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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00444951 |
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® compared with Mencevax® in terms of their serum bactericidal antibody and total and serogroup-specific salivary IgG and IgA antibody responses.
Condition | Intervention | Phase |
Neisseria Meningitidis Meningococcal Infections |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Biological: Group A, C, W135 and Y polysaccharide meningococcal vaccine |
Phase III |
MedlinePlus related topics: | Diphtheria |
Drug Information available for: | Meningococcal Vaccines |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 429 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Menactra® group: Have received previously a dose of an A, C, Y, W 135 and at least one dose of an A, C meningococcal polysaccharide vaccine
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Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
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2: Experimental
Mencevax® group: Have received previously a dose of an A, C, Y, W 135 and at least one dose of an A, C meningococcal polysaccharide vaccine
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Biological: Group A, C, W135 and Y polysaccharide meningococcal vaccine
0.5 mL, Subcutaneous
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3: Experimental
Control group: Have not previously received any meningococcal vaccine
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Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
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Ages Eligible for Study: | 16 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Related Info 
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Related Info 
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Responsible Party: | Sanofi pasteur Inc ( Mecdical Monitor ) |
Study ID Numbers: | MTA40 |
First Received: | March 7, 2007 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00444951 |
Health Authority: | Saudi Arabia: Ministry of Health |
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