Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
Condition: Tetanus; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: Infanrix hexa™; Prevenar 13®; GSK217744
Intervention description: 3 doses, intramuscular into left thigh; 3 co-administered doses, intramuscular into right thigh; 3 doses, intramuscular into left thigh
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 721.0
Sex: All
Minimum age: 60 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: combination vaccine; Primary vaccination

Summary:

      This study is designed to evaluate the safety and immunogenicity of new formulations of GSK
      Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination
      course to healthy infants at 2, 3 and 4 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female between, and including, 60 and 90 days of age at the time of the
             first vaccination.

          -  Born after a gestation period of 37 to 42 weeks inclusive.

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) can and will comply with the requirements of the protocol.

          -  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:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccines
             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 a vaccine not foreseen by the study protocol, within 30 days prior
             to the first study visit, or planned administration during the study period, with the
             exception of oral rotavirus vaccination which is allowed at any time during the study.

          -  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, polio, hepatitis
             B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B
             vaccination at birth.

          -  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).

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Acute disease and/or fever at the time of enrolment.