Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults
Condition: Tetanus; Acellular Pertussis; Diphtheria
MeSH terms: Diphtheria
Intervention: Boostrix
Intervention description: Single dose intramuscular administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 19 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Booster; Tdap; Immunogenicity; Repeat dose; Safety; BoostrixTM; Persistence

Summary:

      The purpose of this follow-up study is to evaluate the persistence of antibodies against all
      the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to
      assess immunogenicity and safety of another dose of Boostrix, administered in this study.
      This protocol posting deals with objectives and outcome measures of the extension phase. The
      objectives and outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00109330).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol (e.g. completion of the diary cards, return for follow-up
             visit).

          -  Subjects who have received a dose of Tdap or Td vaccines 10 years (+/-300 days) back,
             in study NCT00109330.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,
                  hysterectomy, ovariectomy or post-menopause.

          -  Female subjects of childbearing potential may be enrolled in the study, if the subject

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 1 month after completion of the vaccine dose.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the dose of study vaccine, or planned use
             during the study period.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within six months prior to the booster vaccine dose .
             For corticosteroids, this will mean prednisone (≥ 20 mg/day (for adult subjects), or
             equivalent. Inhaled and topical steroids are allowed.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before and ending 31 days after the dose of vaccine,
             with the exception of Influenza vaccine which is allowed throughout the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational vaccine/product (pharmaceutical product or device).

          -  Previous vaccination against diphtheria, tetanus or pertussis since the last dose
             received in the Study NCT00109330.

          -  History of diphtheria, tetanus or pertussis diseases following the receipt of booster
             dose in the Study NCT00109330.

          -  Severe allergic reaction (e.g. anaphylaxis) after previous administration of any
             tetanus toxoid, diphtheria toxoid, or pertussis-antigen containing vaccines, or any
             component of Boostrix.

          -  Hypersensitivity to latex.

          -  Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of
             unknown etiology occurring within 7 days following previous vaccination with
             pertussis-containing vaccine.

          -  History of any neurological disorders or seizures.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥ 99.5°F for oral, axillary or tympanic route, or
                  ≥ 100.4°F for rectal route. The preferred route for recording temperature in this
                  study will be oral.

               -  Subjects with a minor illness (such as mild diarrhea, mild upper respiratory
                  infection) without fever may, be enrolled at the discretion of the investigator.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the booster dose of study vaccine or planned administration during the study
             period.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions up to 1 month post-vaccination.