Evaluation of Boostrix™10 Years After Previous Booster Vaccination
Condition: Acellular Pertussis; Tetanus; Diphtheria
MeSH terms: Diphtheria
Intervention: Boostrix™; Boostrix™-US formulation
Intervention description: Intramuscular, single dose; Intramuscular, single dose
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 28 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immune persistence; Boostrix; dTpa booster study

Summary:

      The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a
      dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa
      in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to
      participate in this study.This protocol posting deals with objectives & outcome measures of
      the booster phase. The objectives & outcome measures of the primary phase are presented in a
      separate study (see reference).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the
             investigational vaccine formulation in the study 263855/029.

          -  Written informed consent obtained from the subject. Additional criteria to be checked
             before the booster vaccination.

          -  Healthy subjects as established by medical history and clinical examination.

          -  Female subjects of non-childbearing potential may receive the booster vaccine.

          -  Female subjects of childbearing potential may receive the booster vaccine, if the
             subject:

               -  practices/has practiced adequate contraception for 30 days prior to vaccination,
                  and

               -  has a negative pregnancy test on the day of vaccination, and

               -  agrees to continue adequate contraception during the entire booster epoch.

        Exclusion Criteria:

        Exclusion criteria to be checked at study entry:

          -  Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose
             received in the study 263855/029.

          -  History of diphtheria, tetanus, or laboratory confirmed pertussis disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on
             medical history and physical examination.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Occurrence of transient thrombocytopenia or neurological complications following an
             earlier immunisation against diphtheria and/or tetanus.

          -  Occurrence of any of the following adverse event after a previous administration of a
             DTP vaccine :

               -  hypersensitivity reaction to any component of the vaccine,

               -  encephalopathy of unknown aetiology occurring within seven days following
                  previous vaccination with pertussis-containing vaccine,

               -  fever >= 40 °C (axillary temperature) within 48 hours of vaccination not due to
                  another identifiable cause,

               -  collapse or shock-like state within 48 hours of vaccination,

               -  convulsions with or without fever, occurring within three days of vaccination.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests.

        Additional exclusion criteria to be checked for subjects before the booster vaccination
        administration:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the booster dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the booster dose.

          -  Administration of a vaccine not foreseen by the study protocol within 30 days prior to
             booster vaccination, or planned administration during the active 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 product.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the booster dose or planned administration during the study period.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.