Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
Diphtheria, Tetanus, Pertussis
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Recombinant Hepatitis B, Poliomyelitis, Haemophilus influenzae type b, Tetanus protein
Eligibility Criteria
Inclusion Criteria: 2 months old infants on the day of inclusion Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses Able to attend all scheduled visits and to comply with all trial procedures Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life. 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 corticosteroids therapy Subjects with congenital or acquired immunodeficiency in the child's surrounding 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 Blood or blood-derived products received since birth Any vaccination in the 4 weeks preceding the first trial vaccination Vaccination planned in the 4 weeks following the trial vaccination Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s) Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination History of seizures Febrile or acute illness on the day of inclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1: DTaP-IPV-Hep B-PRP-T
Group 2: Tritanrix-Hep B/Hib™+OPV