Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Hepatitis B, Polio, Diphtheria
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, Polio, Diphtheria, Pertussis, H influenzae type b
Eligibility Criteria
Inclusion Criteria: Two-month old infants of either gender 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 the parent(s) or other legal representative(s) and an institution official other than an investigator 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 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 since birth Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination Vaccination planned in the 4 weeks following trial vaccination History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s) Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of seizures Febrile (axillary temperature 37.4°C [rectal equivalent 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-IPV-Hep B-PRP-T
Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC
Participants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T); One dose each at 2, 3, and 4 months of age.
Participants will receive 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.