Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: Poliorix
Intervention description: All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 60 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: IPV

Summary:

      The study will evaluate the safety and reactogenicity of Poliorix given as primary
      vaccination course to Chinese children at 2, 3 and 4 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female infant between, and including, 60 and 90 days of age at the time of
             the first vaccination.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

          -  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(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  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,
             Hib and/or hepatitis B vaccine(s).

          -  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.

          -  Evidence of previous or intercurrent poliomyelitis disease or vaccination.

          -  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 vaccine(s).

          -  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.