Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Condition: Tetanus; Diphtheria; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis); DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Intervention description: 0.5 mL, IM; 0.5 mL, IM
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1045.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL

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.