Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
Condition: Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria; Tetanus; Poliomyelitis
MeSH terms: Diphtheria; Poliomyelitis
Intervention: Infanrix™-IPV/Hib
Intervention description: Intramuscular, three doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 60 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined vaccine

Summary:

      This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a
      three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female infant between, and including, 60 and 90 days of age at the time of
             the first study visit.

          -  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 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:

          -  Use of any investigational or non-registered product other than the study vaccine
             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
             vaccination, or planned administration during the study period, with the exception of
             hepatitis B 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/or Hib disease.

          -  Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or
             Haemophilus influenzae type b diseases.

          -  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.

          -  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 > 37.0 ºC or other moderate to severe
        illness within 24 hours of study vaccine administration.