Clinical trial NCT00467519: Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Official title: Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Diphtheria
Pertussis
Keywords: Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-30
Enrollment: 1045
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 and safety of this formulation as a 5th dose.

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.


Eligibility 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 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
timeFrame: Pre-dose and 30 days post-vaccination
measure: Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
timeFrame: Pre-dose and 30 days post-vaccination
measure: Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
timeFrame: 30 Days post-vaccination
measure: Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
timeFrame: 30 Days post-vaccination
measure: Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
timeFrame: Pre-dose and 30 Days Post-vaccination
Secondary outcomes:
Other outcomes:
measure: Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
timeFrame: Days 0 to 7 post-vaccination
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Fayetteville
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Oakland
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Crestview Hills
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Bossier City
country: United States
state: Louisiana
city: Frederick
country: United States
state: Maryland
city: Bellevue
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Rochester
country: United States
state: New York
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Gresham
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Rydal
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Tullahoma
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Springville
country: United States
state: Utah
city: Chesapeake
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: LaCrosse
country: United States
state: Wisconsin
city: Edmonton
country: Canada
state: Alberta
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References: