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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00269477 |
Purpose
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02. In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis Meningococcal Infection |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Persistence of Bactericidal Antibodies in Adolescents and Adults Aged 15 to 23 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier |
| Enrollment: | 239 |
| Study Start Date: | December 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM
|
| 2: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM
|
| 3: Active Comparator |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM
|
| 4: Active Comparator |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM
|
Eligibility| Ages Eligible for Study: | 15 Years to 23 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| Marietta, Georgia, United States, 30062 | |
| United States, Massachusetts | |
| Woburn, Massachusetts, United States, 01801 | |
| United States, Ohio | |
| Akron, Ohio, United States, 44308 | |
| Columbus, Ohio, United States, 43205 | |
| United States, Pennsylvania | |
| Sellersville, Pennsylvania, United States, 18960 | |
| United States, Tennessee | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Virginia | |
| Norfolk, Virginia, United States, 23510 | |
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
More Information
| Responsible Party: | Sanofi Pasteur Inc ( Medical Monitor ) |
| Study ID Numbers: | MTA35 |
| Study First Received: | December 22, 2005 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00269477 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Meningitis Meningococcal infection Neisseria meningitidis Menactra® Menomune® |
|
Bacterial Infections Communicable Diseases Central Nervous System Infections Meningococcal Infections Nervous System Diseases |
Central Nervous System Diseases Infection Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |