Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
Condition: Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Intervention: ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed; BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Intervention description: 0.5 mL, IM; 0.5 mL, IM
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 647.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tetanus; diphtheria; acellular pertussis

Summary:

      This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and
      BOOSTRIX® vaccines among US adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 11 - 18 years of age at the time of vaccination in this trial

          -  Signed Institutional Review Board (IRB)-approved informed assent / consent form.

          -  Able to attend all scheduled visits and to comply with all trial procedures.

          -  For a female, negative serum/urine pregnancy test.

        Exclusion Criteria:

          -  Any condition which, in the opinion of the investigator, would pose a health risk to
             the participant or interfere with the evaluation of the vaccine.

          -  Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic,
             psychiatric etc) that is unstable or that might:

               -  interfere with the ability to participate fully in the study; or

               -  interfere with evaluation of the vaccine.

          -  Known or suspected impairment of immunologic function.

          -  Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at
             the time of inclusion.

          -  History of documented tetanus, diphtheria or pertussis disease within the preceding 5
             years.

          -  Known or suspected receipt of a tetanus or diphtheria-containing vaccine within the
             preceding 2 years.

          -  Known or suspected receipt of a pertussis-containing vaccine within the preceding 5
             years.

          -  Administration of immune globulin or other blood products within the last three
             months, or injected or oral corticosteroids or other therapy expected to materially
             alter immune function within six weeks of the study vaccine. Individuals on a tapering
             dose schedule of oral steroids lasting less than 7 days may be included in the trial
             as long as they have not received more than one course within the last two weeks prior
             to enrollment.

          -  Received any vaccine in the 21-day period prior to enrollment or scheduled to receive
             any vaccination after enrollment and prior to visit 2.

          -  Suspected or known hypersensitivity to any of the vaccine components or to latex.