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Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
This study is currently recruiting participants.
Verified by Sanofi-Aventis, November 2008
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00467519
  Purpose

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:

  • To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.
  • To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up.
  • To describe the safety profile following vaccine administration.

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

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough
Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine Tetanus Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning immune response to Tdap after booster vaccination. [ Time Frame: 1 Month post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of Tdap after vaccination [ Time Frame: 180 Days Post-vaccination ] [ Designated as safety issue: Yes ]

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
2: Experimental Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Healthy, as determined by medical history and physical examination.
  • Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0.
  • Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.
  • Signed and dated informed assent form from the subject if required by the IRB.
  • Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.
  • Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for DTaP.

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the original trial period.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
  • Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the past 3 months.
  • Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine).
  • History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically).
  • Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467519

Contacts
Contact: Public Registry RegistryContactUs@sanofipasteur.com

Locations
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
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

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

Keywords provided by Sanofi-Aventis:
Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 15, 2009