Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Condition: Hepatitis B; Polio; Diphtheria; Pertussis
MeSH terms: Hepatitis B; Whooping Cough; Diphtheria; Hepatitis
Intervention: DTaP-IPV-HB-PRP~T vaccine; DTaP-IPV//PRP~T combined; Hepatitis B vaccine
Intervention description: 0.5 mL, Intramuscular (IM); 0.5 mL, IM; 0.5 mL, IM
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 310.0
Sex: All
Minimum age: 50 Days
Maximum age: 71 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B; Polio; Diphtheria; Pertussis; H influenzae type b

Summary:

      To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is
      non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three
      dose (2-3-4 month) primary series.

      Immunogenicity

        -  To assess pre- and post-primary series

        -  To assess pre- and post-booster series.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Two-month old infants of either gender on the day of inclusion

          -  Born at full term of pregnancy (>=37 weeks) with a birth weight >=2.5 kg

          -  Informed consent form signed by the parent(s) or other legal representative(s) and an
             institution official other than an investigator

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Participation in another clinical trial in the 4 weeks preceding the first trial
             vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term
             systemic corticosteroid therapy

          -  Systemic hypersensitivity to any of the vaccine components or history of a life
             threatening reaction to a vaccine containing the same substances

          -  Chronic illness at a stage that could interfere with trial conduct or completion

          -  Blood or blood-derived products received since birth

          -  Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination

          -  Vaccination planned in the 4 weeks following trial vaccination

          -  History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae
             type b or hepatitis B infection(s) (confirmed either clinically, serologically or
             microbiologically)

          -  Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity

          -  Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB
             infection(s)

          -  Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular
             vaccination

          -  History of seizures

          -  Febrile (axillary temperature 37.4°C [rectal equivalent temperature >=38.0°C]) or
             acute illness on the day of inclusion.