Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT01018732
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2009-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D008585', 'term': 'Meningitis, Meningococcal'}, {'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': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'safety was assessed up to 28 days after vaccination.', 'description': 'All the AEs reported were solicited post-injection reactions', 'eventGroups': [{'id': 'EG000', 'title': 'I: MenACWY-CRM Vaccine', 'description': 'Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago', 'otherNumAtRisk': 50, 'otherNumAffected': 38, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'II: Licensed Polysaccharide Meningococcal Vaccine', 'description': 'Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago', 'otherNumAtRisk': 50, 'otherNumAffected': 36, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'III: Meningococcal Naive', 'description': 'Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive', 'otherNumAtRisk': 53, 'otherNumAffected': 46, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I:MenACWY', 'description': 'Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.'}, {'id': 'OG001', 'title': 'II:Licensed Polysacharide Meningococcal Vaccine', 'description': 'Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.'}, {'id': 'OG002', 'title': 'III: Meningococcal-naive', 'description': 'Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.'}], 'classes': [{'title': 'Men A', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '45'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '59'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '23'}]}]}, {'title': 'Men C', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '87'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '75'}, {'value': '51', 'groupId': 'OG002', 'lowerLimit': '37', 'upperLimit': '65'}]}]}, {'title': 'Men W-135', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '84'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '70'}, {'value': '51', 'groupId': 'OG002', 'lowerLimit': '37', 'upperLimit': '65'}]}]}, {'title': 'Men Y', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '87'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '64'}, {'value': '55', 'groupId': 'OG002', 'lowerLimit': '40', 'upperLimit': '68'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (5 years after primary vaccination)', 'description': 'Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \\>= 8 \\[i.e. percentage of subjects with hsBA titer \\>=8\\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (all subjects who had no major protocol violation as defined prior to database lock).'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I:MenACWY', 'description': 'Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.'}, {'id': 'OG001', 'title': 'II:Licensed Polysacharide Meningococcal Vaccine', 'description': 'Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.'}, {'id': 'OG002', 'title': 'III: Meningococcal-naive', 'description': 'Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.'}], 'classes': [{'title': 'Baseline, Men A', 'categories': [{'measurements': [{'value': '5.16', 'groupId': 'OG000', 'lowerLimit': '3.46', 'upperLimit': '7.7'}, {'value': '7.31', 'groupId': 'OG001', 'lowerLimit': '4.94', 'upperLimit': '11'}, {'value': '3.06', 'groupId': 'OG002', 'lowerLimit': '2.06', 'upperLimit': '4.55'}]}]}, {'title': 'Day 8, Men A,', 'categories': [{'measurements': [{'value': '1059', 'groupId': 'OG000', 'lowerLimit': '585', 'upperLimit': '1917'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '80'}, {'value': '34', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '61'}]}]}, {'title': 'Day 29, Men A, (N=48, G I)', 'categories': [{'measurements': [{'value': '819', 'groupId': 'OG000', 'lowerLimit': '514', 'upperLimit': '1305'}, {'value': '147', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '232'}, {'value': '113', 'groupId': 'OG002', 'lowerLimit': '72', 'upperLimit': '179'}]}]}, {'title': 'Baseline, Men C', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '33'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '31'}, {'value': '7.34', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '12'}]}]}, {'title': 'Day 8, Men C', 'categories': [{'measurements': [{'value': '1603', 'groupId': 'OG000', 'lowerLimit': '893', 'upperLimit': '2877'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '64'}, {'value': '70', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '124'}]}]}, {'title': 'Day 29, Men C', 'categories': [{'measurements': [{'value': '1217', 'groupId': 'OG000', 'lowerLimit': '717', 'upperLimit': '2066'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '86'}, {'value': '127', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '214'}]}]}, {'title': 'Baseline, Men W-135', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '49'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '7.02', 'upperLimit': '19'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '6.31', 'upperLimit': '18'}]}]}, {'title': 'Day 8, Men W-135', 'categories': [{'measurements': [{'value': '1685', 'groupId': 'OG000', 'lowerLimit': '1042', 'upperLimit': '2725'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '54'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '101'}]}]}, {'title': 'Day 29, Men W-135', 'categories': [{'measurements': [{'value': '1644', 'groupId': 'OG000', 'lowerLimit': '1090', 'upperLimit': '2481'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '71'}, {'value': '79', 'groupId': 'OG002', 'lowerLimit': '52', 'upperLimit': '118'}]}]}, {'title': 'Baseline, Men Y', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '45'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '4.91', 'upperLimit': '12'}, {'value': '8.69', 'groupId': 'OG002', 'lowerLimit': '5.45', 'upperLimit': '14'}]}]}, {'title': 'Day 8, Men Y, (N=48, GI)', 'categories': [{'measurements': [{'value': '2561', 'groupId': 'OG000', 'lowerLimit': '1526', 'upperLimit': '4298'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '35'}, {'value': '64', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '107'}]}]}, {'title': 'Day 29, Men Y', 'categories': [{'measurements': [{'value': '2092', 'groupId': 'OG000', 'lowerLimit': '1340', 'upperLimit': '3268'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '98'}, {'value': '110', 'groupId': 'OG002', 'lowerLimit': '70', 'upperLimit': '170'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.39', 'ciLowerLimit': '1.39', 'ciUpperLimit': '4.1', 'groupDescription': 'Day 1, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.2', 'groupDescription': 'Day 1, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.9', 'groupDescription': 'Day 1, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.59', 'ciUpperLimit': '2.91', 'groupDescription': 'Day 8, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24', 'ciLowerLimit': '11', 'ciUpperLimit': '52', 'groupDescription': 'Day 8, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31', 'ciLowerLimit': '14', 'ciUpperLimit': '69', 'groupDescription': 'Day 8, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.42', 'groupDescription': 'Day 29, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.56', 'ciLowerLimit': '3.01', 'ciUpperLimit': '10', 'groupDescription': 'Day 29, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.22', 'ciLowerLimit': '3.86', 'ciUpperLimit': '13', 'groupDescription': 'Day 29, Men A, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.64', 'ciLowerLimit': '1.4', 'ciUpperLimit': '4.99', 'groupDescription': 'Day 1, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.97', 'groupDescription': 'Day 1, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.78', 'ciLowerLimit': '1.47', 'ciUpperLimit': '5.27', 'groupDescription': 'Day 1, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.13', 'groupDescription': 'Day 8, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45', 'ciLowerLimit': '21', 'ciUpperLimit': '97', 'groupDescription': 'Day 8, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23', 'ciLowerLimit': '10', 'ciUpperLimit': '51', 'groupDescription': 'Day 8, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.2', 'ciUpperLimit': '0.82', 'groupDescription': 'Day 29, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24', 'ciLowerLimit': '12', 'ciUpperLimit': '48', 'groupDescription': 'Day 29, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.61', 'ciLowerLimit': '4.69', 'ciUpperLimit': '20', 'groupDescription': 'Day 29, Men C, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.55', 'ciUpperLimit': '2.21', 'groupDescription': 'Day 1, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.51', 'ciLowerLimit': '1.27', 'ciUpperLimit': '4.96', 'groupDescription': 'Day 1, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.77', 'ciLowerLimit': '1.38', 'ciUpperLimit': '5.57', 'groupDescription': 'Day 1, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.04', 'groupDescription': 'Day 8, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50', 'ciLowerLimit': '26', 'ciUpperLimit': '94', 'groupDescription': 'Day 8, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27', 'ciLowerLimit': '14', 'ciUpperLimit': '52', 'groupDescription': 'Day 8, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.04', 'groupDescription': 'Day 29, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35', 'ciLowerLimit': '20', 'ciUpperLimit': '60', 'groupDescription': 'Day 29, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of titer', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21', 'ciLowerLimit': '12', 'ciUpperLimit': '36', 'groupDescription': 'Day 29, Men W-135, Pairwise comparison of geometric mean titer', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, 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'96', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '100'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '45'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '66', 'upperLimit': '90'}]}]}, {'title': 'Men W-135, Day 8', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '100'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '52'}, {'value': '48', 'groupId': 'OG002', 'lowerLimit': '34', 'upperLimit': '63'}]}]}, {'title': 'Men W-135, Day 29', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '100'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '62'}, {'value': '58', 'groupId': 'OG002', 'lowerLimit': '43', 'upperLimit': '72'}]}]}, {'title': 'Men Y, Day 8, (N=48, G I)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '99'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '48'}, {'value': '54', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '68'}]}]}, {'title': 'Men Y, Day 29', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '99'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '69'}, {'value': '76', 'groupId': 'OG002', 'lowerLimit': '62', 'upperLimit': '87'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8, Day 29 (5 years after primary vaccination)', 'description': 'For a subject with hSBA titer \\<4 at baseline, seroresponse is defined as a postvaccination hSBA titer \\>=8; and for a subject with hSBA titer \\>=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I:MenACWY', 'description': 'Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.'}, {'id': 'OG001', 'title': 'II:Licensed Polysacharide Meningococcal Vaccine', 'description': 'Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.'}, {'id': 'OG002', 'title': 'III: Meningococcal-naive', 'description': 'Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.'}], 'classes': [{'title': 'Local Reactions (any-total)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Pain (any)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Erythema (any)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Induration (any)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Sytemic Reactions (any-total)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Chills (any)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Nausea (any)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Malaise (any)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia (any)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Arthalgia (any)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Headache (any)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Fever >= 38C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Stayed at home', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Analgesic antipyretic medication used', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 7', 'description': 'Local and systemic reactions were solicited to assess safety and tolerability of vaccination', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'I: MenACWY-CRM Vaccine', 'description': 'Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago'}, {'id': 'FG001', 'title': 'II: Licensed Polysaccharide Meningococcal Vaccine', 'description': 'Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago'}, {'id': 'FG002', 'title': 'III: Meningococcal Naive', 'description': 'Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Inappropriate Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unable to Classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 3 centers in the USA', 'preAssignmentDetails': 'All subjects enrolled were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'I: MenACWY-CRM Vaccine', 'description': 'Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago'}, {'id': 'BG001', 'title': 'II: Licensed Polysaccharide Meningococcal Vaccine', 'description': 'Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago'}, {'id': 'BG002', 'title': 'III: Meningococcal Naive', 'description': 'Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '19.2', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '20.5', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '19.5', 'spread': '2.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2009-11-18', 'resultsFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-09', 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination', 'timeFrame': 'Day 1 (5 years after primary vaccination)', 'description': 'Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \\>= 8 \\[i.e. percentage of subjects with hsBA titer \\>=8\\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y'}, {'measure': 'Geometric Mean Titer After Booster Vaccination', 'timeFrame': 'Day 8, Day 29 (5 years after primary vaccination)', 'description': 'Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination', 'timeFrame': 'Day 1 (5 years after primary vaccination )', 'description': 'Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) \\>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y'}, {'measure': 'Geometric Mean Titer at 5 Years After Primary Vaccination', 'timeFrame': 'Day 1 (5 years after primary vaccination )', 'description': 'Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y'}, {'measure': 'Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination', 'timeFrame': 'Day 7, Day 28 post booster (5 years after primary vaccination)', 'description': 'Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \\>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.'}, {'measure': 'Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination', 'timeFrame': 'Day 7, Day 28 post booster (5 years after primary vaccination)', 'description': 'Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \\>= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.'}, {'measure': 'Geometric Mean Ratio After Booster Vaccination', 'timeFrame': 'Day 8 and Day 29 (at 5 Years After Primary Vaccination)', 'description': 'Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1'}, {'measure': 'Percentage of Subjects With hSBA Seroresponse After Booster Vaccination', 'timeFrame': 'Day 8, Day 29 (5 years after primary vaccination)', 'description': 'For a subject with hSBA titer \\<4 at baseline, seroresponse is defined as a postvaccination hSBA titer \\>=8; and for a subject with hSBA titer \\>=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.'}, {'measure': 'Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination', 'timeFrame': 'Up to Day 7', 'description': 'Local and systemic reactions were solicited to assess safety and tolerability of vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meningococcal', 'ACWY', 'Conjugate Vaccine', 'Meningitis', 'Adolescents', 'Persistence'], 'conditions': ['Meningococcal Disease', 'Meningococcal Meningitis']}, 'referencesModule': {'references': [{'pmid': '21177912', 'type': 'RESULT', 'citation': 'Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011 Mar;18(3):483-6. doi: 10.1128/CVI.00304-10. Epub 2010 Dec 22.'}, {'pmid': '23114372', 'type': 'RESULT', 'citation': 'Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2013 Apr;32(4):e170-7. doi: 10.1097/INF.0b013e318279ac38.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.', 'detailedDescription': 'Persistence of antibody response at 5 years after one dose of MenACWY or Menomune'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.\n* Female subjects were to be negative for pregnancy\n\nExclusion Criteria:\n\n* History of meningococcal disease\n* Receipt of any meningococcal vaccine outside of parent study (V59P6)\n* Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy\n* receipt of any vaccine 14 days prior to the study, or expected through the duration of the study\n* any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study'}, 'identificationModule': {'nctId': 'NCT01018732', 'briefTitle': 'A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.', 'orgStudyIdInfo': {'id': 'V59P6E1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I: MenACWY-CRM vaccine', 'description': 'Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study.', 'interventionNames': ['Biological: Novartis Meningococcal (MenACWY-CRM) vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'II: Licensed Polysaccharide Meningococcal vaccine', 'description': 'Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study.', 'interventionNames': ['Biological: Novartis Meningococcal (MenACWY-CRM) vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'III: Meningococcal Naive', 'description': 'Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study.', 'interventionNames': ['Biological: Novartis Meningococcal (MenACWY-CRM) vaccine']}], 'interventions': [{'name': 'Novartis Meningococcal (MenACWY-CRM) vaccine', 'type': 'BIOLOGICAL', 'description': 'All subjects will have blood draws at Day 1, Day 8, and Day 29.', 'armGroupLabels': ['I: MenACWY-CRM vaccine', 'II: Licensed Polysaccharide Meningococcal vaccine', 'III: Meningococcal Naive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}