Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
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
Eligibility Criteria
Inclusion Criteria: At Screening: 0 to 3 day old infants Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg Apgar score ≥ 7 at three minutes after birth Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate) At Inclusion: Six weeks of age Received a dose of Hepatitis B (HB) in the first three days of life Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: At Screening: Illness at a stage that could interfere with trial conduct or completion Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth) Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth) Acute illness on the day of screening. At Screening and at Inclusion: Blood or blood-derived products received since birth Planned participation in another clinical trial during the present trial period Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg) Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B) At Inclusion: Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG) Participation in another clinical trial before the first trial vaccination Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Vaccination other than with the study vaccines planned in the 12 weeks following inclusion Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically) History of seizures Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Sites / Locations
- Filinvest
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1: DTaP-Hep B-PRP-T + OPV vaccine
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.