Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01973218
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2013-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Solicited AEs were collected between Day 1 to 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AE's leading to premature withdrawal) from Day 1 to Day 61 (throughout the study)", 'eventGroups': [{'id': 'EG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study', 'otherNumAtRisk': 175, 'otherNumAffected': 167, 'seriousNumAtRisk': 174, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study', 'otherNumAtRisk': 88, 'otherNumAffected': 63, 'seriousNumAtRisk': 88, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Total', 'description': 'Total of subjects', 'otherNumAtRisk': 263, 'otherNumAffected': 230, 'seriousNumAtRisk': 262, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE INDURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 166}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 214}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'EATING DISORDERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 40}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 37}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 75}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 109}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 262, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'PAROVARIAN CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 262, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMenb', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'OG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'classes': [{'title': 'H44/76 strain (Day 1)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '33'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '34'}]}]}, {'title': 'H44/76 strain (Day 61)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '99'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '38'}]}]}, {'title': '5/99 strain (Day 1)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '18'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '19'}]}]}, {'title': '5/99 strain (Day 61)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '25'}]}]}, {'title': 'NZ98/254 strain (Day 1)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '22'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '24'}]}]}, {'title': 'NZ98/254 strain (Day 61)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '27'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and Day 61', 'description': 'Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the Full Analysis Set (FAS) i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.'}, {'type': 'SECONDARY', 'title': 'The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'OG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'classes': [{'title': 'H44/76 strain (Day 1)', 'categories': [{'measurements': [{'value': '2.31', 'groupId': 'OG000', 'lowerLimit': '1.94', 'upperLimit': '2.74'}, {'value': '2.18', 'groupId': 'OG001', 'lowerLimit': '1.72', 'upperLimit': '2.77'}]}]}, {'title': 'H44/76 strain (Day 61)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '112'}, {'value': '2.56', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': '3.43'}]}]}, {'title': '5/99 strain (Day 1)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.31', 'upperLimit': '1.72'}, {'value': '1.37', 'groupId': 'OG001', 'lowerLimit': '1.16', 'upperLimit': '1.61'}]}]}, {'title': '5/99 strain (Day 61)', 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000', 'lowerLimit': '284', 'upperLimit': '432'}, {'value': '1.84', 'groupId': 'OG001', 'lowerLimit': '1.34', 'upperLimit': '2.52'}]}]}, {'title': 'NZ98/254 strain (Day 1)', 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '2.02'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '1.27', 'upperLimit': '1.99'}]}]}, {'title': 'NZ98/254 strain (Day 61)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '40'}, {'value': '1.77', 'groupId': 'OG001', 'lowerLimit': '1.35', 'upperLimit': '2.32'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 61', 'description': 'The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.'}, {'type': 'SECONDARY', 'title': 'The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'OG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'classes': [{'title': 'H44/76 strain', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '49'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.51'}]}]}, {'title': '5/99 strain', 'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000', 'lowerLimit': '181', 'upperLimit': '301'}, {'value': '1.34', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.81'}]}]}, {'title': 'NZ98/254 strain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '23'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.35'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 61/ Day 1', 'description': 'The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints'}, {'type': 'SECONDARY', 'title': 'The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'OG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'classes': [{'title': 'H44/76 strain', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '96'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '16'}]}]}, {'title': '5/99 strain', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '13'}]}]}, {'title': 'NZ98/254 strain', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '88'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '13'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 61', 'description': 'Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.'}, {'type': 'SECONDARY', 'title': 'The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'OG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'classes': [{'title': 'Day1', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '24'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '29'}]}]}, {'title': 'Day61', 'categories': [{'measurements': [{'value': '1208', 'groupId': 'OG000', 'lowerLimit': '1025', 'upperLimit': '1423'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '32'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 61', 'description': 'The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints'}, {'type': 'SECONDARY', 'title': 'The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'OG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '62'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.22'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 61/Day 1', 'description': 'The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'OG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'classes': [{'title': 'Any Local (1st vacc; N=174, 87)', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Injec site pain (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Injec site erythema I (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Injec site erythema II (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injec site swelling I (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injec site swelling II (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injec site induration I (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Injec site induration II (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Local (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Injec site pain (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Injec site erythema I (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Injec site erythema II (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Injec site swelling I (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Injec site swelling II (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Injec site induration I (2nd vacc; N=172,88)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Injec site induration II (2nd vacc; N=172,88)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Systemic (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Nausea (1st vacc; N=174,88)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Malaise (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Headache (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Body Temperature (≥38°C) (1st vacc; N=174,87)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Prevention of pain/fever (1st vacc;N=174,87)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment of pain/fever (1st vacc;N=174,87)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Medically attended fever (1st vacc;N=174,86)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Systemic (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Nausea (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Malaise (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Headache (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Body Temperature (≥38°C) (2nd vacc; N=173,88)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Prevention of pain/fever (2nd vacc;N=173,88)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment of pain/fever (2nd vacc;N=173,88)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Medically attended fever (2nd vacc;N=171,88)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through day 7 after each vaccination', 'description': 'The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'OG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Possibly or Probably Related AES', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'At least possibly related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Medically attended AEs', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'AEs resulting in premature withdrawal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 61', 'description': 'The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.', 'unitOfMeasure': 'number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'FG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 7 study sites in Korea.', 'preAssignmentDetails': 'All enrolled subjects were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'rMENB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study'}, {'id': 'BG001', 'title': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '13.4', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '13.5', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2013-10-25', 'resultsFirstSubmitDate': '2015-02-20', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-20', 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.', 'timeFrame': 'Day 1 and Day 61', 'description': 'Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.'}], 'secondaryOutcomes': [{'measure': 'The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.', 'timeFrame': 'Day 1 and Day 61', 'description': 'The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.'}, {'measure': 'The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.', 'timeFrame': 'Day 61/ Day 1', 'description': 'The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.'}, {'measure': 'The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.', 'timeFrame': 'Day 61', 'description': 'Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.'}, {'measure': 'The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.', 'timeFrame': 'Day 1 and Day 61', 'description': 'The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.'}, {'measure': 'The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.', 'timeFrame': 'Day 61/Day 1', 'description': 'The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.'}, {'measure': 'The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.', 'timeFrame': 'Day 1 through day 7 after each vaccination', 'description': 'The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.'}, {'measure': 'The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.', 'timeFrame': 'Day 1 through Day 61', 'description': 'The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meningitis, adolescents, Meningococcal B'], 'conditions': ['Meningococcal Disease']}, 'referencesModule': {'references': [{'pmid': '26826544', 'type': 'DERIVED', 'citation': 'Lee HJ, Choe YJ, Hong YJ, Kim KH, Park SE, Kim YK, Oh CE, Lee H, Song H, Bock H, Casula D, Bhusal C, Arora AK. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trial. Vaccine. 2016 Feb 24;34(9):1180-6. doi: 10.1016/j.vaccine.2016.01.033. Epub 2016 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;\n2. Available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period);\n3. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;\n4. With a negative urine pregnancy test (for female subjects only).\n\nExclusion Criteria:\n\n1. History of any meningococcal vaccine administration;\n2. Current or previous, confirmed or suspected disease caused by N. meningitidis;\n3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;\n4. Pregnancy or nursing (breastfeeding) mothers;\n5. Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;\n6. Any serious chronic or progressive disease;\n7. Family members and household members of research staff;\n8. Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;\n9. Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment;\n10. Antibiotics within 6 days prior to enrollment;\n11. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy;\n12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;\n13. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;\n14. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period;\n15. Participation in another clinical trial within the last 90 days or planned for during study.'}, 'identificationModule': {'nctId': 'NCT01973218', 'briefTitle': 'Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 Years in Korea', 'orgStudyIdInfo': {'id': 'V72_42'}, 'secondaryIdInfos': [{'id': '20130090378', 'type': 'OTHER', 'domain': 'MFDS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rMenB', 'description': 'Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study.', 'interventionNames': ['Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo/MenACWY', 'description': 'Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.', 'interventionNames': ['Biological: Placebo', 'Biological: Meningococcal ACWY-CRM conjugate vaccine']}], 'interventions': [{'name': 'Meningococcal B Recombinant vaccine rMenB+OMV NZ', 'type': 'BIOLOGICAL', 'description': 'Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.', 'armGroupLabels': ['rMenB']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.', 'armGroupLabels': ['Placebo/MenACWY']}, {'name': 'Meningococcal ACWY-CRM conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197'], 'description': 'Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.', 'armGroupLabels': ['Placebo/MenACWY']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-702', 'city': 'Seo-gu', 'state': 'Busan', 'country': 'South Korea', 'facility': '06 Kosin University Gospel Hospital 34, amnam-dong'}, {'zip': '425-707', 'city': 'Ansan-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': '05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu', 'geoPoint': {'lat': 37.32361, 'lon': 126.82194}}, {'zip': '626-770', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': '04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '463-707', 'city': 'Bundang-gu', 'state': 'Seongnam', 'country': 'South Korea', 'facility': '07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil'}, {'zip': '110-744,', 'city': 'Jongno-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': '01 Seoul National University Hospital 101 Daehang-ro,'}, {'zip': '158-710', 'city': 'Yangch’ŏn-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': '03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong', 'geoPoint': {'lat': 37.52056, 'lon': 126.87472}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': '02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}