Combined Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus And Haemophilus Influenzae Type B Conjugate 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, Acellular Pertussis, Inactivated Poliovirus And Haemophilus Influenzae Type B Conjugate Vaccine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
100917 (DTPa-IPV-052) IV An open, multicentric, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3, 4, 5 and 18 months of age, in healthy infants. DTPa-IPV/Hib: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b vaccine.
213503/044 (DTPa-IPV-044) IV Open study to assess the immunogenicity after two and three doses of GlaxoSmithKline (GSK) Biologicals’ Hib vaccine combined with GSK Biologicals’ DTPa-IPV vaccine given to Swedish infants in a 3, 5, 12 month schedule. DTPa-IPV/Hib: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, enhanced potency inactivated polio and Haemophilus influenzae type b vaccine
213503/050 (DTPa-IPV-050) III A phase IIIb, observer-blind, randomized, multicenter, active comparator study to evaluate the safety and immunogenicity of a booster dose of DTPa-IPV/Hib at 18 months of age with GSK Biologicals’ DTPa-IPV/Hib compared to Aventis Pasteurs’ DTPa-IPV/Hib vaccine (Pentacel™), after an initial primary vaccination series administered at 2, 4, and 6 months of age with Aventis Pasteurs’ Pentacel™. DTPa-IPV/Hib: GlaxoSmithKline Biologicals’ diphtheria, tetanus, pertussis, inactivated poliovirus and Haemophilus influenzae type b (Hib); Pentacel™ (Penta): Sanofi Pasteur’s (previously Aventis Pasteur) diphtheria, tetanus, pertussis, inactivated poliovirus and Haemophilus influenzae type b (Hib).
217744/068 III An open, randomized study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-IPV/Hib and HBV vaccines compared to an investigational vaccination regimen in healthy infants born to hepatitis B surface antigen negative mothers and previously primed at birth with a dose of GSK Biologicals’ hepatitis B vaccine.
217744/069 III A Phase III, open, randomized, primary vaccination study of GlaxoSmithKline Biologicals’ investigational vaccination regimen and GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered concomitantly with GlaxoSmithKline Biologicals’ HBV vaccine in healthy infants born to hepatitis B surface antigen negative mothers and previously primed with a birth dose of GlaxoSmithKline Biologicals’ HBV vaccine. A booster dose of the primary course regimen will be administered at the age of 15-18 months.
347414/008 II A phase II, randomised, single-blind, controlled study to assess the immunogenicity and the safety of GlaxoSmithKline Biologicals’ investigational vaccination regimen administered concomitantly in separate injections with GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine as a primary vaccination course to healthy infants at 2, 4 and 6 months of age and as a booster dose at 12 to 18 months of age. DTPa-IPV: combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine; Hib: Haemophilus influenzae type b vaccine.
347414/023 II A phase II, single-blind, randomized, controlled study to evaluate the immunogenicity and safety of four different formulations of an investigational vaccination regimen when given intramuscularly as primary vaccination in infants at 3, 4 ˝ and 6 months of age.