Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
Condition: Poliomyelitis; Tetanus; Acellular Pertussis; Diphtheria; Haemophilus Influenzae Type b
MeSH terms: Diphtheria; Poliomyelitis
Intervention: Infanrix™-IPV+Hib; Infanrix™ IPV; Hiberix™; Synflorix™; Rotarix™
Intervention description: Intramuscular, 3 doses; Intramuscular, 3 doses; Intramuscular, 3 doses; Intramuscular, 3 doses; Oral, 2 doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 454.0
Sex: All
Minimum age: 42 Days
Maximum age: 69 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary vaccination; combination vaccine; South Korea

Summary:

      This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine
      when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6
      months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female between, and including, 42 and 69 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 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 vaccine(s)
             within 30 days preceding the first dose, 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, with the exception of hepatitis B and Bacillus
             Calmette-Guérin vaccination; or planned administration during the study period, with
             the exception of hepatitis B and influenza vaccines, which will be allowed at least 7
             days before or 30 days after the administration of the DTPa vaccine.

          -  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 and
             Hib vaccination or disease.

          -  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.