Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Synflorix; Infanrix IPV/Hib
Intervention description: 1, 2, 3 or 4 Intramuscular injections, depending on age group; 4 intramuscular injections
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 9 Weeks
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Booster vaccination; Catch-up vaccination; Pneumococcal vaccine; Immunogenicity; Safety; Pneumococcal disease

Summary:

      The purpose of this phase IIIb study is to determine whether children who have not received a
      3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of
      age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity,
      safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be
      evaluated for four different age groups with different schedules:

      < 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age
      group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose
      vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no
      booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between, and including

               -  9-12 weeks of age at the time of first vaccination for the <6 Mo group.

               -  7-11 months of age at the time of first vaccination for the 7-11 Mo group.

               -  12-23 months of age at the time of first vaccination for the 12-23 Mo group.

               -  24 months to 5 years at the time of first vaccination for the >= 24 Mo group.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Born after a gestation period between 36 and 42 weeks.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the first dose of study vaccine, or planned use
             during the entire study period for each age-group.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting one month before and ending one month after each dose of
             vaccine(s).

          -  Previous vaccination against S. pneumoniae.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of seizures (this criterion does not apply to subjects who have had a single,
             uncomplicated febrile convulsion in the past) or neurological disease.

          -  Acute disease at the time of enrolment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination

          -  A family history of congenital or hereditary immunodeficiency.

          -  Major congenital defects or serious chronic illness.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the entire study period.