Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK1024850A; Pneumococcal conjugate vaccine GSK1024850A
Intervention description: Intramuscular injection, 1 dose; Intramuscular injection, 2 doses
Intervention MeSH terms: Vaccines; 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: 172.0
Sex: All
Minimum age: 36 Months
Maximum age: 46 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccine; Pneumococcal disease; Safety; Immunogenicity

Summary:

      The purpose of this study is to assess the immune memory induced by primary and booster
      vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through
      evaluation of the immune responses following vaccination with a booster dose of pneumococcal
      conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses
      following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in
      age-matched unprimed children.

      The study also aims to assess the antibody persistence in the fourth year of life following
      primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first
      year of life.

      The study is also designed to evaluate the immunogenicity in terms of antibody response and
      the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse
      events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the
      fourth year of life.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = 00307034)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between, and including, +- 36-46 months of age at the time of
             vaccination.

          -  For primed subjects: having completed the full vaccination course with GSK1024850A in
             the primary study (NCT00307034).

          -  Subjects for whom the investigator believes that their parent(s)/guardian(s) can and
             will comply with the requirements of the protocol.

          -  Written informed consent obtained from the parent(s)/guardian(s) 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 product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of the study vaccines, or
             planned use during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within 6 months prior to vaccination.

          -  For primed subjects: administration of any pneumococcal vaccine since the end of the
             primary study (NCT00307034).

          -  For unprimed subjects: previous vaccination with any pneumococcal vaccine.

          -  Administration of immunoglobulins and/or any blood products less than 6 months prior
             to the vaccination or planned administration during the study period.

          -  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 study vaccine.

          -  Acute disease at the time of enrolment.