Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK1024850A
Intervention description: Intramuscular injection, 1 or 2 doses
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: 218.0
Sex: All
Minimum age: 15 Months
Maximum age: 21 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Booster vaccination; Pneumococcal vaccine; Catch-up vaccination; Pneumococcal disease; Safety; Immunogenicity

Summary:

      The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK
      Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster
      dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects
      previously enrolled in the primary vaccination study NCT00678301.

      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 = NCT00678301).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.

          -  A male or female, between and including 15-21 months of age at the time of visit 1.

          -  For the Pn-Pn group, subjects who completed the full vaccination course in study
             NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the
             control group of study NCT00678301.

          -  Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s)
             of the subject. Where parent(s)/LAR(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.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or
             planned use during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to vaccination.

          -  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. Locally recommended vaccines for example Oral Polio Vaccine or
             influenza vaccine are always allowed, even if concomitantly administered with the
             study vaccines, but should be documented in the CRF.

          -  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).

          -  Administration of any pneumococcal vaccine since the end of study NCT00678301.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, since the
             end of study NCT00678301, based on medical history and physical examination.

          -  Major congenital defects or serious chronic illness.

          -  History of any progressive neurological disorders or seizures.

          -  Acute disease and/or fever at the time of enrolment.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  Administration of immunoglobulins and/or any blood products less than 3 months prior
             to visit 1 or planned use during the study.

          -  Child in care.