Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Infections
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Hepatitis
Intervention: DTaP-HB-PRP~T vaccine + OPV; Tritanrix-HepB/Hib™ + OPV vaccine; Oral Polio Vaccine
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: Single (Outcomes Assessor)
Enrollment: 379.0
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; Haemophilus Influenzae

Summary:

      The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T
      vaccine in countries that follow the World Health Organization-Expanded Program of
      Immunization (WHO-EPI) schedule.

      The primary objective is:

        -  To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a
           lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to
           hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.

      The secondary objectives are:

        -  To describe in each group the immunogenicity parameters one month after the 3-dose
           primary series at 6, 10, and 14 weeks of age; and

        -  To evaluate the overall safety in terms of any adverse events in the first 28 days after
           each injection and any serious adverse events during the entire trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.

          -  Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks
             of pregnancy and up to 4 days after delivery

          -  Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg

          -  Informed consent form signed by one parent or other legal representative if
             appropriate (independent witness is mandatory if parent is illiterate)

          -  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.

          -  Chronic illness at a stage that could interfere with the conduct or completion of the
             trial

          -  Blood or blood-derived products received since birth

          -  HB vaccination since birth

          -  Any vaccination in the four weeks preceding the first trial vaccination

          -  Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG)
             during the trial

          -  Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus
             influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or
             microbiologically)

          -  Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity

          -  Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM)
             vaccination

          -  History of seizures

          -  Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.