Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK1024850A
Intervention description: 1 or 2 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: 466.0
Sex: All
Minimum age: 31 Months
Maximum age: 44 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Catch-up vaccination; Pneumococcal vaccine; Immune memory; Nasopharyngeal carriage; Immunogenicity; Pneumococcal disease; Safety

Summary:

      The objective of this study is to evaluate the immune memory through the administration of an
      additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody
      persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H.
      influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate
      vaccine GSK1024850A in previous primary and booster studies. For subjects that did not
      receive the investigational vaccine during the primary and booster study, the objective is to
      evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK
      Biologicals' pneumococcal conjugate vaccine GSK1024850A.

      This protocol posting deals with objectives & outcome measures of the extension phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT00370318). The objectives & outcome measures of the booster phase are presented
      in a separate protocol posting (NCT00496015).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/ guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  A male or female between, and including, 31 and 34 months of age at the time of the
             enrolment.

          -  Subjects who previously participated in study NCT00496015

          -  For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a
             booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.

          -  For the subjects in the unprimed group: subjects who received a dose of the
             meningococcal vaccine GSK134612.

          -  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 product (drug or vaccine) other than the
             study vaccine within 30 days preceding enrolment, or planned use during the entire
             study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs during the entire study period.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before each dose of study vaccine and ending
             30 days after.

          -  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 (pharmaceutical product or device).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  History of seizures or progressive neurological disease.

          -  Acute disease at the time of enrolment, defined as the presence of a mild, moderate or
             severe illness with or without fever.

          -  Administration or planned use of immunoglobulins and/ or any blood products during the
             entire study period.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Major congenital defects or serious chronic illness.

          -  Subjects of which both parents have a history of atopia (polinosis, asthma, atopic
             eczema).

          -  Administration of any pneumococcal vaccine since the end of study NCT00496015.