Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
Condition: Tetanus; Diphtheria; Pertussis; Whooping Cough
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 423.0
Sex: All
Minimum age: 11 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adacel® vaccine; Tetanus; Diphtheria; whooping cough; Pertussis; BOOSTRIX® vaccine

Summary:

      The aim of this study is to describe immunogenicity of a single booster dose of Adacel
      vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.

      Primary objective:

        -  To describe seroprotection rates against tetanus and diphtheria in subjects randomized
           to receive either Adacel or Boostrix vaccine.

      Observational objectives:

        -  To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean
           antibody concentrations (GMCs) in subjects randomized to receive either Adacel or
           Boostrix vaccine.

        -  To describe booster response rates against tetanus, diphtheria, and pertussis in
           subjects randomized to receive either Adacel or Boostrix vaccine.

        -  To describe the rates of adverse events (AEs) immediately post-vaccination, and the
           rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with
           Adacel or Boostrix vaccine from Visit 1 through Visit 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is 11 to < 13 years of age at the time of vaccination

          -  Received exactly 5 doses of pertussis vaccine at < 7 years of age

          -  Informed consent and assent forms have been signed and dated

          -  Subject is able to attend all scheduled visits and to comply with all trial
             procedures.

        Exclusion Criteria:

          -  Subject is pregnant, or lactating, or of child bearing potential without using an
             effective method of contraception or not practicing abstinence for at least 4 weeks
             prior to vaccination and until at least 4 weeks after vaccination

          -  Any condition that, in the opinion of the Investigator, would pose a health risk to
             the participant or interfere with the evaluation of the vaccine

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks) within the past 3 months)

          -  Known or suspected receipt of any whole-cell pertussis-containing vaccine

          -  A personal history of physician-diagnosed or laboratory-confirmed pertussis disease
             within the last 2 years

          -  A previous severe reaction to pertussis, diphtheria or tetanus vaccine including
             immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of
             receiving the vaccine

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

          -  Suspected or known hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing
             any of the same substances

          -  Receipt of any vaccine within 30 days before receiving study vaccine, or plans to
             receive another vaccine before the 2nd visit; except that influenza vaccine may have
             been received between 30 and 15 days (but no less than 15 days) before receiving study
             vaccine

          -  Participation in another interventional clinical trial investigating a vaccine, drug,
             medical device, or medical procedure in the 30 days preceding the first study
             vaccination or during the course of the study, at the discretion of the Sponsor

          -  Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as
             reported by the subject's parent/guardian

          -  Laboratory-confirmed thrombocytopenia, which may be a contraindication for
             intramuscular (IM) vaccination, at the discretion of the Investigator

          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
             which may be a contraindication for IM vaccination, at the discretion of the
             Investigator

          -  Personal history of Guillain-Barré syndrome

          -  Moderate or severe acute illness/infection (according to Investigator judgment) or
             febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. (A
             prospective subject should not be enrolled in the study until the condition has
             resolved or the febrile event has subsided.)

          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol or drug use that, in the opinion of the Investigator, might interfere
             with the ability to comply with trial procedures.