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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00347958 |
To provide safety data on revaccination with ADACEL® vaccine.
To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.
Condition | Intervention | Phase |
---|---|---|
Tetanus Diphtheria Pertussis |
Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Enrollment: | 545 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | October 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 15 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Serious chronic disease (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:
United States, Arkansas | |
Jonesboro, Arkansas, United States, 72401 | |
United States, Louisiana | |
Bossier City, Louisiana, United States, 71111 | |
United States, Ohio | |
University Heights, Ohio, United States, 44118 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15241 | |
Canada, British Columbia | |
Coquitlam, British Columbia, Canada, V3C 4J2 | |
Surrey, British Columbia, Canada, V3R-8P8 | |
Canada, Manitoba | |
Winnipeg, Manitoba, Canada, R3E 3P4 | |
Canada, Nova Scotia | |
Halifax, Nova Scotia, Canada, B3K-6R8 | |
Canada, Quebec | |
Beauport, Quebec, Canada, G1E 7G9 | |
Montreal, Quebec, Canada, H3H LP3 |
Study Director: | Clinical Trials | sanofi pasteur |
Responsible Party: | Sanofi Pasteur Inc ( Medical Director ) |
Study ID Numbers: | TD518 |
Study First Received: | July 3, 2006 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00347958 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Tetanus, Diphtheria, Pertussis |
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Cough Whooping Cough |
Diphtheria Clostridium Infections Tetanus Whooping cough Gram-Negative Bacterial Infections |
Bordetella Infections Corynebacterium Infections Infection Actinomycetales Infections |