Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
Condition: Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Intervention: Boostrix-Polio
Intervention description: A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 415.0
Sex: All
Minimum age: 9 Years
Maximum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; vaccine; DTP; Poliomyelitis; Pertussis; Booster; Tetanus

Summary:

      Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be
      evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will
      be evaluated in terms of immunogenicity, safety and reactogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they or their parents/guardians can and
             will comply with the requirements of the protocol should be enrolled in the study.

          -  A male or female subject who received a booster vaccination with dTpa-IPV or dTpa +
             IPV in study 711866/001.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Females of childbearing potential at the time of study entry must have a negative
             pregnancy test prior to administration of the dose of vaccine and are required to be
             abstinent or to use adequate contraceptive precautions for one month prior to
             vaccination. Subjects are required to agree to continue such precautions for two
             months after vaccination.

          -  Written informed consent obtained from both parents/ guardians of the subject; assent
             from the subject himself/herself should also be requested whenever possible.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressant 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
             vaccination, or planned administration during 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, pertussis, or poliomyelitis
             since the booster dose received in study 711866/001.

          -  History of diphtheria, tetanus, pertussis, or poliomyelitis 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 immunoglobulin 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 events (AEs) 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
             within 48 hours of vaccination

          -  Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within
             48 hours of receipt of a previous dose of DTP vaccine convulsions with or without
             fever, occurring within 3 days of vaccination.

          -  Acute disease at the time of enrolment.

          -  Pregnant or lactating female.