Status:
COMPLETED
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Tetanus
Diphtheria
Eligibility:
All Genders
4-6 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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 Diphtheria, tetanus and acellular pertussis (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 intra muscular vaccination.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
1045 Patients enrolled
Trial Details
Trial ID
NCT00467519
Start Date
April 1 2007
End Date
December 1 2009
Last Update
February 7 2014
Active Locations (43)
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1
Birmingham, Alabama, United States, 35205
2
Birmingham, Alabama, United States, 35244
3
Fayetteville, Arkansas, United States, 72703
4
Jonesboro, Arkansas, United States, 72401