Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A); Wyeth-Lederle's Prevenar™; GSK Biologicals' Hiberix™
Intervention description: Intramuscular injection, administered as a single dose; Intramuscular injection, administered as a single dose; Intramuscular injection, administered as a single dose
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: Single (Participant)
Enrollment: 450.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Pneumococcal vaccine; Immunogenicity; Pneumococcal disease; Booster vaccination

Summary:

      The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a
      booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix
      at 12-18 months of age, in children primed with the same vaccines in primary study
      NCT00680914.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female between, and including, 12-18 months of age at the time of booster
             vaccination.

          -  Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and
             will comply with the requirements of the protocol.

          -  Subjects who received three doses of pneumococcal conjugate vaccine in study
             NCT00680914.

          -  Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.

          -  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 (drug or vaccine) 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 (pharmaceutical product or device).

          -  Chronic administration (defined as more than 14 days) 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 and/or Hib vaccine since the end of study
             NCT00680914.

          -  Planned administration/administration of a vaccine not allowed by the study protocol
             during the period starting 1 month (30 days) before the administration of the booster
             dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the
             exception of vaccines included in the Korean routine immunization which can be given
             at least one week before the administration of the study vaccines or after study end.

          -  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 vaccines.

          -  Known hypersensitivity to any component of the study vaccines including anaphylactic
             reactions following the administration of the study vaccines.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A
             temperature greater than or equal to these cut-offs warrants deferral of the
             vaccination pending recovery of the subject.

          -  Acute disease at the time of enrolment.