Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
Condition: Acellular Pertussis; Tetanus; Diphtheria
MeSH terms: Diphtheria
Intervention: Taking of blood samples; Boostrix; Adacel
Intervention description: No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.; A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.; A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1954.0
Sex: All
Minimum age: 28 Years
Maximum age: 73 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Persistence; immunogenicity

Summary:

      The purpose of this study is to evaluate the persistence of antibodies against all the
      vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, 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 = NCT00346073).
    

Eligibility criteria:

        Inclusion Criteria:

        • Persistence follow-up phase up to Year 9 time point:

        The following criteria are applicable to subjects who refuse vaccination at Year 8 time
        point:

        All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will
        be considered eligible to participate in this study.

        Written informed consent must be obtained from the subject prior to each study time point.

        Vaccination phase at Year 9 applicable for subjects in Boostrix and Adacel groups only:

        The following criterion is applicable to subjects willing to consent to vaccination at Year
        9 time point in the Boostrix and Adacel groups:

        • All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073
        will be considered eligible to participate in this study.

        Vaccination phase at Year 9 applicable for subjects in the Control group only:

        The following criterion is applicable to subjects willing to consent to vaccination at Year
        9 time point in the Control group only:

        • Subjects within the age range of 28-73 years will be considered eligible to participate
        in this study in the Control group.

        Vaccination phase at Year 9 applicable for ALL subjects (Control, Boostrix and Adacel
        groups):

        The following criteria are applicable to subjects willing to consent to vaccination at Year
        9 time point in the Boostrix, Adacel and Control groups:

        All subjects must satisfy the following criteria at study entry at Year 9 time point:

        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 visits).

        Written informed consent obtained from the subject for vaccination at Year 9 time point.

        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 child bearing 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 for 1 month after completion of the
                  vaccine dose

        Exclusion Criteria:

        The following criteria should be checked at the time of Year 9 vaccination time point. If
        any criteria is applicable, the subject must not be vaccinated in the study:

        For subjects in Boostrix and Adacel groups:

        • Administration of Tdap vaccine since the last dose received in the study NCT00346073.

        For subjects in the Control group:

        • Administration of Tdap (Boostrix or Adacel) vaccine at any time prior to the
        administration of Boostrix vaccine in this study.

        For ALL subjects (Control, Boostrix and Adacel groups):

        Use of any investigational or non-registered product other than the study vaccine within 30
        days preceding the dose of study vaccine, or planned use during the study period, 31 days
        (Day 0-30).

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within six months prior to Visit 6 (pre-vacc). 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 30 days after the dose of vaccine,
             with the exception of inactivated Influenza vaccine which is allowed throughout the
             study period, 31 days (Day 0-30).

             -- 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.

          -  Hypersensitivity to latex.

          -  History of diphtheria, tetanus or pertussis diseases.

          -  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.

          -  History of any neurological disorders or seizures.

          -  Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of
             unknown etiology occurring within seven days following previous vaccination with
             pertussis-containing vaccine.

          -  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 ≥ 100.4°F by any 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 three months
             preceding the dose of study vaccine or planned administration during the study period,
             31 days (Day 0-30).

        Administration of any tetanus or diphtheria containing vaccine or any registered or
        investigational vaccine utilizing a diphtheria toxoid or tetanus toxoid carrier within 5
        years prior to the administration of Boostrix vaccine in this study.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions during the 31 day (Day 0-30) follow-up period post-vaccination.