Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: PoliorixTM
Intervention description: Single dose, intramuscular administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Poliomyelitis Vaccines; IPV

Summary:

      The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster
      dose to Chinese children at 18-24 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female toddler between, and including, 18 and 24 months of age at the time
             of the booster vaccination.

          -  Subjects who received three doses of OPV as primary vaccination in the first year of
             life as per Chinese recommendations.

          -  Subjects who the investigator believes that their parents/ guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        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 vaccination

          -  Administration of a vaccine not foreseen by the study protocol within 30 days prior to
             vaccination, or planned administration during the study period, with exception of DTP
             and/or Hib vaccine(s).

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the booster vaccination, or planned administration during 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 product

          -  Previous booster vaccination against poliomyelitis since the end of the primary
             vaccination series.

          -  History of poliomyelitis disease.

          -  History of seizures or progressive neurological disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  Major congenital defects or serious chronic illness.

        The following condition is temporary or self-limiting and a subject may be vaccinated once
        the condition has resolved and no other exclusion criteria are met:

        • Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe
        illness within 24 hours of study vaccine administration.