Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
Condition: Infections, Streptococcal
MeSH terms: Infections; Streptococcal Infections
Intervention: Pneumococcal vaccine GSK2189242A; Placebo; Prevnar 13®; PedvaxHIB®
Intervention description: 4 doses administered intramuscularly; 4 doses administered intramuscularly; 4 doses administered intramuscularly; 4 doses administered intramuscularly
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1806.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nasopharyngeal carriage; safety; immunogenicity; US; Pneumococcal vaccine; efficacy; Streptococcus pneumoniae; infants

Summary:

      The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis
      media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine
      GSK2189242A in Native American infants aged less than 24 months, living in the southwestern
      US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the
      impact on acute lower respiratory tract infections (ALRI) up to the second year of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who the investigator believes that their parent(s)/Legally Authorized
             Representative(s) (LARs) can and will comply with the requirements of the protocol.

          -  A male or female American Indian infant between, and including, 6 and 12 weeks (42-90
             days) of age at the time of the first vaccination.

          -  Voluntary, written informed consent obtained from the parents/LAR(s) of the subject.
             Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a
             witness.

          -  Healthy subject as established by medical history and clinical examination before
             entering into the study.

          -  Born after a gestation period of more than 35 6/7 weeks.

        Exclusion Criteria:

        For all 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 since
             birth.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             starting from 30 days before each dose and ending 30 days after each dose of study
             vaccines, with the exception of licensed inactivated influenza vaccines and
             recommended pediatric 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.

          -  Obstruction or anomalies of the nasopharyngeal space.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s) including latex.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Acute disease and/or fever at the time of enrollment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Any medical or social condition which might interfere with the assessment of the study
             objectives in the opinion of the investigator.

        For infants in the Immuno/reacto subgroup only:

        • Previous vaccination against H. influenzae type b.