Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™
Condition: Infections, Streptococcal; Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK 1024850A; Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
Intervention description: One dose of vaccine will be injected intramuscularly into the deltoid.; One dose of vaccine will be injected intramuscularly into the deltoid.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 46 Months
Maximum age: 50 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Haemophilus influenzae; Streptococcus pneumoniae; safety; Pneumococcal conjugate vaccine; immunogenicity

Summary:

      The aim of this study is to assess the immune response, safety and reactogenicity following
      administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4
      years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or
      Prevenar™ vaccine within the first 6 months of life and a booster dose of plain
      polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

      Antibody persistence will also be assessed at approximately 4 years of age in children
      previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a
      booster dose of Pneumovax 23™.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      4. The objectives & outcome measures of the primary phase are presented in a separate
      protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are
      presented in a separate protocol posting (NCT 00333450).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between, and including, 46-50 months of age at the time of vaccination.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  Subjects who previously participated in study NCT00333450 in centres with more than 2
             subjects and received a booster dose of Pneumovax 23™.

          -  Written informed consent obtained from both parents/guardians of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the vaccination, or planned use during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the vaccination.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting one month before study vaccination and during the entire
             study period.

          -  Administration of any pneumococcal vaccine since the end of study NCT00333450.

          -  Administration of immunoglobulins and/or any blood products less than 3 months prior
             to the vaccination or planned use during the study period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical

          -  History of any neurologic disorders or seizures

          -  Anaphylactic reaction following previous administration of the vaccine or history of
             reactions or allergic disease likely to be exacerbated by any component of the
             vaccine.

          -  History of hypotonic-hyporesponsive episode after any previous vaccination.

          -  Major congenital defects or serious chronic illness.

          -  History of invasive pneumococcal diseases.

          -  Acute disease at the time of vaccination

          -  Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A
             temperature greater than or equal to these cut-offs warrants deferral of the
             vaccination pending recovery of the subject.