK134612 followed one month later by Infanrix hexa™', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612', 'Biological: Infanrix™ hexa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Infanrix hexa™ followed one month later by Meningococcal vaccine GSK134612', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612', 'Biological: Infanrix™ hexa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'Meningitec™ vaccination', 'interventionNames': ['Biological: Meningitec™']}], 'interventions': [{'name': 'Meningococcal vaccine GSK134612', 'type': 'BIOLOGICAL', 'description': 'Single dose intramuscular injection', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Infanrix™ hexa', 'type': 'BIOLOGICAL', 'description': 'Single dose intramuscular injection', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Meningitec™', 'type': 'BIOLOGICAL', 'description': 'Single dose intramuscular injection', 'armGroupLabels': ['Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-4070', 'city': 'Eferding', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.30866, 'lon': 14.02233}}, {'zip': 'A 2491', 'city': 'Neufeld/Leitha', 'country': 'Austria', 'facility': 'GSK Investigational Site'}, {'zip': 'A-5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': 'A-9500', 'city': 'Villach', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.61028, 'lon': 13.85583}}, {'zip': 'A-4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '74357', 'city': 'Bönnigheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.04018, 'lon': 9.09386}}, {'zip': '75015', 'city': 'Bretten', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.03685, 'lon': 8.70745}}, {'zip': '74072', 'city': 'Heilbronn', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': '76189', 'city': 'Karlsruhe', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '71672', 'city': 'Marbach', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.56692, 'lon': 9.72694}}, {'zip': '77704', 'city': 'Oberkirch', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.53241, 'lon': 8.07864}}, {'zip': '71720', 'city': 'Oberstenfeld', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.02611, 'lon': 9.32083}}, {'zip': '75172', 'city': 'Pforzheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.88436, 'lon': 8.69892}}, {'zip': '74523', 'city': 'Schwäbisch Hall', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.11127, 'lon': 9.73908}}, {'zip': '70469', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '88069', 'city': 'Tettnang', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.66857, 'lon': 9.59132}}, {'zip': '63739', 'city': 'Aschaffenburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '87600', 'city': 'Kaufbeuren', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.88238, 'lon': 10.62192}}, {'zip': '86916', 'city': 'Kaufering', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.09121, 'lon': 10.87913}}, {'zip': '96317', 'city': 'Kronach', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'zip': '81241', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81735', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '86720', 'city': 'Nördlingen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.85122, 'lon': 10.48868}}, {'zip': '82140', 'city': 'Olching', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.2, 'lon': 11.33333}}, {'zip': '34225', 'city': 'Braunatal', 'state': 'Hesse', 'country': 'Germany', 'facility': 'GSK Investigational Site'}, {'zip': '37269', 'city': 'Eschwege', 'state': 'Hesse', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.18386, 'lon': 10.05329}}, {'zip': '63110', 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