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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00539032 |
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 their serum bactericidal antibody and total and serogroup-specific antibody responses for the two study groups. Safety of Menactra vaccine will be described
Condition | Intervention | Phase |
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Meningitis Meningococcemia |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 225 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Control group got same intervention
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Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM
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Ages Eligible for Study: | 5 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Responsible Party: | Sanofi Pasteur, Inc. ( Medical Monitor ) |
Study ID Numbers: | MTA47 |
Study First Received: | October 2, 2007 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00539032 |
Health Authority: | Saudi Arabia: Ministry of Health |
N. meningitidis Meningitis Meningococcemia |
Meningococcemia Central Nervous System Infections Central Nervous System Diseases Neisseria meningitidis Meningitis |
Nervous System Diseases |