Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT01086969
Status:
COMPLETED
Last Update Posted:
2012-02-06
First Post:
2010-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D016920', 'term': 'Meningitis, Bacterial'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020806', 'term': 'Central Nervous System 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': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': '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': 'Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Age 2 to 11 Years Group', 'description': 'Participants at age 2 to 11 years on enrollment.', 'otherNumAtRisk': 100, 'otherNumAffected': 30, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Age 12 to 17 Years Group', 'description': 'Participants aged 12 to 17 years at enrollment.', 'otherNumAtRisk': 100, 'otherNumAffected': 23, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Age 18 to 55 Years Group', 'description': 'Participants aged 18 to 55 years at enrollment', 'otherNumAtRisk': 100, 'otherNumAffected': 38, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 2 to 11 Years Group', 'description': 'Participants at age 2 to 11 years on enrollment.'}, {'id': 'OG001', 'title': 'Age 12 to 17 Years Group', 'description': 'Participants aged 12 to 17 years at enrollment.'}, {'id': 'OG002', 'title': 'Age 18 to 55 Years Group', 'description': 'Participants aged 18 to 55 years at enrollment'}], 'classes': [{'title': 'Serogroup A (Pre-vaccination; N= 100, 100, 100)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '23', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup A (Post-vaccination; N= 99, 97, 98)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup C (Pre-vaccination; N= 100, 100, 100)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '66', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup C (Post-vaccination; N= 99, 98, 100)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup Y (Pre-vaccination; N= 100, 100, 100)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup Y (Post-vaccination; N= 99, 97, 98)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '98', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup W-135 (Pre-vaccination; N=100, 100, 100)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '52', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup W-135 (Post-vaccination; N= 99, 97, 99)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 21 days post-vaccination', 'description': 'Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Menactra vaccine antibody titers were determined in the immunogenicity analysis set.'}, {'type': 'PRIMARY', 'title': 'Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 2 to 11 Years Group', 'description': 'Participants at age 2 to 11 years on enrollment.'}, {'id': 'OG001', 'title': 'Age 12 to 17 Years Group', 'description': 'Participants aged 12 to 17 years at enrollment.'}, {'id': 'OG002', 'title': 'Age 18 to 55 Years Group', 'description': 'Participants aged 18 to 55 years at enrollment'}], 'classes': [{'title': 'Serogroup A (Pre-vaccination; N= 100, 100, 100)', 'categories': [{'measurements': [{'value': '9.51', 'groupId': 'OG000', 'lowerLimit': '6.43', 'upperLimit': '14.1'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '9.65', 'upperLimit': '23.4'}, {'value': '9.78', 'groupId': 'OG002', 'lowerLimit': '6.90', 'upperLimit': '13.9'}]}]}, {'title': 'Serogroup A (Post-vaccination; N= 99, 97, 98)', 'categories': [{'measurements': [{'value': '1145', 'groupId': 'OG000', 'lowerLimit': '854', 'upperLimit': '1536'}, {'value': '1324', 'groupId': 'OG001', 'lowerLimit': '1002', 'upperLimit': '1750'}, {'value': '2261', 'groupId': 'OG002', 'lowerLimit': '1749', 'upperLimit': '2924'}]}]}, {'title': 'Serogroup C (Pre-vaccination; N= 100, 100, 100)', 'categories': [{'measurements': [{'value': '9.92', 'groupId': 'OG000', 'lowerLimit': '7.01', 'upperLimit': '14.0'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '26.2'}, {'value': '56.9', 'groupId': 'OG002', 'lowerLimit': '36.6', 'upperLimit': '88.3'}]}]}, {'title': 'Serogroup C (Post-vaccination; N= 99, 98, 100)', 'categories': [{'measurements': [{'value': '610', 'groupId': 'OG000', 'lowerLimit': '392', 'upperLimit': '949'}, {'value': '2343', 'groupId': 'OG001', 'lowerLimit': '1563', 'upperLimit': '3512'}, {'value': '7486', 'groupId': 'OG002', 'lowerLimit': '5380', 'upperLimit': '10417'}]}]}, {'title': 'Serogroup Y (Pre-vaccination; N= 100, 100, 100)', 'categories': [{'measurements': [{'value': '355', 'groupId': 'OG000', 'lowerLimit': '256', 'upperLimit': '491'}, {'value': '309', 'groupId': 'OG001', 'lowerLimit': '222', 'upperLimit': '430'}, {'value': '156', 'groupId': 'OG002', 'lowerLimit': '110', 'upperLimit': '222'}]}]}, {'title': 'Serogroup Y (Post-vaccination; N= 99, 97, 98)', 'categories': [{'measurements': [{'value': '1964', 'groupId': 'OG000', 'lowerLimit': '1607', 'upperLimit': '2399'}, {'value': '3190', 'groupId': 'OG001', 'lowerLimit': '2502', 'upperLimit': '4067'}, {'value': '3926', 'groupId': 'OG002', 'lowerLimit': '2855', 'upperLimit': '5398'}]}]}, {'title': 'Serogroup W-135 (Pre-vaccination; N=100, 100, 100)', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '47.7'}, {'value': '47.8', 'groupId': 'OG001', 'lowerLimit': '32.3', 'upperLimit': '70.9'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '44.1'}]}]}, {'title': 'Serogroup W-135 (Post-vaccination; N= 99, 97, 99)', 'categories': [{'measurements': [{'value': '1756', 'groupId': 'OG000', 'lowerLimit': '1240', 'upperLimit': '2486'}, {'value': '2538', 'groupId': 'OG001', 'lowerLimit': '1947', 'upperLimit': '3307'}, {'value': '3183', 'groupId': 'OG002', 'lowerLimit': '2360', 'upperLimit': '4293'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 30 post-vaccination', 'description': 'Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.', 'unitOfMeasure': '1/dilution (1/dil)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were determined in the immunogenicity analysis set'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 2 to 11 Years Group', 'description': 'Participants at age 2 to 11 years on enrollment.'}, {'id': 'OG001', 'title': 'Age 12 to 17 Years Group', 'description': 'Participants aged 12 to 17 years at enrollment.'}, {'id': 'OG002', 'title': 'Age 18 to 55 Years Group', 'description': 'Participants aged 18 to 55 years at enrollment'}], 'classes': [{'title': 'Serogroup A (N = 99, 97, 98)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '96', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup C (N = 99, 98, 100)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '96', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup Y (N = 99, 97, 98)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Serogroup W-135 (N = 99, 97, 99)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '97', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to 30 post-vaccination', 'description': 'Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Four-fold antibody increase were determined in the immunogenicity analysis set'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 2 to 11 Years Group', 'description': 'Participants at age 2 to 11 years on enrollment.'}, {'id': 'OG001', 'title': 'Age 12 to 17 Years Group', 'description': 'Participants aged 12 to 17 years at enrollment.'}, {'id': 'OG002', 'title': 'Age 18 to 55 Years Group', 'description': 'Participants aged 18 to 55 years at enrollment'}], 'classes': [{'title': 'Any Solicited injection site pain', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '38', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 pain (Incapacitating)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Any Solicited injection site erythema', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 erythema (≥5 cm [2-11 years] or >10 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Any Solicited injection site swelling', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 swelling (≥5 cm [2-11 years] or >10 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Any Solicited fever', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 fever (≥ 39.0°C)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Any Solicited headache', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 headache (significant)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Any Solicited malaise', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 malaise (significant)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Any Solicited myalgia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 myalgia (significant)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to 7 post-vaccination', 'description': 'Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety parameters were assessed in the safety analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Age 2 to 11 Years Group', 'description': 'Participants at age 2 to 11 years on enrollment.'}, {'id': 'FG001', 'title': 'Age 12 to 17 Years Group', 'description': 'Participants aged 12 to 17 years at enrollment.'}, {'id': 'FG002', 'title': 'Age 18 to 55 Years Group', 'description': 'Participants aged 18 to 55 years at enrollment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 11 June to 01 October 2010 in 3 clinical centers in India.', 'preAssignmentDetails': 'A total of 300 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Age 2 to 11 Years Group', 'description': 'Participants at age 2 to 11 years on enrollment.'}, {'id': 'BG001', 'title': 'Age 12 to 17 Years Group', 'description': 'Participants aged 12 to 17 years at enrollment.'}, {'id': 'BG002', 'title': 'Age 18 to 55 Years Group', 'description': 'Participants aged 18 to 55 years at enrollment'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '14.2', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '18.7', 'spread': '13.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-02', 'studyFirstSubmitDate': '2010-03-11', 'resultsFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2010-03-12', 'lastUpdatePostDateStruct': {'date': '2012-02-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-03', 'studyFirstPostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination', 'timeFrame': 'Baseline and 21 days post-vaccination', 'description': 'Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.'}, {'measure': 'Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination', 'timeFrame': 'Day 0 and Day 30 post-vaccination', 'description': 'Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.'}, {'measure': 'Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination', 'timeFrame': 'Day 0 to 30 post-vaccination', 'description': 'Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.'}, {'measure': 'Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination', 'timeFrame': 'Day 0 to 7 post-vaccination', 'description': 'Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meningococcal Infection', 'Meningitis, Bacterial', 'Menactra®'], 'conditions': ['Meningococcal Infection', 'Meningitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration.\n\nPrimary Objectives:\n\n* To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination.\n* To describe the safety profile of participants after one dose of Menactra®.', 'detailedDescription': 'Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Aged 2 to 11 years or Aged 12 to 17 years or Aged 18 to 55 years of age on the day of inclusion\n* For participants aged 2 to 11 years: Provision of informed consent form signed by the parent(s) or legal representative.\n* For participants aged 12 to 17 years: Provision of assent form signed by the participant and informed consent form signed by the parent(s) or legal representative.\n* For participants aged 18 to 55 years: Provision of informed consent form signed by the participant. If the participant or the participant's parents or legally accepted representative (participants aged 2 to 17 years) are illiterate, an independent witness is required to sign the consent form.\n* Participant and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures\n* For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active)\n\nExclusion Criteria :\n\n* For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active)\n* Breast-feeding woman\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy\n* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances\n* Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator\n* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures\n* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response\n* Receipt or planned receipt of any vaccine (other than influenza vaccine which can be given 2 weeks or more before vaccination) in the 4 weeks preceding or following the trial vaccination\n* Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen , or Hepatitis C seropositivity as reported by the participant/parent/guardian and/or based on medical history\n* History of documented invasive meningococcal disease\n* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine\n* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination\n* Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent\n* Personal or family history of Guillain-Barré Syndrome\n\nTemporary contraindications delaying vaccination until resolved:\n\n* Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination\n* Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw"}, 'identificationModule': {'nctId': 'NCT01086969', 'briefTitle': 'A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India', 'orgStudyIdInfo': {'id': 'MTA51'}, 'secondaryIdInfos': [{'id': 'UTN: U1111-1111-5608', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Participants in three age cohorts - Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age will be enrolled.', 'interventionNames': ['Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)']}], 'interventions': [{'name': 'Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560070', 'city': 'Bangalore', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '400022', 'city': 'Mumbai', 'country': 'India', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '110002', 'city': 'New Delhi', 'country': 'India', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur SA.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}