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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00467519 |
Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose.
Primary Objective:
- To compare the immune responses of Tdap Vaccine to DTaP vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.
Secondary/Observational Objectives:
Condition | Intervention | Phase |
---|---|---|
Tetanus Diphtheria Pertussis |
Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 1000 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
0.5 mL, IM
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2: Experimental |
Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM
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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 :
Contact: Public Registry | RegistryContactUs@sanofipasteur.com |
United States, Arkansas | |
Recruiting | |
Little Rock, Arkansas, United States, 72205 | |
Recruiting | |
Jonesboro, Arkansas, United States, 72401 | |
United States, California | |
Recruiting | |
Fountain Valley, California, United States, 92708 | |
United States, Georgia | |
Recruiting | |
Marietta, Georgia, United States, 30062 | |
Recruiting | |
Woodstock, Georgia, United States, 30189 | |
United States, Louisiana | |
Recruiting | |
Bossier City, Louisiana, United States, 71111 | |
United States, Maryland | |
Recruiting | |
Frederick, Maryland, United States, 21702 | |
United States, Nebraska | |
Recruiting | |
Omaha, Nebraska, United States, 68132 | |
Recruiting | |
Omaha, Nebraska, United States, 68131 | |
Recruiting | |
Bellevue, Nebraska, United States, 68123 | |
United States, New York | |
Recruiting | |
Rochester, New York, United States, 14618 | |
United States, Pennsylvania | |
Recruiting | |
Pittsburgh, Pennsylvania, United States, 15241 | |
Recruiting | |
Norristown, Pennsylvania, United States, 19401 | |
Recruiting | |
Rydal, Pennsylvania, United States, 19046 | |
Recruiting | |
Uniontown, Pennsylvania, United States, 15401 | |
Recruiting | |
Pittsburgh, Pennsylvania, United States, 15236 | |
Recruiting | |
Erie, Pennsylvania, United States, 16505 | |
United States, Tennessee | |
Recruiting | |
Kingsport, Tennessee, United States, 37660 | |
Recruiting | |
Tullahoma, Tennessee, United States, 37388 | |
United States, Utah | |
Recruiting | |
Layton, Utah, United States, 84041 | |
United States, Virginia | |
Recruiting | |
Midlothian, Virginia, United States, 23113 | |
United States, Washington | |
Recruiting | |
Spokane, Washington, United States, 99202 |
Study Director: | Clinical Trials | sanofi pasteur |
Responsible Party: | Sanofi Pasteur Inc ( Medical Monitor ) |
Study ID Numbers: | TD517 |
Study First Received: | April 27, 2007 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00467519 |
Health Authority: | United States: Food and Drug Administration |
Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL |
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 |