Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK1024850A; DTPa
Intervention description: Intramuscular injection, 4 doses; Subcutaneous injection, 4 doses
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 360.0
Sex: All
Minimum age: 90 Days
Maximum age: 118 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal disease; Immunogenicity; Booster vaccination; Pneumococcal vaccine; Primary vaccination; Safety

Summary:

      This study will aim to evaluate the immunogenicity, safety and reactogenicity of
      GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when
      co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy
      Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of
      age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator/co-investigator believes that their parent(s)/Legally
             Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the
             protocol.

          -  A male or female between, and including, 90 and 118 days of age (3 months) at the time
             of the first vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

        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 study vaccine(s), or planned
             use during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before the first dose of study vaccine(s) and
             ending on the last study visit, with the exception of Haemophilus influenzae type b
             vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine,
             Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.

          -  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).

          -  Administration of any pneumococcal vaccine since birth except for the DTPa group for
             whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be
             allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e.
             from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the
             booster dose of the DTPa vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of, or intercurrent diphtheria, tetanus, pertussis disease.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study vaccines.

          -  Major congenital defects or serious chronic illness.

          -  History of any seizures or progressive neurological disease.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Child in care.

          -  Acute disease and/or fever at the time of enrolment.