Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Intervention: DTaP-IPV-HB-PRP~T; Tritanrix-HepB/Hib
Intervention description: 0.5 mL, Intramuscular (IM); 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2133.0
Sex: All
Minimum age: 50 Days
Maximum age: 71 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Recombinant Hepatitis B; Poliomyelitis; Haemophilus influenzae type b; Tetanus protein

Summary:

      To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence
      rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the
      three vaccinations at 2, 4, and 6 months of age for each subject.

      To evaluate the overall safety in terms of:

      Any solicited adverse reactions in the first 7 days after each injection, Any adverse events
      and reactions in the first 30 days after each injection, Any serious adverse events during
      the trial.

      Immunogenicity:

      To document the immune response to Hepatitis B antigen of the three batches of the
      investigational DTaP-IPV-HB-PRP~T vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  2 months old infants 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 one or both parents or by the legally acceptable
             representative and 1 or 2 independent witnesses

          -  Able to attend all scheduled visits and to comply with all trial procedures

          -  Has complied with the national immunization calendar (BCG for both countries) for the
             first 2 months of life.

        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 corticosteroids therapy

          -  Subjects with congenital or acquired immunodeficiency in the child's surrounding

          -  Systemic hypersensitivity to any of the vaccine components or history of a
             life-threatening reaction to the trial vaccine or 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 in the 4 weeks preceding the first trial vaccination

          -  Vaccination planned in the 4 weeks following the trial vaccination

          -  Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus
             influenzae type b or hepatitis B infection(s) (confirmed either clinically,
             serologically or microbiologically)

          -  Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B
             surface antigen

          -  Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or
             Haemophilus influenzae type b infection(s)

          -  Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination

          -  History of seizures

          -  Febrile or acute illness on the day of inclusion.