Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
Condition: Tetanus; Poliomyelitis; Neisseria Meningitidis; Haemophilus Influenzae Type b; Diphtheria; Acellular Pertussis; Hepatitis B
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: GSK2202083A vaccine; Infanrix hexa; Menjugate
Intervention description: Intramuscular, three doses; Intramuscular, three doses; Intramuscular, two doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 16 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined vaccine; Primary vaccination

Summary:

      This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A
      vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female infant between, and including, 8 and 16 weeks at the time of the
             first vaccination.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

          -  Subjects who the investigator believes that their parents/ guardians can and will
             comply with the requirements of the protocol.

          -  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:

          -  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.

          -  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
             randomisation, or planned administration from randomisation to study Visit 3, or from
             30 days before to 30 days after study Visit 4, with the exception of influenza and
             human rotavirus vaccines. The administration of other vaccines, including conjugated
             pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to
             31 days before study Visit 4.

          -  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, hepatitis B,
             poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at
             birth.

          -  History of seizures or progressive neurological disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  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 if no other exclusion criteria is met:

        • Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe
        illness within 24 hours of study vaccine administration