Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: GSK Biologicals' Synflorix™; GSK Biologicals' Polio Sabin™; GSK Biologicals' Zilbrix™ Hib
Intervention description: 3 IM doses.; 3 oral doses; 3 IM doses.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pneumococcal conjugate vaccine; Streptococcus pneumoniae

Summary:

      The purpose of this study is to assess the immunogenicity in terms of antibody response and
      the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse
      events following primary vaccination of African Sub-Saharan infants with pneumococcal
      conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell
      pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4
      months of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between, and including 6-10 weeks of age at the time of the
             first vaccination.

          -  Subjects for whom the investigator believes that their parent(s)/guardian(s) can and
             will comply with the requirements of the protocol should be enrolled in the study.

          -  Written or oral, signed or thumb-printed informed consent obtained from the
             parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate,
             the consent form will be countersigned by a witness.

          -  Free of any known or suspected health problems (as established by medical history and
             clinical examination before entering into the study), that would contraindicate the
             initiation of routine immunizations outside a clinical trial context.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of the study vaccines, or
             planned use 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 (pharmaceutical product or device).

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period (Hepatitis B immunoglobulins at birth are
             allowed).

          -  Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae
             type b and/or Streptococcus pneumoniae.

          -  History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus
             and Haemophilus influenzae type b disease.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of any neurological disorders or seizures.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrolment. Study entry should be delayed until the
             illness has improved.

          -  Babies for which birth weight is < 2 kilogram (if known) at Visit 1