Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 2:02 PM
Study NCT ID:
NCT03869866
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, '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 subject 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': 'AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months.', 'description': 'Analysis was performed on SafAS population.', 'eventGroups': [{'id': 'EG000', 'title': 'MenACYW', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 288, 'otherNumAffected': 69, 'seriousNumAtRisk': 288, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 41, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 49, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}], 'seriousEvents': [{'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Hypertensive Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, W, and Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.4'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '96.5'}]}]}, {'title': 'Serogroup W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000', 'lowerLimit': '87.4', 'upperLimit': '94.3'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 post-dose', 'description': 'Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA. Seroprotection rate is defined as percentage of participants with rSBA titer \\>=1.8 who received MenACYW conjugate vaccine. Percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set (FAS) consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'title': 'Serogroup A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '635', 'groupId': 'OG000', 'lowerLimit': '477', 'upperLimit': '845'}]}]}, {'title': 'Serogroup C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2038', 'groupId': 'OG000', 'lowerLimit': '1529', 'upperLimit': '2718'}]}]}, {'title': 'Serogroup W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2710', 'groupId': 'OG000', 'lowerLimit': '1929', 'upperLimit': '3807'}]}]}, {'title': 'Serogroup Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2539', 'groupId': 'OG000', 'lowerLimit': '1970', 'upperLimit': '3272'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 post-dose', 'description': 'Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '38.8'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '172'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '72.1'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000', 'lowerLimit': '102', 'upperLimit': '165'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 post-dose', 'description': 'Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'title': 'Day 0 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.040', 'groupId': 'OG000', 'lowerLimit': '0.033', 'upperLimit': '0.049'}]}]}, {'title': 'Day 30 (post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.429', 'groupId': 'OG000', 'lowerLimit': '0.291', 'upperLimit': '0.631'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose Day 0 and Day 30 post-dose', 'description': 'Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.', 'unitOfMeasure': 'International units/milliliter (IU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Seroprotective Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'title': 'Day 0 (pre-dose): >=0.01 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000', 'lowerLimit': '83.4', 'upperLimit': '91.3'}]}]}, {'title': 'Day 0 (pre-dose): >=0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '33.9'}]}]}, {'title': 'Day 30 (post-dose): >=0.01 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '95.7'}]}]}, {'title': 'Day 30 (post-dose): >=0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000', 'lowerLimit': '50.8', 'upperLimit': '62.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose Day 0 and Day 30 post-dose', 'description': 'Seroprotective levels defined as antibody titers \\>= 0.01 IU/mL and \\>= 0.1 IU/mL of antibody concentrations to tetanus toxoid. Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by ECL assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human IgG conjugate. Percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited Systemic Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 minutes post-dose', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions \\[i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set (SafAS) consisted of participants who had received at least 1 dose of the study vaccine and had any safety data available.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injection Site Reactions and Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'title': 'Solicited injection site reaction', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Solicited systemic reaction', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days post-dose', 'description': 'All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection site reaction is an AR at and around the injection site. Injection site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SafAS consisted of participants who had received at least 1 dose of the study vaccine and had any safety data available. Only those participants with data collected are reported.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited Non-Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 30 post-dose', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SafAS consisted of participants who had received at least 1 dose of the study vaccine and had any safety data available.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to end of study, approximately 44 days', 'description': 'A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SafAS consisted of participants who had received at least 1 dose of the study vaccine and had any safety data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 milliliter (mL) intramuscular (IM) injection on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}]}, {'type': 'Vaccinated', 'comment': 'Participants who had received at least 1 dose of the study vaccine.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '286'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was conducted at 3 centers in 2 countries between 08 April 2019 to 18 March 2022.', 'preAssignmentDetails': 'A total of 290 participants who met all the inclusion criteria were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MenACYW Conjugate Vaccine', 'description': 'Participants received a single dose of meningococcal polysaccharide \\[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\\] 0.5 mL IM injection on Day 0.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '6.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '188', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '290', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants with data in case report form (CRF) consisted of all study participants with CRF, i.e with data in the clinical database.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-14', 'size': 681917, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-07T09:20', 'hasProtocol': True}, {'date': '2022-11-30', 'size': 325587, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-07T09:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2019-03-08', 'resultsFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-07', 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, W, and Y', 'timeFrame': 'Day 30 post-dose', 'description': 'Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA. Seroprotection rate is defined as percentage of participants with rSBA titer \\>=1.8 who received MenACYW conjugate vaccine. Percentages are rounded off to the tenth decimal place.'}, {'measure': 'Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA', 'timeFrame': 'Day 30 post-dose', 'description': 'Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers.'}, {'measure': 'Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA)', 'timeFrame': 'Day 30 post-dose', 'description': 'Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid', 'timeFrame': 'Pre-dose Day 0 and Day 30 post-dose', 'description': 'Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.'}, {'measure': 'Percentage of Participants Who Achieved Seroprotective Levels', 'timeFrame': 'Pre-dose Day 0 and Day 30 post-dose', 'description': 'Seroprotective levels defined as antibody titers \\>= 0.01 IU/mL and \\>= 0.1 IU/mL of antibody concentrations to tetanus toxoid. Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by ECL assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human IgG conjugate. Percentages are rounded off to the tenth decimal place.'}, {'measure': 'Number of Participants With Unsolicited Systemic Adverse Events (AEs)', 'timeFrame': 'Within 30 minutes post-dose', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions \\[i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination\\].'}, {'measure': 'Number of Participants With Solicited Injection Site Reactions and Systemic Reactions', 'timeFrame': 'Up to 7 days post-dose', 'description': 'All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection site reaction is an AR at and around the injection site. Injection site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site.'}, {'measure': 'Number of Participants With Unsolicited Non-Serious Adverse Events', 'timeFrame': 'Up to Day 30 post-dose', 'description': 'An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination).'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 up to end of study, approximately 44 days', 'description': 'A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers (Meningococcal Infection)']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are:\n\n* To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine\n* To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hSBA) before and after a single dose of MenACYW conjugate vaccine\n* To describe the antibody responses against tetanus toxoid at baseline and after a single dose of MenACYW conjugate vaccine\n* To describe the safety profile of a single dose of MenACYW conjugate vaccine', 'detailedDescription': 'Study duration per participant is approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '56 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n* Aged ≥ 56 years on the day of inclusion\n* Informed consent form has been signed and dated\n* Able to attend all scheduled visits and to comply with all trial procedures\n* Intending to go on a Hajj or Umrah pilgrimage (but not within the next 10 to 12 months after vaccination)\n\nExclusion criteria:\n\n* Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination (to be considered of non-childbearing potential, a female must be 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 prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.\n* Any previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y).\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).\n* Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances .\n* Personal history of Guillain-Barre syndrome (GBS).\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 thrombocytopenia, contraindicating intramuscular vaccination, in the Investigator's opinion.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.\n* 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 (eg, human immunodeficiency virus \\[HIV\\], hepatitis B, hepatitis C) 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 investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C). 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.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03869866', 'acronym': 'MEQ00063', 'briefTitle': 'Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older', 'orgStudyIdInfo': {'id': 'MEQ00063'}, 'secondaryIdInfos': [{'id': 'U1111-1183-6163', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MenACYW conjugate vaccine', 'description': 'MenACYW conjugate single injection at Day 0', 'interventionNames': ['Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine']}], 'interventions': [{'name': 'Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['MenQuadfi®'], 'description': 'Pharmaceutical form: Solution for injection Route of administration: Intramuscular', 'armGroupLabels': ['MenACYW conjugate vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11-0236', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Investigational Site Number : 4220001', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '06590', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Investigational Site Number : 7920002', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06800', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Investigational Site Number : 7920001', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], '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'}}}}