Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-03 @ 6:10 AM
Study NCT ID:
NCT00539032
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2007-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunology and Safety of Menactra® in Children in Saudi Arabia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '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 for up to 28 days post-vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Menactra® Booster Group', 'description': 'Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.', 'otherNumAtRisk': 151, 'otherNumAffected': 32, 'seriousNumAtRisk': 151, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group 2: Menactra® Primary Vaccine (Control) Group', 'description': 'Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.', 'otherNumAtRisk': 85, 'otherNumAffected': 15, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Postoperative wound infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Menactra® Booster Group', 'description': 'Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.'}, {'id': 'OG001', 'title': 'Group 2: Menactra® Primary Vaccine (Control) Group', 'description': 'Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Erythema', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Erythema (≥ 5 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling (≥ 5 cm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic Reaction', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (> 39.0 ºC)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0-7 Post-vaccination', 'description': 'Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Menactra® Booster Group', 'description': 'Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.'}, {'id': 'OG001', 'title': 'Group 2: Menactra® Primary Vaccine (Control) Group', 'description': 'Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.'}], 'classes': [{'title': 'Serogroup A: Pre-vaccination', 'categories': [{'measurements': [{'value': '168.9', 'groupId': 'OG000', 'lowerLimit': '117.4', 'upperLimit': '243.1'}, {'value': '196.4', 'groupId': 'OG001', 'lowerLimit': '119.0', 'upperLimit': '324.0'}]}]}, {'title': 'Serogroup A: Day 28 Post-vaccination', 'categories': [{'measurements': [{'value': '6991.7', 'groupId': 'OG000', 'lowerLimit': '6107.6', 'upperLimit': '8003.8'}, {'value': '8263.3', 'groupId': 'OG001', 'lowerLimit': '6913.1', 'upperLimit': '9877.2'}]}]}, {'title': 'Serogroup C: Pre-vaccination', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '3.0'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '5.9'}]}]}, {'title': 'Serogroup C: Day 28 Post-vaccination', 'categories': [{'measurements': [{'value': '167.2', 'groupId': 'OG000', 'lowerLimit': '115.3', 'upperLimit': '242.7'}, {'value': '512.0', 'groupId': 'OG001', 'lowerLimit': '334.4', 'upperLimit': '761.2'}]}]}, {'title': 'Serogroup Y: Pre-vaccination', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '15.2'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '21.6'}]}]}, {'title': 'Serogroup Y: Day 28 Post-vaccination', 'categories': [{'measurements': [{'value': '2120.2', 'groupId': 'OG000', 'lowerLimit': '1799.0', 'upperLimit': '2498.9'}, {'value': '2558.3', 'groupId': 'OG001', 'lowerLimit': '2015.5', 'upperLimit': '3247.3'}]}]}, {'title': 'Serogroup W-135: Pre-vaccination', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '3.8'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.5'}]}]}, {'title': 'Serogroup W-135: Day 28 Post-vaccination', 'categories': [{'measurements': [{'value': '2387.7', 'groupId': 'OG000', 'lowerLimit': '1950.1', 'upperLimit': '2923.5'}, {'value': '2763.2', 'groupId': 'OG001', 'lowerLimit': '2153.9', 'upperLimit': '3544.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers by serum bactericidal assay were determined in the per-protocol population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Menactra® Booster Group', 'description': 'Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.'}, {'id': 'OG001', 'title': 'Group 2: Menactra® Primary Vaccine (Control) Group', 'description': 'Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.'}], 'classes': [{'title': 'Serogroup A', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup C', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup Y', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup W-135', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 Post-vaccination', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': '4-Fold rise in Menactra® vaccine antibodies were evaluated in the per-protocol population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Menactra® Booster Group', 'description': 'Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.'}, {'id': 'FG001', 'title': 'Group 2: Menactra® Primary Vaccine (Control) Group', 'description': 'Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 30 September to 03 November 2007, at 4 health centers in Saudi Arabia.', 'preAssignmentDetails': 'A total of 238 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Menactra® Booster Group', 'description': 'Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.'}, {'id': 'BG001', 'title': 'Group 2: Menactra® Primary Vaccine (Control) Group', 'description': 'Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'spread': '0.60', 'groupId': 'BG000'}, {'value': '6.52', 'spread': '1.22', 'groupId': 'BG001'}, {'value': '6.26', 'spread': '0.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}], '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': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2007-10-02', 'resultsFirstSubmitDate': '2009-09-09', 'studyFirstSubmitQcDate': '2007-10-02', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-22', 'studyFirstPostDateStruct': {'date': '2007-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®', 'timeFrame': 'Days 0-7 Post-vaccination', 'description': 'Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.'}], 'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.', 'timeFrame': 'Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination'}, {'measure': 'Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.', 'timeFrame': 'Day 28 Post-vaccination'}]}, 'conditionsModule': {'keywords': ['N. meningitidis', 'Meningitis', 'Meningococcemia'], 'conditions': ['Meningitis', 'Meningococcemia']}, 'referencesModule': {'references': [{'pmid': '22855388', 'type': 'DERIVED', 'citation': 'Khalil M, Al-Mazrou Y, Findlow H, Chadha H, Bosch Castells V, Johnson DR, Borrow R. Safety and immunogenicity of a meningococcal quadrivalent conjugate vaccine in five- to eight-year-old Saudi Arabian children previously vaccinated with two doses of a meningococcal quadrivalent polysaccharide vaccine. Clin Vaccine Immunol. 2012 Oct;19(10):1561-6. doi: 10.1128/CVI.00260-12. Epub 2012 Aug 1.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (Control Group). This study will evaluate the administration of Menactra® in terms of the serum bactericidal antibody it induces in the two study groups. Safety of Menactra® vaccine will be described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Healthy, as determined by medical history and physical examination.\n* Aged between 5 to 8 years on the day of inclusion (from 5th birthday to 1 day before 9th birthday inclusive).\n* For the Booster Group , two doses of a quadrivalent (A, C, Y, W-135) meningococcal polysaccharide vaccine received before age 2 years\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\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 a 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 trial 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 trial vaccination, or scheduled to receive any vaccination during the 14-day period after trial vaccination.\n* Previous history of documented invasive meningococcal disease.\n* For the Control Group, previous history of any meningococcal vaccination.\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.'}, 'identificationModule': {'nctId': 'NCT00539032', 'briefTitle': 'Immunology and Safety of Menactra® in Children in Saudi Arabia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Evaluation of the Response to a Single Dose of Menactra® in Children Aged 5 to 8 Years Who Had Previously Received Two Doses of Quadrivalent (A, C, Y, W-135) Meningococcal Polysaccharide Vaccine Before Age 2 Years in Saudi Arabia', 'orgStudyIdInfo': {'id': 'MTA47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Menactra® Booster Group', 'description': 'Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.', 'interventionNames': ['Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Menactra® Primary Vaccine (Control) Group', 'description': 'Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.', 'interventionNames': ['Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate']}], 'interventions': [{'name': 'Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra® Vaccine'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group 1: Menactra® Booster Group']}, {'name': 'Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra® Vaccine'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group 2: Menactra® Primary Vaccine (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'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}