Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-13 @ 12:16 PM
Study NCT ID:
NCT02752906
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D008585', 'term': 'Meningitis, Meningococcal'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022401', 'term': 'Meningococcal Vaccines'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi Pasteur Inc.'}, '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': 'Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination.', 'description': 'A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, meningococcal-vaccine naive adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.', 'otherNumAtRisk': 402, 'deathsNumAtRisk': 402, 'otherNumAffected': 255, 'seriousNumAtRisk': 402, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Group 2: Menactra ®', 'description': 'Healthy, meningococcal-vaccine naive adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of Menactra vaccine on Day 0.', 'otherNumAtRisk': 407, 'deathsNumAtRisk': 407, 'otherNumAffected': 263, 'seriousNumAtRisk': 407, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 178, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 196, 'numAffected': 196}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 110, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 108, 'numAffected': 108}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Myalgia', 'notes': 'Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 148, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 161, 'numAffected': 158}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Headache', 'notes': 'Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 168, 'numAffected': 155}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 152, 'numAffected': 137}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}], 'seriousEvents': [{'term': 'Intestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Allergy To Arthropod Sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Clavicle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Healthy, meningococcal vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Menactra ®', 'description': 'Healthy, meningococcal-vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '89.0', 'upperLimit': '94.7'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '83.4', 'upperLimit': '90.3'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '98.6'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '88.6', 'upperLimit': '94.3'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '98.7'}, {'value': '95.6', 'groupId': 'OG001', 'lowerLimit': '93.1', 'upperLimit': '97.4'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '99.3'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '87.4', 'upperLimit': '93.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.0', 'ciLowerLimit': '0.735', 'ciUpperLimit': '9.38', 'groupDescription': 'Serogroup A', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \\> -10%, the non- inferiority assumption was rejected.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '2.16', 'ciUpperLimit': '8.76', 'groupDescription': 'Serogroup C', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \\> -10%, the non-inferiority assumption was rejected.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-0.907', 'ciUpperLimit': '4.55', 'groupDescription': 'Serogroup Y', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \\> -10%, the non-inferiority assumption was rejected.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.4', 'ciLowerLimit': '4.30', 'ciUpperLimit': '10.9', 'groupDescription': 'Serogroup W', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \\> -10%, the non-inferiority assumption was rejected.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'The serum bactericidal assay using human complement (hSBA) vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \\>= 1:16 for participants with pre-vaccination hSBA titers \\< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \\>= 1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Analysis Set-2 (PPAS2): included all participants who had no protocol deviations (not meet inclusion/exclusion criteria, participant did not received vaccine, administration of vaccine not done as per-protocol). PPAS2 defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 30 after vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Healthy, meningococcal vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Menactra ®', 'description': 'Healthy, meningococcal-vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '83.9'}, {'value': '66.1', 'groupId': 'OG001', 'lowerLimit': '53.0', 'upperLimit': '77.7'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000', 'lowerLimit': '71.2', 'upperLimit': '92.2'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '76.1', 'upperLimit': '94.3'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '80.0', 'upperLimit': '97.0'}, {'value': '83.9', 'groupId': 'OG001', 'lowerLimit': '72.3', 'upperLimit': '92.0'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '98.9'}, {'value': '83.9', 'groupId': 'OG001', 'lowerLimit': '72.3', 'upperLimit': '92.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 (post-vaccination)', 'description': 'The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \\>= 1:16 for participants with pre-vaccination hSBA titers \\< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \\>= 1:8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Analysis Set-1 (PPAS1): included all participants who received at least 1 dose of study vaccine(s) and had no protocol deviations (not meet inclusion/exclusion criteria, participant did not received vaccine). PPAS1 defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 6 after vaccination.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Healthy, meningococcal vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Menactra ®', 'description': 'Healthy, meningococcal-vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '497', 'groupId': 'OG000', 'lowerLimit': '436', 'upperLimit': '568'}, {'value': '296', 'groupId': 'OG001', 'lowerLimit': '256', 'upperLimit': '343'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '2618', 'groupId': 'OG000', 'lowerLimit': '2227', 'upperLimit': '3078'}, {'value': '599', 'groupId': 'OG001', 'lowerLimit': '504', 'upperLimit': '711'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '2070', 'groupId': 'OG000', 'lowerLimit': '1807', 'upperLimit': '2371'}, {'value': '811', 'groupId': 'OG001', 'lowerLimit': '699', 'upperLimit': '941'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '1747', 'groupId': 'OG000', 'lowerLimit': '1508', 'upperLimit': '2025'}, {'value': '723', 'groupId': 'OG001', 'lowerLimit': '614', 'upperLimit': '853'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'Meningococcal antibody responses against Serogroups A, C, Y, and W were measured by hSBA.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPAS2.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Healthy, meningococcal vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Menactra ®', 'description': 'Healthy, meningococcal-vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.'}], 'classes': [{'title': 'Pain-Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}]}, {'title': 'Pain-Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Pain-Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Pain-Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Swelling-Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever-Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fever-Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever-Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fever-Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Headache-Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}, {'title': 'Headache-Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Headache-Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Headache-Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Malaise-Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia-Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days post-vaccination', 'description': 'A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema and swelling (Grade 1: \\>=25 millimeter \\[mm\\] to \\<= 50 mm, Grade 2: \\>=51 to \\<=100 mm, Grade 3: \\> 100 mm). Solicited systemic reactions: Fever (Grade 1: \\>=38.0 degree Celsius (°C) to \\<=38.4°C, Grade 2: \\>=38.5°C to \\<=38.9 °C, Grade 3: \\>= 39°C), headache, malaise, and myalgia (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity. Number of participants with any of the Grade (1, 2 or 3) and with each Grade (1, 2 and 3) solicited injection-site and systemic reactions were reported.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Safety Analysis Set which included participants who have received at least one dose of the study vaccine and have any safety data available. Here 'number analyzed' signifies number of participants with available data for specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Healthy, meningococcal vaccine-primed adolescents (greater than or equal to \\[\\>=\\] 15 to less than \\[\\<\\] 18 years) or adults (\\>= 18 years) received a single dose of a Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.'}, {'id': 'FG001', 'title': 'Menactra ®', 'description': 'Healthy, meningococcal-vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ®) vaccine on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '402'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '396'}, {'groupId': 'FG001', 'numSubjects': '402'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Study participants were enrolled in 30 centers from 15 April 2016 to 02 August 2016.', 'preAssignmentDetails': 'A total of 810 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '407', 'groupId': 'BG001'}, {'value': '810', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Healthy, meningococcal vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.'}, {'id': 'BG001', 'title': 'Menactra ®', 'description': 'Healthy, meningococcal-vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '5.96', 'groupId': 'BG000'}, {'value': '19.9', 'spread': '5.59', 'groupId': 'BG001'}, {'value': '20.0', 'spread': '5.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '342', 'groupId': 'BG000'}, {'value': '340', 'groupId': 'BG001'}, {'value': '682', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '407', 'groupId': 'BG001'}, {'value': '810', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 810}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2018-01-15', 'completionDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2016-04-22', 'dispFirstSubmitQcDate': '2018-01-15', 'resultsFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2016-04-22', 'dispFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-19', 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'The serum bactericidal assay using human complement (hSBA) vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \\>= 1:16 for participants with pre-vaccination hSBA titers \\< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \\>= 1:8.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination', 'timeFrame': 'Day 6 (post-vaccination)', 'description': 'The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \\>= 1:16 for participants with pre-vaccination hSBA titers \\< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \\>= 1:8.'}, {'measure': 'Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine', 'timeFrame': 'Day 30 (post-vaccination)', 'description': 'Meningococcal antibody responses against Serogroups A, C, Y, and W were measured by hSBA.'}, {'measure': 'Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine', 'timeFrame': 'Within 7 days post-vaccination', 'description': 'A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema and swelling (Grade 1: \\>=25 millimeter \\[mm\\] to \\<= 50 mm, Grade 2: \\>=51 to \\<=100 mm, Grade 3: \\> 100 mm). Solicited systemic reactions: Fever (Grade 1: \\>=38.0 degree Celsius (°C) to \\<=38.4°C, Grade 2: \\>=38.5°C to \\<=38.9 °C, Grade 3: \\>= 39°C), headache, malaise, and myalgia (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity. Number of participants with any of the Grade (1, 2 or 3) and with each Grade (1, 2 and 3) solicited injection-site and systemic reactions were reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meningitis', 'Meningococcal Meningitis', 'Meningococcal Infections', 'MenACYW Conjugate vaccine', 'Licensed Meningococcal Conjugate Vaccine (MCV4)'], 'conditions': ['Meningitis', 'Meningococcal Meningitis', 'Meningococcal Infections']}, 'referencesModule': {'references': [{'pmid': '32209015', 'type': 'RESULT', 'citation': 'Anez G, Hedrick J, Simon MW, Christensen S, Jeanfreau R, Yau E, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1292-1298. doi: 10.1080/21645515.2020.1733867. Epub 2020 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the past 4-10 years.\n\nPrimary Objective:\n\n* To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW Conjugate vaccine compared to those observed following the administration of a booster dose of Menactra® in participants who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 4 to 10 years before the booster dose.\n\nSecondary Objectives:\n\n* To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of 120 participants.\n* To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination.\n\nObservational Objectives:\n\n* To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination.\n* To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by rabbit serum bactericidal assay (rSBA) in a subset of participants.\n* To describe the safety profile of MenACYW Conjugate vaccine compared to that of a licensed Menactra® after booster vaccination.', 'detailedDescription': 'Healthy adolescents and adults who had received 1 dose of a quadrivalent meningococcal Conjugate vaccine 4 to 10 years previously were randomized to receive either 1 dose of MenACYW Conjugate vaccine or licensed Menactra®. All participants underwent immunogenicity assessment at baseline (pre-vaccination) and post-vaccination and were also evaluated for safety up to Day 180 post-vaccination. In addition, a subset had an additional blood sample collected at 6 days post-vaccination for immunogenicity assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged \\>= 15 years on the day of inclusion.\n* Participant has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to study vaccination.\n* Participant aged 15 to \\< 18 years: assent form signed and dated by the participant and informed consent form (ICF) signed and dated by the parent or guardian.\n* Participant aged \\>=18 years: ICF signed and dated by the participant.\n* Participants aged 15 to \\< 18 years: both the participant and parent / guardian were able to attend all scheduled visits and to comply with all trial procedures.\n* Participants aged \\>= 18 years: able to attend all scheduled visits and to comply with all trial procedures.\n\nExclusion Criteria:\n\n* Participant was pregnant, lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).\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 Day 30 visit except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.\n* Previous vaccination against meningococcal disease with either an investigational or approved meningococcal B vaccine.\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months.\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.\n* At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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 vaccine(s) used in the trial or to a vaccine containing any of the same substances.\n* Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.\n* Personal history of Guillain-Barré syndrome.\n* Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion.\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.\n* Current alcohol abuse or drug addiction.\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.\n* Moderate or severe acute illness/infection (according to the Investigator's judgment) on the day of vaccination or febrile illness (temperature \\>= 100.4°Fahrenheit \\[F\\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has 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."}, 'identificationModule': {'nctId': 'NCT02752906', 'briefTitle': 'Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine', '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': 'MET56'}, 'secondaryIdInfos': [{'id': 'U1111-1161-2710', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2018-001470-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MenACYW Conjugate Vaccine', 'description': 'Healthy, meningococcal vaccine-primed adolescents (greater than or equal to \\[\\>=\\] 15 to less than \\[\\< \\]18 years) or adults (\\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.', 'interventionNames': ['Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Menactra®', 'description': 'Healthy, meningococcal- vaccine-primed adolescents (\\>= 15 to \\< 18 years) or adults (\\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.', 'interventionNames': ['Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine']}], 'interventions': [{'name': 'Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['MenACYW Conjugate vaccine'], 'description': '0.5 milliliter (mL), Intramuscular', 'armGroupLabels': ['MenACYW Conjugate Vaccine']}, {'name': 'Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Menactra®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 016', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 032', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 026', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 022', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '90241', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 005', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '91744', 'city': 'La Puente', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 014', 'geoPoint': {'lat': 34.02001, 'lon': -117.94951}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 029', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123-1881', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 001', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 013', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '40356', 'city': 'Nicholasville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 027', 'geoPoint': {'lat': 37.88063, 'lon': -84.573}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 015', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 018', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 010', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 008', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 028', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68504', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 023', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 031', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 006', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Investigational Site Number 012', 'geoPoint': {'lat': 46.87719, 'lon': 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States', 'facility': 'Investigational Site Number 007', 'geoPoint': {'lat': 41.23339, 'lon': -80.44868}}, {'zip': '37388', 'city': 'Tullahoma', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 024', 'geoPoint': {'lat': 35.36202, 'lon': -86.20943}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 020', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 003', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number 017', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '00981', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Investigational Site Number 030', 'geoPoint': {'lat': 18.46633, 'lon': 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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'}}}}