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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00258856 |
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.
Condition | Intervention | Phase |
Meningitis Meningococcal Infection |
Biological: Polysaccharide Diphtheria Conjugate Vaccine |
Phase II |
MedlinePlus related topics: | Diphtheria Meningitis |
ChemIDplus related topics: | Meningococcal Vaccines |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier |
Enrollment: | 487 |
Study Start Date: | January 2006 |
Study Completion Date: | November 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, I.M.
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2: Experimental |
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, I.M.
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3: Experimental |
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, I.M.
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4: Experimental |
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, I.M.
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Ages Eligible for Study: | 7 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |||||
Jonesboro, Arkansas, United States, 72401 | |||||
Little Rock, Arkansas, United States, 72205 | |||||
United States, Georgia | |||||
Marietta, Georgia, United States, 30062 | |||||
United States, Maryland | |||||
Baltimore, Maryland, United States, 21201-1559 | |||||
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, Utah | |||||
Salt Lake City, Utah, United States, 84123 | |||||
United States, Virginia | |||||
Norfolk, Virginia, United States, 23510 |
Sanofi-Aventis |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Related Info 
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Related Info 
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Responsible Party: | Sanofi Pasteur, Inc. ( Medical Monitor ) |
Study ID Numbers: | MTA23 |
First Received: | November 24, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00258856 |
Health Authority: | United States: Food and Drug Administration |
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