Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK 2189242A (LD formulation 1); Pneumococcal vaccine GSK 2189242A (HD formulation 2); Synflorix™; Prevnar13™; Tritanrix™-HepB/Hib; Polio Sabin™; M-Vac™; Stamaril™
Intervention description: Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Orally; Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1320.0
Sex: All
Minimum age: 56 Days
Maximum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Haemophilus influenzae; Streptococcus pneumoniae; The Gambia; immunogenicity; nasopharyngeal carriage; infants; safety; Pneumococcal vaccine; children

Summary:

      This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of
      GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and
      co-administered with other routine paediatric vaccines in infants in The Gambia. Two
      formulations containing different doses of pneumococcal antigen and two different schedules
      will be tested in infants.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol

          -  Male or female between, and including,

               -  2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1
                  (children).

               -  8 to 10 weeks (56-76 days) of age at the time of the first vaccination for
                  subjects in Cohort 2 (infants).

          -  Signed or thumb-printed informed consent obtained from the parents/LAR(s) of the
             subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Permanent residence in the study area and no intention of leaving during the study
             period.

        Additional inclusion criteria for subjects in Cohort 1:

        • Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP)
        vaccination.

        Exclusion Criteria:

        Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the study period starting from 30 days before each dose and ending 30 days
             after each dose of vaccine(s), with the exception of licensed flu vaccines.

          -  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

          -  Previous vaccination against S. pneumoniae.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Malnutrition

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  Major congenital defects or any chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease and/or fever at the time of enrolment.

          -  Administration of immunoglobulins and/ or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Contraindications to any co-administered vaccine.

          -  Any medical condition that would contraindicate the initiation of routine immunization
             outside a clinical trial context.

        Additional exclusion criteria for subjects in Cohort 1:

        • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
        Haemophilus influenzae type b with the exception of vaccines where the first dose should be
        given within the first two weeks of life according to the national recommendations (for
        example Bacillus Calmette-Guérin [BCG] and hepatitis B vaccination).