Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
Condition: Hepatitis B; Polio; Diphtheria; Pertussis; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Whooping Cough; Diphtheria; Hepatitis
Intervention: DTaP-IPV-HB-PRP~T; CombAct-HIB®; Engerix B® Pediatric
Intervention description: 0.5 mL, Intramuscular (IM); 0.5 mL, IM; 0.5 mL, IM
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 622.0
Sex: All
Maximum age: 3 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B; Polio; Diphtheria; Pertussis; H. influenzae type b

Summary:

      The purpose of this study is to document the immunological response to the investigational
      hexavalent vaccine at the 6, 10, and 14 weeks schedule

      The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined
      vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric
      and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B
      (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6,
      10, and 14 weeks) with no HB vaccination at birth.

      The secondary Objectives are:

      To describe the safety in terms of any adverse events in the first 28 days after each
      injection and any serious adverse events during the entire trial.

      To describe Immunogenicity after the primary series and prior to and after a booster
      vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  0 to 3 day old infants

          -  Mother seronegative for Human Immunodeficiency Virus (HIV)

          -  Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg

          -  Apgar score >7 at 5 or 10 minutes of life

          -  Informed consent form signed by a parent or other legal guardian and by an independent
             witness if the parent or other legal guardian is illiterate

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Current or planned participation in another clinical trial during the entire duration
             of the present trial

          -  Suspected congenital or acquired immunodeficiency

          -  Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based
             on clinical history

          -  Chronic illness at a stage that could interfere with trial conduct or completion

          -  Blood or blood-derived products received since birth

          -  Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from
             birth to 18 weeks of age

          -  Oral Poliovirus Vaccine (OPV) administration at birth

          -  Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C
             seropositivity

          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination

          -  History of seizures

          -  Febrile or acute illness on the day of inclusion.