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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00258895 |
Primary Objectives:
Observational Objectives:
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Pertussis |
Biological: DTaP |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 650 |
Study Start Date: | March 2005 |
Study Completion Date: | April 2007 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
DAPTACEL Primed
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Biological: DTaP
0.5 mL, Intramuscular
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2: Experimental
Pentacel Primed
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Biological: DTaP
0.5 mL, Intramuscular
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Ages Eligible for Study: | 4 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc ( Medical Director ) |
Study ID Numbers: | P3T11 |
Study First Received: | November 24, 2005 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00258895 |
Health Authority: | United States: Food and Drug Administration |
DAPTACEL® Pentacel™ Diphtheria Tetanus |
Pertussis Whooping cough Acellular Pertussis Vaccine Adsorbed |
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 |