Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT00667602
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2008-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008585', 'term': 'Meningitis, Meningococcal'}, {'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'GCP compliance issues were identified at one site, data collected for this site were not used in this data posting.'}}, 'adverseEventsModule': {'timeFrame': 'Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180.', 'description': 'Data collected from one site were not included in the data analysis for outcome measures and the AE section.', 'eventGroups': [{'id': 'EG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.', 'otherNumAtRisk': 195, 'otherNumAffected': 192, 'seriousNumAtRisk': 195, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.', 'otherNumAtRisk': 192, 'otherNumAffected': 184, 'seriousNumAtRisk': 192, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.', 'otherNumAtRisk': 179, 'otherNumAffected': 170, 'seriousNumAtRisk': 179, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 102}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 110}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 104}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 73}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 111}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 76}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 94}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 49}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis Diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Amphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperpyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Food Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Accidental exposure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neuroblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '89'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '95'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8', 'ciLowerLimit': '-15', 'ciUpperLimit': '-1', 'groupDescription': 'The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)'}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination', 'description': 'Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '94'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7', 'ciLowerLimit': '-13', 'ciUpperLimit': '-2', 'groupDescription': 'The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)'}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination', 'description': 'Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'titer ≥ 1:8, prevacc, Men A, (N=159,23)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '29'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'titer ≥ 1:8, postvacc, Men A (N=166,23)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '97'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'titer ≥ 1:8, prevacc, Men C (N=161,152)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '84'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '11'}]}]}, {'title': 'titer ≥ 1:8, postvacc, Men C (N=167,153)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '95'}]}]}, {'title': 'titer ≥ 1:8, prevacc, Men W, (N=157,23)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '75'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'titer ≥ 1:8, postvacc, Men W, (N=165,22)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '99'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '23'}]}]}, {'title': 'titer ≥ 1:8, prevacc, Men Y, (N=156, 23)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '76'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'titer ≥ 1:8, postvacc, Men Y, (N=163,22)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '98'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '23'}]}]}, {'title': 'titer ≥ 1:4, prevacc, Men A, (N=159,23)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '33'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'titer ≥ 1:4, postvacc, Men A, (N=166,23)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '98'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'titer ≥ 1:4, prevacc, Men C, (N=161,152)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '92'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '13'}]}]}, {'title': 'titer ≥ 1:4, postvacc, Men C, (N=167,153)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '99'}]}]}, {'title': 'titer ≥ 1:4, prevacc, Men W, (N=157,23)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '81'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'titer ≥ 1:4, postvacc, Men W, (N=165,22)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '99'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '23'}]}]}, {'title': 'titer ≥ 1:4, prevacc, Men Y, (N=156,23)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '84'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': 'titer ≥ 1:4, postvacc, Men Y, (N=163,22)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '23'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72', 'ciLowerLimit': '64', 'ciUpperLimit': '79', 'groupDescription': 'Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.', 'statisticalMethod': 'Percentage difference', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PMenACWY - PMenC \\> -10%).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '3', 'ciUpperLimit': '13', 'groupDescription': 'Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.', 'statisticalMethod': 'Percentage difference', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PMenACWY - PMenC \\> -10%).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '80', 'ciLowerLimit': '73', 'ciUpperLimit': '86', 'groupDescription': 'Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.', 'statisticalMethod': 'Percentage difference', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PMenACWY - PMenC \\> -10%).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-2', 'ciUpperLimit': '5', 'groupDescription': 'Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.', 'statisticalMethod': 'Percentage difference', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PMenACWY - PMenC \\> -10%).'}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C.\n2. Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'titer ≥ 1:8, pre-vacc, Men A, (N=171)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '3'}]}]}, {'title': 'titer ≥ 1:8, post-vacc, Men A, (N=172)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '57'}]}]}, {'title': 'titer ≥ 1:8, pre-vacc, Men W, (N=168)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}]}]}, {'title': 'titer ≥ 1:8, post-vacc, Men W, (N=170)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '68'}]}]}, {'title': 'titer ≥ 1:8, pre-vacc, Men Y, (N=160)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'titer ≥ 1:8, post-vacc, Men Y, (N=167)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '58'}]}]}, {'title': 'titer ≥ 1:4, pre-vacc, Men A, (N=171)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '3'}]}]}, {'title': 'titer ≥ 1:4, post-vacc, Men A, (N=172)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '65'}]}]}, {'title': 'titer ≥ 1:4, pre-vacc, Men W, (N=168)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'titer ≥ 1:4, post-vacc, Men W, (N=170)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '70'}]}]}, {'title': 'titer ≥ 1:4, pre-vacc, Men Y, (N=160)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'titer ≥ 1:4, post-vacc, Men Y, (N=167)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '63'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination.', 'description': 'Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y.\n\nSerogroup C is not shown here as it is shown in other outcome measures.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'Prevaccination (month 12) (N=174, 152)', 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.77', 'upperLimit': '2.51'}, {'value': '2.29', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.75'}]}]}, {'title': 'Postvaccination (month 13) (N=175,153)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '28'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '39'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.12', 'groupDescription': 'For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '(GMTMenACWY/GMTMenC \\> 0.5).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.93', 'groupDescription': 'For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '(GMTMenACWY/GMTMenC \\> 0.5).'}], 'paramType': 'MEAN', 'timeFrame': '1 month postvaccination', 'description': 'Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'prevacc, Men A (N=171)', 'categories': [{'measurements': [{'value': '1.99', 'groupId': 'OG000', 'lowerLimit': '1.72', 'upperLimit': '2.3'}]}]}, {'title': 'postvacc Men A (N=172)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7.71', 'upperLimit': '13'}]}]}, {'title': 'prevacc, Men W (N=168)', 'categories': [{'measurements': [{'value': '2.12', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '2.62'}]}]}, {'title': 'postvacc Men W (N=170)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '19'}]}]}, {'title': 'prevacc, Men Y (N=160)', 'categories': [{'measurements': [{'value': '1.92', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '2.32'}]}]}, {'title': 'postvacc Men Y (N=167)', 'categories': [{'measurements': [{'value': '7.05', 'groupId': 'OG000', 'lowerLimit': '5.43', 'upperLimit': '9.15'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month postvaccination', 'description': 'Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'prevacc, Men A (N=159,23)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.92', 'upperLimit': '3.97'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.46', 'upperLimit': '2.73'}]}]}, {'title': 'postvacc Men A (N=166,23)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '99'}, {'value': '2.22', 'groupId': 'OG001', 'lowerLimit': '1.22', 'upperLimit': '4.04'}]}]}, {'title': 'prevacc, Men C (N=161,152)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '28'}, {'value': '2.29', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.75'}]}]}, {'title': 'postvacc, Men C (N=167,153)', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000', 'lowerLimit': '197', 'upperLimit': '314'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '39'}]}]}, {'title': 'prevacc, Men W (N=157,23)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '17'}, {'value': '1.71', 'groupId': 'OG001', 'lowerLimit': '1.06', 'upperLimit': '2.74'}]}]}, {'title': 'postvacc, Men W (N=165,22)', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000', 'lowerLimit': '153', 'upperLimit': '295'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '4.03'}]}]}, {'title': 'prevacc, Men Y (N=156,23)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9.44', 'upperLimit': '14'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '2.63'}]}]}, {'title': 'postvacc, Men Y (N=163,22)', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000', 'lowerLimit': '119', 'upperLimit': '205'}, {'value': '1.93', 'groupId': 'OG001', 'lowerLimit': '1.06', 'upperLimit': '3.52'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'ciLowerLimit': '8.43', 'ciUpperLimit': '13', 'groupDescription': 'For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 .', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '(GMTMenACWY/GMTMenjugate \\> 0.5).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '6.35', 'ciUpperLimit': '10', 'groupDescription': 'For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '(GMTMenACWY/GMTMenjugate \\> 0.5).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month postvaccination', 'description': '1. The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C.\n2. The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and concomitant dose of PCV7 and DTPa-IPV-HepBHib at 12 months.'}, {'id': 'OG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'Anti-Diphtheria Toxin ≥ 0.1 IU/mL N= (168,173,152)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'Anti-Diphtheria Toxin ≥ 1.0 IU/mL N= (168,173,152)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}]}]}, {'title': 'Anti-Tetanus Toxin ≥ 0.1 IU/mL N= (168,173,152)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'Anti-Tetanus Toxin ≥ 1.0 IU/mL N= (168,173,152)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '98'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '98'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '93', 'upperLimit': '99'}]}]}, {'title': 'FHA ELISA N=(160,169,152)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '95'}, {'value': '96', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '99'}]}]}, {'title': 'PRN ELISA N=(160,169,152)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '99'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'PT ELISA N=(159,165,151)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '97'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '99'}]}]}, {'title': 'polio 1 N=(157,161,148)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '96', 'upperLimit': '100'}]}]}, {'title': 'polio 2 N=157,(161,148)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'polio 3 N=(146,151,143)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '97', 'upperLimit': '100'}]}]}, {'title': 'Hep B N=(157,161,147)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '96', 'upperLimit': '100'}]}]}, {'title': 'Anti-PRP (HIB) ≥ 0.15 μg/mL N=(168,173,151)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '98', 'upperLimit': '100'}]}]}, {'title': 'Anti-PRP (HIB) ≥ 1.0 μg/mL N=(168,173,151)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '96', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2', 'ciUpperLimit': '2', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2', 'ciUpperLimit': '2', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-3', 'ciUpperLimit': '5', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-3', 'ciUpperLimit': '4', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2', 'ciUpperLimit': '2', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2', 'ciUpperLimit': '2', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-6', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-6', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-2', 'ciUpperLimit': '4', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-2', 'ciUpperLimit': '4', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-3', 'ciUpperLimit': '2', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-3', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2', 'ciUpperLimit': '3', 'pValueComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2', 'ciUpperLimit': '2', 'pValueComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2', 'ciUpperLimit': '2', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-2', 'ciUpperLimit': '4', 'pValueComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-4', 'ciUpperLimit': '2', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': 'PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-3', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-4', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC)'}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination', 'description': 'The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed.\n\nFor Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration \\< LLQ) is defined as post-vaccination antibody concentration \\>= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration \\>=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration.\n\nDiptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) \\>=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA\\>=1.0 IU/mL.\n\nPolio type 1, 2 and 3: bNT (neutralization test) with \\>=1:8.\n\nHepB (HBV): primary endpoint ELISA \\>=10mU/mL.\n\nPRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'PNC 4 N=(168,150)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '88'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '88'}, {'value': '87', 'groupId': 'OG002', 'lowerLimit': '81', 'upperLimit': '92'}]}]}, {'title': 'PNC 6B N=(168,149)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '96'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '95'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '93', 'upperLimit': '99'}]}]}, {'title': 'PNC 9V N=(168,150)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '94'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '93'}, {'value': '93', 'groupId': 'OG002', 'lowerLimit': '88', 'upperLimit': '97'}]}]}, {'title': 'PNC 14 N=(167,150)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '96', 'upperLimit': '100'}]}]}, {'title': 'PNC 18C N=(168,150)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '77'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '82'}, {'value': '86', 'groupId': 'OG002', 'lowerLimit': '79', 'upperLimit': '91'}]}]}, {'title': 'PNC 19 F N=(168,150)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '87'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '86'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '84', 'upperLimit': '94'}]}]}, {'title': 'PNC 23 F N=(168,150)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '92'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '93'}, {'value': '94', 'groupId': 'OG002', 'lowerLimit': '89', 'upperLimit': '97'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-13', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6', 'ciLowerLimit': '-12', 'ciUpperLimit': '-1', 'groupDescription': 'Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-11', 'ciUpperLimit': '2', 'groupDescription': 'Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-3', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10', 'ciLowerLimit': '-19', 'ciUpperLimit': '-2', 'groupDescription': 'Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10', 'ciLowerLimit': '-17', 'ciUpperLimit': '-2', 'groupDescription': 'Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-12', 'ciUpperLimit': '1', 'groupDescription': 'Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-12', 'ciUpperLimit': '4', 'groupDescription': 'Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-11', 'ciUpperLimit': '0', 'groupDescription': 'Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3', 'ciLowerLimit': '-10', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-4', 'ciUpperLimit': '3', 'groupDescription': 'Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15', 'ciLowerLimit': '-24', 'ciUpperLimit': '-6', 'groupDescription': 'Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-17', 'ciUpperLimit': '-1', 'groupDescription': 'Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6', 'ciLowerLimit': '-13', 'ciUpperLimit': '0', 'groupDescription': 'Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).'}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination', 'description': 'To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age.\n\nSeroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'hSBA ≥ 1:8, postvacc, Men C. N=(17,14,13)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '98'}, {'value': '92', 'groupId': 'OG002', 'lowerLimit': '64', 'upperLimit': '100'}]}]}, {'title': 'hSBA ≥ 1:8, perisistence, Men C. N=(17,14,13)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '90'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '87'}, {'value': '54', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '81'}]}]}, {'title': 'hSBA ≥ 1:4, postvacc, Men C. N=(17,14,13)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '100'}]}]}, {'title': 'hSBA ≥ 1:4, persistence, Men C. N=(17,14,13)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '93'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '92'}, {'value': '77', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination and 6-18 months postvaccination.', 'description': 'Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set (persistence subgroup).'}, {'type': 'SECONDARY', 'title': 'Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'hSBA ≥ 1:8, postvacc, Men A (N=17,14)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '99'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '72'}]}]}, {'title': 'hSBA ≥ 1:8, persistence, Men A (N=16,14)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '59'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '34'}]}]}, {'title': 'hSBA ≥ 1:4, post-vacc, Men A (N=17,12)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '79'}]}]}, {'title': 'hSBA ≥ 1:4, persistence, Men A (N=16,14)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '65'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '43'}]}]}, {'title': 'hSBA ≥ 1:8, postvacc, Men W (N=17,12)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '90'}]}]}, {'title': 'hSBA ≥ 1:8, persistence, Men W (N=16,14)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '93'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '92'}]}]}, {'title': 'hSBA ≥ 1:4, postvacc, Men W (N=17,13)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '98'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'hSBA ≥ 1:4, persistence, Men W (N=16,14)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '98'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '92'}]}]}, {'title': 'hSBA ≥ 1:8, postvacc, Men Y (N=17,12)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '65'}]}]}, {'title': 'hSBA ≥ 1:8, persistence, Men Y (N=14,14)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '95'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '49', 'upperLimit': '95'}]}]}, {'title': 'hSBA ≥ 1:4, postvacc, Men Y (N=17,12)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '79'}]}]}, {'title': 'hSBA ≥ 1:4, persistence, Men Y (N=14,14)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '98'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination 6-18 months postvaccination', 'description': 'Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set (persistence subset).'}, {'type': 'SECONDARY', 'title': 'Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG002', 'title': 'MenC(1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'Month 13', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000', 'lowerLimit': '139', 'upperLimit': '419'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '66'}, {'value': '30', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '56'}]}]}, {'title': '6 - 18 months after month 12', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '7.45', 'upperLimit': '29'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '5.65', 'upperLimit': '25'}, {'value': '8.95', 'groupId': 'OG002', 'lowerLimit': '4.15', 'upperLimit': '19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month postvaccination and 6-18 months postvaccination.', 'description': 'Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set (subjects enrolled in Australia).'}, {'type': 'SECONDARY', 'title': 'Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'Month 12, Ser A (N= 17, 12)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '86'}, {'value': '6.69', 'groupId': 'OG001', 'lowerLimit': '3.28', 'upperLimit': '14'}]}]}, {'title': '6 - 18 months after Month 12, Ser A (N=16,14)', 'categories': [{'measurements': [{'value': '4.41', 'groupId': 'OG000', 'lowerLimit': '2.78', 'upperLimit': '7'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '4.56'}]}]}, {'title': 'Month 12, Ser W (N= 17, 12)', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '340'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '6.26', 'upperLimit': '28'}]}]}, {'title': '6 - 18 months after Month 12, Ser W (N=16,14)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '39'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '9.77', 'upperLimit': '42'}]}]}, {'title': 'Month 12, Ser Y (N= 17, 12)', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '246'}, {'value': '5.13', 'groupId': 'OG001', 'lowerLimit': '2.87', 'upperLimit': '9.17'}]}]}, {'title': '6 - 18 months after Month 12, Ser Y (N=14,14)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '38'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '9.15', 'upperLimit': '28'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6-18 months postvaccination.', 'description': 'Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set (only for subjects enrolled in Australia).'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'rSBA titer ≥ 1:8, prevacc (N=140,140,139)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '79'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'rSBA titer ≥ 1:8, postvacc (N=156,157,145)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '96'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '99'}]}]}, {'title': 'rSBA titer ≥ 1:128, prevacc (N=140,140,139)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '39'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.018', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'rSBA titer ≥ 1:128, postvacc (N=156,157,145)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '96'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '82'}, {'value': '88', 'groupId': 'OG002', 'lowerLimit': '82', 'upperLimit': '93'}]}]}, {'title': 'four fold rise (N=132,140,139)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '92'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '95'}, {'value': '96', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71', 'ciLowerLimit': '63', 'ciUpperLimit': '78', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-3', 'ciUpperLimit': '6', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-2', 'ciUpperLimit': '7', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-11', 'ciUpperLimit': '1', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31', 'ciLowerLimit': '24', 'ciUpperLimit': '39', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-2', 'ciUpperLimit': '4', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '-3', 'ciUpperLimit': '11', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': 'PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13', 'ciLowerLimit': '-22', 'ciUpperLimit': '-5', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': 'PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10', 'ciLowerLimit': '-17', 'ciUpperLimit': '-4', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': 'PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-11', 'ciUpperLimit': '1', 'groupDescription': 'For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.', 'testedNonInferiority': True, 'nonInferiorityComment': 'PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).'}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.\n2. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'rSBA titer ≥ 1:128, Men A', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}]}]}, {'title': 'rSBA titer ≥ 1:128, Men W', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '99'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '97'}]}]}, {'title': 'rSBA titer ≥ 1:128, Men Y', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '95'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '92'}]}]}, {'title': 'rSBA titer ≥ 1:8, Men A', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}]}]}, {'title': 'rSBA titer ≥ 1:8, Men W', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '88', 'upperLimit': '99'}]}]}, {'title': 'rSBA titer ≥ 1:8, Men Y', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '94'}]}]}, {'title': 'Four Fold Rise of rSBA titer, Men A', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '85'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '88', 'upperLimit': '99'}]}]}, {'title': 'Four Fold Rise of rSBA titer, Men W', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '99'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '99'}]}]}, {'title': 'Four Fold Rise of rSBA titer, Men Y', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '98'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.\n2. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'GMT, prevacc (N=140,140,139)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '33'}, {'value': '2.22', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '2.8'}, {'value': '2.03', 'groupId': 'OG002', 'lowerLimit': '1.62', 'upperLimit': '2.54'}]}]}, {'title': 'GMT, postvacc (N=156,157,145)', 'categories': [{'measurements': [{'value': '353', 'groupId': 'OG000', 'lowerLimit': '260', 'upperLimit': '479'}, {'value': '131', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '176'}, {'value': '266', 'groupId': 'OG002', 'lowerLimit': '197', 'upperLimit': '359'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.83', 'groupDescription': 'For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': '(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.\n2. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'GMT, prevacc, Men A (N=73,82)', 'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '587'}, {'value': '6.83', 'groupId': 'OG001', 'lowerLimit': '3.34', 'upperLimit': '14'}]}]}, {'title': 'GMT, postvacc, Men A', 'categories': [{'measurements': [{'value': '3136', 'groupId': 'OG000', 'lowerLimit': '2013', 'upperLimit': '4886'}, {'value': '3258', 'groupId': 'OG001', 'lowerLimit': '2113', 'upperLimit': '5022'}]}]}, {'title': 'GMT, prevacc, Men W (N=59,75)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '33'}, {'value': '2.32', 'groupId': 'OG001', 'lowerLimit': '1.46', 'upperLimit': '3.69'}]}]}, {'title': 'GMT, postvacc, Men W', 'categories': [{'measurements': [{'value': '708', 'groupId': 'OG000', 'lowerLimit': '421', 'upperLimit': '1191'}, {'value': '1306', 'groupId': 'OG001', 'lowerLimit': '786', 'upperLimit': '2169'}]}]}, {'title': 'GMT, prevacc, Men Y (N=32,49)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '40'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '1.42', 'upperLimit': '4.06'}]}]}, {'title': 'GMT, postvacc, Men Y (N=76,81)', 'categories': [{'measurements': [{'value': '574', 'groupId': 'OG000', 'lowerLimit': '320', 'upperLimit': '1028'}, {'value': '598', 'groupId': 'OG001', 'lowerLimit': '336', 'upperLimit': '1066'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y.\n2. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP set.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'OG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'classes': [{'title': 'Any Local N=(195,192,179)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness (MenACWY-CRM197/MenC)N=(194,192,178)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Erythema (MenACWY-CRM197/MenC) N=(194,192,178)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Induration (MenACWY-CRM197/MenC) N=(194,192,178)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness (DTPa-IPV-HepB-Hib) N=(189,190,176)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'Erythema (DTPa-IPV-HepB-Hib)B N=(189,190,176)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'Induration (DTPa-IPV-HepB-Hib) N=(189,190,176)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness (PCV7) N=(189,190,176)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Erythema (PCV7) N=(189,190,176)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'Induration (PCV7) N=(189,190,176)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'Any Systemic reactions N=(195,192,179)', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}]}, {'title': 'Change in eating habits N=(189, 191,177)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Sleepiness N=(191,191,179)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}]}, {'title': 'Persistent crying N=(189,191,177)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}, {'title': 'Irritability N=(191,191,179)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting N=(191,191,179)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhoea N=(191,191,179)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Rash N=(191,191,179)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Fever ≥ 38.5C N=(191,192,179)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Others N=(195,192,179)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Analgesic-Antipyretic medication N=(191,192,179)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 to day 7 postvaccination', 'description': 'Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups.\n\nsafety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'FG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'FG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '228'}, {'groupId': 'FG002', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '213'}, {'groupId': 'FG002', 'numSubjects': '197'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All participants enrolled were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '662', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'MenACWY-CRM197 (2dose) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'BG001', 'title': 'MenACWY-CRM197 (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'BG002', 'title': 'MenC (1dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '208.4', 'spread': '23.7', 'groupId': 'BG000'}, {'value': '209.8', 'spread': '22.2', 'groupId': 'BG001'}, {'value': '209.3', 'spread': '21.9', 'groupId': 'BG002'}, {'value': '209.2', 'spread': '22.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '305', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As one site has been excluded, the number of subjects included in the analysis are MenACWY-CRM197 (2dose) + Concomitant Vaccines N= 196, MenACWY-CRM197 (1dose) + Concomitant Vaccines N= 205 and MenC (1dose) + Concomitant Vaccines N= 193'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 662}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'dispFirstSubmitDate': '2011-02-18', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-03', 'studyFirstSubmitDate': '2008-04-24', 'dispFirstSubmitQcDate': '2011-02-18', 'resultsFirstSubmitDate': '2013-02-18', 'studyFirstSubmitQcDate': '2008-04-25', 'dispFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-03', 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C', 'timeFrame': '1 month postvaccination', 'description': 'Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.'}], 'secondaryOutcomes': [{'measure': 'Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C', 'timeFrame': '1 month postvaccination', 'description': 'Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.'}, {'measure': 'Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C.\n2. Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y.'}, {'measure': 'Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y', 'timeFrame': '1 month postvaccination.', 'description': 'Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y.\n\nSerogroup C is not shown here as it is shown in other outcome measures.'}, {'measure': 'Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C', 'timeFrame': '1 month postvaccination', 'description': 'Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.'}, {'measure': 'Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y', 'timeFrame': '1 month postvaccination', 'description': 'Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.'}, {'measure': 'Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y', 'timeFrame': '1 month postvaccination', 'description': '1. The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C.\n2. The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y.'}, {'measure': 'Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)', 'timeFrame': '1 month postvaccination', 'description': 'The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed.\n\nFor Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration \\< LLQ) is defined as post-vaccination antibody concentration \\>= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration \\>=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration.\n\nDiptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) \\>=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA\\>=1.0 IU/mL.\n\nPolio type 1, 2 and 3: bNT (neutralization test) with \\>=1:8.\n\nHepB (HBV): primary endpoint ELISA \\>=10mU/mL.\n\nPRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.'}, {'measure': 'Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)', 'timeFrame': '1 month postvaccination', 'description': 'To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age.\n\nSeroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL.'}, {'measure': 'Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C', 'timeFrame': '1 month postvaccination and 6-18 months postvaccination.', 'description': 'Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).'}, {'measure': 'Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y', 'timeFrame': '1 month postvaccination 6-18 months postvaccination', 'description': 'Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).'}, {'measure': 'Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C', 'timeFrame': '1 month postvaccination and 6-18 months postvaccination.', 'description': 'Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).'}, {'measure': 'Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y', 'timeFrame': '6-18 months postvaccination.', 'description': 'Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).'}, {'measure': 'Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.\n2. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.'}, {'measure': 'Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.\n2. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.'}, {'measure': 'Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.\n2. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.'}, {'measure': 'Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y', 'timeFrame': '1 month postvaccination.', 'description': '1. Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y.\n2. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y.'}, {'measure': 'Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination', 'timeFrame': 'From day 1 to day 7 postvaccination', 'description': 'Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups.\n\nsafety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups'}]}, 'conditionsModule': {'keywords': ['Meningococcal', 'ACWY', 'Conjugate Vaccine', 'Meningitis', 'Toddlers', 'Infants', 'Concomitant Vaccination'], 'conditions': ['Meningococcal Meningitis']}, 'referencesModule': {'references': [{'pmid': '33325757', 'type': 'DERIVED', 'citation': 'Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry\n\nExclusion Criteria:\n\n* who previously received any meningococcal vaccine;\n* who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;\n* who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;\n* Subjects with any serious, acute or chronic progressive disease'}, 'identificationModule': {'nctId': 'NCT00667602', 'briefTitle': 'Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers', 'orgStudyIdInfo': {'id': 'V59P22'}, 'secondaryIdInfos': [{'id': '2007-004754-82'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM197 (2 doses) + Concomitant Vaccines', 'description': 'Infants received two doses of MenACWY-CRM197 at 6 to 8 and 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months.', 'interventionNames': ['Biological: MenACWY-CRM197 (two doses)', 'Biological: PCV7', 'Biological: DTPa-IPV-HepB-Hib']}, {'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM197 (1 dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenACWY-CRM197 at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.', 'interventionNames': ['Biological: PCV7', 'Biological: DTPa-IPV-HepB-Hib', 'Biological: MenACWY-CRM197 (one dose)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MenC (1 dose) + Concomitant Vaccines', 'description': 'Infants received one dose of MenC vaccine at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.', 'interventionNames': ['Biological: MenC', 'Biological: PCV7', 'Biological: DTPa-IPV-HepB-Hib']}], 'interventions': [{'name': 'MenACWY-CRM197 (two doses)', 'type': 'BIOLOGICAL', 'description': 'Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.', 'armGroupLabels': ['MenACWY-CRM197 (2 doses) + Concomitant Vaccines']}, {'name': 'MenC', 'type': 'BIOLOGICAL', 'description': 'One 0.5mL dose of MenC vaccine was administered by intramuscular injection.', 'armGroupLabels': ['MenC (1 dose) + Concomitant Vaccines']}, {'name': 'PCV7', 'type': 'BIOLOGICAL', 'description': 'One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.', 'armGroupLabels': ['MenACWY-CRM197 (1 dose) + Concomitant Vaccines', 'MenACWY-CRM197 (2 doses) + Concomitant Vaccines', 'MenC (1 dose) + Concomitant Vaccines']}, {'name': 'DTPa-IPV-HepB-Hib', 'type': 'BIOLOGICAL', 'description': 'One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.', 'armGroupLabels': ['MenACWY-CRM197 (1 dose) + Concomitant Vaccines', 'MenACWY-CRM197 (2 doses) + Concomitant Vaccines', 'MenC (1 dose) + Concomitant Vaccines']}, {'name': 'MenACWY-CRM197 (one dose)', 'type': 'BIOLOGICAL', 'description': 'One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.', 'armGroupLabels': ['MenACWY-CRM197 (1 dose) + Concomitant Vaccines']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55543', 'city': 'Bad Kreuznach', 'country': 'Germany', 'facility': 'Site 22', 'geoPoint': {'lat': 49.8414, 'lon': 7.86713}}, {'zip': '07356', 'city': 'Bad Lobenstein', 'country': 'Germany', 'facility': 'Site 38', 'geoPoint': {'lat': 50.45223, 'lon': 11.6393}}, {'zip': '58802', 'city': 'Balve', 'country': 'Germany', 'facility': 'Site 24', 'geoPoint': {'lat': 51.3315, 'lon': 7.86424}}, {'zip': '12589', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 3', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12619', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 27', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12627', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 20', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12627', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 26', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13189', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 13', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13189', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 31', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site 25', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '74357', 'city': 'Bönnigheim', 'country': 'Germany', 'facility': 'Site 15', 'geoPoint': {'lat': 49.04018, 'lon': 9.09386}}, {'zip': '37269', 'city': 'Eschwege', 'country': 'Germany', 'facility': 'Site 39', 'geoPoint': {'lat': 51.18386, 'lon': 10.05329}}, {'zip': '24937', 'city': 'Flensburg', 'country': 'Germany', 'facility': 'Site 32', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'zip': '67227', 'city': 'Frankenthal', 'country': 'Germany', 'facility': 'Site 16', 'geoPoint': {'lat': 49.53414, 'lon': 8.35357}}, {'zip': '24960', 'city': 'Glücksburg', 'country': 'Germany', 'facility': 'Site 33', 'geoPoint': {'lat': 54.83503, 'lon': 9.55218}}, {'zip': '22147', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Site 35', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '77694', 'city': 'Kehl', 'country': 'Germany', 'facility': 'Site 2', 'geoPoint': {'lat': 48.57297, 'lon': 7.81523}}, {'zip': '55127', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Site 28', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Site 44', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81669', 'city': 'München-Ramersdorf', 'country': 'Germany', 'facility': 'Site 43'}, {'zip': '98724', 'city': 'Neuhaus am Rennweg', 'country': 'Germany', 'facility': 'Site 42', 'geoPoint': {'lat': 50.51006, 'lon': 11.13787}}, {'zip': '24534', 'city': 'Neumünster', 'country': 'Germany', 'facility': 'Site 21', 'geoPoint': {'lat': 54.07399, 'lon': 9.98456}}, {'zip': '24534', 'city': 'Neumünster', 'country': 'Germany', 'facility': 'Site 9', 'geoPoint': {'lat': 54.07399, 'lon': 9.98456}}, {'zip': '71720', 'city': 'Oberstenfeld', 'country': 'Germany', 'facility': 'Site 10', 'geoPoint': {'lat': 49.02611, 'lon': 9.32083}}, {'zip': '70193', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Site 4', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '70469', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Site 19', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '82362', 'city': 'Weilheim I OB', 'country': 'Germany', 'facility': 'Site 30'}, {'zip': '69168', 'city': 'Wiesloch', 'country': 'Germany', 'facility': 'Site 6', 'geoPoint': {'lat': 49.29504, 'lon': 8.69846}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}