Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Intervention: DTaP-HB PRP~T Combined Vaccine; DTaP-HB-PRP~T vaccine; Oral Polio Vaccine
Intervention description: 0.5 mL, Intramuscular (IM); 0.5 mL, IM; 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: None (Open Label)
Enrollment: 1843.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b

Summary:

      DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs
      for immunization in infancy, while offering the benefit of a reduced number of injections,
      and potentially of an increased acceptance.

      Primary Objectives:

        -  To describe the antibody persistence at 12 to 18 months following a three-dose primary
           series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14
           weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.

        -  To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18
           months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or
           Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine
           given at birth.

      Secondary Objective:

        -  To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when
           administered concomitantly with Oral Polio Vaccine (OPV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578
             days of age inclusive)

          -  Participated in the AL201 study and completed the three-dose primary series with
             either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age,
             and received hepatitis B vaccine at birth

          -  Informed consent form signed by one parent or legal representative if appropriate
             (independent witness 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 trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term
             (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months

          -  Known 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 in the last 3 months

          -  Any vaccination in the 4 weeks preceding the trial vaccination

          -  Vaccination planned in the 4 weeks following the trial vaccination

          -  Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion

          -  History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b,
             hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically,
             or microbiologically)

          -  Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus
             influenzae type b, hepatitis B or poliovirus 3 types antigen, since the end of the
             primary series

          -  Thrombocytopenia or a bleeding disorder contraindicating IM vaccination

          -  Serious adverse event related to any vaccination in the AL201 study.