Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Synflorix; Infanrix Hexa; Havrix
Intervention description: Intramuscular injection, 1 or 2 doses; 1 Intramuscular injection; 1 Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 163.0
Sex: All
Minimum age: 18 Months
Maximum age: 21 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Pneumococcal disease; Safety; Booster vaccination; Pneumococcal vaccine

Summary:

      This is a booster study in 2 groups of healthy children less than 3 years old to measure the
      reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine,
      when given as a booster or as a two-dose catch-up vaccination.

      This protocol posting deals with objectives and outcome measures of the booster phase. The
      objectives and outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00338351).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between, and including, 18-21 months of age at the time of vaccination.

          -  Subjects who previously participated in the primary study and received 3 doses of
             study or control vaccines during the primary study.

          -  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.

        Exclusion Criteria:

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned
             use during the study period (active phase and extended safety follow-up).

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting one month (30 days) before the booster doses of vaccine(s)
             and during the active phase of the study (up to the follow-up visit (Visit 3)).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of seizures (subjects who have had a single, uncomplicated febrile convulsion
             in the past can be included) or progressive neurological disease.

          -  Acute disease at the time of enrolment.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within 6 months prior to the booster doses of study vaccines.

          -  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 within the last 3 months
             prior to booster or follow-up vaccination or planned administration during the active
             phase of the study.