Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
Condition: Tetanus; Diphtheria; Pertussis; Whooping Cough
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine; Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1330.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adacel vaccine; Tetanus; Diphtheria; whooping cough

Summary:

      The purpose of this study is to describe the safety and immunogenicity of repeat
      administration of Adacel vaccine approximately 10 years following initial administration of
      the vaccine. Antibody levels prior to revaccination will also be used to characterize
      antibody persistence following initial vaccination 10 years earlier.

      Primary Objectives:

        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine
           to those induced by Td Adsorbed vaccine.

        -  To compare booster response rates against tetanus and diphtheria induced by Adacel
           vaccine to those induced by Td Adsorbed vaccine.

        -  To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by
           Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants.

      Secondary Objectives:

        -  To describe the rates of immediate reactions, solicited reactions, unsolicited adverse
           events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td
           Adsorbed vaccine.

        -  To describe booster response rates for pertussis antigens following revaccination with
           Adacel vaccine.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subject is ≥ 18 to < 65 years of age at the time of vaccination.

          -  Received Adacel vaccine no less than 9 and no more than 11 years previously.

          -  Informed consent form has 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. Females who are
             pre-menarche or post-menopausal for at least one year, or surgically sterile will not
             be excluded.

          -  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 tetanus toxoid (T), tetanus and diphtheria toxoids (Td),
             or tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine since receipt
             of the qualifying dose of Adacel vaccine described in Inclusion Criterion #2.

          -  A personal history of physician-diagnosed or laboratory-confirmed pertussis disease
             within the last 10 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.

          -  Laboratory-confirmed thrombocytopenia, which may be a contraindication for 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 intramuscular (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.