Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants
Condition: Tetanus; Acellular Pertussis; Diphtheria
MeSH terms: Diphtheria
Intervention: DTPa-IPV; DTPa; IMOVAX Polio®
Intervention description: 3 intramuscular injections; 3 intramuscular injections; 3 intramuscular injections
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 458.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of
      combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been
      updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol .

          -  A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the
             time of the first vaccination.

          -  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.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first
             dose of the study vaccine.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the study period (i.e. Day 0 to Month 7), with the exception of Bacille
             Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine
             and Hib vaccine.

          -  Planned administration/ administration of a vaccine foreseen by the study protocol
             (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine)
             during the period 30 days before and one week after the study vaccine dose.

          -  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 (pharmaceutical product or device).

          -  Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease.

          -  History of diphtheria, tetanus, pertussis and/or poliovirus diseases.

          -  Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study
             period.

          -  Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from
             intramuscular injection.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s).

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.