Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK1024850A (Synflorix); Prevenar; GSK Biologicals' Hiberix™
Intervention description: 3 doses administered intramuscularly.; 3 doses administered intramuscularly.; 3 doses administered intramuscularly.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 503.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus pneumoniae; pneumococcal conjugate vaccine

Summary:

      The purposes of this study are:

      To demonstrate the immunogenicity in terms of antibody response following primary vaccination
      of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™
      when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during
      the first 6 months of life.

      To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and
      serious adverse events following primary vaccination of Korean infants with the pneumococcal
      conjugate vaccine GSK 1024850A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between, and including 6-12 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 and signed informed consent obtained from the parent(s)/guardian(s) of the
             child/ward.

          -  Free of any known or suspected health problems as established by medical history and
             clinical examination before entering into the study.

          -  Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at
             least 2.5 kilogram.

        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.

          -  Planned administration/administration of a vaccine not allowed by the study protocol
             during the study period. Vaccines included in the Korean routine immunization schedule
             can be administered at least one week before or at least one month after the
             administration of the study vaccines. Recommended live vaccines not included in the
             Korean routine immunization schedule can be given at least one month before or at
             least one month after the administration of the study vaccines.

          -  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 Streptococcus pneumoniae and/or Haemophilus influenzae
             type b.

          -  History of, or intercurrent Streptococcus pneumoniae and/or 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.