Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Intervention: GSK2197870A; Prevenar™; Menitorix™; Pediacel™; Menjugate™
Intervention description: 3 doses given at 2, 3 and 4 months of age; 3 co-administered doses, intramuscular into right thigh; 1 booster dose at 12 months of age; 3 doses given at 2, 3 and 4 months of age; 2 doses given at 3 and 4 months of age
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 284.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: combined; Vaccines

Summary:

      The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals'
      GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy
      infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a
      booster dose of GSK Biologicals' Menitorix™ at 12 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy the following criteria at study entry:

          -  A male or female infant between, and including, 6 and 12 weeks of age at the time of
             the first vaccination.

          -  Born after 36 to 42 weeks of gestation.

          -  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.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If any apply, the
        subject must not be included in the study:

          -  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. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5
             mg/kg/day. Inhaled and topical steroids are allowed.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Administration of a vaccine not foreseen by the study protocol within 30 days prior to
             vaccination, or planned administration 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 .

          -  Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis,
             Hib, pneumococcal and/or group C meningococcal vaccination or disease.

          -  History of seizures or progressive neurological disease (one episode of febrile
             convulsion does not constitute an exclusion criterion).

          -  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(s).

          -  Major congenital defects or serious chronic illness.

        The following condition is temporary or self limiting and a subject may be vaccinated once
        the condition has resolved and no other exclusion criteria are met:

        • Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe
        illness within 24 hours of study vaccine administration