Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT04084769
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C570015', 'term': '4CMenB vaccine'}, {'id': 'C000729870', 'term': 'MenB-FHbp vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', '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': 'Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59.', 'description': 'Analysis performed on SafAS population.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).', 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 129, 'seriousNumAtRisk': 186, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).', 'otherNumAtRisk': 184, 'deathsNumAtRisk': 184, 'otherNumAffected': 116, 'seriousNumAtRisk': 184, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 83, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 88, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 71, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 63, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 114, 'numAffected': 77}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 123, 'numAffected': 85}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 61, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 61, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 58, 'numAffected': 58}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 69, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 67, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 42, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '97.6'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '99.1'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '99.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\\<) 1:8, or a \\>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per-Protocol Analysis Set 2 (PPAS2) population that included participants who received 1 dose of study vaccine in MET59 and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '96.4'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \\>=1:16 for participants with pre-vaccination hSBA titer \\<1:8, or a \\>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '92.2'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '62.9', 'upperLimit': '88.8'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '96.4'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '98.6'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '99.5'}, {'value': '91.1', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '97.5'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '99.9'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '96.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \\>=1:16 for participants with pre-vaccination hSBA titer \\<1:8, or a \\>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>=1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per-Protocol Analysis Set 1 (PPAS1) population that included participants who received 1 dose of study vaccine in MET59 and had valid serology result with no relevant protocol deviations; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Groups 1 and 2. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '97.6'}, {'value': '95.6', 'groupId': 'OG001', 'lowerLimit': '84.9', 'upperLimit': '99.5'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '100'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '88.2', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '92.1', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '92.1', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \\>=1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS1 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000', 'lowerLimit': '133', 'upperLimit': '625'}, {'value': '161', 'groupId': 'OG001', 'lowerLimit': '93.0', 'upperLimit': '280'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '3799', 'groupId': 'OG000', 'lowerLimit': '2504', 'upperLimit': '5763'}, {'value': '919', 'groupId': 'OG001', 'lowerLimit': '500', 'upperLimit': '1690'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '1658', 'groupId': 'OG000', 'lowerLimit': '973', 'upperLimit': '2826'}, {'value': '800', 'groupId': 'OG001', 'lowerLimit': '467', 'upperLimit': '1371'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '1928', 'groupId': 'OG000', 'lowerLimit': '1187', 'upperLimit': '3131'}, {'value': '708', 'groupId': 'OG001', 'lowerLimit': '463', 'upperLimit': '1082'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 6 (post-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS1 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '97.6'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '88.4', 'upperLimit': '96.4'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '99.1'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '99.9'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '99.4'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '99.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.65', 'ciLowerLimit': '-3.58', 'ciUpperLimit': '6.95', 'groupDescription': 'Serogroup A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% Confidence Interval (CI) of the difference in percentage was calculated from the Wilson Score method without continuity correction.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.74', 'ciLowerLimit': '-5.50', 'ciUpperLimit': '1.60', 'groupDescription': 'Serogroup C', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-4.09', 'ciUpperLimit': '1.14', 'groupDescription': 'Serogroup Y', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-4.72', 'ciUpperLimit': '2.07', 'groupDescription': 'Serogroup W', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \\>=1:16 for participants with pre-vaccination hSBA titer \\<1:8, or a \\>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>=1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A: Day 0', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '77.9'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '63.7', 'upperLimit': '77.6'}]}]}, {'title': 'Serogroup A: Day 30', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.9', 'upperLimit': '100'}]}]}, {'title': 'Serogroup C: Day 0', 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '92.4'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '58.2'}]}]}, {'title': 'Serogroup C: Day 30', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Serogroup Y: Day 0', 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '85.6'}, {'value': '52.8', 'groupId': 'OG001', 'lowerLimit': '45.2', 'upperLimit': '60.4'}]}]}, {'title': 'Serogroup Y: Day 30', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W: Day 0', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '91.0'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '71.0', 'upperLimit': '83.7'}]}]}, {'title': 'Serogroup W: Day 30', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer \\>=1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.'}, {'type': 'SECONDARY', 'title': 'GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A: Day 0', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '9.89', 'upperLimit': '13.8'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '9.72', 'upperLimit': '13.7'}]}]}, {'title': 'Serogroup A: Day 30', 'categories': [{'measurements': [{'value': '502', 'groupId': 'OG000', 'lowerLimit': '388', 'upperLimit': '649'}, {'value': '399', 'groupId': 'OG001', 'lowerLimit': '318', 'upperLimit': '502'}]}]}, {'title': 'Serogroup C: Day 0', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '28.8', 'upperLimit': '46.7'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '8.03', 'upperLimit': '13.0'}]}]}, {'title': 'Serogroup C: Day 30', 'categories': [{'measurements': [{'value': '3708', 'groupId': 'OG000', 'lowerLimit': '3146', 'upperLimit': '4369'}, {'value': '2533', 'groupId': 'OG001', 'lowerLimit': '2076', 'upperLimit': '3091'}]}]}, {'title': 'Serogroup Y: Day 0', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '25.2'}, {'value': '8.35', 'groupId': 'OG001', 'lowerLimit': '6.70', 'upperLimit': '10.4'}]}]}, {'title': 'Serogroup Y: Day 30', 'categories': [{'measurements': [{'value': '2308', 'groupId': 'OG000', 'lowerLimit': '1925', 'upperLimit': '2767'}, {'value': '3036', 'groupId': 'OG001', 'lowerLimit': '2547', 'upperLimit': '3620'}]}]}, {'title': 'Serogroup W: Day 0', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '33.1'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '18.1'}]}]}, {'title': 'Serogroup W: Day 30', 'categories': [{'measurements': [{'value': '2290', 'groupId': 'OG000', 'lowerLimit': '1934', 'upperLimit': '2711'}, {'value': '2574', 'groupId': 'OG001', 'lowerLimit': '2178', 'upperLimit': '3041'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000', 'lowerLimit': '65.3', 'upperLimit': '78.5'}, {'value': '71.1', 'groupId': 'OG001', 'lowerLimit': '64.0', 'upperLimit': '77.4'}, {'value': '73.7', 'groupId': 'OG002', 'lowerLimit': '63.6', 'upperLimit': '82.2'}, {'value': '73.1', 'groupId': 'OG003', 'lowerLimit': '62.9', 'upperLimit': '81.8'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '91.3'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '45.3', 'upperLimit': '59.9'}, {'value': '86.3', 'groupId': 'OG002', 'lowerLimit': '77.7', 'upperLimit': '92.5'}, {'value': '85.1', 'groupId': 'OG003', 'lowerLimit': '76.3', 'upperLimit': '91.6'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '84.6'}, {'value': '55.3', 'groupId': 'OG001', 'lowerLimit': '47.9', 'upperLimit': '62.5'}, {'value': '88.3', 'groupId': 'OG002', 'lowerLimit': '80.0', 'upperLimit': '94.0'}, {'value': '80.9', 'groupId': 'OG003', 'lowerLimit': '71.4', 'upperLimit': '88.2'}]}]}, {'title': 'Serogroup W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '91.3'}, {'value': '77.9', 'groupId': 'OG001', 'lowerLimit': '71.3', 'upperLimit': '83.6'}, {'value': '90.5', 'groupId': 'OG002', 'lowerLimit': '82.8', 'upperLimit': '95.6'}, {'value': '91.4', 'groupId': 'OG003', 'lowerLimit': '83.8', 'upperLimit': '96.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \\>=1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).'}, {'id': 'OG003', 'title': 'Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '14.5'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '14.6'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '10.0', 'upperLimit': '16.3'}, {'value': '12.7', 'groupId': 'OG003', 'lowerLimit': '9.70', 'upperLimit': '16.6'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '27.4', 'upperLimit': '43.6'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '9.17', 'upperLimit': '15.3'}, {'value': '38.4', 'groupId': 'OG002', 'lowerLimit': '27.3', 'upperLimit': '54.0'}, {'value': '43.3', 'groupId': 'OG003', 'lowerLimit': '29.8', 'upperLimit': '63.0'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '24.2'}, {'value': '9.19', 'groupId': 'OG001', 'lowerLimit': '7.39', 'upperLimit': '11.4'}, {'value': '26.0', 'groupId': 'OG002', 'lowerLimit': '19.6', 'upperLimit': '34.5'}, {'value': '22.0', 'groupId': 'OG003', 'lowerLimit': '16.1', 'upperLimit': '30.0'}]}]}, {'title': 'Serogroup W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000', 'lowerLimit': '22.4', 'upperLimit': '33.4'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '18.3'}, {'value': '28.1', 'groupId': 'OG002', 'lowerLimit': '21.8', 'upperLimit': '36.2'}, {'value': '32.7', 'groupId': 'OG003', 'lowerLimit': '24.5', 'upperLimit': '43.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Groups 1, 3 and 4: MenACYW Conjugate Vaccine', 'description': 'Included all participants of Groups 1, 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Participants of Group 1 participants received a single IM dose of MenACYW Conjugate vaccine and Group 3 and 4 participants received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine, respectively, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A: Day 0 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '49.3', 'upperLimit': '59.6'}, {'value': '35.8', 'groupId': 'OG001', 'lowerLimit': '27.7', 'upperLimit': '44.6'}]}]}, {'title': 'Serogroup A: Day 30 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '96.7'}, {'value': '81.2', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '87.5'}]}]}, {'title': 'Serogroup C: Day 0 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '22.9'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '19.5'}]}]}, {'title': 'Serogroup C: Day 30 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '99.2'}, {'value': '74.2', 'groupId': 'OG001', 'lowerLimit': '65.9', 'upperLimit': '81.5'}]}]}, {'title': 'Serogroup Y: Day 0 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '7.1'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '8.5'}]}]}, {'title': 'Serogroup Y: Day 30 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '99.1'}, {'value': '88.7', 'groupId': 'OG001', 'lowerLimit': '82.1', 'upperLimit': '93.5'}]}]}, {'title': 'Serogroup W: Day 0 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '45.0'}, {'value': '40.3', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': '49.1'}]}]}, {'title': 'Serogroup W: Day 30 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '100'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '87.5', 'upperLimit': '96.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \\>=1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for pooled population of groups 1, 3 and 4 as pre-specified in the protocol."}, {'type': 'SECONDARY', 'title': 'GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Groups 1, 3 and 4: MenACYW Conjugate Vaccine', 'description': 'Included all participants of Groups 1, 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Participants of Group 1 participants received a single IM dose of MenACYW Conjugate vaccine and Group 3 and 4 participants received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine, respectively, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A: Day 0 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.28', 'groupId': 'OG000', 'lowerLimit': '6.53', 'upperLimit': '8.11'}, {'value': '5.72', 'groupId': 'OG001', 'lowerLimit': '4.75', 'upperLimit': '6.87'}]}]}, {'title': 'Serogroup A: Day 30 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '39.9', 'upperLimit': '51.1'}, {'value': '32.8', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '43.1'}]}]}, {'title': 'Serogroup A: Day 0 of MET59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '14.1'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '9.41', 'upperLimit': '14.3'}]}]}, {'title': 'Serogroup C: Day 0 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.48', 'groupId': 'OG000', 'lowerLimit': '3.22', 'upperLimit': '3.76'}, {'value': '2.98', 'groupId': 'OG001', 'lowerLimit': '2.69', 'upperLimit': '3.30'}]}]}, {'title': 'Serogroup C: Day 30 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '417', 'groupId': 'OG000', 'lowerLimit': '348', 'upperLimit': '500'}, {'value': '49.7', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': '76.4'}]}]}, {'title': 'Serogroup C: Day 0 of MET59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '44.5'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '8.09', 'upperLimit': '14.9'}]}]}, {'title': 'Serogroup Y: Day 0 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.36', 'groupId': 'OG000', 'lowerLimit': '2.22', 'upperLimit': '2.50'}, {'value': '2.30', 'groupId': 'OG001', 'lowerLimit': '2.13', 'upperLimit': '2.48'}]}]}, {'title': 'Serogroup Y: Day 30 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '78.6', 'upperLimit': '105'}, {'value': '36.1', 'groupId': 'OG001', 'lowerLimit': '27.2', 'upperLimit': '47.8'}]}]}, {'title': 'Serogroup Y: Day 0 of MET59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '18.8', 'upperLimit': '25.1'}, {'value': '8.49', 'groupId': 'OG001', 'lowerLimit': '6.50', 'upperLimit': '11.1'}]}]}, {'title': 'Serogroup W: Day 0 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.34', 'groupId': 'OG000', 'lowerLimit': '4.76', 'upperLimit': '6.00'}, {'value': '5.54', 'groupId': 'OG001', 'lowerLimit': '4.57', 'upperLimit': '6.72'}]}]}, {'title': 'Serogroup W: Day 30 of MET50 or MET43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '73.6', 'upperLimit': '92.9'}, {'value': '45.1', 'groupId': 'OG001', 'lowerLimit': '34.3', 'upperLimit': '59.4'}]}]}, {'title': 'Serogroup W: Day 0 of MET59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '33.0'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '18.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for pooled population of groups 1, 3 and 4 as pre-specified in the protocol."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).'}, {'id': 'OG002', 'title': 'Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).'}, {'id': 'OG003', 'title': 'Pooled Groups 3 and 4: MenACYW Conjugate Vaccine', 'description': 'Included all participants of Groups 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Participants of Group 3 and 4 participants received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '97.6'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '86.1', 'upperLimit': '97.5'}, {'value': '95.5', 'groupId': 'OG002', 'lowerLimit': '88.8', 'upperLimit': '98.7'}, {'value': '94.4', 'groupId': 'OG003', 'lowerLimit': '89.9', 'upperLimit': '97.3'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '99.1'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '92.2', 'upperLimit': '99.7'}, {'value': '96.6', 'groupId': 'OG002', 'lowerLimit': '90.4', 'upperLimit': '99.3'}, {'value': '97.2', 'groupId': 'OG003', 'lowerLimit': '93.6', 'upperLimit': '99.1'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '99.9'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100'}, {'value': '97.8', 'groupId': 'OG002', 'lowerLimit': '92.1', 'upperLimit': '99.7'}, {'value': '98.3', 'groupId': 'OG003', 'lowerLimit': '95.2', 'upperLimit': '99.7'}]}]}, {'title': 'Serogroup W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '99.4'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '100'}, {'value': '96.6', 'groupId': 'OG002', 'lowerLimit': '90.4', 'upperLimit': '99.3'}, {'value': '97.8', 'groupId': 'OG003', 'lowerLimit': '94.3', 'upperLimit': '99.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \\>=1:16 for participants with pre-vaccination hSBA titer \\<1:8, or a \\>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>=1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS2 population. Here, 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).'}, {'id': 'OG002', 'title': 'Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).'}, {'id': 'OG003', 'title': 'Pooled Groups 3 and 4: MenACYW Conjugate Vaccine', 'description': 'Included all participants of Groups 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Participants of Group 3 and 4 participants received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '77.9'}, {'value': '73.3', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '82.1'}, {'value': '71.6', 'groupId': 'OG002', 'lowerLimit': '61.0', 'upperLimit': '80.7'}, {'value': '72.5', 'groupId': 'OG003', 'lowerLimit': '65.3', 'upperLimit': '78.9'}]}]}, {'title': 'Serogroup A: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG003', 'lowerLimit': '96.9', 'upperLimit': '100'}]}]}, {'title': 'Serogroup C: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '92.4'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '77.9', 'upperLimit': '92.9'}, {'value': '86.5', 'groupId': 'OG002', 'lowerLimit': '77.6', 'upperLimit': '92.8'}, {'value': '86.6', 'groupId': 'OG003', 'lowerLimit': '80.7', 'upperLimit': '91.2'}]}]}, {'title': 'Serogroup C: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'Serogroup Y: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '85.6'}, {'value': '89.9', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '95.3'}, {'value': '80.9', 'groupId': 'OG002', 'lowerLimit': '71.2', 'upperLimit': '88.5'}, {'value': '85.4', 'groupId': 'OG003', 'lowerLimit': '79.3', 'upperLimit': '90.2'}]}]}, {'title': 'Serogroup Y: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '98.0', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '91.0'}, {'value': '91.1', 'groupId': 'OG001', 'lowerLimit': '83.2', 'upperLimit': '96.1'}, {'value': '90.9', 'groupId': 'OG002', 'lowerLimit': '82.9', 'upperLimit': '96.0'}, {'value': '91.0', 'groupId': 'OG003', 'lowerLimit': '85.8', 'upperLimit': '94.8'}]}]}, {'title': 'Serogroup W: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '98.0', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \\>=1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS2 population. Here, 'number analyzed'=participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol."}, {'type': 'SECONDARY', 'title': 'GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'OG001', 'title': 'Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).'}, {'id': 'OG002', 'title': 'Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).'}, {'id': 'OG003', 'title': 'Pooled Groups 3 and 4: MenACYW Conjugate Vaccine', 'description': 'Included all participants of Groups 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Participants of Group 3 and 4 participants received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine at Day 0 in the present study (MET59).'}], 'classes': [{'title': 'Serogroup A: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '9.89', 'upperLimit': '13.8'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '9.78', 'upperLimit': '16.0'}, {'value': '12.3', 'groupId': 'OG002', 'lowerLimit': '9.37', 'upperLimit': '16.2'}, {'value': '12.4', 'groupId': 'OG003', 'lowerLimit': '10.4', 'upperLimit': '14.9'}]}]}, {'title': 'Serogroup A: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '502', 'groupId': 'OG000', 'lowerLimit': '388', 'upperLimit': '649'}, {'value': '593', 'groupId': 'OG001', 'lowerLimit': '426', 'upperLimit': '825'}, {'value': '667', 'groupId': 'OG002', 'lowerLimit': '477', 'upperLimit': '933'}, {'value': '629', 'groupId': 'OG003', 'lowerLimit': '498', 'upperLimit': '794'}]}]}, {'title': 'Serogroup C: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '28.8', 'upperLimit': '46.7'}, {'value': '37.6', 'groupId': 'OG001', 'lowerLimit': '26.6', 'upperLimit': '53.3'}, {'value': '42.4', 'groupId': 'OG002', 'lowerLimit': '29.4', 'upperLimit': '61.0'}, {'value': '39.9', 'groupId': 'OG003', 'lowerLimit': '31.1', 'upperLimit': '51.2'}]}]}, {'title': 'Serogroup C: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3708', 'groupId': 'OG000', 'lowerLimit': '3146', 'upperLimit': '4369'}, {'value': '4741', 'groupId': 'OG001', 'lowerLimit': '3882', 'upperLimit': '5791'}, {'value': '3472', 'groupId': 'OG002', 'lowerLimit': '2667', 'upperLimit': '4518'}, {'value': '4064', 'groupId': 'OG003', 'lowerLimit': '3446', 'upperLimit': '4793'}]}]}, {'title': 'Serogroup Y: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '25.2'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '33.6'}, {'value': '21.0', 'groupId': 'OG002', 'lowerLimit': '15.4', 'upperLimit': '28.7'}, {'value': '23.2', 'groupId': 'OG003', 'lowerLimit': '18.9', 'upperLimit': '28.5'}]}]}, {'title': 'Serogroup Y: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2308', 'groupId': 'OG000', 'lowerLimit': '1925', 'upperLimit': '2767'}, {'value': '2600', 'groupId': 'OG001', 'lowerLimit': '2042', 'upperLimit': '3311'}, {'value': '2469', 'groupId': 'OG002', 'lowerLimit': '1881', 'upperLimit': '3241'}, {'value': '2534', 'groupId': 'OG003', 'lowerLimit': '2117', 'upperLimit': '3034'}]}]}, {'title': 'Serogroup W: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '33.1'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '36.4'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '22.5', 'upperLimit': '40.1'}, {'value': '29.1', 'groupId': 'OG003', 'lowerLimit': '24.1', 'upperLimit': '35.2'}]}]}, {'title': 'Serogroup W: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2290', 'groupId': 'OG000', 'lowerLimit': '1934', 'upperLimit': '2711'}, {'value': '2702', 'groupId': 'OG001', 'lowerLimit': '2134', 'upperLimit': '3422'}, {'value': '2064', 'groupId': 'OG002', 'lowerLimit': '1601', 'upperLimit': '2662'}, {'value': '2363', 'groupId': 'OG003', 'lowerLimit': '1988', 'upperLimit': '2810'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on PPAS2 population. Here, 'number analyzed'=participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'FG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'FG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).'}, {'id': 'FG003', 'title': 'Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '190'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'Safety Analysis Set (SAfAS)', 'comment': 'Participants who had received at least one dose of study vaccine in MET59 and had available safety data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '92'}]}, {'type': 'Full Analysis Set', 'comment': 'Participants who had a valid pre-vaccination serology result.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '190'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'Per-Protocol Analysis Set 1 (PPAS1)', 'comment': 'Participants who received at least 1 dose of the study vaccine in MET59 and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by serum bactericidal assay using human complement (hSBA) assessed at Day 06 after vaccination in Groups 1 and 2.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Per-Protocol Analysis Set 2 (PPAS2)', 'comment': 'Participants who received at least 1 dose of the study vaccine in MET59 and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or serum bactericidal assay using baby rabbit complement (rSBA) assessed at Day 30 after vaccination.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '186'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from 03-September-2019 to 07-March-2020 at 30 active sites in the United States and Puerto Rico.', 'preAssignmentDetails': 'A total of 570 participants who received meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine or Menveo (meningococcal Group B) vaccine either in Study MET50 (NCT02199691), or Study MET43 (NCT02842853), or outside of Sanofi Pasteur trials were enrolled in the present study (MET59).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '570', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'BG001', 'title': 'Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).'}, {'id': 'BG002', 'title': 'Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).'}, {'id': 'BG003', 'title': 'Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '1.59', 'groupId': 'BG000'}, {'value': '15.8', 'spread': '1.37', 'groupId': 'BG001'}, {'value': '15.1', 'spread': '1.12', 'groupId': 'BG002'}, {'value': '15.3', 'spread': '1.34', 'groupId': 'BG003'}, {'value': '15.4', 'spread': '1.43', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '270', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '300', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '497', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-10', 'size': 873365, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-03T10:16', 'hasProtocol': True}, {'date': '2020-10-13', 'size': 597875, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-03T10:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The laboratory personnel who performed the serology testing were blinded to the group assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Partially-randomized design: all participants primed with MenACYW Conjugate vaccine who meet the inclusion/exclusion criteria were randomly assigned to Group 1, 3, or 4, while participants primed with Menveo vaccine were automatically allocated to Group 2 (not randomized).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 570}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2019-09-04', 'resultsFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-08-03', 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1', 'timeFrame': 'Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\\<) 1:8, or a \\>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.'}, {'measure': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2', 'timeFrame': 'Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \\>=1:16 for participants with pre-vaccination hSBA titer \\<1:8, or a \\>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'timeFrame': 'Day 6 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \\>=1:16 for participants with pre-vaccination hSBA titer \\<1:8, or a \\>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>=1:8.'}, {'measure': 'Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'timeFrame': 'Day 6 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \\>=1:8.'}, {'measure': 'Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'timeFrame': 'Day 6 (post-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'timeFrame': 'Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \\>=1:16 for participants with pre-vaccination hSBA titer \\<1:8, or a \\>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>=1:8.'}, {'measure': 'Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer \\>=1:8.'}, {'measure': 'GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0', 'timeFrame': 'Day 0 (pre-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \\>=1:8.'}, {'measure': 'GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0', 'timeFrame': 'Day 0 (pre-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43', 'timeFrame': 'Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \\>=1:8.'}, {'measure': 'GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4', 'timeFrame': 'Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \\>=1:16 for participants with pre-vaccination hSBA titer \\<1:8, or a \\>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \\>=1:8.'}, {'measure': 'Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59', 'description': 'Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \\>=1:8.'}, {'measure': 'GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4', 'timeFrame': 'Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningococcal Immunisation (Healthy Volunteers)']}, 'referencesModule': {'references': [{'pmid': '36899125', 'type': 'DERIVED', 'citation': 'Zambrano B, Peterson J, Deseda C, Julien K, Spiegel CA, Seyler C, Simon M, Hoki R, Anderson M, Brabec B, Anez G, Shi J, Pan J, Hagenbach A, Von Barbier D, Varghese K, Jordanov E, Dhingra MS. Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study. Pediatr Res. 2023 Sep;94(3):1035-1043. doi: 10.1038/s41390-023-02478-5. Epub 2023 Mar 10.'}], 'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=25314&tenant=MT_SNY_9011', 'label': 'MET59 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine:\n\n* In Group 1 participants who were first vaccinated with 1 dose of MenACYW Conjugate vaccine 3-6 years before the booster dose.\n* In Group 2 participants who were first vaccinated with 1 dose of Menveo vaccine (meningococcal \\[Groups A, C, Y and W135\\] Oligosaccharide Diphtheria CRM197 Conjugate vaccine) 3-6 years before the booster dose.\n\nSecondary Objective:\n\nTo describe:\n\n* The vaccine seroresponse, seroprotection (serum bactericidal assay using human complement \\[hSBA\\] titer greater than or equal to \\[\\>=\\]1:8), and antibody responses (geometric mean titers \\[GMTs\\]) of meningococcal serogroups A, C, Y, and W measured using hSBA in serum specimens collected 6 days (±1 day) after vaccination in a subset of 50 participants per group (Groups 1 and 2).\n* The vaccine seroresponse, seroprotection (hSBA titer \\>=1:8), and antibody responses (GMTs) to serogroups A, C, Y, and W measured using hSBA on Day (D)0 (pre-vaccination) and D30 (+14 days) after vaccination with MenACYW Conjugate vaccine alone (Groups 1 and 2).\n* The antibody persistence (GMTs and vaccine seroprotection; hSBA titer \\>=1:8) of meningococcal serogroups A, C, Y, and W before a booster dose in participants who received either MenACYW Conjugate vaccine or Menveo vaccine 3-6 years earlier.\n* The antibody persistence (GMTs and vaccine seroprotection; hSBA titer \\>=1:8) of meningococcal serogroups A, C, Y, and W in participants who received either a single dose MenACYW Conjugate vaccine (participants randomized to MET59 Groups 1, 3, and 4) or Menveo vaccine (participants assigned to MET59 Group 2), as part of study MET50, or MET43 (participants randomized to MET59 Groups 1, 3 and 4).\n* To describe the vaccine seroresponse, seroprotection (hSBA titer \\>=1:8), and antibody responses (GMTs) to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with meningococcal serogroup B (MenB) vaccine (Groups 3 and 4), compared to those when it was given alone (Group 1).', 'detailedDescription': 'Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, 1 or 2 additional visits at Day 6 and Day 30, 2 phone calls and a safety follow-up/end of study visit, at Day 8 and Day 180 after vaccine administration, respectively.\n\nSafety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs) throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n* Aged \\>= 13 to less than (\\<) 26 years on the day of inclusion.\n* Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only).\n* For MET59 Group 2 only (Menveo vaccine-primed participants only; enrichment population): participants had a documented record of having received 1 dose of Menveo vaccine 3-6 years earlier either as part of a clinical trial or as routine vaccination. Participants who participated in MET50 Group 4 can be enrolled if they fulfill this criterion.\n* Participants aged 13 to \\< 18 years: assent form had been signed and dated by the participant and informed consent form (ICF) had been signed and dated by the parent or guardian.\n* Participants aged \\>=18 (or legal age of majority, if different from 18 years of age) to \\< 26 years: ICF had been signed and dated by the participants.\n* Participant aged 13 to \\< 18 years: both the participant and parent or guardian were able to attend all scheduled visits and complied with all trial procedures.\n* Participants aged \\>=18 (or legal age of majority, if different from 18 years of age) to \\< 26 years: able to attend all scheduled visits and complied with all trial procedures.\n\nExclusion criteria:\n\n* Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.\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 before Visit 3 (Day 30) except for influenza vaccination, which might be received at least 2 weeks before study investigational vaccine.\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months.\n* Receipt of any meningococcal vaccine including a licensed or investigational MenACWY vaccine or MenB vaccine since participation in study MET50 or MET43.\n* Menveo vaccine-primed participants only (enrichment group for Group 2): receipt of more than 1 dose of Menveo vaccine or vaccination with another licensed or investigational MenACWY vaccine or with a licensed or investigational MenB vaccine.\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 travelling 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 vaccines used in the trial or to a vaccine containing any of the same substances.\n* Personal history of Guillain-Barré syndrome.\n* Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination.\n* Verbal report of thrombocytopenia, contraindicating IM vaccination.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.\n* Current alcohol abuse or drug addiction.\n* Chronic illness (e.g., Human immunodeficiency viruses, hepatitis B, hepatitis C) 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 \\>= 100.4 degree Fahrenheit). A prospective participant should not be 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 an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04084769', 'briefTitle': 'Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults', 'orgStudyIdInfo': {'id': 'MET59'}, 'secondaryIdInfos': [{'id': 'U1111-1217-2137', 'type': 'OTHER', 'domain': 'UTN'}, {'id': '2019-004461-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: MenACYW Conjugate vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 (NCT02199691) or MET43 (NCT02842853), received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).', 'interventionNames': ['Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)', 'description': 'Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).', 'interventionNames': ['Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: MenACYW Conjugate vaccine + Trumenba vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).', 'interventionNames': ['Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine', 'Biological: Meningococcal Group B vaccine (Trumenba®)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: MenACYW Conjugate vaccine + Bexsero vaccine', 'description': 'Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).', 'interventionNames': ['Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine', 'Biological: Meningococcal group B vaccine (Bexsero®)']}], 'interventions': [{'name': 'Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form: Solution for injection Route of administration: IM', 'armGroupLabels': ['Group 1: MenACYW Conjugate vaccine', 'Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)', 'Group 3: MenACYW Conjugate vaccine + Trumenba vaccine', 'Group 4: MenACYW Conjugate vaccine + Bexsero vaccine']}, {'name': 'Meningococcal Group B vaccine (Trumenba®)', 'type': 'BIOLOGICAL', 'otherNames': ['Trumenba®'], 'description': 'Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM', 'armGroupLabels': ['Group 3: MenACYW Conjugate vaccine + Trumenba vaccine']}, {'name': 'Meningococcal group B vaccine (Bexsero®)', 'type': 'BIOLOGICAL', 'otherNames': ['Bexsero®'], 'description': 'Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM', 'armGroupLabels': ['Group 4: MenACYW Conjugate vaccine + Bexsero vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 8400012', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92123-1881', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400005', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 8400013', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '40517', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 8400033', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '63044', 'city': 'Bridgeton', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 8400034', 'geoPoint': {'lat': 38.767, 'lon': -90.41151}}, {'zip': '68504', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8400027', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68505', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8400002', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8400004', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8400030', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44121', 'city': 'South Euclid', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8400028', 'geoPoint': {'lat': 41.52311, 'lon': -81.51846}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 8400009', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '16505', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 8400038', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8400039', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 8400018', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '37388', 'city': 'Tullahoma', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 8400029', 'geoPoint': {'lat': 35.36202, 'lon': -86.20943}}, {'zip': '84037', 'city': 'Kaysville', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400031', 'geoPoint': {'lat': 41.03522, 'lon': -111.93855}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400001', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400014', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400040', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}, {'zip': '84064', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400011', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'zip': '84067', 'city': 'Roy', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400023', 'geoPoint': {'lat': 41.16161, 'lon': -112.02633}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400003', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400007', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400022', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400015', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400036', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '84075-9645', 'city': 'Syracuse', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400032', 'geoPoint': {'lat': 41.08939, 'lon': -112.06467}}, {'zip': '84088-8865', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 8400024', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number 8400037', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '00981', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Investigational Site Number 6300001', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', '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'}}}}