Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Diphtheria, Tetanus, Pertussis
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b, Haemophilus Influenzae
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age.