Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-25 @ 8:08 PM
Study NCT ID:
NCT03476135
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D008585', 'term': 'Meningitis, Meningococcal'}], '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': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).', 'description': 'SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 36, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 43, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'notes': 'Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '8.15', 'upperLimit': '18.1'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '22.9'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '153'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '7.03', 'upperLimit': '19.4'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '24.2', 'upperLimit': '39.5'}, {'value': '17.6', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '23.7'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '34.4', 'upperLimit': '68.4'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '32.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per-Protocol Analysis Set (PPAS) which included all participants who received at least 1 dose of the study vaccine, had a valid post-vaccination blood sample result and had no certain protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '763', 'groupId': 'OG000', 'lowerLimit': '521', 'upperLimit': '1117'}, {'value': '659', 'groupId': 'OG001', 'lowerLimit': '427', 'upperLimit': '1017'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '5894', 'groupId': 'OG000', 'lowerLimit': '4325', 'upperLimit': '8031'}, {'value': '1592', 'groupId': 'OG001', 'lowerLimit': '1165', 'upperLimit': '2174'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '2013', 'groupId': 'OG000', 'lowerLimit': '1451', 'upperLimit': '2792'}, {'value': '2806', 'groupId': 'OG001', 'lowerLimit': '2066', 'upperLimit': '3813'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '2656', 'groupId': 'OG000', 'lowerLimit': '1601', 'upperLimit': '4406'}, {'value': '3444', 'groupId': 'OG001', 'lowerLimit': '2387', 'upperLimit': '4970'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (post-booster vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS.'}, {'type': 'PRIMARY', 'title': 'Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '314'}, {'value': '281', 'groupId': 'OG001', 'lowerLimit': '131', 'upperLimit': '606'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000', 'lowerLimit': '60.9', 'upperLimit': '169'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '6.14', 'upperLimit': '22.9'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000', 'lowerLimit': '65.0', 'upperLimit': '219'}, {'value': '126', 'groupId': 'OG001', 'lowerLimit': '69.1', 'upperLimit': '230'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000', 'lowerLimit': '54.6', 'upperLimit': '234'}, {'value': '126', 'groupId': 'OG001', 'lowerLimit': '63.6', 'upperLimit': '250'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '4240', 'groupId': 'OG000', 'lowerLimit': '3352', 'upperLimit': '5365'}, {'value': '5702', 'groupId': 'OG001', 'lowerLimit': '4575', 'upperLimit': '7107'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '8629', 'groupId': 'OG000', 'lowerLimit': '6573', 'upperLimit': '11328'}, {'value': '4871', 'groupId': 'OG001', 'lowerLimit': '3750', 'upperLimit': '6327'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '5499', 'groupId': 'OG000', 'lowerLimit': '4502', 'upperLimit': '6717'}, {'value': '7814', 'groupId': 'OG001', 'lowerLimit': '6465', 'upperLimit': '9445'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '16103', 'groupId': 'OG000', 'lowerLimit': '12691', 'upperLimit': '20431'}, {'value': '19793', 'groupId': 'OG001', 'lowerLimit': '15538', 'upperLimit': '25214'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (post-booster vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS.'}, {'type': 'PRIMARY', 'title': 'Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'title': 'Serogroup A: Day 0 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000', 'lowerLimit': '3.12', 'upperLimit': '4.33'}, {'value': '3.67', 'groupId': 'OG001', 'lowerLimit': '3.15', 'upperLimit': '4.29'}]}]}, {'title': 'Serogroup A: Day 30 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '109'}, {'value': '49.6', 'groupId': 'OG001', 'lowerLimit': '32.1', 'upperLimit': '76.7'}]}]}, {'title': 'Serogroup A: Day 0 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '8.11', 'upperLimit': '17.4'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '20.2'}]}]}, {'title': 'Serogroup A: Day 30 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '755', 'groupId': 'OG000', 'lowerLimit': '520', 'upperLimit': '1097'}, {'value': '629', 'groupId': 'OG001', 'lowerLimit': '418', 'upperLimit': '948'}]}]}, {'title': 'Serogroup C: Day 0 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '2.04', 'upperLimit': '3.01'}, {'value': '2.30', 'groupId': 'OG001', 'lowerLimit': '2.12', 'upperLimit': '2.50'}]}]}, {'title': 'Serogroup C: Day 30 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '594', 'groupId': 'OG000', 'lowerLimit': '445', 'upperLimit': '793'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '43.1'}]}]}, {'title': 'Serogroup C: Day 0 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '149'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '7.28', 'upperLimit': '18.3'}]}]}, {'title': 'Serogroup C: Day 30 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5744', 'groupId': 'OG000', 'lowerLimit': '4230', 'upperLimit': '7800'}, {'value': '1618', 'groupId': 'OG001', 'lowerLimit': '1204', 'upperLimit': '2172'}]}]}, {'title': 'Serogroup Y: Day 0 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.17', 'groupId': 'OG000', 'lowerLimit': '1.95', 'upperLimit': '2.42'}, {'value': '2.27', 'groupId': 'OG001', 'lowerLimit': '2.05', 'upperLimit': '2.52'}]}]}, {'title': 'Serogroup Y: Day 30 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000', 'lowerLimit': '73.9', 'upperLimit': '149'}, {'value': '75.8', 'groupId': 'OG001', 'lowerLimit': '54.2', 'upperLimit': '106'}]}]}, {'title': 'Serogroup Y: Day 0 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '42.7'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '24.0'}]}]}, {'title': 'Serogroup Y: Day 30 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2048', 'groupId': 'OG000', 'lowerLimit': '1486', 'upperLimit': '2823'}, {'value': '2710', 'groupId': 'OG001', 'lowerLimit': '2022', 'upperLimit': '3633'}]}]}, {'title': 'Serogroup W: Day 0 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'comment': 'The 95% confidence interval was not computable as the standard deviation of the sample was 0, since all participants had the same value.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.12', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '2.24'}]}]}, {'title': 'Serogroup W: Day 30 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.8', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '96.7'}, {'value': '40.1', 'groupId': 'OG001', 'lowerLimit': '30.6', 'upperLimit': '52.6'}]}]}, {'title': 'Serogroup W: Day 0 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '69.5'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '30.9'}]}]}, {'title': 'Serogroup W: Day 30 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2776', 'groupId': 'OG000', 'lowerLimit': '1682', 'upperLimit': '4584'}, {'value': '3235', 'groupId': 'OG001', 'lowerLimit': '2278', 'upperLimit': '4594'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis in both MET54 and MET62 was performed on Full Analysis Set for Persistence (FASP) which included all participants who had a valid pre-vaccination blood sample result. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'PRIMARY', 'title': 'Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'title': 'Serogroup A: Day 0 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '5.25', 'upperLimit': '28.8'}, {'value': '4.88', 'groupId': 'OG001', 'lowerLimit': '2.74', 'upperLimit': '8.69'}]}]}, {'title': 'Serogroup A: Day 30 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3198', 'groupId': 'OG000', 'lowerLimit': '2559', 'upperLimit': '3996'}, {'value': '7633', 'groupId': 'OG001', 'lowerLimit': '5879', 'upperLimit': '9909'}]}]}, {'title': 'Serogroup A: Day 0 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '283'}, {'value': '239', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': '503'}]}]}, {'title': 'Serogroup A: Day 30 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4096', 'groupId': 'OG000', 'lowerLimit': '3223', 'upperLimit': '5205'}, {'value': '5341', 'groupId': 'OG001', 'lowerLimit': '4275', 'upperLimit': '6674'}]}]}, {'title': 'Serogroup C: Day 0 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.21', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '2.70'}, {'value': '2.15', 'groupId': 'OG001', 'lowerLimit': '1.86', 'upperLimit': '2.47'}]}]}, {'title': 'Serogroup C: Day 30 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2711', 'groupId': 'OG000', 'lowerLimit': '2156', 'upperLimit': '3409'}, {'value': '414', 'groupId': 'OG001', 'lowerLimit': '283', 'upperLimit': '607'}]}]}, {'title': 'Serogroup C: Day 0 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '160'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '6.11', 'upperLimit': '20.6'}]}]}, {'title': 'Serogroup C: Day 30 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8474', 'groupId': 'OG000', 'lowerLimit': '6483', 'upperLimit': '11075'}, {'value': '4817', 'groupId': 'OG001', 'lowerLimit': '3759', 'upperLimit': '6175'}]}]}, {'title': 'Serogroup Y: Day 0 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.88', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '4.42'}, {'value': '4.29', 'groupId': 'OG001', 'lowerLimit': '2.48', 'upperLimit': '7.44'}]}]}, {'title': 'Serogroup Y: Day 30 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2667', 'groupId': 'OG000', 'lowerLimit': '2063', 'upperLimit': '3447'}, {'value': '2836', 'groupId': 'OG001', 'lowerLimit': '2127', 'upperLimit': '3781'}]}]}, {'title': 'Serogroup Y: Day 0 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000', 'lowerLimit': '67.1', 'upperLimit': '213'}, {'value': '123', 'groupId': 'OG001', 'lowerLimit': '67.6', 'upperLimit': '223'}]}]}, {'title': 'Serogroup Y: Day 30 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5553', 'groupId': 'OG000', 'lowerLimit': '4565', 'upperLimit': '6755'}, {'value': '7498', 'groupId': 'OG001', 'lowerLimit': '6213', 'upperLimit': '9049'}]}]}, {'title': 'Serogroup W: Day 0 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'comment': 'The 95% confidence interval was not computable as the standard deviation of the sample was 0, since all participants had the same value.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.24', 'groupId': 'OG001', 'lowerLimit': '1.78', 'upperLimit': '2.81'}]}]}, {'title': 'Serogroup W: Day 30 (MET54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5793', 'groupId': 'OG000', 'lowerLimit': '4346', 'upperLimit': '7720'}, {'value': '4214', 'groupId': 'OG001', 'lowerLimit': '3162', 'upperLimit': '5616'}]}]}, {'title': 'Serogroup W: Day 0 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '219'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '57.9', 'upperLimit': '219'}]}]}, {'title': 'Serogroup W: Day 30 (MET62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15839', 'groupId': 'OG000', 'lowerLimit': '12530', 'upperLimit': '20023'}, {'value': '18710', 'groupId': 'OG001', 'lowerLimit': '14737', 'upperLimit': '23753'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis in both MET54 and MET62 was performed on FASP. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'PRIMARY', 'title': 'Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.12', 'groupId': 'OG000', 'lowerLimit': '2.05', 'upperLimit': '4.75'}, {'value': '3.02', 'groupId': 'OG001', 'lowerLimit': '2.11', 'upperLimit': '4.31'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.', 'unitOfMeasure': 'International unit per milliliter(IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '8.41', 'upperLimit': '12.8'}, {'value': '9.36', 'groupId': 'OG001', 'lowerLimit': '7.61', 'upperLimit': '11.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (post-booster vaccination)', 'description': 'Anti-tetanus antibodies were measured by ECL assay.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Immediate Adverse Event After Vaccination in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 minutes after vaccination', 'description': 'Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set which included participants who had received at least one dose of the study vaccine and had any safety data available.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after vaccination', 'description': 'A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited Adverse Event After Vaccination in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days after vaccination', 'description': 'An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'OG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days after vaccination', 'description': 'A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'FG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 8 sites in Finland from 27 February 2018 to 10 September 2018.', 'preAssignmentDetails': 'A total of 91 participants who received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine or Nimenrix® vaccine in previous study MET54 (NCT03205358) were enrolled in this study (MET62).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'BG001', 'title': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.35', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '0.33', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '0.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Analysis was performed on all enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-15', 'size': 832902, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-17T11:14', 'hasProtocol': True}, {'date': '2018-09-30', 'size': 593329, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-17T11:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2019-09-05', 'completionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2018-03-19', 'dispFirstSubmitQcDate': '2019-09-05', 'resultsFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2018-03-19', 'dispFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-19', 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.'}, {'measure': 'Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'timeFrame': 'Day 30 (post-booster vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.'}, {'measure': 'Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.'}, {'measure': 'Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'timeFrame': 'Day 30 (post-booster vaccination)', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.'}, {'measure': 'Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.'}, {'measure': 'Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.'}, {'measure': 'Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.'}, {'measure': 'Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62', 'timeFrame': 'Day 30 (post-booster vaccination)', 'description': 'Anti-tetanus antibodies were measured by ECL assay.'}, {'measure': 'Number of Participants With Immediate Adverse Event After Vaccination in MET62', 'timeFrame': 'Within 30 minutes after vaccination', 'description': 'Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.'}, {'measure': 'Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62', 'timeFrame': 'Within 7 days after vaccination', 'description': 'A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.'}, {'measure': 'Number of Participants With Unsolicited Adverse Event After Vaccination in MET62', 'timeFrame': 'Within 30 days after vaccination', 'description': 'An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.'}, {'measure': 'Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62', 'timeFrame': 'Within 30 days after vaccination', 'description': 'A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meningococcal Meningitis', 'MenACYW conjugate vaccine', 'Quadrivalent meningococcal vaccine'], 'conditions': ['Meningococcal Infections']}, 'descriptionModule': {'briefSummary': 'This was an open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine in children in Finland who had been vaccinated 3 years earlier as toddlers with either MenACYW conjugate vaccine or Nimenrix® as part of the MET54 study (NCT03205358).\n\nThe objectives were:\n\n* To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.\n* To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.\n* To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.\n* To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.', 'detailedDescription': 'Healthy children who were vaccinated 3 years earlier at 12 to 23 months of age in study MET54 (NCT03205358) were eligible for enrollment. All participants received a single booster dose of MenACYW conjugate vaccine on Day 0. Immunogenicity was assessed at pre-vaccination and 30 days after vaccination. Safety was assessed throughout the study period, and included solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 30 (Visit 2), and serious adverse events occurring throughout the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '61 Months', 'minimumAge': '46 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participated in and completed (attended Visit 2) study MET54.\n* Informed consent form had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness, if required by local regulations).\n* Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.\n* Covered by health insurance where applicable.\n\nExclusion Criteria:\n\n* Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.\n* Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at a gap of at least 2 weeks before or after the study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. If the participant was due to receive vaccination(s) recommended for his/her age by the national immunization schedule at the time of the study, the participant was recommended to complete his/her immunization schedule after Visit 2.\n* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine) with the exception of the single dose of meningococcal vaccine administered as part of study MET54.\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months.\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* History of meningococcal infection, confirmed either clinically, serologically, or microbiologically\n* At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.\n* Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.\n* Personal history of Guillain-Barré syndrome.\n* Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.\n* Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.\n* Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \\>= 38.0 degree Celsius \\[°C\\]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided.\n* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.\n* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study."}, 'identificationModule': {'nctId': 'NCT03476135', 'briefTitle': 'Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers', 'orgStudyIdInfo': {'id': 'MET62'}, 'secondaryIdInfos': [{'id': '2017-001993-40', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1183-5988', 'type': 'OTHER', 'domain': 'WHO (Universal Trial Number)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'description': 'Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).', 'interventionNames': ['Biological: MenACYW conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)', 'description': 'Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).', 'interventionNames': ['Biological: MenACYW conjugate vaccine']}], 'interventions': [{'name': 'MenACYW conjugate vaccine', 'type': 'BIOLOGICAL', 'description': 'Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular', 'armGroupLabels': ['Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)', 'Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02230', 'city': 'Espoo', 'country': 'Finland', 'facility': 'Sanofi Pasteur Investigational Site 2460005', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Sanofi Pasteur Investigational Site 2460006', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00930', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Sanofi Pasteur Investigational Site 2460002', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '04400', 'city': 'Järvenpää', 'country': 'Finland', 'facility': 'Sanofi Pasteur Investigational Site 2460007', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Sanofi Pasteur Investigational Site 2460008', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '28100', 'city': 'Pori', 'country': 'Finland', 'facility': 'Sanofi Pasteur Investigational Site 2460001', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Sanofi Pasteur Investigational Site 2460003', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Sanofi Pasteur Investigational Site 2460004', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur, a Sanofi Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}