Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Intervention: DTaP-HB-PRP~T combined vaccine; Tritanrix-HepB/Hib™ vaccine; Oral poliomyelitis vaccine (OPV)
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; Oral co-administered with study vaccine.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2133.0
Sex: All
Minimum age: 42 Days
Maximum age: 50 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b

Summary:

      This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T
      combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6,
      10, and 14 weeks of age.
    

Eligibility criteria:

        Inclusion Criteria:

        At Screening:

          -  0 to 3 day old infants

          -  Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg

          -  Apgar score ≥ 7 at three minutes after birth

          -  Informed consent form signed by one parent or legal representative if appropriate
             (independent witness mandatory if parent is illiterate)

        At Inclusion:

          -  Six weeks of age

          -  Received a dose of Hepatitis B (HB) in the first three days of life

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

        At Screening:

          -  Illness at a stage that could interfere with trial conduct or completion

          -  Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at
             birth)

          -  Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except
             BCG if not given at birth)

          -  Acute illness on the day of screening.

        At Screening and at Inclusion:

          -  Blood or blood-derived products received since birth

          -  Planned participation in another clinical trial during the present trial period

          -  Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or
             as carrying the HB surface antigen (HBsAg)

          -  Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination

          -  Known hypersensitivity to any component of any vaccine to be used in the trial
             (including neomycin and polymixin B)

        At Inclusion:

          -  Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)

          -  Participation in another clinical trial before the first trial vaccination

          -  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 the trial vaccine or a vaccine containing the same substances

          -  Chronic illness at a stage that could interfere with trial conduct or completion

          -  Vaccination other than with the study vaccines planned in the 12 weeks following
             inclusion

          -  Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or
             HB infection (confirmed clinically, serologically, or microbiologically)

          -  History of seizures

          -  Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.