Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.
Condition: Acellular Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Boostrix TM
Intervention description: Single booster dose of vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 20 Years
Maximum age: 24 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dTpa vaccine; pertussis; Tdap; Boostrix; booster; tetanus; diphtheria

Summary:

      The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in
      adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only
      subjects who received booster vaccination in the previous clinical study are eligible for
      participation in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004.

          -  A male or female subject, recruited 10 years after booster vaccination in study
             263855/004.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  If the subject is female, she must be of non-childbearing potential, or, if of
             childbearing potential, she must use adequate contraception for 30 days prior to
             vaccination and continue for 2 months after completion of the vaccination series.

          -  Written informed consent obtained from the subject.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             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.

          -  Previous booster vaccination against tetanus, diphtheria or pertussis since the last
             dose received in study 263855/004.

          -  History of documented diphtheria, tetanus, or pertussis diseases.

          -  Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on
             medical history and physical examination.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the booster dose or planned administration during the study period.

          -  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 7 days following previous
                  vaccination with pertussis-containing vaccine,

               -  fever >= 40°C within 48 hours of vaccination not due to another identifiable
                  cause,

               -  collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48
                  hours of vaccination,

               -  convulsions with or without fever, occurring within 3 days of vaccination.

          -  Acute disease at the time of enrolment.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions within 2 months after completion of the vaccination series.