Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: Poliorix TM; Infanrix TM
Intervention description: Intramuscular administration, 3 doses; Intramuscular administration, 3 doses
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 3 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: poliomyelitis; diphtheria; Primary immunization; pertussis; Children; tetanus

Summary:

      The purpose of this study is to assess reactogenicity and safety of simultaneous
      administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK
      Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in
      their first year of life according to National Calendar of Prophylactic Immunisation of
      Russian Federation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  A male or female aged 3 months including at the time of the vaccination.

          -  Written informed consent obtained from the parent of the subject.

          -  Healthy subjects as established by medical history and clinical examination and
             thermometry before entering into the study, that don't have contraindications for
             vaccination against diphtheria, tetanus, pertussis and poliomyelitis

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines 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 immunosuppressants or other
             immune-modifying drugs from birth.

          -  Administration of immunoglobulins and/or any blood products from birth or planned
             administration during the study period.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of the vaccination, except recombinant hepatitis B vaccine, Haemophilus
             influenzae type B vaccine and seasonal/pandemic influenza prophylactic.

          -  Participation in another clinical study at any time during the study, in which the
             subject has been or will be exposed to an investigational or a non-registered product
             (pharmaceutical product or device).

          -  Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by
             any reasons it was made in timeframe not stated by National Calendar of Prophylactic
             Vaccines of Russian Federation.

          -  Medical history of convulsions and progressive neurological disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             physical examination (no laboratory testing required).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  Chronic diseases and serious congenital defects.

          -  Acute disease at the time of enrolment.