Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT00262002
Status:
COMPLETED
Last Update Posted:
2014-06-18
First Post:
2005-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017325', 'term': 'Hepatitis B Vaccines'}, {'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014121', 'term': 'Toxoids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccineUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccine and Diagnostics S.r.l'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single site are postponed until the publication of the pool data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).', 'description': "Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.", 'eventGroups': [{'id': 'EG000', 'title': 'UK234+ (MenACWY Ad+ at 2,3,4 m)', 'description': 'Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.', 'otherNumAtRisk': 90, 'otherNumAffected': 90, 'seriousNumAtRisk': 90, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'UK24+ (MenACWY Ad+ at 2,4 m)', 'description': 'Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.', 'otherNumAtRisk': 90, 'otherNumAffected': 89, 'seriousNumAtRisk': 90, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'UKMenC (Menjugate at 2,4m)', 'description': 'Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.', 'otherNumAtRisk': 45, 'otherNumAffected': 45, 'seriousNumAtRisk': 45, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'CA246+ (MenACWY Ad+ at 2,4,6m)', 'description': 'Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.', 'otherNumAtRisk': 98, 'otherNumAffected': 97, 'seriousNumAtRisk': 98, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'CA24+ (MenACWY Ad+ at 2,4m)', 'description': 'Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.', 'otherNumAtRisk': 98, 'otherNumAffected': 97, 'seriousNumAtRisk': 98, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'UK24- (MenACWY Ad- at 2,4m)', 'description': 'Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.', 'otherNumAtRisk': 90, 'otherNumAffected': 90, 'seriousNumAtRisk': 90, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': 'CA24- (MenACWY Ad- at 2,4m)', 'description': 'Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.', 'otherNumAtRisk': 90, 'otherNumAffected': 89, 'seriousNumAtRisk': 90, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 34}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 36}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 28}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CRYING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 73}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 78}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 84}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INJECTION SITE INDURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 59}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 41}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 45}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 85}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 85}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 77}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRONCHIOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CROUP INFECTIOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ORAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'OTITIS MEDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 39}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 68}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 70}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 57}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 63}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'EATING DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 42}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 37}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DERMATITIS DIAPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'IDIOPATHIC THROMBOCYTOPENIC PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SUPRAVENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ERYTHEMA MULTIFORME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PETECHIAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ACROCHORDON EXCISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CIRCUMCISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HYDROCELE OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'INGUINAL HERNIA REPAIR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'TENDON SHEATH INCISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG001', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - baseline (n=69,80)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '14'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Ser A - 1 month after primary vacc (n=69,80)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '98'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '89'}]}]}, {'title': 'Ser C - baseline (n=79,86)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '28'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '24'}]}]}, {'title': 'Ser C - 1 month after primary vacc (n=79,86)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '99'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}]}]}, {'title': 'Ser W - baseline (n=69,78)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '66'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '42'}]}]}, {'title': 'Ser W - 1 month after primary vacc (n=69,78)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '100'}]}]}, {'title': 'Ser Y - baseline', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '31'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '27'}]}]}, {'title': 'Ser Y - 1 month after primary vacc', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '98'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at 1 month after the 3 dose primary vaccination series', 'description': 'Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG001', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - baseline (n=69,80)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Ser A - 1 month after primary vacc (n=69,80)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '95'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '85'}]}]}, {'title': 'Ser C - baseline (n=79,86)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '17'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '11'}]}]}, {'title': 'Ser C - 1 month after primary vacc (n=79,86)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '97'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}]}]}, {'title': 'Ser W - baseline (n=69,78)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '59'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '40'}]}]}, {'title': 'Ser W - 1 month after primary vacc (n=69,78)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '95'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '99'}]}]}, {'title': 'Ser Y - baseline', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '23'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '20'}]}]}, {'title': 'Ser Y - 1 month after primary vaccination', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '97'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 month after the 3 dose primary vaccination series', 'description': 'Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG001', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - baseline (n=69,80)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '2.04', 'upperLimit': '2.38'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.86', 'upperLimit': '2.15'}]}]}, {'title': 'Ser A - 1 month after primary vacc (n=69,80)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '74'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '29'}]}]}, {'title': 'Ser C - baseline (n=79,86)', 'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000', 'lowerLimit': '2.36', 'upperLimit': '3.31'}, {'value': '2.64', 'groupId': 'OG001', 'lowerLimit': '2.25', 'upperLimit': '3.11'}]}]}, {'title': 'Ser C - 1 month after primary vacc (n=79,86)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '112'}, {'value': '124', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '172'}]}]}, {'title': 'Ser W - baseline (n=69,78)', 'categories': [{'measurements': [{'value': '5.76', 'groupId': 'OG000', 'lowerLimit': '4.39', 'upperLimit': '7.57'}, {'value': '4.03', 'groupId': 'OG001', 'lowerLimit': '3.12', 'upperLimit': '5.21'}]}]}, {'title': 'Ser W - 1 month after primary vacc (n=69,78)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '92'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '102'}]}]}, {'title': 'Ser Y - baseline', 'categories': [{'measurements': [{'value': '2.72', 'groupId': 'OG000', 'lowerLimit': '2.34', 'upperLimit': '3.17'}, {'value': '2.64', 'groupId': 'OG001', 'lowerLimit': '2.28', 'upperLimit': '3.05'}]}]}, {'title': 'Ser Y - 1 month after primary vacc', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '77'}, {'value': '2.64', 'groupId': 'OG001', 'lowerLimit': '2.28', 'upperLimit': '3.05'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 1 month after the 3 dose primary vaccination series', 'description': 'Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG001', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG002', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - hSBA ≥1:4, baseline (N=68,79,78,83)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Ser A - hSBA ≥1:4, 1m after 2n vacc(N=68,79,78,83)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '72'}, {'value': '66', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '76'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '62'}, {'value': '57', 'groupId': 'OG003', 'lowerLimit': '45', 'upperLimit': '67'}]}]}, {'title': 'Ser A - hSBA ≥1:8, baseline (N=68,79,78,83)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.032', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0.03', 'upperLimit': '7'}]}]}, {'title': 'Ser A - hSBA≥1:8, 1m after 2nd vacc(N=68,79,78,83)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '67'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '69'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '32', 'upperLimit': '55'}, {'value': '49', 'groupId': 'OG003', 'lowerLimit': '38', 'upperLimit': '61'}]}]}, {'title': 'Ser C - hSBA ≥1:4, baseline (N=77,74,79,85)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '23'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '25'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '31'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '30'}]}]}, {'title': 'Ser C - hSBA ≥1:4,1m after 2nd vacc(N=77,74,79,85)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '92'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '96'}, {'value': '86', 'groupId': 'OG002', 'lowerLimit': '76', 'upperLimit': '93'}, {'value': '93', 'groupId': 'OG003', 'lowerLimit': '85', 'upperLimit': '97'}]}]}, {'title': 'Ser C - hSBA ≥1:8, baseline (N=77,74,79,85)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '18'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '25'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '19'}]}]}, {'title': 'Ser C - hSBA ≥1:8,1m after 2nd vacc(N=77,74,79,85)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '91'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '92'}, {'value': '82', 'groupId': 'OG002', 'lowerLimit': '72', 'upperLimit': '90'}, {'value': '89', 'groupId': 'OG003', 'lowerLimit': '81', 'upperLimit': '95'}]}]}, {'title': 'Ser W - hSBA ≥1:4, baseline (N=73,74,72,75)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '57'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '36'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '55'}, {'value': '19', 'groupId': 'OG003', 'lowerLimit': '11', 'upperLimit': '29'}]}]}, {'title': 'Ser W - hSBA ≥1:4,1m after 2nd vacc(N=73,74,72,75)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '97'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '96'}, {'value': '82', 'groupId': 'OG002', 'lowerLimit': '71', 'upperLimit': '90'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '87', 'upperLimit': '99'}]}]}, {'title': 'Ser W - hSBA ≥1:8, baseline (N=73,74,72,75)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '49'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '30'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '48'}, {'value': '16', 'groupId': 'OG003', 'lowerLimit': '9', 'upperLimit': '26'}]}]}, {'title': 'Ser W -hSBA ≥1:8,1m after 2nd vacc(N=73,74,72,75)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '91'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '92'}, {'value': '75', 'groupId': 'OG002', 'lowerLimit': '63', 'upperLimit': '84'}, {'value': '92', 'groupId': 'OG003', 'lowerLimit': '83', 'upperLimit': '97'}]}]}, {'title': 'Ser Y - hSBA ≥1:4, baseline (N=76,74,77,85)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '29'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '19'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '47'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '27'}]}]}, {'title': 'Ser Y -hSBA ≥1:4,1m after 2nd vacc(N=76,74,77,85)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '92'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '93'}, {'value': '74', 'groupId': 'OG002', 'lowerLimit': '63', 'upperLimit': '83'}, {'value': '91', 'groupId': 'OG003', 'lowerLimit': '82', 'upperLimit': '96'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, baseline (N=76,74,77,85)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '26'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '19'}]}]}, {'title': 'Ser Y -hSBA ≥1:8,1m after 2nd vacc(N=76,74,77,85)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '85'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '88'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '59', 'upperLimit': '80'}, {'value': '86', 'groupId': 'OG003', 'lowerLimit': '77', 'upperLimit': '92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 month after second vaccination', 'description': 'Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG001', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG002', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - baseline (n=68,79,78,83)', 'categories': [{'measurements': [{'value': '2.17', 'groupId': 'OG000', 'lowerLimit': '2.01', 'upperLimit': '2.35'}, {'value': '2.07', 'groupId': 'OG001', 'lowerLimit': '1.93', 'upperLimit': '2.23'}, {'value': '2.05', 'groupId': 'OG002', 'lowerLimit': '1.91', 'upperLimit': '2.21'}, {'value': '2.08', 'groupId': 'OG003', 'lowerLimit': '1.94', 'upperLimit': '2.23'}]}]}, {'title': 'Ser A - 1 month after 2nd vacc (n=68,79,78,83)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8.36', 'upperLimit': '16'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '7.91', 'upperLimit': '15'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '5.31', 'upperLimit': '10'}, {'value': '7.16', 'groupId': 'OG003', 'lowerLimit': '5.26', 'upperLimit': '9.73'}]}]}, {'title': 'Ser C - baseline (n=77,74,79,85)', 'categories': [{'measurements': [{'value': '2.54', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': '3.02'}, {'value': '2.77', 'groupId': 'OG001', 'lowerLimit': '2.33', 'upperLimit': '3.31'}, {'value': '2.48', 'groupId': 'OG002', 'lowerLimit': '2.09', 'upperLimit': '2.94'}, {'value': '2.87', 'groupId': 'OG003', 'lowerLimit': '2.44', 'upperLimit': '3.39'}]}]}, {'title': 'Ser C - 1 month after 2nd vacc (n=77,74,79,85)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '74'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '79'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '57'}, {'value': '69', 'groupId': 'OG003', 'lowerLimit': '49', 'upperLimit': '96'}]}]}, {'title': 'Ser W - baseline (n=73,74,79,75)', 'categories': [{'measurements': [{'value': '5.33', 'groupId': 'OG000', 'lowerLimit': '4.09', 'upperLimit': '6.94'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '2.77', 'upperLimit': '4.69'}, {'value': '5.14', 'groupId': 'OG002', 'lowerLimit': '3.94', 'upperLimit': '6.71'}, {'value': '3.02', 'groupId': 'OG003', 'lowerLimit': '2.33', 'upperLimit': '3.93'}]}]}, {'title': 'Ser W - 1 month after 2nd vacc (n=73,74,79,75)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '67'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '61'}, {'value': '29', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '69', 'groupId': 'OG003', 'lowerLimit': '50', 'upperLimit': '96'}]}]}, {'title': 'Ser Y - baseline (n=76,74,77,85)', 'categories': [{'measurements': [{'value': '2.56', 'groupId': 'OG000', 'lowerLimit': '2.19', 'upperLimit': '2.99'}, {'value': '2.27', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': '2.66'}, {'value': '3.39', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '3.96'}, {'value': '2.76', 'groupId': 'OG003', 'lowerLimit': '2.38', 'upperLimit': '3.21'}]}]}, {'title': 'Ser Y - 1 month after 2nd vacc (n=76,74,77,85)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '37'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '38'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '29'}, {'value': '41', 'groupId': 'OG003', 'lowerLimit': '30', 'upperLimit': '56'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 1 month after second vaccination', 'description': 'Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG004', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '16'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '33'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '17'}, {'value': '3', 'groupId': 'OG004', 'lowerLimit': '0.067', 'upperLimit': '14'}]}]}, {'title': 'Ser A -hSBA≥1:4, 1 m after booster vacc', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '93'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '88'}, {'value': '94', 'groupId': 'OG002', 'lowerLimit': '84', 'upperLimit': '98'}, {'value': '92', 'groupId': 'OG003', 'lowerLimit': '79', 'upperLimit': '98'}, {'value': '95', 'groupId': 'OG004', 'lowerLimit': '82', 'upperLimit': '99'}]}]}, {'title': 'Ser A - hSBA ≥1:8, at 12 months of age', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '14'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '24'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '0.065', 'upperLimit': '13'}, {'value': '3', 'groupId': 'OG004', 'lowerLimit': '0.067', 'upperLimit': '14'}]}]}, {'title': 'Ser A - hSBA ≥1:8, 1 m after booster vaccination', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '91'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '87'}, {'value': '92', 'groupId': 'OG002', 'lowerLimit': '82', 'upperLimit': '97'}, {'value': '90', 'groupId': 'OG003', 'lowerLimit': '76', 'upperLimit': '97'}, {'value': '92', 'groupId': 'OG004', 'lowerLimit': '79', 'upperLimit': '98'}]}]}, {'title': 'Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '53'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '46'}, {'value': '60', 'groupId': 'OG002', 'lowerLimit': '47', 'upperLimit': '72'}, {'value': '48', 'groupId': 'OG003', 'lowerLimit': '32', 'upperLimit': '64'}, {'value': '33', 'groupId': 'OG004', 'lowerLimit': '19', 'upperLimit': '49'}]}]}, {'title': 'Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '99'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '98'}, {'value': '98', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG003', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '47'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '40'}, {'value': '52', 'groupId': 'OG002', 'lowerLimit': '40', 'upperLimit': '65'}, {'value': '35', 'groupId': 'OG003', 'lowerLimit': '21', 'upperLimit': '52'}, {'value': '25', 'groupId': 'OG004', 'lowerLimit': '13', 'upperLimit': '41'}]}]}, {'title': 'Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '99'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '98'}, {'value': '98', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '83', 'upperLimit': '99'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '69'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '69'}, {'value': '81', 'groupId': 'OG002', 'lowerLimit': '68', 'upperLimit': '90'}, {'value': '74', 'groupId': 'OG003', 'lowerLimit': '57', 'upperLimit': '88'}, {'value': '69', 'groupId': 'OG004', 'lowerLimit': '51', 'upperLimit': '83'}]}]}, {'title': 'Ser W - hSBA≥1:4, 1m after booster vaccination', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '61'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '58'}, {'value': '68', 'groupId': 'OG002', 'lowerLimit': '55', 'upperLimit': '80'}, {'value': '49', 'groupId': 'OG003', 'lowerLimit': '31', 'upperLimit': '66'}, {'value': '54', 'groupId': 'OG004', 'lowerLimit': '37', 'upperLimit': '71'}]}]}, {'title': 'Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '64'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '65'}, {'value': '86', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '93'}, {'value': '65', 'groupId': 'OG003', 'lowerLimit': '48', 'upperLimit': '79'}, {'value': '63', 'groupId': 'OG004', 'lowerLimit': '46', 'upperLimit': '78'}]}]}, {'title': 'Ser Y - hSBA≥1:4, 1 m after booster vaccination', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, at 12 months of age', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '52'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '54'}, {'value': '72', 'groupId': 'OG002', 'lowerLimit': '60', 'upperLimit': '83'}, {'value': '45', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '62'}, {'value': '53', 'groupId': 'OG004', 'lowerLimit': '36', 'upperLimit': '69'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, 1 m after booster vaccination', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '91', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months of age and 1 month after booster vaccination', 'description': 'Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA24+ (MenACWY Ad+ at 2, 4m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG004', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - at 12 months of age (n=64,61,62,39,38)', 'categories': [{'measurements': [{'value': '2.31', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.66'}, {'value': '2.22', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '2.57'}, {'value': '2.97', 'groupId': 'OG002', 'lowerLimit': '2.57', 'upperLimit': '3.44'}, {'value': '2.18', 'groupId': 'OG003', 'lowerLimit': '1.74', 'upperLimit': '2.73'}, {'value': '2.07', 'groupId': 'OG004', 'lowerLimit': '1.65', 'upperLimit': '2.6'}]}]}, {'title': 'Ser A - 1 month after booster (n=64,61,62,39,38)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '72'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '47'}, {'value': '134', 'groupId': 'OG002', 'lowerLimit': '87', 'upperLimit': '207'}, {'value': '67', 'groupId': 'OG003', 'lowerLimit': '43', 'upperLimit': '106'}, {'value': '59', 'groupId': 'OG004', 'lowerLimit': '38', 'upperLimit': '93'}]}]}, {'title': 'Ser C - at 12 months of age(n=67,63,65,40,40)', 'categories': [{'measurements': [{'value': '5.18', 'groupId': 'OG000', 'lowerLimit': '3.83', 'upperLimit': '7.02'}, {'value': '3.94', 'groupId': 'OG001', 'lowerLimit': '2.88', 'upperLimit': '5.39'}, {'value': '7.94', 'groupId': 'OG002', 'lowerLimit': '5.84', 'upperLimit': '11'}, {'value': '4.64', 'groupId': 'OG003', 'lowerLimit': '3.11', 'upperLimit': '6.91'}, {'value': '4.07', 'groupId': 'OG004', 'lowerLimit': '2.73', 'upperLimit': '6.06'}]}]}, {'title': 'Ser C - 1 month after booster(n=67,63,65,40,40)', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000', 'lowerLimit': '159', 'upperLimit': '349'}, {'value': '129', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '194'}, {'value': '429', 'groupId': 'OG002', 'lowerLimit': '288', 'upperLimit': '639'}, {'value': '216', 'groupId': 'OG003', 'lowerLimit': '130', 'upperLimit': '356'}, {'value': '258', 'groupId': 'OG004', 'lowerLimit': '56', 'upperLimit': '426'}]}]}, {'title': 'Ser W - at 12 months of age(n=57,41,57,35,35)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '5.76', 'upperLimit': '11'}, {'value': '6.49', 'groupId': 'OG001', 'lowerLimit': '4.34', 'upperLimit': '9.7'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '23'}, {'value': '8.84', 'groupId': 'OG003', 'lowerLimit': '5.63', 'upperLimit': '14'}, {'value': '11', 'groupId': 'OG004', 'lowerLimit': '7.04', 'upperLimit': '17'}]}]}, {'title': 'Ser W - 1 month after booster (n=57,41,57,35,35)', 'categories': [{'measurements': [{'value': '503', 'groupId': 'OG000', 'lowerLimit': '347', 'upperLimit': '732'}, {'value': '311', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '485'}, {'value': '792', 'groupId': 'OG002', 'lowerLimit': '544', 'upperLimit': '1154'}, {'value': '381', 'groupId': 'OG003', 'lowerLimit': '224', 'upperLimit': '650'}, {'value': '402', 'groupId': 'OG004', 'lowerLimit': '236', 'upperLimit': '684'}]}]}, {'title': 'Ser Y - at 12 months of age (n=66,63,65,40,38)', 'categories': [{'measurements': [{'value': '6.65', 'groupId': 'OG000', 'lowerLimit': '4.88', 'upperLimit': '9.06'}, {'value': '6.83', 'groupId': 'OG001', 'lowerLimit': '4.98', 'upperLimit': '9.37'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '26'}, {'value': '7.99', 'groupId': 'OG003', 'lowerLimit': '5.29', 'upperLimit': '12'}, {'value': '7.63', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '12'}]}]}, {'title': 'Ser Y- 1 month after booster(n=66,63,65,40,38)', 'categories': [{'measurements': [{'value': '508', 'groupId': 'OG000', 'lowerLimit': '358', 'upperLimit': '723'}, {'value': '438', 'groupId': 'OG001', 'lowerLimit': '305', 'upperLimit': '628'}, {'value': '1395', 'groupId': 'OG002', 'lowerLimit': '979', 'upperLimit': '1989'}, {'value': '308', 'groupId': 'OG003', 'lowerLimit': '191', 'upperLimit': '499'}, {'value': '527', 'groupId': 'OG004', 'lowerLimit': '322', 'upperLimit': '862'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'at 12 months of age and 1 month after booster vaccination', 'description': 'Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UKMenC (Menjugate 2, 4 m)', 'description': 'Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose ( of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG004', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '18'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '16'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '13'}]}]}, {'title': 'Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '4', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '11'}]}]}, {'title': 'Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '97'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '53'}, {'value': '32', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '44'}, {'value': '48', 'groupId': 'OG003', 'lowerLimit': '36', 'upperLimit': '60'}, {'value': '35', 'groupId': 'OG004', 'lowerLimit': '24', 'upperLimit': '46'}]}]}, {'title': 'Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81)', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '96'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '46'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '38'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '28', 'upperLimit': '52'}, {'value': '30', 'groupId': 'OG004', 'lowerLimit': '20', 'upperLimit': '41'}]}]}, {'title': 'Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '70'}, {'value': '57', 'groupId': 'OG002', 'lowerLimit': '41', 'upperLimit': '72'}, {'value': '64', 'groupId': 'OG003', 'lowerLimit': '51', 'upperLimit': '75'}, {'value': '75', 'groupId': 'OG004', 'lowerLimit': '64', 'upperLimit': '85'}]}]}, {'title': 'Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '20'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '61'}, {'value': '45', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': '61'}, {'value': '52', 'groupId': 'OG003', 'lowerLimit': '40', 'upperLimit': '64'}, {'value': '61', 'groupId': 'OG004', 'lowerLimit': '48', 'upperLimit': '72'}]}]}, {'title': 'Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '18'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '63'}, {'value': '56', 'groupId': 'OG002', 'lowerLimit': '43', 'upperLimit': '68'}, {'value': '60', 'groupId': 'OG003', 'lowerLimit': '48', 'upperLimit': '72'}, {'value': '59', 'groupId': 'OG004', 'lowerLimit': '48', 'upperLimit': '70'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.067', 'upperLimit': '14'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '55'}, {'value': '45', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '58'}, {'value': '51', 'groupId': 'OG003', 'lowerLimit': '39', 'upperLimit': '63'}, {'value': '46', 'groupId': 'OG004', 'lowerLimit': '34', 'upperLimit': '57'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months of age', 'description': 'The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UKMenC (Menjugate at 2, 4 m)', 'description': 'Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG004', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - at 12 months of age (n=36,62,65,77,78)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.62', 'upperLimit': '2.48'}, {'value': '2.32', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '2.73'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '1.88', 'upperLimit': '2.58'}, {'value': '2.29', 'groupId': 'OG003', 'lowerLimit': '1.98', 'upperLimit': '2.65'}, {'value': '2.18', 'groupId': 'OG004', 'lowerLimit': '1.89', 'upperLimit': '2.52'}]}]}, {'title': 'Ser C - at 12 months of age (n=36,69,69,73,82)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '40'}, {'value': '5.04', 'groupId': 'OG001', 'lowerLimit': '3.73', 'upperLimit': '6.81'}, {'value': '3.85', 'groupId': 'OG002', 'lowerLimit': '2.85', 'upperLimit': '5.21'}, {'value': '5.43', 'groupId': 'OG003', 'lowerLimit': '4.05', 'upperLimit': '7.27'}, {'value': '4.42', 'groupId': 'OG004', 'lowerLimit': '3.35', 'upperLimit': '5.84'}]}]}, {'title': 'Ser W - at 12 months of age (n=34,62,42,69,69)', 'categories': [{'measurements': [{'value': '2.42', 'groupId': 'OG000', 'lowerLimit': '1.55', 'upperLimit': '3.78'}, {'value': '8.38', 'groupId': 'OG001', 'lowerLimit': '6.03', 'upperLimit': '12'}, {'value': '7.02', 'groupId': 'OG002', 'lowerLimit': '4.71', 'upperLimit': '10'}, {'value': '8.15', 'groupId': 'OG003', 'lowerLimit': '5.97', 'upperLimit': '11'}, {'value': '12', 'groupId': 'OG004', 'lowerLimit': '8.81', 'upperLimit': '16'}]}]}, {'title': 'Ser Y - at 12 months of age (n=38,69,66,73,79)', 'categories': [{'measurements': [{'value': '2.15', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '3.28'}, {'value': '6.72', 'groupId': 'OG001', 'lowerLimit': '4.92', 'upperLimit': '9.18'}, {'value': '7.64', 'groupId': 'OG002', 'lowerLimit': '5.55', 'upperLimit': '11'}, {'value': '7.84', 'groupId': 'OG003', 'lowerLimit': '5.79', 'upperLimit': '11'}, {'value': '7.12', 'groupId': 'OG004', 'lowerLimit': '5.32', 'upperLimit': '9.54'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'at 12 months of age', 'description': 'The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age'}, {'id': 'OG001', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - hSBA ≥1:4, at 12 months of age (n=58,79)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '33'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '47'}]}]}, {'title': 'Ser A - hSBA ≥1:8, at 12 months of age(n=58,79)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '27'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '40'}]}]}, {'title': 'Ser C - hSBA ≥1:4, at 12 months of age(n=70,84)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '70'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '84'}]}]}, {'title': 'Ser C - hSBA ≥1:8, at 12 months of age(n=70,84)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '59'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '78'}]}]}, {'title': 'Ser W - hSBA ≥1:4, at 12 months of age(n=58,75)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '87'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '95'}]}]}, {'title': 'Ser W - hSBA ≥1:8, at 12 months of age(n=58,75)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '78'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '89'}]}]}, {'title': 'Ser Y - hSBA ≥1:4, at 12 months of age(n=71,86)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '92'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '78', 'upperLimit': '93'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, at 12 months of age(n=71,86)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '81'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '87'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months of age', 'description': 'The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG001', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - at 12 months of age (n=58,79)', 'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '2.55', 'upperLimit': '3.57'}, {'value': '3.93', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '4.54'}]}]}, {'title': 'Ser C - at 12 months of age (n=70,84)', 'categories': [{'measurements': [{'value': '7.56', 'groupId': 'OG000', 'lowerLimit': '5.61', 'upperLimit': '10'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '18'}]}]}, {'title': 'Ser W - at 12 months of age (n=58,75)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '21'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '27'}]}]}, {'title': 'Ser Y - at 12 months of age (n=71,86)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '29'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'at 12 months of age', 'description': 'The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CA246+ (MenACWY Ad+ at 2,4,6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A-hSBA≥1:4,before challenge at 12m (n=44)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '43'}]}]}, {'title': 'Ser A - hSBA ≥1:4, 1 month after PS (n=44)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '96'}]}]}, {'title': 'Ser A-hSBA ≥1:8,before challenge at 12m (n=44)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '38'}]}]}, {'title': 'Ser A - hSBA ≥1:8, 1 month after PS (n=44)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '95'}]}]}, {'title': 'Ser C-hSBA ≥1:4,before challenge at 12m (n=43)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '86'}]}]}, {'title': 'Ser C - hSBA ≥1:4, 1 month after PS (n=43)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '99'}]}]}, {'title': 'Ser C-hSBA ≥1:8, before challenge at 12m (n=43)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '79'}]}]}, {'title': 'Ser C - hSBA ≥1:8, 1 month after PS (n=43)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '97'}]}]}, {'title': 'Ser W-hSBA ≥1:4,before challenge at 12m (n=40)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '93'}]}]}, {'title': 'Ser W - hSBA ≥1:4, 1 month after PS (n=40)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}]}]}, {'title': 'Ser W-hSBA ≥1:8,before challenge at 12m (n=40)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '85'}]}]}, {'title': 'Ser W - hSBA ≥1:8, 1 month after PS (n=40)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '99'}]}]}, {'title': 'Ser Y-hSBA ≥1:4,before challenge at 12m (n=44)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '96'}]}]}, {'title': 'Ser Y - hSBA ≥1:4, 1 month after PS (n=44)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}]}]}, {'title': 'Ser Y-hSBA ≥1:8,before challenge at 12m (N=44)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '89'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, 1 month after PS (n=44)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'before challenge at 12 months of age and 1 month after PS challenge.', 'description': 'The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CA246+ (MenACWY Ad+ at 2, 4,6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - before challenge at 12 months of age(n=44)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '4.2'}]}]}, {'title': 'Ser A - 1 month after PS challenge (n=44)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '48'}]}]}, {'title': 'Ser C - before challenge at 12 months of age(n=43)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8.41', 'upperLimit': '18'}]}]}, {'title': 'Ser C - 1 month after PS challenge (n=43)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '133'}]}]}, {'title': 'Ser W - before challenge at 12 months of age(n=40)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '25'}]}]}, {'title': 'Ser W - 1 month after PS challenge (n=40)', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000', 'lowerLimit': '152', 'upperLimit': '410'}]}]}, {'title': 'Ser Y - before challenge at 12 months of age(n=44)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '28'}]}]}, {'title': 'Ser Y - 1 month after PS challenge (n=44)', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000', 'lowerLimit': '117', 'upperLimit': '294'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'before challenge at 12 months of age and 1 month after PS challenge.', 'description': 'The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CA24+ (MenACWY Ad+ at 2, 4m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG001', 'title': 'CA24- (MenACWY Ad- at 2, 4m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - hSBA≥1:4,before challange at 12m (n=40,39)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '20'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '21'}]}]}, {'title': 'Ser A - hSBA ≥1:4,1 month after PS (n=40,39)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '89'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '98'}]}]}, {'title': 'Ser A - hSBA≥1:8,before challange at 12m (n=40,39)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '17'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '17'}]}]}, {'title': 'Ser A - hSBA ≥1:8, 1 month after PS (n=40,39)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '89'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '96'}]}]}, {'title': 'Ser C - hSBA≥1:4,before challange at 12m (n=41,39)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '60'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '55'}]}]}, {'title': 'Ser C - hSBA ≥1:4, 1 month after PS (n=41,39)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '99'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '99'}]}]}, {'title': 'Ser C - hSBA≥1:8,before challange at 12m(n=41,39)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '55'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '53'}]}]}, {'title': 'Ser C - hSBA ≥1:8, 1 month after PS (n=41,39)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '98'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '97'}]}]}, {'title': 'Ser W - hSBA ≥1:4,before challange at 12m(n=41,38)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '74'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '85'}]}]}, {'title': 'Ser W - hSBA ≥1:4, 1 month after PS (n=41,38)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'Ser W - hSBA ≥1:8,before challange at 12m(n=41,38)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '67'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '74'}]}]}, {'title': 'Ser W - hSBA ≥1:8, 1 month after PS (n=41,38)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'Ser Y - hSBA ≥1:4,before challange at 12m(n=42,38)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '70'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '71'}]}]}, {'title': 'Ser Y - hSBA ≥1:4, 1 month after PS (n=42,38)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'Ser Y - hSBA ≥1:8,before challange at 12m (n=42,38', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '66'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '59'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, 1 month after PS (n=42,38)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before challenge at 12 months of age and 1 month after PS challenge.', 'description': 'The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG001', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - before challenge at 12 months (n=40,39)', 'categories': [{'measurements': [{'value': '2.22', 'groupId': 'OG000', 'lowerLimit': '1.77', 'upperLimit': '2.76'}, {'value': '2.31', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '2.89'}]}]}, {'title': 'Ser A - 1 month after PS challenge (n=40,39)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '44'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '86'}]}]}, {'title': 'Ser C - before challenge at 12 months (n=41,39)', 'categories': [{'measurements': [{'value': '5.21', 'groupId': 'OG000', 'lowerLimit': '3.51', 'upperLimit': '7.72'}, {'value': '5.07', 'groupId': 'OG001', 'lowerLimit': '3.38', 'upperLimit': '7.59'}]}]}, {'title': 'Ser C - 1 month after PS challenge (n=41,39)', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '231'}, {'value': '181', 'groupId': 'OG001', 'lowerLimit': '109', 'upperLimit': '301'}]}]}, {'title': 'Ser W - before challenge at 12 months (n=41,38)', 'categories': [{'measurements': [{'value': '7.48', 'groupId': 'OG000', 'lowerLimit': '4.94', 'upperLimit': '11'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '7.08', 'upperLimit': '17'}]}]}, {'title': 'Ser W - 1 month after PS challenge (n=41,38)', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000', 'lowerLimit': '224', 'upperLimit': '597'}, {'value': '555', 'groupId': 'OG001', 'lowerLimit': '333', 'upperLimit': '924'}]}]}, {'title': 'Ser Y - before challenge at 12 months (n=42,38)', 'categories': [{'measurements': [{'value': '6.73', 'groupId': 'OG000', 'lowerLimit': '4.51', 'upperLimit': '10'}, {'value': '6.79', 'groupId': 'OG001', 'lowerLimit': '4.45', 'upperLimit': '10'}]}]}, {'title': 'Ser Y - 1 month after PS challenge (n=42,38)', 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000', 'lowerLimit': '175', 'upperLimit': '448'}, {'value': '288', 'groupId': 'OG001', 'lowerLimit': '176', 'upperLimit': '472'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before challenge at 12 months of age and 1 month after PS challenge.', 'description': 'Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG001', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG002', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA24+ (MenACWY Ad+ at 2, 4m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - hSBA ≥1:4, baseline (n=69,80,38,79)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '14'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Ser A - hSBA≥1:4,1m after 1st vacc (n=69,80,38,79)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '98'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '89'}, {'value': '60', 'groupId': 'OG002', 'lowerLimit': '48', 'upperLimit': '72'}, {'value': '66', 'groupId': 'OG003', 'lowerLimit': '54', 'upperLimit': '76'}]}]}, {'title': 'Ser A - hSBA ≥1:8, baseline (n=69,80,38,79)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0.032', 'upperLimit': '7'}]}]}, {'title': 'Ser A - hSBA≥1:8,1m after 1st vacc (n=69,80,38,79)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '95'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '85'}, {'value': '54', 'groupId': 'OG002', 'lowerLimit': '42', 'upperLimit': '67'}, {'value': '58', 'groupId': 'OG003', 'lowerLimit': '47', 'upperLimit': '69'}]}]}, {'title': 'Ser C - hSBA ≥1:4, baseline (n=79,86,40,74)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '28'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '24'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '23'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '8', 'upperLimit': '25'}]}]}, {'title': 'Ser C - hSBA≥1:4,1m after 1st vacc (n=79,86,40,74)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '99'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '74', 'upperLimit': '92'}, {'value': '91', 'groupId': 'OG003', 'lowerLimit': '81', 'upperLimit': '96'}]}]}, {'title': 'Ser C - hSBA ≥1:8, baseline (n=79,86,40,74)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '17'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '18'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '8', 'upperLimit': '25'}]}]}, {'title': 'Ser C - hSBA≥1:8,1m after 1st vacc (n=79,86,40,74)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '97'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '83', 'groupId': 'OG002', 'lowerLimit': '73', 'upperLimit': '91'}, {'value': '85', 'groupId': 'OG003', 'lowerLimit': '75', 'upperLimit': '92'}]}]}, {'title': 'Ser W - hSBA ≥1:4, baseline (n=69,78,73,74)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '66'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '42'}, {'value': '45', 'groupId': 'OG002', 'lowerLimit': '34', 'upperLimit': '57'}, {'value': '24', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '36'}]}]}, {'title': 'Ser W - hSBA≥1:4,1m after 1st vacc (n=69,78,73,74)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '100'}, {'value': '92', 'groupId': 'OG002', 'lowerLimit': '83', 'upperLimit': '97'}, {'value': '91', 'groupId': 'OG003', 'lowerLimit': '81', 'upperLimit': '96'}]}]}, {'title': 'Ser W - hSBA ≥1:8, baseline (n=69,78,73,74)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '59'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '40'}, {'value': '37', 'groupId': 'OG002', 'lowerLimit': '26', 'upperLimit': '49'}, {'value': '19', 'groupId': 'OG003', 'lowerLimit': '11', 'upperLimit': '30'}]}]}, {'title': 'Ser W - hSBA≥1:8,1m after 1st vacc (n=69,78,73,74)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '95'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '99'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '73', 'upperLimit': '91'}, {'value': '85', 'groupId': 'OG003', 'lowerLimit': '75', 'upperLimit': '92'}]}]}, {'title': 'Ser Y - hSBA ≥1:4, baseline (n=81,87,76,74)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '31'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '27'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '29'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '19'}]}]}, {'title': 'Ser Y - hSBA≥1:4,1m after 1st vacc (n=81,87,76,74)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '98'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '74', 'upperLimit': '92'}, {'value': '86', 'groupId': 'OG003', 'lowerLimit': '77', 'upperLimit': '93'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, baseline (n=81,87,76,74)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '23'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '20'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '11'}]}]}, {'title': 'Ser Y - hSBA≥1:8,1m after 1st vacc (n=81,87,76,74)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '97'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '94'}, {'value': '76', 'groupId': 'OG002', 'lowerLimit': '65', 'upperLimit': '85'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '69', 'upperLimit': '88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 month after the 2 or 3 dose primary vaccination series', 'description': 'The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG001', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Ser A - hSBA ≥1:4, at 12 months of age (n=44,40)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '43'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '20'}]}]}, {'title': 'Ser A - hSBA ≥1:4, at 1 month after PS (n=44,40)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '96'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '89'}]}]}, {'title': 'Ser A - hSBA ≥1:8, at 12 months of age (n=44,40)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '38'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '17'}]}]}, {'title': 'Ser A - hSBA ≥1:8, at 1 month after PS (n=44,40)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '95'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '89'}]}]}, {'title': 'Ser C - hSBA ≥1:4, at 12 months of age (n=43,41)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '86'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '60'}]}]}, {'title': 'Ser C - hSBA ≥1:4, at 1 month after PS (n=43,41)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '99'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '99'}]}]}, {'title': 'Ser C - hSBA ≥1:8, at 12 months of age (n=43,41)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '79'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '55'}]}]}, {'title': 'Ser C - hSBA ≥1:8, at 1 month after PS (n=43,41)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '97'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '98'}]}]}, {'title': 'Ser W - hSBA ≥1:4, at 12 months of age (n=40,41)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '93'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '74'}]}]}, {'title': 'Ser W - hSBA ≥1:4, at 1 month after PS (n=40,41)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}, {'title': 'Ser W - hSBA ≥1:8, at 12 months of age (n=40,41)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '85'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '67'}]}]}, {'title': 'Ser W - hSBA ≥1:8, at 1 month after PS (n=40,41)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '99'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}, {'title': 'Ser Y - hSBA ≥1:4, at 12 months of age (n=44,42)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '96'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '70'}]}]}, {'title': 'Ser Y - hSBA ≥1:4, at 1 month after PS (n=44,42)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, at 12 months of age (n=44,42)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '89'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '66'}]}]}, {'title': 'Ser Y - hSBA ≥1:8, at 1 month after PS (n=44,42)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months of age and 1 month after PS challenge', 'description': 'The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG003', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG004', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG005', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '85'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '88'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '58', 'upperLimit': '80'}, {'value': '93', 'groupId': 'OG003', 'lowerLimit': '83', 'upperLimit': '98'}, {'value': '87', 'groupId': 'OG004', 'lowerLimit': '77', 'upperLimit': '94'}, {'value': '71', 'groupId': 'OG005', 'lowerLimit': '59', 'upperLimit': '81'}]}]}, {'title': 'Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '28'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '24'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '29'}, {'value': '19', 'groupId': 'OG004', 'lowerLimit': '10', 'upperLimit': '30'}, {'value': '15', 'groupId': 'OG005', 'lowerLimit': '8', 'upperLimit': '26'}]}]}, {'title': 'antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '99'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '97', 'groupId': 'OG003', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '96', 'groupId': 'OG004', 'lowerLimit': '88', 'upperLimit': '99'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '48'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '53'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '28'}, {'value': '25', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '36'}, {'value': '49', 'groupId': 'OG004', 'lowerLimit': '37', 'upperLimit': '61'}, {'value': '37', 'groupId': 'OG005', 'lowerLimit': '26', 'upperLimit': '49'}]}]}, {'title': 'antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '84'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '99'}, {'value': '67', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '78'}, {'value': '97', 'groupId': 'OG003', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '97', 'groupId': 'OG004', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '20'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '27'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '17', 'groupId': 'OG004', 'lowerLimit': '9', 'upperLimit': '27'}, {'value': '11', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '20'}]}]}, {'title': 'antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '45'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '93'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '47'}, {'value': '82', 'groupId': 'OG003', 'lowerLimit': '71', 'upperLimit': '90'}, {'value': '82', 'groupId': 'OG004', 'lowerLimit': '71', 'upperLimit': '90'}, {'value': '86', 'groupId': 'OG005', 'lowerLimit': '76', 'upperLimit': '93'}]}]}, {'title': 'antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '35'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '21'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '22', 'groupId': 'OG005', 'lowerLimit': '13', 'upperLimit': '34'}]}]}, {'title': 'antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '92'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '92', 'groupId': 'OG002', 'lowerLimit': '83', 'upperLimit': '97'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '97', 'groupId': 'OG005', 'lowerLimit': '90', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 month after the 2 or 3 dose primary vaccination series', 'description': 'To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.'}, {'type': 'SECONDARY', 'title': 'ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG003', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG004', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG005', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Tetanus - baseline (n=69,71,70,67,69,72)', 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.41'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.4'}, {'value': '0.23', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '0.29'}, {'value': '0.28', 'groupId': 'OG003', 'lowerLimit': '0.22', 'upperLimit': '0.37'}, {'value': '0.25', 'groupId': 'OG004', 'lowerLimit': '0.19', 'upperLimit': '0.32'}, {'value': '0.18', 'groupId': 'OG005', 'lowerLimit': '0.14', 'upperLimit': '0.23'}]}]}, {'title': 'Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.87'}, {'value': '0.92', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '1.13'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.14', 'upperLimit': '1.72'}, {'value': '0.6', 'groupId': 'OG003', 'lowerLimit': '0.48', 'upperLimit': '0.73'}, {'value': '0.97', 'groupId': 'OG004', 'lowerLimit': '0.79', 'upperLimit': '1.19'}, {'value': '0.68', 'groupId': 'OG005', 'lowerLimit': '0.55', 'upperLimit': '0.83'}]}]}, {'title': 'Diphtheria - baseline (n=69,71,70,67,69,72)', 'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000', 'lowerLimit': '0.026', 'upperLimit': '0.047'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.053'}, {'value': '0.027', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.035'}, {'value': '0.031', 'groupId': 'OG003', 'lowerLimit': '0.024', 'upperLimit': '0.042'}, {'value': '0.032', 'groupId': 'OG004', 'lowerLimit': '0.024', 'upperLimit': '0.042'}, {'value': '0.016', 'groupId': 'OG005', 'lowerLimit': '0.012', 'upperLimit': '0.021'}]}]}, {'title': 'Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72)', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.29'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '0.82', 'upperLimit': '1.28'}, {'value': '1.72', 'groupId': 'OG002', 'lowerLimit': '1.38', 'upperLimit': '2.14'}, {'value': '1.06', 'groupId': 'OG003', 'lowerLimit': '0.84', 'upperLimit': '1.32'}, {'value': '0.98', 'groupId': 'OG004', 'lowerLimit': '0.78', 'upperLimit': '1.22'}, {'value': '1.49', 'groupId': 'OG005', 'lowerLimit': '1.19', 'upperLimit': '1.87'}]}]}, {'title': 'Hib - baseline (n=70,77,69,73,72,73)', 'categories': [{'measurements': [{'value': '0.078', 'groupId': 'OG000', 'lowerLimit': '0.056', 'upperLimit': '0.11'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.21'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '0.078', 'upperLimit': '0.15'}, {'value': '0.089', 'groupId': 'OG003', 'lowerLimit': '0.063', 'upperLimit': '0.12'}, {'value': '0.15', 'groupId': 'OG004', 'lowerLimit': '0.11', 'upperLimit': '0.21'}, {'value': '0.064', 'groupId': 'OG005', 'lowerLimit': '0.045', 'upperLimit': '0.09'}]}]}, {'title': 'Hib - 1 m after 1st vacc (n=70,77,69,73,72,73)', 'categories': [{'measurements': [{'value': '4.63', 'groupId': 'OG000', 'lowerLimit': '3.14', 'upperLimit': '6.83'}, {'value': '4.55', 'groupId': 'OG001', 'lowerLimit': '3.08', 'upperLimit': '6.72'}, {'value': '4.53', 'groupId': 'OG002', 'lowerLimit': '3.07', 'upperLimit': '6.68'}, {'value': '0.47', 'groupId': 'OG003', 'lowerLimit': '0.32', 'upperLimit': '0.7'}, {'value': '5.67', 'groupId': 'OG004', 'lowerLimit': '3.89', 'upperLimit': '8.28'}, {'value': '0.42', 'groupId': 'OG005', 'lowerLimit': '0.28', 'upperLimit': '0.63'}]}]}, {'title': 'Hepatitis B - baseline (n=65,na,66,na,na,67)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '4.25', 'upperLimit': '8.2'}, {'value': '5.79', 'groupId': 'OG003', 'lowerLimit': '4.15', 'upperLimit': '8.09'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.21', 'groupId': 'OG005', 'lowerLimit': '3.03', 'upperLimit': '5.87'}]}]}, {'title': 'Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '378', 'groupId': 'OG002', 'lowerLimit': '258', 'upperLimit': '554'}, {'value': '69', 'groupId': 'OG003', 'lowerLimit': '47', 'upperLimit': '102'}, {'value': 'NA', 'comment': 'not performed due to insufficient sera', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '133', 'groupId': 'OG005', 'lowerLimit': '90', 'upperLimit': '195'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 1 month after the 2 or 3 dose primary vaccination series', 'description': 'To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UKMenC (Menjugate at 2, 4 m)', 'description': 'Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG003', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG004', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'hSBA ≥1:4, baseline', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '38'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '23'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '25'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '31'}, {'value': '20', 'groupId': 'OG004', 'lowerLimit': '12', 'upperLimit': '30'}]}]}, {'title': 'hSBA ≥1:4, 1 month after second vaccination', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '92'}, {'value': '91', 'groupId': 'OG002', 'lowerLimit': '81', 'upperLimit': '96'}, {'value': '86', 'groupId': 'OG003', 'lowerLimit': '76', 'upperLimit': '93'}, {'value': '93', 'groupId': 'OG004', 'lowerLimit': '85', 'upperLimit': '97'}]}]}, {'title': 'hSBA ≥1:8, baseline', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '24'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '18'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '25'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '11', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '19'}]}]}, {'title': 'hSBA ≥1:8, 1 month after second vaccination', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '100'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '91'}, {'value': '85', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '92'}, {'value': '82', 'groupId': 'OG003', 'lowerLimit': '72', 'upperLimit': '90'}, {'value': '89', 'groupId': 'OG004', 'lowerLimit': '81', 'upperLimit': '95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 1 month after second vaccination', 'description': 'The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population after second vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}, {'value': '90', 'groupId': 'OG005'}, {'value': '90', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'UKMenC (Menjugate at 2, 4 m)', 'description': 'Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG004', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG005', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG006', 'title': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Tenderness', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}]}]}, {'title': 'Eating habit Change', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}]}]}, {'title': 'Persistent Crying', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}, {'value': '73', 'groupId': 'OG006'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}]}, {'title': 'Fever (≥38°C)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Analgesics/Antipyretics', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after each vaccination', 'description': 'Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on safety dataset "n" population - subjects who received at least one study dose and had Post baseline safety data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '90', 'groupId': 'OG007'}, {'value': '44', 'groupId': 'OG008'}, {'value': '43', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'UK234+ (MenACWY Ad+ at 2,3,4 m)', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'OG001', 'title': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG002', 'title': 'UKMenC (Menjugate at 2, 4 m)', 'description': 'Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'OG003', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment', 'description': 'Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG004', 'title': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG005', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG006', 'title': 'CA24+ (MenACWY Ad+ at 2, 4 m) - PS', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG007', 'title': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'OG008', 'title': 'CA24- (MenACWY Ad- at 2, 4 m) - ACWY', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'OG009', 'title': 'CA24- (MenACWY Ad- at 2, 4 m) - PS', 'description': 'Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'classes': [{'title': 'Tenderness', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '66', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '36', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}]}, {'title': 'Eating habit change', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}]}, {'title': 'Persistent crying', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}]}, {'title': 'Fever (≥38°C)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Analgesics/Antipyretics', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after vaccination at 12 months of age', 'description': 'The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on safety dataset "n" population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UK234+ (MenACWY Ad+ at 2,3,4 m)', 'description': 'Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'FG001', 'title': 'UK24+ (MenACWY Ad+ at 2,4 m)', 'description': 'Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'FG002', 'title': 'UKMenC (Menjugate at 2,4m)', 'description': 'Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'FG003', 'title': 'CA246+ (MenACWY Ad+ at 2,4,6m)', 'description': 'Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'FG004', 'title': 'CA24+ (MenACWY Ad+ at 2,4m)', 'description': 'Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'FG005', 'title': 'UK24- (MenACWY Ad- at 2,4m)', 'description': 'Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'FG006', 'title': 'CA24- (MenACWY Ad- at 2,4m)', 'description': 'Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.\n\nOne dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '98'}, {'groupId': 'FG004', 'numSubjects': '98'}, {'groupId': 'FG005', 'numSubjects': '90'}, {'groupId': 'FG006', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '93'}, {'groupId': 'FG004', 'numSubjects': '91'}, {'groupId': 'FG005', 'numSubjects': '83'}, {'groupId': 'FG006', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Inapropriate enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were enrolled at two centers in Canada and one in UK.', 'preAssignmentDetails': 'The two selected countries provided data on different infant vaccination schedules (at 2 and 4 months of age; at 2, 3, and 4 months of age: and at 2, 4, and 6 months of age), and on different recommended concomitant vaccinations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}, {'value': '601', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'UK234+ (MenACWY Ad+ at 2,3,4 m)', 'description': 'Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.'}, {'id': 'BG001', 'title': 'UK24+ (MenACWY Ad+ at 2,4 m)', 'description': 'Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'BG002', 'title': 'UKMenC (Menjugate at 2,4m)', 'description': 'Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.'}, {'id': 'BG003', 'title': 'CA246+ (MenACWY Ad+ at 2,4,6m)', 'description': 'Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'BG004', 'title': 'CA24+ (MenACWY Ad+ at 2,4m)', 'description': 'Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'BG005', 'title': 'UK24- (MenACWY Ad- at 2,4m)', 'description': 'Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.'}, {'id': 'BG006', 'title': 'CA24- (MenACWY Ad- at 2,4m)', 'description': 'Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '61.3', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '65.6', 'spread': '6.9', 'groupId': 'BG003'}, {'value': '65.8', 'spread': '6.9', 'groupId': 'BG004'}, {'value': '64.1', 'spread': '5.5', 'groupId': 'BG005'}, {'value': '69.4', 'spread': '10.0', 'groupId': 'BG006'}, {'value': '64.6', 'spread': '7.3', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '304', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '46', 'groupId': 'BG006'}, {'value': '297', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-16', 'studyFirstSubmitDate': '2005-12-02', 'resultsFirstSubmitDate': '2013-09-02', 'studyFirstSubmitQcDate': '2005-12-02', 'lastUpdatePostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-16', 'studyFirstPostDateStruct': {'date': '2005-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine', 'timeFrame': 'Baseline and at 1 month after the 3 dose primary vaccination series', 'description': 'Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.'}], 'secondaryOutcomes': [{'measure': 'Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine', 'timeFrame': 'Baseline and 1 month after the 3 dose primary vaccination series', 'description': 'Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.'}, {'measure': 'Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine', 'timeFrame': 'Baseline and 1 month after the 3 dose primary vaccination series', 'description': 'Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.'}, {'measure': 'Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines', 'timeFrame': 'Baseline and 1 month after second vaccination', 'description': 'Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.'}, {'measure': 'Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines', 'timeFrame': 'Baseline and 1 month after second vaccination', 'description': 'Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.'}, {'measure': 'Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine', 'timeFrame': 'at 12 months of age and 1 month after booster vaccination', 'description': 'Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.'}, {'measure': 'Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines', 'timeFrame': 'at 12 months of age and 1 month after booster vaccination', 'description': 'Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.'}, {'measure': 'Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine', 'timeFrame': 'at 12 months of age', 'description': 'The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.'}, {'measure': 'Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.', 'timeFrame': 'at 12 months of age', 'description': 'The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.'}, {'measure': 'Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine', 'timeFrame': 'at 12 months of age', 'description': 'The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.'}, {'measure': 'Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine', 'timeFrame': 'at 12 months of age', 'description': 'The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.'}, {'measure': 'Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine', 'timeFrame': 'before challenge at 12 months of age and 1 month after PS challenge.', 'description': 'The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.'}, {'measure': 'Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine', 'timeFrame': 'before challenge at 12 months of age and 1 month after PS challenge.', 'description': 'The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.'}, {'measure': 'Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine', 'timeFrame': 'Before challenge at 12 months of age and 1 month after PS challenge.', 'description': 'The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.'}, {'measure': 'Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine', 'timeFrame': 'Before challenge at 12 months of age and 1 month after PS challenge.', 'description': 'Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.'}, {'measure': 'Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine', 'timeFrame': 'Baseline and 1 month after the 2 or 3 dose primary vaccination series', 'description': 'The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.'}, {'measure': 'Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine', 'timeFrame': 'at 12 months of age and 1 month after PS challenge', 'description': 'The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.'}, {'measure': 'Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines', 'timeFrame': 'Baseline and 1 month after the 2 or 3 dose primary vaccination series', 'description': 'To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.'}, {'measure': 'ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B', 'timeFrame': 'Baseline and 1 month after the 2 or 3 dose primary vaccination series', 'description': 'To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.'}, {'measure': 'Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)', 'timeFrame': 'Baseline and 1 month after second vaccination', 'description': 'The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.'}, {'measure': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-', 'timeFrame': '7 days after each vaccination', 'description': 'Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.'}, {'measure': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age', 'timeFrame': '7 days after vaccination at 12 months of age', 'description': 'The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.'}]}, 'conditionsModule': {'conditions': ['Prevention of Meningococcal Disease']}, 'referencesModule': {'references': [{'pmid': '18182599', 'type': 'RESULT', 'citation': 'Snape MD, Perrett KP, Ford KJ, John TM, Pace D, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):173-84. doi: 10.1001/jama.2007.29-c.'}, {'pmid': '19209097', 'type': 'RESULT', 'citation': 'Perrett KP, Snape MD, Ford KJ, John TM, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. Pediatr Infect Dis J. 2009 Mar;28(3):186-93. doi: 10.1097/INF.0b013e31818e037d.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nIndividuals eligible for enrollment in this study were male, and female infants:\n\n* Who were healthy 2-month old infants (55-89 days, inclusive) born after full term pregnancy with an estimated gestational age ≥ 37 weeks, and a birth weight ≥ 2.5 kg;\n* For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;\n* Who were available for all the visits scheduled in the study;\n* Who were in good health as determined by:\n\n * Medical history;\n * Physical examination;\n * Clinical judgment of the investigator.\n\nExclusion Criteria\n\nIneligible for the study were infants:\n\n* Whose parents/legal guardians were unwilling, or unable to give written informed consent for the subject to participate in the study;\n* Who previously received any meningococcal vaccine;\n* Who received prior vaccination with D, T, P (acellular, or whole cell), IPV, or OPV, HBV, H influenzae type b (Hib), or Pneumococcus;\n* Who had a previously ascertained or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus, or B pertussis (history of laboratory-confirmed or clinical condition of spasmodic cough for a period ≥ 2 weeks associated with apnea or whooping cough);\n* Who had household contact with and/or intimate exposure to an individual with laboratory-confirmed N meningitis (serogroups A, C, W-135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection since birth;\n* Who had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or known hypersensitivity to any vaccine component;\n* Who had experienced significant acute or chronic infection within the previous 7 days, or fever (≥ 38.0°C) within the previous 3 days;\n* Who had any present, or suspected serious, acute (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition, or insulin-dependent diabetes); or progressive neurological disease; or a genetic anomaly or known cytogenic disorders (e.g., Downs syndrome);\n* Who had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):\n\n * receipt of any immunosuppressive therapy since birth;\n * receipt of immunostimulant since birth;\n * receipt of any systemic corticosteroid since birth.\n* Who had a suspected or known HIV infection, or HIV-related disease;\n* Who had ever received blood, blood products and/or plasma derivatives, or any parenteral immunoglobulin preparation;\n* Who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;\n* Who had a history of seizure disorder:\n\n * Febrile seizure;\n * Any other seizure disorder.\n* Who had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who received an oral or parenteral β-lactam antibiotic \\[examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.\\] may be enrolled 7 days following the last dose);\n* Who with their parents/legal guardians were planning to leave the area of the study site before the end of the study period;\n* Who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;\n* Who had taken any antipyretic medication in the previous 6 hours.'}, 'identificationModule': {'nctId': 'NCT00262002', 'briefTitle': 'Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age', 'orgStudyIdInfo': {'id': 'V59P5'}, 'secondaryIdInfos': [{'id': '2004-000195-13'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'description': 'Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age in the UK group. A fourth dose of MenACWY Ad+ was given at 12 months of age.', 'interventionNames': ['Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)', 'Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)']}, {'type': 'EXPERIMENTAL', 'label': 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.', 'interventionNames': ['Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)', 'Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)']}, {'type': 'EXPERIMENTAL', 'label': 'UKMenC (Menjugate at 2, 4 m)', 'description': 'Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.', 'interventionNames': ['Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)', 'Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)', 'Biological: Menjugate (Men C conjugated vaccine)']}, {'type': 'EXPERIMENTAL', 'label': 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'description': 'Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age of the Canadian group (Prevnar at 6 months was optional and was given if available).One subgroup of subjects was given a reduced dose (1/5) of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.', 'interventionNames': ['Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)', 'Biological: MenACWY PS (MenACWY-CRM, polysaccharide vaccine)', 'Biological: HBV (Hepatitis B vaccine)', 'Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)', 'Biological: MMR (Measles, Mumps and Rubella vaccine)', 'Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)']}, {'type': 'EXPERIMENTAL', 'label': 'CA24+ (MenACWY Ad+ at 2, 4 m)', 'description': 'Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (1/5) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.', 'interventionNames': ['Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)', 'Biological: MenACWY PS (MenACWY-CRM, polysaccharide vaccine)', 'Biological: HBV (Hepatitis B vaccine)', 'Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)', 'Biological: MMR (Measles, Mumps and Rubella vaccine)', 'Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)']}, {'type': 'EXPERIMENTAL', 'label': 'UK24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.', 'interventionNames': ['Biological: MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)', 'Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)']}, {'type': 'EXPERIMENTAL', 'label': 'CA24- (MenACWY Ad- at 2, 4 m)', 'description': 'Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.', 'interventionNames': ['Biological: MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)', 'Biological: MenACWY PS (MenACWY-CRM, polysaccharide vaccine)', 'Biological: HBV (Hepatitis B vaccine)', 'Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)', 'Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)']}], 'interventions': [{'name': 'MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)', 'type': 'BIOLOGICAL', 'description': 'MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.', 'armGroupLabels': ['CA24- (MenACWY Ad- at 2, 4 m)', 'UK24- (MenACWY Ad- at 2, 4 m)']}, {'name': 'MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)', 'type': 'BIOLOGICAL', 'description': 'MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.', 'armGroupLabels': ['CA24+ (MenACWY Ad+ at 2, 4 m)', 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'UKMenC (Menjugate at 2, 4 m)']}, {'name': 'MenACWY PS (MenACWY-CRM, polysaccharide vaccine)', 'type': 'BIOLOGICAL', 'description': 'MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.', 'armGroupLabels': ['CA24+ (MenACWY Ad+ at 2, 4 m)', 'CA24- (MenACWY Ad- at 2, 4 m)', 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)']}, {'name': 'HBV (Hepatitis B vaccine)', 'type': 'BIOLOGICAL', 'description': 'Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.', 'armGroupLabels': ['CA24+ (MenACWY Ad+ at 2, 4 m)', 'CA24- (MenACWY Ad- at 2, 4 m)', 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)']}, {'name': 'Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)', 'type': 'BIOLOGICAL', 'description': 'Prevnar was administered IM in the anterolateral area of the left thigh.', 'armGroupLabels': ['CA24+ (MenACWY Ad+ at 2, 4 m)', 'CA24- (MenACWY Ad- at 2, 4 m)', 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)']}, {'name': 'MMR (Measles, Mumps and Rubella vaccine)', 'type': 'BIOLOGICAL', 'description': 'MMR at 12 month of age, administered in the left arm.', 'armGroupLabels': ['CA24+ (MenACWY Ad+ at 2, 4 m)', 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)']}, {'name': 'DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)', 'type': 'BIOLOGICAL', 'description': 'DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.', 'armGroupLabels': ['CA24+ (MenACWY Ad+ at 2, 4 m)', 'CA24- (MenACWY Ad- at 2, 4 m)', 'CA246+ (MenACWY Ad+ at 2, 4, 6 m)', 'UK234+ (MenACWY Ad+ at 2, 3, 4 m)', 'UK24+ (MenACWY Ad+ at 2, 4 m)', 'UK24- (MenACWY Ad- at 2, 4 m)', 'UKMenC (Menjugate at 2, 4 m)']}, {'name': 'Menjugate (Men C conjugated vaccine)', 'type': 'BIOLOGICAL', 'description': 'Menjugate was injected IM in the anterolateral area of the right thigh.', 'armGroupLabels': ['UKMenC (Menjugate at 2, 4 m)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vaccine Evaluation Center', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Clinical Trial Research Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Vaccine Group', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Vaccines & Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}