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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00772070 |
This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier.
Primary Objective:
To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.
Condition | Intervention | Phase |
---|---|---|
Meningitis Meningococcemia |
Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD |
Enrollment: | 173 |
Study Start Date: | March 2003 |
Study Completion Date: | May 2004 |
Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Previously received one dose of TetraMenD (in trial 603-02)
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Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine
0.05 mL, Subcutaneous
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2: Experimental
Meningococcal vaccine-naїve.
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Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine
0.05 mL, Subcutaneous
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This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune vaccine in Stage I and were administered a full dose of Menactra vaccine 6 months later.
Ages Eligible for Study: | 3 Years to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
United States, Arkansas | |
Little Rock, Arkansas, United States, 72211 | |
Jonesboro, Arkansas, United States, 72401 | |
United States, Massachusetts | |
Woburn, Massachusetts, United States, 01801 | |
United States, Missouri | |
Bridgeton, Missouri, United States, 63044 | |
United States, New York | |
Rochester, New York, United States, 14620 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15241 | |
Sellersville, Pennsylvania, United States, 18960 | |
United States, Virginia | |
Norfolk, Virginia, United States, 23501 |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc ( Medical Monitor ) |
Study ID Numbers: | MTA17 |
Study First Received: | October 13, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00772070 |
Health Authority: | United States: Food and Drug Administration |
Meningitis Meningococcemia Neisseria meningitidis |
Bacterial Infections Antibodies Gram-Positive Bacterial Infections Meningococcemia Central Nervous System Infections |
Central Nervous System Diseases Neisseria meningitidis Diphtheria Immunoglobulins Meningitis |
Corynebacterium Infections Nervous System Diseases Actinomycetales Infections |