Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT01027351
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2009-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period.', 'description': 'The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.', 'eventGroups': [{'id': 'EG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 42, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperpyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 42}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 41}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharingitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Heat stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eating disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'cystic lymphangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'H 44/76 strain', 'categories': [{'measurements': [{'value': '3.24', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '4.52'}, {'value': '5.34', 'groupId': 'OG001', 'lowerLimit': '3.47', 'upperLimit': '8.23'}, {'value': '4.25', 'groupId': 'OG002', 'lowerLimit': '3.22', 'upperLimit': '5.6'}]}]}, {'title': '5/99 strain (N=28, 17, 40)', 'categories': [{'measurements': [{'value': '5.11', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '11'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '77'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.36'}]}]}, {'title': 'NZ 98/254 strain', 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '1.51'}, {'value': '2.77', 'groupId': 'OG001', 'lowerLimit': '1.81', 'upperLimit': '4.23'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': 'M10713 strain (N=28, 15, 40)', 'categories': [{'measurements': [{'value': '9.15', 'groupId': 'OG000', 'lowerLimit': '5.01', 'upperLimit': '17'}, {'value': '5.34', 'groupId': 'OG001', 'lowerLimit': '2.35', 'upperLimit': '12'}, {'value': '8.75', 'groupId': 'OG002', 'lowerLimit': '5.22', 'upperLimit': '15'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 months after last vaccination; Baseline for Naïve', 'description': 'Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Modified- Intended to treat (MITT), 40 months of age, antibody persistence population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'hSBA ≥1:4 (H44/76 strain)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '64'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '86'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '77'}]}]}, {'title': 'hSBA≥1:4 (5/99 strain; N=28, 17, 40)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '63'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '93'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0.063', 'upperLimit': '13'}]}]}, {'title': 'hSBA≥1:4 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.087', 'upperLimit': '18'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '67'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'hSBA≥1:4 (M10713 strain; N=28, 15, 40)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '84'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '88'}, {'value': '68', 'groupId': 'OG002', 'lowerLimit': '51', 'upperLimit': '81'}]}]}, {'title': 'hSBA ≥1:8 (H44/76 strain)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '32'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '62'}, {'value': '30', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '47'}]}]}, {'title': 'hSBA≥1:8 (5/99 strain; N=28, 17, 40)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '63'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '93'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0.063', 'upperLimit': '13'}]}]}, {'title': 'hSBA≥1:8 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'hSBA≥1:8 (M10713 strain; N=28, 15, 40)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '78'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '68'}, {'value': '45', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '62'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 months after last vaccination; baseline for naïve', 'description': 'The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported.\n\nThe serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT , 40 months of age, antibody persistence population.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG003', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'Local', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Injection-site pain', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Injection-site erythema', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Injection-site swelling', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Injection-site induration', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Systemic', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Changes in eating habits', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Fever (≥38°C)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Antipyretic preventive medication used', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Antipyretic treatment medication used', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Medically attended fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1-7 after booster vaccination', 'description': 'The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety population i.e all subjects who received at least one Men B vaccination and provided post-baseline safety data.'}, {'type': 'SECONDARY', 'title': 'Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'H44/76 strain', 'categories': [{'measurements': [{'value': '3.59', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '7.15'}, {'value': '3.47', 'groupId': 'OG001', 'lowerLimit': '1.39', 'upperLimit': '8.64'}, {'value': '4.25', 'groupId': 'OG002', 'lowerLimit': '3.22', 'upperLimit': '5.6'}]}]}, {'title': '5/99 strain', 'categories': [{'measurements': [{'value': '9.57', 'groupId': 'OG000', 'lowerLimit': '3.88', 'upperLimit': '24'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '3.3'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.36'}]}]}, {'title': 'NZ 98/254 strain', 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.57'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.72', 'upperLimit': '1.38'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': 'M10713 strain (N=13, 8, 40)', 'categories': [{'measurements': [{'value': '3.26', 'groupId': 'OG000', 'lowerLimit': '1.49', 'upperLimit': '7.11'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1.11', 'upperLimit': '8.11'}, {'value': '8.75', 'groupId': 'OG002', 'lowerLimit': '5.22', 'upperLimit': '15'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 months after vaccination; Baseline for Naïve', 'description': 'Persisting GMTs against N.meningitidis B strains in children (at 40 months of age) who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT, 40 months of age, antibody persistence population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'hSBA ≥1:4 (H44/76 strain)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '82'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '76'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '77'}]}]}, {'title': 'hSBA≥1:4 (5/99 strain)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '82'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0.063', 'upperLimit': '13'}]}]}, {'title': 'hSBA≥1:4 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'hSBA≥1:4 (M10713 strain; N=13, 8, 40)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '81'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '65'}, {'value': '68', 'groupId': 'OG002', 'lowerLimit': '51', 'upperLimit': '81'}]}]}, {'title': 'hSBA ≥1:8 (H44/76 strain)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '53'}, {'value': '30', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '47'}]}]}, {'title': 'hSBA≥1:8 (5/99 strain)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '71'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0.063', 'upperLimit': '13'}]}]}, {'title': 'hSBA≥1:8 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'hSBA≥1:8 (M10713 strain; N=13, 8, 40)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '45'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '53'}, {'value': '45', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '62'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 months after vaccination; baseline for naïve', 'description': 'The percentages of subjects with persisting hSBA titers ≥ 1:4 and ≥1:8, against N.meningitidis B strains at 40 months of age; who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study are reported.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT, 40 months of age, antibody persistence population.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'H44/76 strain', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '145'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '141'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '7.96', 'upperLimit': '19'}]}]}, {'title': '5/99 strain (N=28, 18, 38)', 'categories': [{'measurements': [{'value': '778', 'groupId': 'OG000', 'lowerLimit': '448', 'upperLimit': '1349'}, {'value': '1708', 'groupId': 'OG001', 'lowerLimit': '859', 'upperLimit': '3396'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '40'}]}]}, {'title': 'NZ 98/254 strain', 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '2.85'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '91'}, {'value': '7.73', 'groupId': 'OG002', 'lowerLimit': '4.62', 'upperLimit': '13'}]}]}, {'title': 'M10713 strain (N=28, 18, 38)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '59'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '67'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '6.7', 'upperLimit': '19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post- booster/ dose 1 for Naïve', 'description': 'The GMTs against N.meningitidis B strains in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, booster response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'hSBA ≥1:4 (H44/76 strain)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '100'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '97'}]}]}, {'title': 'hSBA≥1:4 (5/99 strain; N=28, 18, 38)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '100'}, {'value': '76', 'groupId': 'OG002', 'lowerLimit': '60', 'upperLimit': '89'}]}]}, {'title': 'hSBA≥1:4 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '33'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '99'}, {'value': '66', 'groupId': 'OG002', 'lowerLimit': '49', 'upperLimit': '80'}]}]}, {'title': 'hSBA≥1:4 (M10713 strain; N=28, 18, 38)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '100'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '100'}, {'value': '76', 'groupId': 'OG002', 'lowerLimit': '60', 'upperLimit': '89'}]}]}, {'title': 'hSBA ≥1:8 ( H44/76 strain)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '100'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '78'}]}]}, {'title': 'hSBA≥1:8 (5/99 strain; N=28, 18, 38)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '100'}, {'value': '71', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '85'}]}]}, {'title': 'hSBA≥1:8 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '28'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '99'}, {'value': '58', 'groupId': 'OG002', 'lowerLimit': '41', 'upperLimit': '74'}]}]}, {'title': 'hSBA≥1:8 (M10713 strain; N=28, 18, 38)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '98'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '100'}, {'value': '61', 'groupId': 'OG002', 'lowerLimit': '43', 'upperLimit': '76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post- booster/ dose 1 for Naïve', 'description': 'The percentages of subjects (who had previously received four doses MenB vaccine in parent study) with hSBA titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects .', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, booster response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'H44/76 strain', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '98'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '100'}, {'value': '41', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '58'}]}]}, {'title': '5/99 strain (N=27, 16, 37)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '100'}, {'value': '68', 'groupId': 'OG002', 'lowerLimit': '50', 'upperLimit': '82'}]}]}, {'title': 'NZ 98/254 strain', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '28'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '96'}, {'value': '57', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '73'}]}]}, {'title': 'M10713 strain (N=27, 15, 37)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '61'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '88'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '29'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post - booster/ -dose 1 for Naïve', 'description': 'The percentages of subjects (who had previously received four doses MenB vaccine in parent study) showing a 4-fold increase in hSBA titers over baseline against N.meningitidis B strains, after receiving a booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.\n\nBaseline is defined as either the time that the (first) booster dose was given or the time of the first vaccination in this study.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, booster response.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'H44/76 strain (dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '185'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '190'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '7.96', 'upperLimit': '19'}]}]}, {'title': 'H44/76 strain (dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '198'}, {'value': '145', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '255'}, {'value': '88', 'groupId': 'OG002', 'lowerLimit': '66', 'upperLimit': '117'}]}]}, {'title': '5/99 strain (dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '2379', 'groupId': 'OG000', 'lowerLimit': '1164', 'upperLimit': '4859'}, {'value': '509', 'groupId': 'OG001', 'lowerLimit': '192', 'upperLimit': '1348'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '40'}]}]}, {'title': '5/99 strain (dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '5240', 'groupId': 'OG000', 'lowerLimit': '3082', 'upperLimit': '8911'}, {'value': '2413', 'groupId': 'OG001', 'lowerLimit': '1226', 'upperLimit': '4747'}, {'value': '1019', 'groupId': 'OG002', 'lowerLimit': '762', 'upperLimit': '1362'}]}]}, {'title': 'NZ 98/254 strain (dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '3.48'}, {'value': '148', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '384'}, {'value': '7.73', 'groupId': 'OG002', 'lowerLimit': '4.62', 'upperLimit': '13'}]}]}, {'title': 'NZ 98/254 strain (dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '1.86', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '3.88'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '165'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '72'}]}]}, {'title': 'M10713 strain (dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '68'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '74'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '6.7', 'upperLimit': '19'}]}]}, {'title': 'M10713 strain (dose 2; N=12, 8, 36)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '9.25', 'upperLimit': '47'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '98'}, {'value': '33', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '51'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post vaccination', 'description': 'The GMTs against N.meningitidis B strains in children (who had previously received one dose MenB vaccine in parent study) after a two booster doses of either rMenB or rMenB+OMV NZ vaccine given at 40 \\& 42 months of age.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, booster response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'H44/76 strain (≥1:4 - dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '97'}]}]}, {'title': 'H44/76 strain (≥1:4 - dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'H44/76 strain (≥1:8 - dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '78'}]}]}, {'title': 'H44/76 strain (≥1:8 - dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': '5/99 strain (≥1:4 - dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '76', 'groupId': 'OG002', 'lowerLimit': '60', 'upperLimit': '89'}]}]}, {'title': '5/99 strain (≥1:4 - dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': '5/99 strain (≥1:8 - dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '71', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '85'}]}]}, {'title': '5/99 strain (≥1:8 - dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'NZ 98/254 strain (≥1:4 - dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '45'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '66', 'groupId': 'OG002', 'lowerLimit': '49', 'upperLimit': '80'}]}]}, {'title': 'NZ 98/254 strain (≥1:4 - dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '45'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '94', 'groupId': 'OG002', 'lowerLimit': '81', 'upperLimit': '99'}]}]}, {'title': 'NZ 98/254 strain (≥1:8 - dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '45'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '58', 'groupId': 'OG002', 'lowerLimit': '41', 'upperLimit': '74'}]}]}, {'title': 'NZ 98/254 strain (≥1:8 - dose 2; N=13, 8, 36)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '45'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '94', 'groupId': 'OG002', 'lowerLimit': '81', 'upperLimit': '99'}]}]}, {'title': 'M10713 strain (≥1:4 - dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '100'}, {'value': '76', 'groupId': 'OG002', 'lowerLimit': '60', 'upperLimit': '89'}]}]}, {'title': 'M10713 strain (≥1:4 - dose 2; N=12, 8, 36)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '98'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '74', 'upperLimit': '97'}]}]}, {'title': 'M10713 strain (≥1:8 - dose 1; N=13, 7, 38)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '98'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '100'}, {'value': '61', 'groupId': 'OG002', 'lowerLimit': '43', 'upperLimit': '76'}]}]}, {'title': 'M10713 strain (≥1:8 - dose 2; N=12, 8, 36)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '95'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '86', 'groupId': 'OG002', 'lowerLimit': '71', 'upperLimit': '95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post vaccination', 'description': 'The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) with hSBA ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 \\& 42 months of age.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, booster response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'H44/76 strain (dose 1; N=13, 7, 37)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '100'}, {'value': '41', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '58'}]}]}, {'title': '5/99 strain (dose 1; N=13, 7, 37)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '68', 'groupId': 'OG002', 'lowerLimit': '50', 'upperLimit': '82'}]}]}, {'title': 'NZ 98/254 strain (dose 1; N=13, 7, 37)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '45'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '57', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '73'}]}]}, {'title': 'M10713 strain (dose 1; N=12, 7, 37)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '85'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '90'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '29'}]}]}, {'title': 'H44/76 strain (dose 2; N=13, 8, 34)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '100'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '85', 'upperLimit': '100'}]}]}, {'title': '5/99 strain (dose 2; N=13, 8, 34)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'NZ 98/254 strain (dose 2; N=13, 8, 34)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '45'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '100'}, {'value': '94', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '99'}]}]}, {'title': 'M10713 strain (dose 2; N=11, 8, 34)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '89'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '97'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post vaccination', 'description': 'The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) displaying 4-fold increase in antibody titers over baseline against N.meningitidis B strains, after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 \\& 42 months of age.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, booster response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'classes': [{'title': 'hSBA ≥1:4 ( H44/76 strain)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '99'}]}]}, {'title': 'hSBA ≥1:8 (H44/76 strain)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '99'}]}]}, {'title': 'hSBA ≥1:4 (5/99 strain)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}]}]}, {'title': 'hSBA ≥1:8 (5/99 strain)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}]}]}, {'title': 'hSBA ≥1:4 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '99'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}]}]}, {'title': 'hSBA ≥1:8 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '99'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '97'}]}]}, {'title': 'hSBA ≥1:4 (M10713 strain; N=36, 41)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '97'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'hSBA ≥1:8 (M10713 strain; N=36, 41)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '95'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post -vaccine dose two', 'description': 'The percentage of subjects with hSBA ≥ 1:4 and ≥ 1:8 after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 \\& 42 months or 60 \\& 62 months of age are reported.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, 2-dose catch-up regimen.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'classes': [{'title': 'H44/76 strain', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '123'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '47'}]}]}, {'title': '5/99 strain', 'categories': [{'measurements': [{'value': '1019', 'groupId': 'OG000', 'lowerLimit': '688', 'upperLimit': '1510'}, {'value': '865', 'groupId': 'OG001', 'lowerLimit': '601', 'upperLimit': '1244'}]}]}, {'title': 'NZ 98/254 strain', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '69'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '41'}]}]}, {'title': 'M10713 strain (N=36, 41)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '47'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '59'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post vaccine dose two', 'description': 'The geometric mean antibody titers in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 \\& 42 months or 60 \\& 62 months of age are reported.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, 2-dose catch-up regimen.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'classes': [{'title': 'H44/76 strain', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '100'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '85'}]}]}, {'title': '5/99 strain', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'NZ 98/254 strain', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '99'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '97'}]}]}, {'title': 'M10713 strain', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '70'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post vaccine dose 2', 'description': 'The percentages of subjects with four-fold increase in hSBA titers over baseline against N.meningitidis B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 \\& 42 months or 60 \\& 62 months of age.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, 2-dose catch-up regimen.'}, {'type': 'SECONDARY', 'title': 'Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG003', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG004', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'OG005', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'classes': [{'title': 'H44/76 strain (N=24, 16, 13, 5, 28, 46)', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '5.59'}, {'value': '4.68', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '9.52'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '8.08', 'upperLimit': '39'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '3.52', 'upperLimit': '45'}, {'value': '12', 'groupId': 'OG004', 'lowerLimit': '6.27', 'upperLimit': '23'}, {'value': '2.98', 'groupId': 'OG005', 'lowerLimit': '1.86', 'upperLimit': '4.78'}]}]}, {'title': '5/99 strain (N=23, 16, 13, 5, 28, 46)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '99'}, {'value': '136', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '365'}, {'value': '369', 'groupId': 'OG002', 'lowerLimit': '123', 'upperLimit': '1103'}, {'value': '210', 'groupId': 'OG003', 'lowerLimit': '36', 'upperLimit': '1227'}, {'value': '44', 'groupId': 'OG004', 'lowerLimit': '29', 'upperLimit': '67'}, {'value': '1.14', 'groupId': 'OG005', 'lowerLimit': '0.88', 'upperLimit': '1.47'}]}]}, {'title': 'NZ 98/254 strain', 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.38'}, {'value': '4.95', 'groupId': 'OG001', 'lowerLimit': '3.54', 'upperLimit': '6.92'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.69', 'upperLimit': '1.45'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '5.93', 'upperLimit': '20'}, {'value': '2.42', 'groupId': 'OG004', 'lowerLimit': '1.59', 'upperLimit': '3.66'}, {'value': '1.04', 'groupId': 'OG005', 'lowerLimit': '0.96', 'upperLimit': '1.14'}]}]}, {'title': 'M10713 strain (N=22, 16, 12, 5, 27, 46)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '7.22', 'upperLimit': '20'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5.67', 'upperLimit': '19'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '5.85', 'upperLimit': '24'}, {'value': '25', 'groupId': 'OG003', 'lowerLimit': '8.47', 'upperLimit': '74'}, {'value': '8.52', 'groupId': 'OG004', 'lowerLimit': '5.09', 'upperLimit': '14'}, {'value': '18', 'groupId': 'OG005', 'lowerLimit': '12', 'upperLimit': '28'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '18-20 months after last Men B vaccine; baseline for naïve_6062', 'description': 'The persisting GMTs against N.meningitidis B strains in children at 60 months of age who had received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present study are compared with GMTs in vaccine-naïve subjects.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT, 60 months of age, antibody persistence population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG003', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG004', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'OG005', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'classes': [{'title': 'hSBA ≥1:4 (H44/76 strain; N=24, 16, 13, 5, 28, 46)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '67'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '70'}, {'value': '85', 'groupId': 'OG002', 'lowerLimit': '55', 'upperLimit': '98'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '28', 'upperLimit': '99'}, {'value': '71', 'groupId': 'OG004', 'lowerLimit': '51', 'upperLimit': '87'}, {'value': '33', 'groupId': 'OG005', 'lowerLimit': '20', 'upperLimit': '48'}]}]}, {'title': 'hSBA ≥1:4 (5/99 strain; N=23, 16, 13, 5, 28, 46)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '95'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '98'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '48', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '0.055', 'upperLimit': '12'}]}]}, {'title': 'hSBA ≥1:4 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '69', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '89'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '28', 'upperLimit': '99'}, {'value': '31', 'groupId': 'OG004', 'lowerLimit': '15', 'upperLimit': '51'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '0.055', 'upperLimit': '12'}]}]}, {'title': 'hSBA ≥1:4 (M10713 strain; N=22, 16, 12, 5, 27, 46)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '92'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '98'}, {'value': '92', 'groupId': 'OG002', 'lowerLimit': '62', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '48', 'upperLimit': '100'}, {'value': '81', 'groupId': 'OG004', 'lowerLimit': '62', 'upperLimit': '94'}, {'value': '83', 'groupId': 'OG005', 'lowerLimit': '69', 'upperLimit': '92'}]}]}, {'title': 'hSBA ≥1:8 (H44/76 strain; N=24, 16, 13, 5, 28, 46)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '47'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '59'}, {'value': '77', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '95'}, {'value': '60', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '95'}, {'value': '61', 'groupId': 'OG004', 'lowerLimit': '41', 'upperLimit': '78'}, {'value': '26', 'groupId': 'OG005', 'lowerLimit': '14', 'upperLimit': '41'}]}]}, {'title': 'hSBA ≥1:8 (5/99 strain; N=23, 16, 13, 5, 28, 46)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '90'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '98'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '48', 'upperLimit': '100'}, {'value': '93', 'groupId': 'OG004', 'lowerLimit': '76', 'upperLimit': '99'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '0.055', 'upperLimit': '12'}]}]}, {'title': 'hSBA ≥1:8 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '59'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '85'}, {'value': '21', 'groupId': 'OG004', 'lowerLimit': '8', 'upperLimit': '40'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'hSBA ≥1:8 (M10713 strain; N=22, 16, 12, 5, 27, 46)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '79'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '85'}, {'value': '67', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': '90'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '28', 'upperLimit': '99'}, {'value': '48', 'groupId': 'OG004', 'lowerLimit': '29', 'upperLimit': '68'}, {'value': '70', 'groupId': 'OG005', 'lowerLimit': '54', 'upperLimit': '82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18-20 months after last Men B vaccine; baseline for naïve_6062', 'description': 'The percentage of subjects with persisting hSBA titers ≥1:4 and ≥1:8 at 60 months of age against N.meningitidis B strains after having received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present are reported.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT, 60 months of age, antibody persistence population.'}, {'type': 'SECONDARY', 'title': 'Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '113'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '94'}, {'value': '23', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '26'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 months after last Men B vaccination; Baseline for Naïve_4042 group', 'description': 'The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 4 doses of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.\n\nGMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT, 40 months of age, antibody persistence population.'}, {'type': 'SECONDARY', 'title': 'Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '49'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '50'}, {'value': '23', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '26'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 months after last Men B vaccination; baseline for naïve_4042 group', 'description': 'The persisting GMCs against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.\n\nGMCs against vaccine antigen 287-953 were measure using ELISA.', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT, 40 months of age, antibody persistence population.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5592', 'groupId': 'OG000', 'lowerLimit': '3900', 'upperLimit': '8017'}, {'value': '3934', 'groupId': 'OG001', 'lowerLimit': '2540', 'upperLimit': '6093'}, {'value': '64', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '94'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post booster; 1 month post dose for naïve_4042 group', 'description': 'The GMCs against vaccine antigen 287-953 in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of either rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the GMCs following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT, 40 months of age, antibody persistence population.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG002', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}], 'classes': [{'title': 'after 1st booster/vaccine dose (N=13, N=7, N=38)', 'categories': [{'measurements': [{'value': '2100', 'groupId': 'OG000', 'lowerLimit': '1100', 'upperLimit': '4007'}, {'value': '1764', 'groupId': 'OG001', 'lowerLimit': '731', 'upperLimit': '4256'}, {'value': '64', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '94'}]}]}, {'title': 'after 2nd booster/vaccine dose (N=13, N=8, N=36)', 'categories': [{'measurements': [{'value': '3790', 'groupId': 'OG000', 'lowerLimit': '2265', 'upperLimit': '6342'}, {'value': '3660', 'groupId': 'OG001', 'lowerLimit': '1899', 'upperLimit': '7055'}, {'value': '3464', 'groupId': 'OG002', 'lowerLimit': '2782', 'upperLimit': '4313'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after each booster/ vaccine dose', 'description': 'The GMCs against vaccine antigen 287-953 in children (who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study) , are compared with the GMCs in children who received to catch-up doses of rMenB+OMV NZ at 40 \\& 42 months .', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, booster response.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'classes': [{'categories': [{'measurements': [{'value': '3464', 'groupId': 'OG000', 'lowerLimit': '2672', 'upperLimit': '4489'}, {'value': '1744', 'groupId': 'OG001', 'lowerLimit': '1372', 'upperLimit': '2218'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post vaccine dose two', 'description': 'The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at - 40 \\& 42 months or 60 \\& 62 months of age are reported.', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT population, Booster response.'}, {'type': 'SECONDARY', 'title': 'Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'OG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'OG002', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG003', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'OG004', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'OG005', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'classes': [{'categories': [{'measurements': [{'value': '670', 'groupId': 'OG000', 'lowerLimit': '475', 'upperLimit': '945'}, {'value': '320', 'groupId': 'OG001', 'lowerLimit': '210', 'upperLimit': '487'}, {'value': '280', 'groupId': 'OG002', 'lowerLimit': '175', 'upperLimit': '447'}, {'value': '250', 'groupId': 'OG003', 'lowerLimit': '118', 'upperLimit': '532'}, {'value': '121', 'groupId': 'OG004', 'lowerLimit': '88', 'upperLimit': '166'}, {'value': '25', 'groupId': 'OG005', 'lowerLimit': '20', 'upperLimit': '32'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '18-20 months after last Men B vaccine; baseline for naïve_6062', 'description': 'The persisting GMCs against vaccine antigen 287-953 in children at 60 months of age who had either received one or two booster doses of either rMenB or rMenB+OMV NZ vaccine or had received two catch-up doses of rMenB+OMV NZ vaccine at 40 months of age in the present are compared with GMCs in vaccine-naïve subjects.', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the MITT, 60 months of age, antibody persistence population population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'OG001', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'classes': [{'title': 'Local', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site pain', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site erythema', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site induration', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site swelling', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Systemic', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Changes in eating habits', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Fever (≥38°C)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Antipyretic preventive medication used', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Antipyretic treatment medication used', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Medically attended fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1-7 after any vaccination', 'description': 'The safety and tolerability of two catch-up doses of rMenB+OMV NZ vaccine when administered either at 40 \\& 42 months or 60 \\& 62 months of age in children is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the MITT - Two Dose Catch Up Schedule population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'FG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'FG002', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'FG003', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'FG004', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'FG005', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Inappropriate enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from 1 center in the United Kingdom.', 'preAssignmentDetails': 'All subjects were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}, {'value': '163', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': '5rMenB', 'description': 'Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.'}, {'id': 'BG001', 'title': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.'}, {'id': 'BG002', 'title': '3rMenB', 'description': 'Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'BG003', 'title': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.'}, {'id': 'BG004', 'title': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.'}, {'id': 'BG005', 'title': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '41.8', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '41.4', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '40.4', 'spread': '0.7', 'groupId': 'BG003'}, {'value': '41.8', 'spread': '1.7', 'groupId': 'BG004'}, {'value': '61.3', 'spread': '0.9', 'groupId': 'BG005'}, {'value': '47.6', 'spread': '9.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '84', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}, {'value': '163', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Subjects'}], 'populationDescription': 'The analysis was done on the all enrolled set.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2009-12-04', 'resultsFirstSubmitDate': '2013-12-18', 'studyFirstSubmitQcDate': '2009-12-04', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-04', 'studyFirstPostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.', 'timeFrame': '28 months after last vaccination; Baseline for Naïve', 'description': 'Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.'}, {'measure': 'Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age.', 'timeFrame': '28 months after last vaccination; baseline for naïve', 'description': 'The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported.\n\nThe serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).'}, {'measure': 'Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age.', 'timeFrame': 'Day 1-7 after booster vaccination', 'description': 'The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.'}], 'secondaryOutcomes': [{'measure': 'Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age.', 'timeFrame': '28 months after vaccination; Baseline for Naïve', 'description': 'Persisting GMTs against N.meningitidis B strains in children (at 40 months of age) who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.'}, {'measure': 'Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age.', 'timeFrame': '28 months after vaccination; baseline for naïve', 'description': 'The percentages of subjects with persisting hSBA titers ≥ 1:4 and ≥1:8, against N.meningitidis B strains at 40 months of age; who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study are reported.'}, {'measure': 'Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.', 'timeFrame': '1 month post- booster/ dose 1 for Naïve', 'description': 'The GMTs against N.meningitidis B strains in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.'}, {'measure': 'Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.', 'timeFrame': '1 month post- booster/ dose 1 for Naïve', 'description': 'The percentages of subjects (who had previously received four doses MenB vaccine in parent study) with hSBA titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects .'}, {'measure': 'Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.', 'timeFrame': '1 month post - booster/ -dose 1 for Naïve', 'description': 'The percentages of subjects (who had previously received four doses MenB vaccine in parent study) showing a 4-fold increase in hSBA titers over baseline against N.meningitidis B strains, after receiving a booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.\n\nBaseline is defined as either the time that the (first) booster dose was given or the time of the first vaccination in this study.'}, {'measure': 'Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.', 'timeFrame': '1 month post vaccination', 'description': 'The GMTs against N.meningitidis B strains in children (who had previously received one dose MenB vaccine in parent study) after a two booster doses of either rMenB or rMenB+OMV NZ vaccine given at 40 \\& 42 months of age.'}, {'measure': 'Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.', 'timeFrame': '1 month post vaccination', 'description': 'The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) with hSBA ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 \\& 42 months of age.'}, {'measure': 'Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.', 'timeFrame': '1 month post vaccination', 'description': 'The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) displaying 4-fold increase in antibody titers over baseline against N.meningitidis B strains, after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 \\& 42 months of age.'}, {'measure': 'Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.', 'timeFrame': '1 month post -vaccine dose two', 'description': 'The percentage of subjects with hSBA ≥ 1:4 and ≥ 1:8 after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 \\& 42 months or 60 \\& 62 months of age are reported.'}, {'measure': 'Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age.', 'timeFrame': '1 month post vaccine dose two', 'description': 'The geometric mean antibody titers in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 \\& 42 months or 60 \\& 62 months of age are reported.'}, {'measure': 'Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age.', 'timeFrame': '1 month post vaccine dose 2', 'description': 'The percentages of subjects with four-fold increase in hSBA titers over baseline against N.meningitidis B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 \\& 42 months or 60 \\& 62 months of age.'}, {'measure': 'Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age.', 'timeFrame': '18-20 months after last Men B vaccine; baseline for naïve_6062', 'description': 'The persisting GMTs against N.meningitidis B strains in children at 60 months of age who had received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present study are compared with GMTs in vaccine-naïve subjects.'}, {'measure': 'Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age.', 'timeFrame': '18-20 months after last Men B vaccine; baseline for naïve_6062', 'description': 'The percentage of subjects with persisting hSBA titers ≥1:4 and ≥1:8 at 60 months of age against N.meningitidis B strains after having received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present are reported.'}, {'measure': 'Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age.', 'timeFrame': '28 months after last Men B vaccination; Baseline for Naïve_4042 group', 'description': 'The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 4 doses of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.\n\nGMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA).'}, {'measure': 'Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age.', 'timeFrame': '28 months after last Men B vaccination; baseline for naïve_4042 group', 'description': 'The persisting GMCs against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.\n\nGMCs against vaccine antigen 287-953 were measure using ELISA.'}, {'measure': 'Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age.', 'timeFrame': '1 month post booster; 1 month post dose for naïve_4042 group', 'description': 'The GMCs against vaccine antigen 287-953 in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of either rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the GMCs following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.'}, {'measure': 'Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age.', 'timeFrame': '1 month after each booster/ vaccine dose', 'description': 'The GMCs against vaccine antigen 287-953 in children (who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study) , are compared with the GMCs in children who received to catch-up doses of rMenB+OMV NZ at 40 \\& 42 months .'}, {'measure': 'Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age.', 'timeFrame': '1 month post vaccine dose two', 'description': 'The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at - 40 \\& 42 months or 60 \\& 62 months of age are reported.'}, {'measure': 'Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age.', 'timeFrame': '18-20 months after last Men B vaccine; baseline for naïve_6062', 'description': 'The persisting GMCs against vaccine antigen 287-953 in children at 60 months of age who had either received one or two booster doses of either rMenB or rMenB+OMV NZ vaccine or had received two catch-up doses of rMenB+OMV NZ vaccine at 40 months of age in the present are compared with GMCs in vaccine-naïve subjects.'}, {'measure': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age.', 'timeFrame': 'Day 1-7 after any vaccination', 'description': 'The safety and tolerability of two catch-up doses of rMenB+OMV NZ vaccine when administered either at 40 \\& 42 months or 60 \\& 62 months of age in children is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.'}]}, 'conditionsModule': {'keywords': ['Children', 'Pre-school', 'Meningococcal disease', 'Prevention', 'Vaccination'], 'conditions': ['Meningococcal Disease']}, 'referencesModule': {'references': [{'pmid': '25802309', 'type': 'DERIVED', 'citation': "McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Yu LM, Toneatto D, D'Agostino D, Dull PM, Pollard AJ. Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months. CMAJ. 2015 Apr 21;187(7):E215-E223. doi: 10.1503/cmaj.141200. Epub 2015 Mar 23."}, {'pmid': '24062178', 'type': 'DERIVED', 'citation': 'Snape MD, Saroey P, John TM, Robinson H, Kelly S, Gossger N, Yu LM, Wang H, Toneatto D, Dull PM, Pollard AJ. Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. CMAJ. 2013 Oct 15;185(15):E715-24. doi: 10.1503/cmaj.130257. Epub 2013 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if they have not already received these vaccines prior to enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '62 Months', 'minimumAge': '40 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy 40 to 44-months-old children, who participated and completed the study V72P6 (NCT00381615; follow-on subjects)\n* Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)\n\nExclusion Criteria:\n\n* Previous ascertained or suspected disease caused by N. meningitidis\n* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component\n* Any serious chronic or progressive disease\n* Known or suspected impairment/alteration of the immune system\n* Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)'}, 'identificationModule': {'nctId': 'NCT01027351', 'briefTitle': 'Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naïve Children and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Novartis Vaccine as Infants in Study V72P6', 'orgStudyIdInfo': {'id': 'V72P6E1'}, 'secondaryIdInfos': [{'id': 'EUDRACT 2009-013054-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5rMenB', 'description': 'Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.', 'interventionNames': ['Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)']}, {'type': 'EXPERIMENTAL', 'label': '5rMenB+OMV NZ', 'description': 'Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.', 'interventionNames': ['Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.']}, {'type': 'EXPERIMENTAL', 'label': '3rMenB', 'description': 'Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine without OMV (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.', 'interventionNames': ['Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)']}, {'type': 'EXPERIMENTAL', 'label': '3rMenB+OMV NZ', 'description': 'Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.', 'interventionNames': ['Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.']}, {'type': 'EXPERIMENTAL', 'label': 'Naive_4042', 'description': 'Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 40 and 42 months of age in the present study.', 'interventionNames': ['Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.']}, {'type': 'EXPERIMENTAL', 'label': 'Naive_6062', 'description': 'Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 60 and 62 months of age in the present study.', 'interventionNames': ['Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.']}], 'interventions': [{'name': 'Meningococcal (group B) multicomponent recombinant adsorbed vaccine.', 'type': 'BIOLOGICAL', 'description': 'Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.', 'armGroupLabels': ['3rMenB+OMV NZ', '5rMenB+OMV NZ', 'Naive_4042', 'Naive_6062']}, {'name': 'Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)', 'type': 'BIOLOGICAL', 'description': 'Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).', 'armGroupLabels': ['3rMenB', '5rMenB']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LJ', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}