Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diphtheria

Pertussis

Tetanus

Treatments

Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)

Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00467519

TD517

Details and patient eligibility

About

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.

Enrollment

1,045 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.