Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00444951
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2007-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, '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 event data were collected from Day 0 to 1 month post-vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Menactra® Group', 'description': 'Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \\[serogroups A, C, Y, W-135\\] polysaccharide diphtheria toxoid conjugate) vaccine.', 'otherNumAtRisk': 144, 'otherNumAffected': 85, 'seriousNumAtRisk': 144, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Mencevax® Group', 'description': 'Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.', 'otherNumAtRisk': 141, 'otherNumAffected': 66, 'seriousNumAtRisk': 141, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.', 'otherNumAtRisk': 160, 'otherNumAffected': 95, 'seriousNumAtRisk': 160, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 66, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 95, 'numAffected': 95}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 66, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 60, 'numAffected': 60}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 61, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 55, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 61, 'numAffected': 61}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 60, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 138, 'numEvents': 55, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 72, 'numAffected': 72}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Perianal abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group', 'description': 'Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \\[serogroups A, C, Y, W-135\\] polysaccharide diphtheria toxoid conjugate) vaccine.'}, {'id': 'OG001', 'title': 'Mencevax® Group', 'description': 'Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.'}], 'classes': [{'title': 'Serogroup A (Baseline)', 'categories': [{'measurements': [{'value': '651.5', 'groupId': 'OG000', 'lowerLimit': '496.4', 'upperLimit': '854.9'}, {'value': '889.7', 'groupId': 'OG001', 'lowerLimit': '699.5', 'upperLimit': '1131.5'}, {'value': '441.1', 'groupId': 'OG002', 'lowerLimit': '327.8', 'upperLimit': '593.4'}]}]}, {'title': 'Serogroup A (Day 28)', 'categories': [{'measurements': [{'value': '4116.3', 'groupId': 'OG000', 'lowerLimit': '3468.7', 'upperLimit': '4884.9'}, {'value': '3833.4', 'groupId': 'OG001', 'lowerLimit': '3308.4', 'upperLimit': '4441.7'}, {'value': '6351.6', 'groupId': 'OG002', 'lowerLimit': '5508.3', 'upperLimit': '7324.0'}]}]}, {'title': 'Serogroup C (Baseline)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '22.0'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '23.8'}, {'value': '16.8', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '25.4'}]}]}, {'title': 'Serogroup C (Day 28)', 'categories': [{'measurements': [{'value': '288.3', 'groupId': 'OG000', 'lowerLimit': '190.2', 'upperLimit': '437.0'}, {'value': '158.6', 'groupId': 'OG001', 'lowerLimit': '99.7', 'upperLimit': '252.0'}, {'value': '993.4', 'groupId': 'OG002', 'lowerLimit': '714.5', 'upperLimit': '1381.2'}]}]}, {'title': 'Serogroup Y (Baseline)', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000', 'lowerLimit': '49.7', 'upperLimit': '125.0'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '120.7'}, {'value': '16.8', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '25.3'}]}]}, {'title': 'Serogroup Y (Day 28)', 'categories': [{'measurements': [{'value': '2770.1', 'groupId': 'OG000', 'lowerLimit': '2197.0', 'upperLimit': '3492.6'}, {'value': '1936.3', 'groupId': 'OG001', 'lowerLimit': '1425.7', 'upperLimit': '2629.8'}, {'value': '4204.6', 'groupId': 'OG002', 'lowerLimit': '3458.2', 'upperLimit': '5112.0'}]}]}, {'title': 'Serogroup W-135 (Baseline)', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '29.0'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '39.6'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '11.8'}]}]}, {'title': 'Serogroup W-135 (Day 28)', 'categories': [{'measurements': [{'value': '2435.5', 'groupId': 'OG000', 'lowerLimit': '1714.7', 'upperLimit': '3459.3'}, {'value': '1455.7', 'groupId': 'OG001', 'lowerLimit': '958.1', 'upperLimit': '2211.7'}, {'value': '6926.7', 'groupId': 'OG002', 'lowerLimit': '5647.9', 'upperLimit': '8495.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 0) and Day 28 after vaccination', 'unitOfMeasure': 'Titers (1/dil)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were evaluated in participants who received vaccine injection (full analysis set population).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group', 'description': 'Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \\[serogroups A, C, Y, W-135\\] polysaccharide diphtheria toxoid conjugate) vaccine.'}, {'id': 'OG001', 'title': 'Mencevax® Group', 'description': 'Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'Serogroup W-135', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) and Day 28 After Vaccination', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': '4-Fold rise titers were determined in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Menactra® Group', 'description': 'Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \\[serogroups A, C, Y, W-135\\] polysaccharide diphtheria toxoid conjugate) vaccine.'}, {'id': 'OG001', 'title': 'Mencevax® Group', 'description': 'Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}, {'title': 'Any Injection Site Pain', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Injection Site Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Any Injection Site Erythema', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Injection Site Erythema (≥ 5 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Injection Site Swelling', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Injection Site Swelling (≥ 5 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Any Solicited Systemic Reaction', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever (> 39.0 ºC)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activities)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Malaise (Prevents daily activities)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Myalgia (Prevents daily activities)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 7 Post-vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all vaccinated participants, intend-to-treat population (Safety analysis set)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menactra® Group', 'description': 'Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \\[serogroups A, C, Y, W-135\\] polysaccharide diphtheria toxoid conjugate) vaccine.'}, {'id': 'FG001', 'title': 'Mencevax® Group', 'description': 'Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '142'}, {'groupId': 'FG002', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 17 February 2007, to 01 July 2007, in 7 clinic centers in Saudi Arabia.', 'preAssignmentDetails': 'A total of 450 participants who met the inclusion and exclusion criteria were enrolled, and 446 were vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '450', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Menactra® Group', 'description': 'Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal \\[serogroups A, C, Y, W-135\\] polysaccharide diphtheria toxoid conjugate) vaccine.'}, {'id': 'BG001', 'title': 'Mencevax® Group', 'description': 'Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '91', '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': '17.90', 'spread': '1.20', 'groupId': 'BG000'}, {'value': '17.77', 'spread': '1.15', 'groupId': 'BG001'}, {'value': '17.85', 'spread': '1.15', 'groupId': 'BG002'}, {'value': '17.84', 'spread': '1.16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '241', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '450', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, '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': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-16', 'studyFirstSubmitDate': '2007-03-07', 'resultsFirstSubmitDate': '2011-02-09', 'studyFirstSubmitQcDate': '2007-03-07', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-09', 'studyFirstPostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination', 'timeFrame': 'Baseline (Day 0) and Day 28 after vaccination'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination', 'timeFrame': 'Baseline (Day 0) and Day 28 After Vaccination'}, {'measure': 'Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination', 'timeFrame': 'Day 0 to Day 7 Post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['N meningitidis'], 'conditions': ['Neisseria Meningitidis', 'Meningococcal Infections']}, 'referencesModule': {'references': [{'pmid': '25151042', 'type': 'BACKGROUND', 'citation': 'Khalil M, Al-Mazrou Y, Findlow H, Chadha H, Bosch Castells V, Oster P, Borrow R. Meningococcal serogroup C serum and salivary antibody responses to meningococcal quadrivalent conjugate vaccine in Saudi Arabian adolescents previously vaccinated with bivalent and quadrivalent meningococcal polysaccharide vaccine. Vaccine. 2014 Sep 29;32(43):5715-21. doi: 10.1016/j.vaccine.2014.08.026. Epub 2014 Aug 20.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, as determined by medical history and physical examination.\n* Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive).\n* For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment.\n* For the Control group, no previous history of any meningococcal vaccination.\n* Informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old\n* Able to provide a vaccination log or has available vaccination record in the Health Center\n* Able to attend all scheduled visits and to comply with all trial procedures\n\nExclusion Criteria:\n\n* Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)\n* Known or suspected impairment of immunologic function.\n* Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 37.5°C at the time of inclusion.\n* Administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \\< 7 days may be included in the trial provided that they have not received more than one course within the last two weeks prior to enrollment.\n* Oral or injected antibiotic therapy within the 72 hours prior to vaccination\n* Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.\n* Previous history of documented invasive meningococcal disease.\n* Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances\n* Participation in another clinical trial in the 4 weeks preceding the trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine.\n* Personal or family history of Guillain Barré syndrome.\n* For female, known or suspected to be pregnant at the time of inclusion'}, 'identificationModule': {'nctId': 'NCT00444951', 'briefTitle': 'Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Evaluation of the Response to a Single Dose of Menactra® in Adolescents Aged 16 to 19 Years Who Previously Received One Dose of Quadrivalent (A, C, Y, W 135) and at Least One Dose of Bivalent (A, C) Meningococcal Polysaccharide Vaccine in Saudi Arabia.', 'orgStudyIdInfo': {'id': 'MTA40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menactra® group', 'description': 'Have received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Menactra® (Meningococcal \\[serogroups A, C, Y, W-135\\] polysaccharide diphtheria toxoid conjugate) vaccine.', 'interventionNames': ['Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Mencevax® group', 'description': 'Have received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.', 'interventionNames': ['Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Participants have not previously received any meningococcal vaccine, will receive a booster dose of Menactra® (Meningococcal \\[serogroups A, C, Y, W-135\\] polysaccharide diphtheria toxoid conjugate) vaccine.', 'interventionNames': ['Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine']}], 'interventions': [{'name': 'Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Menactra® group']}, {'name': 'Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Mencevax®'], 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['Mencevax® group']}, {'name': 'Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'AlKhaleej', 'state': 'Al-Qassim Region', 'country': 'Saudi Arabia'}, {'city': 'AlRabwa', 'state': 'Al-Qassim Region', 'country': 'Saudi Arabia'}, {'city': 'S. Buraida', 'state': 'Al-Qassim Region', 'country': 'Saudi Arabia'}, {'city': 'Safra-Al Midhnab', 'state': 'Al-Qassim Region', 'country': 'Saudi Arabia'}, {'city': 'Helal Ahmar', 'state': 'Mecca Region', 'country': 'Saudi Arabia'}, {'city': 'Iskan', 'state': 'Mecca Region', 'country': 'Saudi Arabia'}, {'city': 'Mecca', 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'geoPoint': {'lat': 21.42664, 'lon': 39.82563}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}