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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00258908 |
To assess the immunogenicity profile of ADACEL (TdacP vaccine) one month after administration.
To describe the safety profile of ADACEL (TdacP vaccine) when given as a fifth dose.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Pertussis |
Biological: Diphteria, tetanus, and Acellular Pertussis vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Enrollment: | 113 |
Study Start Date: | November 2005 |
Study Completion Date: | August 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged from 6 to 8 years on the day of inclusion
Exclusion Criteria:
Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances with specific focus on subjects who had, after previous administration of DTP or DTaP vaccine, one of the following adverse events
Responsible Party: | Sanofi Pasteur, Inc. ( Medical Director ) |
Study ID Numbers: | TD521 |
Study First Received: | November 24, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00258908 |
Health Authority: | Taiwan: Department of Health |
Tetanus; Diphteria; Acellular 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 |