Booster and Catch-up Vaccination With Vaccine GSK1024850A
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK1024850A; Pneumococcal vaccine GSK1024850A
Intervention description: Intramuscular injection, administered as a single dose; Intramuscular injection, 3 doses
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: 282.0
Sex: All
Minimum age: 9 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Catch-up vaccination; Safety; Pneumococcal vaccine; Pneumococcal disease; Booster vaccination; Immunogenicity

Summary:

      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a
      booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18
      months of age in children primed in primary study NCT00814710.

      This study also aims to assess the persistence of antibodies induced following primary
      vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to
      booster vaccination and following vaccination in the present study at approximately 24 months
      of age.

      The study is also designed to evaluate the immunogenicity, safety and reactogenicity of
      pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the
      second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects for whom the investigator believes that their parent(s)/
             guardian(s) can and will comply with the requirements of the protocol.

          -  Written, signed or thumb-printed informed consent obtained from the
             parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate,
             the consent form will be countersigned by a witness.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        For primed subjects:

          -  Completion of the full vaccination course in study NCT00814710.

          -  9-18 months of age at the time of randomization.

          -  Group A: 9-18 months of age at the time of booster vaccination.

          -  Group B: 15-18 months of age at the time of booster vaccination.

        For unprimed subjects (Group C):

          -  Enrolled in study NCT00814710.

          -  12-18 months of age at the time of first vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product within 30 days preceding the
             vaccination, 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.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to vaccination.

          -  Administration of immunoglobulins and/or any blood products within three months
             preceding the vaccination or planned administration during the study period.

          -  Administration of any pneumococcal vaccine since the end of study NCT00814710.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of reactions or allergic disease likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.