Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02842866
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older
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'}, '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 non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination).', 'description': 'An 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 which included participants who had received at least 1 dose of the study vaccine and have any safety data available.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.', 'otherNumAtRisk': 448, 'deathsNumAtRisk': 448, 'otherNumAffected': 182, 'seriousNumAtRisk': 448, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Group 2: Menomune® Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.', 'otherNumAtRisk': 453, 'deathsNumAtRisk': 453, 'otherNumAffected': 121, 'seriousNumAtRisk': 453, 'deathsNumAffected': 2, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 113, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 66, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 100, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 69, 'numAffected': 69}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 66, 'numAffected': 66}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis Relapsing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Biliary Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Escherichia Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Localised Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Multiple Fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pelvic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal Column Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Foot Deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Joint Contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Invasive Lobular Breast Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung Cancer Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression Suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Benign Prostatic Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Menomune® Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '58.2', 'groupId': 'OG000', 'lowerLimit': '53.4', 'upperLimit': '62.9'}, {'value': '42.5', 'groupId': 'OG001', 'lowerLimit': '37.7', 'upperLimit': '47.3'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '81.0'}, {'value': '49.7', 'groupId': 'OG001', 'lowerLimit': '44.8', 'upperLimit': '54.5'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '70.0', 'upperLimit': '78.4'}, {'value': '43.4', 'groupId': 'OG001', 'lowerLimit': '38.7', 'upperLimit': '48.2'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000', 'lowerLimit': '57.8', 'upperLimit': '67.2'}, {'value': '44.8', 'groupId': 'OG001', 'lowerLimit': '40.0', 'upperLimit': '49.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '9.08', 'ciUpperLimit': '22.2', 'groupDescription': 'Serogroup A', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 95 percent (%) confidence internal (CI) of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was greater than (\\>) -10 percent (%) for all four serogroups.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.5', 'ciLowerLimit': '21.2', 'ciUpperLimit': '33.5', 'groupDescription': 'Serogroup C', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \\>-10% for all four serogroups.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.0', 'ciLowerLimit': '24.6', 'ciUpperLimit': '37.0', 'groupDescription': 'Serogroup Y', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \\>-10% for all four serogroups.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.8', 'ciLowerLimit': '11.2', 'ciUpperLimit': '24.2', 'groupDescription': 'Serogroup W', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \\>-10% for all four serogroups.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 (Post-vaccination)', 'description': 'Vaccine seroresponse for serogroups A, C, Y, and W was measured by serum bactericidal assay using human complement (hSBA). It was defined as post-vaccination hSBA titers ≥1:16 for participants with pre-vaccination hSBA titers less than (\\<) 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': 'Analysis was performed on per protocol analysis set which included all participants who received at least one dose of the study vaccine, had a valid post-vaccination serology result and had no protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Menomune® Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '55.1', 'groupId': 'OG000', 'lowerLimit': '46.8', 'upperLimit': '65.0'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '26.9', 'upperLimit': '36.7'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000', 'lowerLimit': '83.8', 'upperLimit': '123'}, {'value': '24.7', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '29.5'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '81.4'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '25.3'}]}]}, {'title': 'Serogroup W', 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '33.3'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '18.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '1.40', 'ciUpperLimit': '2.20', 'groupDescription': 'Serogroup A', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.10', 'ciLowerLimit': '3.16', 'ciUpperLimit': '5.33', 'groupDescription': 'Serogroup C', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.30', 'ciLowerLimit': '2.57', 'ciUpperLimit': '4.23', 'groupDescription': 'Serogroup Y', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '1.42', 'ciUpperLimit': '2.31', 'groupDescription': 'Serogroup W', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 (Post-vaccination)', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA method.', 'unitOfMeasure': 'titers (1/dilutions)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on per-protocol analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, adult participants aged greater than equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine on Day 0.'}, {'id': 'FG001', 'title': 'Group 2: Menomune® Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Serogroups A, C, Y, and W-135 Combined (Menomune®) Vaccine on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '451'}, {'groupId': 'FG001', 'numSubjects': '455'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '453'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}, {'groupId': 'FG001', 'numSubjects': '452'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study was conducted from 15-July-2016 to 13-February-2017 at 35 sites in the United States and Puerto Rico.', 'preAssignmentDetails': 'Total 907 participants were enrolled in the study, out of which 906 were randomized. 1 participant was not randomized to either of the 2 treatment groups; this participant was not vaccinated and did not provide blood samples, therefore not counted in any analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'BG000'}, {'value': '455', 'groupId': 'BG001'}, {'value': '906', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.'}, {'id': 'BG001', 'title': 'Group 2: Menomune® Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '7.51', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '7.53', 'groupId': 'BG001'}, {'value': '67.1', 'spread': '7.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', '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': '54', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '389', 'groupId': 'BG000'}, {'value': '404', 'groupId': 'BG001'}, {'value': '793', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-20', 'size': 12419891, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-05T12:08', 'hasProtocol': True}, {'date': '2016-07-07', 'size': 504542, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-05T12:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 907}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2018-02-06', 'completionDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2016-07-15', 'dispFirstSubmitQcDate': '2018-02-06', 'resultsFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2016-07-20', 'dispFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-05', 'studyFirstPostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine', 'timeFrame': 'Day 30 (Post-vaccination)', 'description': 'Vaccine seroresponse for serogroups A, C, Y, and W was measured by serum bactericidal assay using human complement (hSBA). It was defined as post-vaccination hSBA titers ≥1:16 for participants with pre-vaccination hSBA titers less than (\\<) 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': 'Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine', 'timeFrame': 'Day 30 (Post-vaccination)', 'description': 'GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meningitis', 'Meningococcal Meningitis', 'Meningococcal Infections', 'MenACYW conjugate vaccine', 'Menomune® - A/C/Y/W-135'], 'conditions': ['Meningitis', 'Meningococcal Meningitis', 'Meningococcal Infections']}, 'referencesModule': {'references': [{'pmid': '32387012', 'type': 'RESULT', 'citation': 'Esteves-Jaramillo A, Koehler T, Jeanfreau R, Neveu D, Jordanov E, Singh Dhingra M. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in >/=56-year-olds: A Phase III randomized study. Vaccine. 2020 Jun 9;38(28):4405-4411. doi: 10.1016/j.vaccine.2020.04.067. Epub 2020 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to demonstrate non-inferiority of immunogenicity and evaluate the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid conjugate vaccine (MenACYW conjugate vaccine) compared to a single dose of Meningococcal Polysaccharide Vaccine Serogroups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in adults 56 years of age and older in the United States.\n\nPrimary objective:\n\n-To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine compared to those observed following the administration of a single dose of Menomune® - A/C/Y/W-135.\n\nSecondary objective:\n\n-To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of Menomune® - A/C/Y/W-135.\n\nObservational objectives:\n\n* To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 in a subset of 100 participants per treatment group.\n* To describe the safety profile of MenACYW conjugate vaccine compared to that of the licensed Menomune® - A/C/Y/W-135 after a single administration.', 'detailedDescription': 'Participants were randomized in a 1:1 ratio to receive a single dose of MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 on Day 0 (Visit 1).\n\nParticipants underwent immunogenicity assessment at baseline (pre-vaccination) and at 30 to 44 days post-vaccination and were also evaluated for safety up to Day 180 post-vaccination.'}, '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 had been signed and dated.\n* Attended all scheduled visits and complied with all trial procedures.\n\nExclusion Criteria:\n\n* Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female must be 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) preceded the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at least 2 weeks before or after study vaccine. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines.\n* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine).\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 latex or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.\n* 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, in the Investigator's opinion.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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, 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 \\[F\\]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided.\n* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.\n* Identified as 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': 'NCT02842866', 'briefTitle': 'Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults Age 56 Years and Older', 'orgStudyIdInfo': {'id': 'MET49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: MenACYW Conjugate Vaccine', 'description': 'Healthy, adult participants aged greater than or equal to (≥) 56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.', 'interventionNames': ['Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Menomune® Vaccine', 'description': 'Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.', 'interventionNames': ['Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined']}], '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 (IM), single dose on Day 0.', 'armGroupLabels': ['Group 1: MenACYW Conjugate Vaccine']}, {'name': 'Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined', 'type': 'BIOLOGICAL', 'otherNames': ['Menomune® - A/C/Y/W-135'], 'description': '0.5 mL, Subcutaneous (SC), single dose on Day 0.', 'armGroupLabels': ['Group 2: Menomune® Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32081', 'city': 'Ponte Vedra', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.22746, 'lon': -81.38008}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21075', 'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '13760', 'city': 'Endwell', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.11285, 'lon': -76.02103}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97527', 'city': 'Grants Pass', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 42.43933, 'lon': -123.33067}}, {'zip': '18012', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29646', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, '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'}}}}