Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Intervention: DTaP-HB-PRP~T vaccine; Tritanrix-HepB/Hib™; Oral Polio Vaccine
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Oral
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 362.0
Sex: All
Minimum age: 15 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b

Summary:

      The present trial is a follow-up of AL203 study (NCT00343889).

      Primary Objectives:

      To describe the antibody persistence at 15 to 18 months of age and the booster effect of a
      dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine
      [OPV]).

      Secondary Objective:

      To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when
      administered concomitantly with OPV in each vaccine group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578
             days of age inclusive)

          -  Participated in the AL203 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

          -  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 intramuscular (IM)
             vaccination

          -  Serious adverse event related to any vaccination in the AL203 study.