Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine has been approved in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
208139/053 (DTPw-HBV-053) IV Open, multicentric, post-marketing surveillance study of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine (TRITANRIX™-HB) injected in healthy infants according to the prescribing information. DTPw-HBV (Tritanrix™-HB): combined diphtheria, tetanus, whole cell pertussis, hepatitis B vaccine
208139/054 (DTPw-HBV-028 Ext. Y7) III An open randomised study in healthy infants vaccinated at birth with Engerix™-B (10 µg) to evaluate the immunogenicity and the reactogenicity of the following GlaxoSmithKline (GSK) Biologicals’ vaccines: 1. combined DTP-HB vaccine (10 µg HBsAg) 2. combined DTP-HB vaccine (5 µg HBsAg) 3. simultaneous administration of Engerix™-B (10 µg) vaccine in right thigh and whole-cell DTP vaccine in left thigh when administered at 2, 4 and 6 months of age. Engerix™-B (HBV): GlaxoSmithKline (GSK) Biologicals’ recombinant hepatitis B vaccine. DTPw-HBV: GSK Biologicals’ combined diphtheria, tetanus, whole cell pertussis, hepatitis B vaccine. DTPw: GSK Biologicals’ combined diphtheria, tetanus, whole cell pertussis vaccine.
763674/001 II A phase II, open, randomized, controlled study to evaluate an investigational vaccination regimen administered as a three dose primary vaccination course at 2, 3 and 4 months of age.
763674/002 II A phase II open, randomized, controlled study to evaluate an investigational vaccination regimen administered as a three dose primary vaccination course at 2, 3 and 4 months of age.