Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
Condition: Tetanus; Hepatitis B; Haemophilus Influenzae Type b; Poliomyelitis; Acellular Pertussis; Diphtheria; Neisseria Meningitidis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: GSK2202083A vaccine; Prevenar 13®; Infanrix hexa™; Menjugate®; Rotarix™
Intervention description: 3 doses given at 2, 4 and 12 months of age; 3 co-administered doses; 3 doses given at 2, 4 and 12 months of age; 3 co-administered doses; Oral, two doses
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 480.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine
      co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4
      months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) can and will comply with the requirements of the protocol.

          -  A male or female infant between, and including, 8 and 12 weeks at the time of the
             first vaccination.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

          -  Written informed consent obtained from the parent(s), Legally Acceptable
             Representative(s) 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.

          -  Child in care.

          -  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 the end of the study
             with the exception of inactivated influenza vaccines. The administration of
             diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae
             type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during
             the study period but other vaccines are 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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib,
             pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B
             virus vaccination at birth.

          -  History of seizures or progressive neurological disease.

          -  Subjects with history of intussusception or uncorrected congenital malformation of the
             gastrointestinal tract that would predispose for intussusception.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of any reaction or hypersensitivity 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 other moderate to severe illness within 24 hours of study
             vaccine administration.

          -  Current gastrointestinal infection.