Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-28 @ 2:17 AM
Study NCT ID:
NCT01214850
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Novartis Vaccine and Diagnostics Carriage Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D022321', 'term': 'Japanese Encephalitis Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited adverse events were collected from Day1 to day 7 post vaccination; unsolicited AEs were collected throughout the study period (Day 1-Day 361)', 'description': 'The enrolled and safety set populations differ as 11 subjects (5 in rMenB+OMV, 4 in MeACWY and 2 in Control groups) did not receive the study vaccination and therefore did not have any safety data.', 'eventGroups': [{'id': 'EG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart', 'otherNumAtRisk': 974, 'otherNumAffected': 200, 'seriousNumAtRisk': 974, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart', 'otherNumAtRisk': 984, 'otherNumAffected': 186, 'seriousNumAtRisk': 984, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart', 'otherNumAtRisk': 985, 'otherNumAffected': 172, 'seriousNumAtRisk': 985, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 145}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 155}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 119}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 112}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 85}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thyroiditis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendiceal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Genital abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leptospirosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Burns third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multiple drug overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Traumatic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Traumatic liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscloskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carcinoid tumor pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian germ cell cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'IGA Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pelvic-ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vulval disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 974, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 984, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}, {'value': '984', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '9'}]}]}, {'title': 'Month 2 (N= 916, 928)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.3828', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.185', 'ciLowerLimit': '0.809', 'ciUpperLimit': '1.737', 'groupDescription': 'Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccination', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '61 days (31 days after receiving the second injection)', 'description': 'Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.\n\nVirulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '981', 'groupId': 'OG000'}, {'value': '984', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'Month 1 (N=956, 947)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.840', 'ciLowerLimit': '0.555', 'ciUpperLimit': '1.273', 'groupDescription': 'Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '31 days after MenACWY-CRM injection', 'description': 'The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Pharyngeal carriage)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}, {'value': '984', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '11'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '11'}]}]}, {'title': '1 month post 1st vaccination (Day 31) N=931, 947', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '11'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '11'}]}]}, {'title': '1 month post 2nd vaccination (Day 61) N=916, 928', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '13'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '12'}]}]}, {'title': '3 months post 2nd vaccination (Day 121) N=860, 885', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '12'}]}]}, {'title': '5 months post 2nd vaccination (Day 181) N=832, 864', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '12'}]}]}, {'title': '11 months post 2nd vaccination (Day 361) N=797,827', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '12'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Pharyngeal carriage)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}, {'value': '984', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '9'}]}]}, {'title': '1 month post 1st vaccination (Day 31) N=931,947', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '10'}]}]}, {'title': '1 month post 2nd vaccination (Day 61) N=916, 928', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '10'}]}]}, {'title': '3 months post 2nd vaccination (Day 121) N=860, 885', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '11'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '11'}]}]}, {'title': '5 months post 2nd vaccination (Day 181) N=832,864', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '11'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '11'}]}]}, {'title': '11 months post 2nd vaccination (Day 361) N=797,827', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Pharyngeal carriage)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}, {'value': '984', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}, {'title': '1 month post 1st vaccination (N=931,947)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': '1 month post 2nd vaccination (N=916,928)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': '3 months post 2nd vaccination (N=860,885)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': '5 months post 2nd vaccination (N=832,864)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': '11 months post 2nd vaccination (N=797,827)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Pharyngeal carriage)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}, {'value': '984', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'Control', 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'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Genogroup B All STs (N=152, 160)', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '162'}, {'value': '146', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': '180'}]}]}, {'title': 'Genogroup B virulent STs (N=142, 142)', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '157'}, {'value': '147', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': '182'}]}]}, {'title': 'All N meningitidis', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000', 'lowerLimit': '176', 'upperLimit': '210'}, {'value': '202', 'groupId': 'OG001', 'lowerLimit': '185', 'upperLimit': '219'}]}]}, {'title': 'Genogroups ABCWY (N=300, 323)', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000', 'lowerLimit': '122', 'upperLimit': '164'}, {'value': '162', 'groupId': 'OG001', 'lowerLimit': '141', 'upperLimit': '183'}]}]}, {'title': 'Serogroups ACWY (N=131, 142)', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '129'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '138'}]}]}, {'title': 'Serogroup Y (N=106, 123)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '132'}, {'value': '117', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '144'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)', 'description': 'The duration of 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'96', 'upperLimit': '146'}, {'value': '146', 'groupId': 'OG001', 'lowerLimit': '122', 'upperLimit': '170'}]}]}, {'title': 'Serogroups ACWY (N=75, 102)', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '143'}, {'value': '120', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '151'}]}]}, {'title': 'Serogroup Y (N=61, 87)', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '146'}, {'value': '120', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '153'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)', 'description': 'The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.', 'unitOfMeasure': 'Number of days', 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hSBA<4(H44/76) (N=60, 18)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '16'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19'}]}]}, {'title': '3months post 2nd dose; hSBA<4(H44/76) (N=56, 17)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}]}]}, {'title': '5 months post 2nd dose; hSBA <4(H44/76) (N=56, 17)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '17'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}]}]}, {'title': '11 months post 2nd dose;hSBA <4(H44/76) (N=56, 16)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '22'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}]}]}, {'title': 'Baseline hSBA ≥4 (H44/76)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '21'}]}]}, {'title': '1month post 1st dose; hSBA ≥4 (H44/76) (N=130, 30)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '27'}]}]}, {'title': '1 month post 2nd dose;hSBA ≥4 (H44/76) (N=130, 30)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '14'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '22'}]}]}, {'title': '3 months post 2nd dose;hSBA ≥4 (H44/76) (N=120,29)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '32'}]}]}, {'title': '5 months post 2nd dose;hSBA ≥4 (H44/76) (N=115,28)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '28'}]}]}, {'title': '11 months post 2nd dose;hSBA ≥4 (H44/76)(N=123,30)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '22'}]}]}, {'title': 'Baseline hSBA < 4 (5/99) (N=77, 23)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '28'}]}]}, {'title': '1month post 1st dose; hSBA<4 (5/99) (N=77, 22)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '29'}]}]}, {'title': '1 month post 2nd dose;hSBA <4 (5/99) (N=77, 22)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}]}]}, {'title': '3 months post 2nd dose;hSBA <4 (5/99) (N=71, 21)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '30'}]}]}, {'title': '5 months post 2nd dose;hSBA <4 (5/99) (N=68, 21)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '30'}]}]}, {'title': '11 months post 2nd dose;hSBA <4(5/99) (N=71, 20)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '16'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'Baseline hSBA ≥4 (5/99) (N=116, 27)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '14'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13'}]}]}, {'title': '1month post 1st dose; hSBA ≥4 (5/99) (N=113, 26)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0.097', 'upperLimit': '20'}]}]}, {'title': '1 month post 2nd dose;hSBA ≥4 (5/99) (N=113, 26)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '15'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '25'}]}]}, {'title': '3 months post 2nd dose;hSBA ≥4 (5/99) (N=105, 25)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '17'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '26'}]}]}, {'title': '5 months post 2nd dose;hSBA ≥4 (5/99) (N=103, 24)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '15'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}]}]}, {'title': '11 months post 2nd dose;hSBA ≥4(5/99) (N=108, 26)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '13'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0.097', 'upperLimit': '20'}]}]}, {'title': 'Baseline hSBA < 4 (NZ98/254) (N=83, 31)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '21'}]}]}, {'title': '1month post 1st dose; hSBA<4(NZ98/254) (N=81, 30)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '22'}]}]}, {'title': '1month post 2nd dose; hSBA<4 (NZ98/254) (N=81, 30)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}]}]}, {'title': '3 months post 2nd dose;hSBA <4 (NZ98/254)(N=75,29)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.087', 'upperLimit': '18'}]}]}, {'title': '5 months post 2nd dose;hSBA <4 (NZ98/254)(N=70,29)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.087', 'upperLimit': '18'}]}]}, {'title': '11 months post 2nd dose;hSBA <4(NZ98/254)(N=75,28)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '18'}]}]}, {'title': 'Baseline hSBA ≥4 (NZ98/254) (N=110, 19)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '17'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '18'}]}]}, {'title': '1month post 1st dose; hSBA ≥4 (NZ98/254)(N=109,18)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '27'}]}]}, {'title': '1 month post 2nd dose;hSBA ≥4 (NZ98/254)(N=109,18)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '17'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '35'}]}]}, {'title': '3 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,17)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '19'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '43'}]}]}, {'title': '5 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,16)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '15'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '38'}]}]}, {'title': '11 months post 2nd dose;hSBA≥4(NZ98/254)(N=104,18)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '27'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (\\<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.\n\nThe serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).\n\nH44/76, 5/99 and NZ98/254 are strains in serogroup B.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Pharyngeal carriage)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline hSBA <8 (MenY) (N=42, 44)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': '1month post 1st dose; hSBA <8 (MenY) (N=39, 40)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.063', 'upperLimit': '13'}]}]}, {'title': '1 month post 2nd dose;hSBA <8 (MenY) (N=39, 40)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': '3 months post 2nd dose;hSBA <8 (MenY) (N=36, 37)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.068', 'upperLimit': '14'}]}]}, {'title': '5 months post 2nd dose;hSBA <8 (MenY) (N=36, 36)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '19'}]}]}, {'title': '11 months post 2nd dose;hSBA <8 (MenY) (N=34, 35)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.074', 'upperLimit': '15'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '19'}]}]}, {'title': 'Baseline hSBA ≥8 (MenY)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '11'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '11'}]}]}, {'title': '1month post 1st dose; hSBA ≥8 (MenY) (N=146,151)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '11'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}]}]}, {'title': '1 month post 2nd dose;hSBA ≥8 (MenY) (N=143, 149)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}]}]}, {'title': '3 months post 2nd dose;hSBA ≥8 (MenY) (N=131, 139)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '14'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '13'}]}]}, {'title': '5 months post 2nd dose;hSBA ≥8 (MenY) (N=130, 134)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}]}]}, {'title': '11 months post 2nd dose;hSBA ≥8 (MenY) (N=129,135)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months after vaccination', 'description': 'The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (\\<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Pharyngeal carriage)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline H44/76', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '75'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '83'}, {'value': '62', 'groupId': 'OG002', 'lowerLimit': '47', 'upperLimit': '75'}]}]}, {'title': '1 month post 2nd dose (H44/76) (N=189, 45, 48)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '87'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '47', 'upperLimit': '76'}]}]}, {'title': '3 months post 2nd dose (H44/76) (N=173, 40, 46)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '85'}, {'value': '65', 'groupId': 'OG002', 'lowerLimit': '50', 'upperLimit': '79'}]}]}, {'title': '5 months post 2nd dose (H44/76) (N=169, 43, 45)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '86'}, {'value': '67', 'groupId': 'OG002', 'lowerLimit': '51', 'upperLimit': '80'}]}]}, {'title': '11 months post 2nd dose (H44/76) (N=177, 41, 46)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '98'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '88'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '82'}]}]}, {'title': 'Baseline 5/99', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '67'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '60'}, {'value': '54', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '68'}]}]}, {'title': '1 month post 2nd dose (5/99) (N=189, 45, 48)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '56'}, {'value': '58', 'groupId': 'OG002', 'lowerLimit': '43', 'upperLimit': '72'}]}]}, {'title': '3 months post 2nd dose (5/99) (N=173, 40, 46)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '65'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '68'}]}]}, {'title': '5 months post 2nd dose (5/99) (N=169, 43, 45)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '65'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '68'}]}]}, {'title': '11 months post 2nd dose (5/99) (N=177, 41, 46)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '99'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '67'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '48', 'upperLimit': '77'}]}]}, {'title': 'Baseline NZ98/254', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '64'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '67'}, {'value': '38', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '53'}]}]}, {'title': '1 month post 2nd dose (NZ98/254) (N=189, 45, 48)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '68'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '59'}]}]}, {'title': '3 months post 2nd dose (NZ98/254) (N=173, 40, 46)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '96'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '64'}, {'value': '48', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '63'}]}]}, {'title': '5 months post 2nd dose (NZ98/254) (N=169, 43, 45)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '94'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '73'}, {'value': '42', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '58'}]}]}, {'title': '11 months post 2nd dose (NZ98/254) (N=177, 41, 46)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '90'}, {'value': '66', 'groupId': 'OG001', 'lowerLimit': '49', 'upperLimit': '80'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Immunogenicity subset) i.e all enrolled subjects who actually received a study vaccination, provided at least one evaluable serum sample after vaccination and whose assay result was available for at least one serogroup.'}, {'type': 'SECONDARY', 'title': 'The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline H44/76', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '8.74', 'upperLimit': '14'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '6.59', 'upperLimit': '18'}, {'value': '9.42', 'groupId': 'OG002', 'lowerLimit': '5.73', 'upperLimit': '15'}]}]}, {'title': '1 month post 2nd dose (H44/76) (N=189, 45, 48)', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000', 'lowerLimit': '192', 'upperLimit': '274'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '7.92', 'upperLimit': '16'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '7.18', 'upperLimit': '15'}]}]}, {'title': '3 months post 2nd dose (H44/76) (N=173, 40, 46)', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000', 'lowerLimit': '116', 'upperLimit': '178'}, {'value': '9.07', 'groupId': 'OG001', 'lowerLimit': '5.79', 'upperLimit': '14'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '7.07', 'upperLimit': '16'}]}]}, {'title': '5 months post 2nd dose (H44/76) (N=169, 43, 45)', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '138'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '7.57', 'upperLimit': '18'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '7.62', 'upperLimit': '18'}]}]}, {'title': '11 months post 2nd dose (H44/76) (N=177, 40, 46)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '84'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '8.84', 'upperLimit': '22'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '8.97', 'upperLimit': '21'}]}]}, {'title': 'Baseline 5/99', 'categories': [{'measurements': [{'value': '6.44', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '8.13'}, {'value': '3.12', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '4.95'}, {'value': '5.49', 'groupId': 'OG002', 'lowerLimit': '3.47', 'upperLimit': '8.67'}]}]}, {'title': '1 month post 2nd dose (5/99) (N=189, 45, 48)', 'categories': [{'measurements': [{'value': '424', 'groupId': 'OG000', 'lowerLimit': '355', 'upperLimit': '507'}, {'value': '2.63', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '3.79'}, {'value': '5.62', 'groupId': 'OG002', 'lowerLimit': '3.95', 'upperLimit': '8.01'}]}]}, {'title': '3 months post 2nd dose (5/99) (N=173, 40, 46)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000', 'lowerLimit': '139', 'upperLimit': '207'}, {'value': '2.95', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': '4.47'}, {'value': '5.6', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '8.26'}]}]}, {'title': '5 months post 2nd dose (5/99) (N=169, 43, 45)', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '128'}, {'value': '3.36', 'groupId': 'OG001', 'lowerLimit': '2.27', 'upperLimit': '4.97'}, {'value': '5.32', 'groupId': 'OG002', 'lowerLimit': '3.63', 'upperLimit': '7.79'}]}]}, {'title': '11 months post 2nd dose (5/99) (N=177, 41, 46)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '67'}, {'value': '3.58', 'groupId': 'OG001', 'lowerLimit': '2.37', 'upperLimit': '5.4'}, {'value': '5.98', 'groupId': 'OG002', 'lowerLimit': '4.05', 'upperLimit': '8.82'}]}]}, {'title': 'Baseline NZ98/254', 'categories': [{'measurements': [{'value': '6.15', 'groupId': 'OG000', 'lowerLimit': '4.82', 'upperLimit': '7.84'}, {'value': '4.32', 'groupId': 'OG001', 'lowerLimit': '2.66', 'upperLimit': '7'}, {'value': '4.16', 'groupId': 'OG002', 'lowerLimit': '2.58', 'upperLimit': '6.72'}]}]}, {'title': '1 month post 2nd dose (NZ98/254) (N=188, 45, 48)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '122'}, {'value': '4.82', 'groupId': 'OG001', 'lowerLimit': '3.11', 'upperLimit': '7.47'}, {'value': '3.88', 'groupId': 'OG002', 'lowerLimit': '2.54', 'upperLimit': '5.93'}]}]}, {'title': '3 months post 2nd dose (NZ98/254) (N=172, 40, 46)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '73'}, {'value': '4.93', 'groupId': 'OG001', 'lowerLimit': '2.89', 'upperLimit': '8.4'}, {'value': '4.72', 'groupId': 'OG002', 'lowerLimit': '2.87', 'upperLimit': '7.76'}]}]}, {'title': '5 months post 2nd dose (NZ98/254) (N=169, 43, 45)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '66'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '3.73', 'upperLimit': '11'}, {'value': '4.67', 'groupId': 'OG002', 'lowerLimit': '2.72', 'upperLimit': '8.03'}]}]}, {'title': '11 months post 2nd dose (NZ98/254) (N=176, 41, 44)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '45'}, {'value': '7.77', 'groupId': 'OG001', 'lowerLimit': '4.38', 'upperLimit': '14'}, {'value': '6.93', 'groupId': 'OG002', 'lowerLimit': '3.99', 'upperLimit': '12'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Immunogenicity subset)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline Men C (N= 49, 194,50)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '97'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '91'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '66', 'upperLimit': '90'}]}]}, {'title': '1 month post 2nd dose (Men C) (N=48, 182, 48)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '88', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '95'}]}]}, {'title': '11 months post 2nd dose (Men C) (N=48, 158, 41)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '99'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '88', 'groupId': 'OG002', 'lowerLimit': '74', 'upperLimit': '96'}]}]}, {'title': 'Baseline Men Y', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '78'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '72', 'upperLimit': '84'}, {'value': '78', 'groupId': 'OG002', 'lowerLimit': '71', 'upperLimit': '83'}]}]}, {'title': '1 month post 2nd dose (Men Y) (N=187, 182, 188)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '86'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '97'}, {'value': '82', 'groupId': 'OG002', 'lowerLimit': '76', 'upperLimit': '88'}]}]}, {'title': '3 months post 2nd dose (Men Y) (N=173,164,175)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '85'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '97'}, {'value': '82', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '87'}]}]}, {'title': '5 months post 2nd dose (Men Y) (N=170, 165, 170)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '84'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '96'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '77', 'upperLimit': '89'}]}]}, {'title': '11 months post 2nd dose (Men Y) (N=177, 158, 165)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '83'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '95'}, {'value': '81', 'groupId': 'OG002', 'lowerLimit': '74', 'upperLimit': '87'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.\n\nAs serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Immunogenicity subset)'}, {'type': 'SECONDARY', 'title': 'The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Baseline Men C (N=49, 194, 50)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '70'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '65'}, {'value': '32', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '53'}]}]}, {'title': '1 month post 2nd dose (Men C) (N=48, 182, 48)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '126'}, {'value': '1302', 'groupId': 'OG001', 'lowerLimit': '1050', 'upperLimit': '1615'}, {'value': '37', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '56'}]}]}, {'title': '11 months post 2nd dose (MenC) (N=48, 158, 41)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '91'}, {'value': '438', 'groupId': 'OG001', 'lowerLimit': '343', 'upperLimit': '560'}, {'value': '41', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '66'}]}]}, {'title': 'Baseline Men Y', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '22'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '23'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '23'}]}]}, {'title': '1 month post 2nd dose (Men Y) (N=187, 182, 188)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '32'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '103'}, {'value': '23', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '28'}]}]}, {'title': '3 months post 2nd dose (Men Y) (N=173, 164, 175)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '30'}, {'value': '69', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '86'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '27'}]}]}, {'title': '5 months post 2nd dose (Men Y (N=170, 165, 170)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '29'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '78'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '28'}]}]}, {'title': '11 months post 2nd dose (Men Y) (N=177, 158, 165)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '26'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '61'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '27'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.\n\nSerogroups A and W were not analysed.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Immunogenicity subset)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': '1 month post 2nd dose from day 1(Men C)N=48,181,48', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '20'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '87'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '14'}]}]}, {'title': '1 month post 2nd dose from day 1(Men Y)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '17'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '52'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '12'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '61 days', 'description': 'The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.\n\nSeroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer \\< 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.\n\nAnalysis was not done for serogroups A and W.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Immunogenicity subset)'}, {'type': 'SECONDARY', 'title': 'The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.'}], 'classes': [{'title': 'Baseline (Men C) (N=46, 6)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '160'}, {'value': '157', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '756'}]}]}, {'title': '1 month post 2nd vaccination (Men C) (N=45, 6)', 'categories': [{'measurements': [{'value': '1905', 'groupId': 'OG000', 'lowerLimit': '1305', 'upperLimit': '2779'}, {'value': '154', 'groupId': 'OG001', 'lowerLimit': '55', 'upperLimit': '434'}]}]}, {'title': '11 months post 2nd vaccination (Men C) (N=45, 6)', 'categories': [{'measurements': [{'value': '691', 'groupId': 'OG000', 'lowerLimit': '464', 'upperLimit': '1028'}, {'value': '125', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '371'}]}]}, {'title': 'Baseline (Men Y)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '32'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '41'}]}]}, {'title': '1 month post 2nd vaccination (Men Y) (N=45, 26)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '142'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '36'}]}]}, {'title': '3 months post 2nd vaccination (Men Y) (N=42, 25)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '110'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '38'}]}]}, {'title': '5 months post 2nd vaccination (Men Y) (N=45, 26)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '103'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '37'}]}]}, {'title': '11 months post 2nd vaccination (Men Y) (N=45, 26)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '76'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '39'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.\n\nAnalysis was not done for serogroups A and W.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Immunogenicity subset)'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.'}], 'classes': [{'title': 'Baseline (Men C) (N=46,6)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '99'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '100'}]}]}, {'title': '1 month post 2nd vaccination (Men C) (N=45, 6)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '100'}]}]}, {'title': '11 months post 2nd vaccination (Men C) (N=45, 6)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '100'}]}]}, {'title': 'Baseline (Men Y)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '91'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '93'}]}]}, {'title': '1 month post 2nd vaccination (Men Y) (N=45, 26)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '99'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '91'}]}]}, {'title': '3 months post 2nd vaccination (Men Y) (N=42, 25)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '99'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '93'}]}]}, {'title': '5 months post 2nd vaccination (Men Y) (N=45, 26)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '99'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '91'}]}]}, {'title': '11 months post 2nd vaccination (Men Y) (N=45, 26)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '98'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.\n\nAnalysis was not done for serogroups A and W.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT dataset (Immunogenicity subset)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'OG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'OG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'classes': [{'title': 'Any local', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}]}, {'title': 'Injection site pain (N=190, 186,191)', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}]}, {'title': 'Injection site erythema (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Injection site induration (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Injection site swelling (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Any systemic', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}]}, {'title': 'Arthralgia (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Nausea (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Malaise (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}]}, {'title': 'Headache (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Rash (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Fever (≥38°C) (N= 190, 186,191)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Any Other', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Temperature (≥40°C) (N= 190, 186, 191)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Antipyretic preventive med. used (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Antipyretic treatment med. used (N=190, 186, 191)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through day 7 after any vaccination', 'description': 'The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.', 'unitOfMeasure': 'number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the Immunogenicity Subset, Safety Population i.e. all subjects in the exposed population who provided postvaccination safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'FG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'FG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '979'}, {'groupId': 'FG001', 'numSubjects': '988'}, {'groupId': 'FG002', 'numSubjects': '987'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '796'}, {'groupId': 'FG001', 'numSubjects': '844'}, {'groupId': 'FG002', 'numSubjects': '826'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '161'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '123'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Adverse event or death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Inappropriate enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from 10 sites in United Kingdom', 'preAssignmentDetails': 'Total 2968 subjects were enrolled of which 14 subjects were not randomized and were therefore removed from the study (2 subjects withdrew consent and 11 subjects were withdrawn due to inappropriate enrollment and 1 withdrawn due to protocol violation).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '979', 'groupId': 'BG000'}, {'value': '988', 'groupId': 'BG001'}, {'value': '987', 'groupId': 'BG002'}, {'value': '2954', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart'}, {'id': 'BG001', 'title': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart'}, {'id': 'BG002', 'title': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '19.9', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '19.9', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '533', 'groupId': 'BG001'}, {'value': '547', 'groupId': 'BG002'}, {'value': '1596', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '463', 'groupId': 'BG000'}, {'value': '455', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}, {'value': '1358', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2968}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'dispFirstSubmitDate': '2012-12-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2010-09-30', 'dispFirstSubmitQcDate': '2012-12-11', 'resultsFirstSubmitDate': '2013-09-04', 'studyFirstSubmitQcDate': '2010-10-04', 'dispFirstPostDateStruct': {'date': '2012-12-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-17', 'studyFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination', 'timeFrame': '61 days (31 days after receiving the second injection)', 'description': 'Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.\n\nVirulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.'}, {'measure': 'Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination', 'timeFrame': '31 days after MenACWY-CRM injection', 'description': 'The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.'}], 'secondaryOutcomes': [{'measure': 'Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported'}, {'measure': 'Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.'}, {'measure': 'The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV', 'timeFrame': 'Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)', 'description': 'The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.'}, {'measure': 'The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM', 'timeFrame': 'Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)', 'description': 'The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.'}, {'measure': 'The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine', 'timeFrame': 'Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)', 'description': 'The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.'}, {'measure': 'The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine', 'timeFrame': 'Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)', 'description': 'The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.'}, {'measure': 'Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (\\<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.\n\nThe serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).\n\nH44/76, 5/99 and NZ98/254 are strains in serogroup B.'}, {'measure': 'Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers', 'timeFrame': 'Up to 12 months after vaccination', 'description': 'The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (\\<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.'}, {'measure': 'Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.'}, {'measure': 'The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.'}, {'measure': 'Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.\n\nAs serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested.'}, {'measure': 'The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.\n\nSerogroups A and W were not analysed.'}, {'measure': 'Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.', 'timeFrame': '61 days', 'description': 'The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.\n\nSeroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer \\< 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.\n\nAnalysis was not done for serogroups A and W.'}, {'measure': 'The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.\n\nAnalysis was not done for serogroups A and W.'}, {'measure': 'Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.', 'timeFrame': 'Up to 361 days after vaccination', 'description': 'The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.\n\nAnalysis was not done for serogroups A and W.'}, {'measure': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group', 'timeFrame': 'Day 1 through day 7 after any vaccination', 'description': 'The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.'}]}, 'conditionsModule': {'keywords': ['Meningococcal vaccines', 'Meningococcal B', 'Meningococcal ACWY serogroups'], 'conditions': ['N. Meningitidis Carriage']}, 'referencesModule': {'references': [{'pmid': '25247300', 'type': 'DERIVED', 'citation': 'Lemee L, Hong E, Etienne M, Deghmane AE, Delbos V, Terrade A, Berthelot G, Caron F, Taha MK. Genetic diversity and levels of expression of factor H binding protein among carriage isolates of Neisseria meningitidis. PLoS One. 2014 Sep 23;9(9):e107240. doi: 10.1371/journal.pone.0107240. eCollection 2014.'}, {'pmid': '25145775', 'type': 'DERIVED', 'citation': 'Read RC, Baxter D, Chadwick DR, Faust SN, Finn A, Gordon SB, Heath PT, Lewis DJ, Pollard AJ, Turner DP, Bazaz R, Ganguli A, Havelock T, Neal KR, Okike IO, Morales-Aza B, Patel K, Snape MD, Williams J, Gilchrist S, Gray SJ, Maiden MC, Toneatto D, Wang H, McCarthy M, Dull PM, Borrow R. Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. Lancet. 2014 Dec 13;384(9960):2123-31. doi: 10.1016/S0140-6736(14)60842-4. Epub 2014 Aug 18.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment;\n* Subjects who were available for all the visits scheduled in the study;\n* Subjects who were in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.\n\nExclusion Criteria:\n\n* History of any serogroup B meningococcal vaccine administration;\n* Current or previous, confirmed or suspected disease caused by N. meningitidis;\n* Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;\n* Significant acute or chronic infection within the previous 7 days or fever (defined as oral temperature ≥38ºC) within the previous day;\n* Antibiotics within 3 days (72 hours) prior to enrollment;\n* Pregnancy or nursing (breastfeeding) mothers;\n* Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the 12 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence were considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry;\n* Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);\n* Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. \\[Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body were allowed\\]; use of immunostimulants;\n* Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;\n* History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;\n* Participation in another clinical trial within the last 90 days or planned for during study;\n* Family members and household members of research staff;\n* Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.'}, 'identificationModule': {'nctId': 'NCT01214850', 'briefTitle': 'Novartis Vaccine and Diagnostics Carriage Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Phase 3 Observer Blind Randomized, Multi-center, Controlled Study to Evaluate the Effect of Novartis Vaccine's Meningococcal B Recombinant and MenACWY Conjugate Vaccines on Pharyngeal Carriage of N. Meningitidis in Young Adults", 'orgStudyIdInfo': {'id': 'V72_29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rMenB+OMV', 'description': 'Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart', 'interventionNames': ['Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)']}, {'type': 'EXPERIMENTAL', 'label': 'MenACWY', 'description': 'Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart', 'interventionNames': ['Biological: MenACWY-CRM conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart', 'interventionNames': ['Biological: Japanese Encephalitis vaccine']}], 'interventions': [{'name': 'Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['rMenB+OMV']}, {'name': 'MenACWY-CRM conjugate vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['MenACWY']}, {'name': 'Japanese Encephalitis vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['IXIARO'], 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Surrey', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clinical Research Center, University of Surrey'}, {'city': 'Bristol, England', 'country': 'United Kingdom', 'facility': "Bristol Children's Vaccine Center, University of Bristol,", 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Liverpool, England', 'country': 'United Kingdom', 'facility': 'Royal Liverpool and Broad Green University Hospital Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London, England', 'country': 'United Kingdom', 'facility': 'St Georges Vaccine Institute, St Georges, University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester, England', 'country': 'United Kingdom', 'facility': 'Manchester Welcome Trust Clinical Research Facility, University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Middlesbrough, England', 'country': 'United Kingdom', 'facility': 'The James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'city': 'Nottingham, England', 'country': 'United Kingdom', 'facility': 'Cripps Health Centre, University Park', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Oxford, England', 'country': 'United Kingdom', 'facility': 'University of Oxford, Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Sheffield, England', 'country': 'United Kingdom', 'facility': 'Clinical Research Facility, Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Southampton, England', 'country': 'United Kingdom', 'facility': 'Wellcome Trust Clinical Research Facility, University of Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Novartis Vaccines and Diagnostics', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}