Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
Condition: Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Intervention: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®); Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
Intervention description: 0.5 ml, IM; 0.5 mL, IM
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 769.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pertussis; Tetanus; Diphtheria; Acellular pertussis; ADACEL®,; Tdap vaccine

Summary:

      The purpose of this study is to collect additional immunogenicity and safety data on
      re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health
      need to establish broader population immunity against pertussis, as well as diphtheria and
      tetanus.

      Primary Objective:

        -  To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805.

          -  Never previously received Tdap vaccine and has not received any tetanus-, diphtheria ,
             or pertussis-containing vaccine in the past 10 years.

          -  Participated in TD9707 or TD9805 but does not meet inclusion/ exclusion criteria or
             willing to undergo phlebotomy but not willing to receive Tdap (ADACEL®) vaccine.

          -  Signed Institutional Review Board (IRB)-approved informed consent form

          -  Able to attend all scheduled visits and to comply with all trial procedures

          -  For a woman, a negative urine pregnancy test and the use of effective method(s) of
             contraception, or the inability to become pregnant

        Exclusion Criteria :

          -  Any condition listed as a contraindication in the ADACEL® Canadian product monograph

          -  Any condition which, in the opinion of the investigator, would pose a health risk to
             the subject or interfere with the evaluation of the vaccine

          -  Chronic illness, at a stage that could interfere with trial conduct or completion, in
             the opinion of the investigator

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
             or long-term systemic (injected or oral) corticosteroid therapy. 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 1 course within the last 2 weeks
             prior to enrollment

          -  Febrile illness (temperature ≥ 37.5°C [99.5°F]) at the time of inclusion

          -  History of documented diphtheria, pertussis, or tetanus disease since participation in
             studies TD9707 or TD9805. Or history of documented diphtheria, pertussis, or tetanus
             disease in the last 10 years.

          -  Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine
             since participation in study TD9707 or TD9805. For Group 2, known or suspected receipt
             of a diphtheria-, pertussis-, or tetanus-containing vaccine in the last 10 years.

          -  Receipt of any vaccine, other than influenza vaccine, in the 28-day period prior to
             Visit 1 or scheduled to receive any vaccine, other than influenza vaccine, in the
             period between Visit 1 and Visit 2. For influenza vaccine only, defer if received in
             the 14 days prior to enrollment or scheduled to receive prior to Visit 2.

          -  Receipt of blood or blood-derived products in the past 3 months

          -  Suspected or known hypersensitivity to any of the vaccine components, or a
             life-threatening reaction after previous administration of the vaccine or a vaccine
             containing the same substances

          -  Unable to attend the scheduled visits or to comply with the study procedures

          -  In females of childbearing potential, known pregnancy or positive serum/urine
             pregnancy test

          -  Breast-feeding woman

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or a medical procedure in the 4 weeks preceding enrollment. Planned participation in
             another clinical trial during the present trial period

          -  Current alcohol or recreational drug use that may interfere with the subject's ability
             to comply with trial procedures

          -  Thrombocytopenia, bleeding disorder, anticoagulation therapy contraindicating
             intramuscular (IM) vaccination

          -  Subject deprived of freedom by an administrative or court order, or in an emergency
             setting, or hospitalized without his/her consent.

          -  Other events which in the judgment of the investigator would preclude vaccination at
             the time of Visit 1 For Group 3

          -  History of documented diphtheria, pertussis, or tetanus disease since participation in
             study TD9707 or TD9805

          -  Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine
             since participation in study TD9707 or TD9805.