Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
NCT ID: NCT00467519
Last Updated: 2014-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1045 participants
INTERVENTIONAL
2007-04-30
2009-12-31
Brief Summary
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Primary Objective:
\- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1
DAPTACEL primed participants
Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
0.5 mL, IM
Group 2
Pentacel primed participants
DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM
Interventions
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Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
0.5 mL, IM
DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
6 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Huntington Beach, California, United States
Oakland, California, United States
Roseville, California, United States
Sacramento, California, United States
Norwich, Connecticut, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Bardstown, Kentucky, United States
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Bossier City, Louisiana, United States
Frederick, Maryland, United States
Bellevue, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Rochester, New York, United States
Fargo, North Dakota, United States
Cleveland, Ohio, United States
Gresham, Oregon, United States
Erie, Pennsylvania, United States
Norristown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Rydal, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Kingsport, Tennessee, United States
Tullahoma, Tennessee, United States
San Antonio, Texas, United States
Layton, Utah, United States
Springville, Utah, United States
Chesapeake, Virginia, United States
Midlothian, Virginia, United States
Spokane, Washington, United States
Spokane, Washington, United States
La Crosse, Wisconsin, United States
Edmonton, Alberta, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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TD517
Identifier Type: -
Identifier Source: org_study_id
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