Combined diphtheria-tetanus-whole cell pertussis, hepatitis B vaccine and Haemophilus influenzae type 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 and Haemophilus influenzae type b vaccine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
213501/016 (DTPw-HBV-Hib/016) IV A post-marketing surveillance study of GlaxoSmithKline (GSK) Biologicals’ Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B vaccine (TRITANRIX™-HB) and Haemophilus influenzae type-b tetanus-conjugate (Hib) vaccine (HIBERIX™) co-administered in the same syringe in 1,000 Filipino subjects.
213501/021 (DTPw-HBV-Hib-021) IV Phase IV, open, multicentric, post-marketing study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B/Haemophilus influenzae type b vaccine (Tritanrix™-HB/Hib) injected in healthy infants previously primed at birth with hepatitis B vaccination.
217744/100 (DTPa-HBV-IPV-100) IV An open, multicentre, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3 and 4 months of age and DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) administered at 5 months of age, as primary vaccination course, followed by administration of GSK Biologicals’ DTPa-IPV/Hib vaccine at 18 months of age in healthy infants who received hepatitis B vaccine at birth and at one month of age.
100478 III A phase III, open, randomized, controlled primary vaccination study to demonstrate non-inferiority of an investigational vaccination regimen as compared to Tritanrix™-HepB/Hiberix™ without a birth dose of hepatitis B vaccine with respect to the immunogenicity of all common antigens when administered to healthy infants at 6, 10 and 14 weeks of age. DTPw-HBV (Tritanrix™-HepB): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, whole cell Bordetella pertussis and Hepatitis B vaccine; Hiberix™ (Hib): GSK Biologicals’ Haemophilus influenzae type b vaccine.
100480 III A phase III, partially blinded, randomized, controlled primary vaccination study to assess the immunogenicity and non-inferiority of investigational vaccination regimens as compared to TritanrixTM-HepB/HiberixTM and as compared to MeningitecTM when administered to healthy infants at 2, 4 and 6 months of age, who have received a birth dose of hepatitis B vaccine. DTPw-HBV (Tritanrix™-HepB): combined diphtheria, tetanus, whole cell Bordetella pertussis and hepatitis B vaccine, HiberixTM: GSK Biologicals’ Haemophilus influenzae type b vaccine, MenC (MeningitecTM): Wyeth’s licensed meningococcal serogroup C vaccine.
104727 III A phase III, multicentre booster vaccination study to assess the immunogenicity, safety and reactogenicity of a fourth dose of an investigational vaccination regimen at 15 to 24 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of Mencevax™ ACWY at 24 to 30 months of age in subjects primed with 3 doses of the investigational vaccination regimen in study 100480. Mencevax™ ACWY: GSK Biologicals’ purified polysaccharides from Neisseria meningitidis of serogroup A, C, W135 and Y conjugate vaccine (MenACWY)
104733 III A phase III, partially double-blinded, randomized, controlled primary vaccination study to assess the non-inferiority of investigational vaccination regimens as compared to Tritanrix™-HepB/Hiberix™ when administered to healthy infants at 2, 4 and 6 months of age. Tritanrix™-HepB (DTPw-HBV): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, whole cell pertussis and hepatitis B vaccine. Hiberix™ (Hib): GSK Biologicals’ Haemophilus influenzae type b conjugate vaccine.
104756 III A phase III, open, single centre booster vaccination study to assess safety and reactogenicity of a dose of DTPw-HBV/Hib vaccine given at 15-18 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of Mencevax™ ACW vaccine given at 24 to 30 months of age in subjects primed in study 759346/007. Tritanrix™-HepB/Hiberix™ (DTPw-HBV/Hib): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, whole cell Bordetella pertussis and hepatitis B vaccine contemporaneously mixed with Haemophilus influenzae type B conjugated vaccine. Mencevax™ ACW (MenACW): GSK Biologicals’ licensed meningococcal polysaccharide A, C, W vaccine.
107007 III A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of an investigational vaccination regimen compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Prevenar™ (7Pn): Wyeth’s 7-valent pneumococcal conjugate vaccine. Tritanrix™-HepB/Hiberix™ (DTPw-HBV/Hib): GlaxoSmithKline (GSK) Biologicals’ diphtheria-tetanus-whole cell pertussis-hepatitis B vaccine extemporaneously mixed with a lyophilized Haemophilus influenzae type b tetanus conjugate vaccine. Poliorix™ (IPV): GSK Biologicals’ inactivated polio vaccine. Polio Sabin™ (OPV): GSK Biologicals’ oral polio vaccine.
100480, 759346/004 & 100791 III A phase III, partially blinded, randomized, controlled primary vaccination study to assess the immunogenicity and non-inferiority of an investigational vaccination regimen as compared to TritanrixTM-HepB/HiberixTM and as compared to MeningitecTM when administered to healthy infants at 2, 4 and 6 months of age, who have received a birth dose of hepatitis B vaccine. 759346/004: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB mixed with the investigational vaccination regimen vaccine as compared to Tritanrix™-HepB/Hiberix™ when administered to healthy infants at 2, 4, 6 months of age, who have received a birth dose of hepatitis B vaccine. 100791: A phase III, partially blinded, randomized, controlled primary vaccination study to assess the reactogenicity and safety of an investigational vaccination regimen as compared to Tritanrix™-HepB/Hiberix™ when administered to healthy infants at 2, 4, 6 months of age, who have received a birth dose of hepatitis B vaccine. DTPw-HBV (Tritanrix™-HepB): GSK Biologicals’ combined diphtheria, tetanus, whole cell Bordetella pertussis Hepatitis B vaccine, Hib (HiberixTM): GSK Biologicals’ Haemophilus influenzae type b vaccine, MenC (MeningitecTM): Wyeth‘s licensed meningococcal serogroup C vaccine.
103812 & 104727 III 103812 (759346/014 BST:013&004 (15-18/24M)): A phase III, multicenter, multicountry, vaccination study to assess the safety and reactogenicity of a booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 (upper limit for age extended from 18 months to 24 months only for Thailand) months of age (single-blind) and of a dose of Mencevax™ ACWY vaccine when administered at 24 to 30 months of age (open label) in subjects who were primed in the safety study 759346/004 and safety study 759346/013 (eTrack No. 100791). 104727 (759346/016 BST 003 (15-24 months)): A phase III, multicentre booster vaccination study to assess the immunogenicity, safety and reactogenicity of a fourth dose of an investigational vaccination regimen at 15 to 24 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of Mencevax™ ACWY at 24 to 30 months of age in subjects primed with 3 doses of an investigational vaccination regimen in study 100480 (759346/003) DTPw-HBV/Hib (Tritanrix™-HepB): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-whole cell Bordetella pertussis-hepatitis B vaccine mixed with Hib (Hiberix™): GSK Biologicals’ Haemophilus influenzae type b vaccine. MenACWY (Mencevax™): GSK Biologicals’ Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine
105239 & 105245 III A phase III, multi-center booster vaccination study to assess the immunogenicity, safety and reactogenicity of a dose of GlaxoSmithKline (GSK) Biologicals’ Mencevax™ ACWY at 24 to 30 months of age in subjects primed in study 100478. Mencevax™ ACWY (MenACWY): GSK Biologicals’ meningococcal serogroups ACWY vaccine
213501/018 (DTPw-HBV-Hib-018) III Phase III, open, randomised study to evaluate the immunogenicity, safety and reactogenicity of two different immunization regimens against hepatitis B, diphtheria, tetanus, pertussis and Haemophilus influenzae type b (Hib) diseases in healthy infants primed with a birth dose of GlaxoSmithKline (GSK) Biologicals’ hepatitis B: • GSK Biologicals’ Hib and quadrivalent diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B (DTPw-HBV) vaccines mixed and administered as a single injection at 1.5, 3 and 5 months of age. • Locally available commercial diphtheria, tetanus, whole cell Bordetella pertussis (DTPw) vaccine administered concomitantly at separate sites with GSK Biologicals’ Hib vaccine at 3, 4 and 5 months of age with GSK Biologicals’ hepatitis B vaccine administered at 1 and 5 months of age.
402764/004 III A phase III, open, randomized study to evaluate the immunogenicity and reactogenicity of investigational vaccination regimens.
104430 II A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of an investigational vaccination regimen as compared to GSK Biologicals’ Hiberix vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age. Tritanrix-HepB (DTPw-HBV): GSK Biologicals’ combined diphtheria, tetanus, whole cell pertussis, hepatitis B vaccine. Hiberix: GSK Biologicals’ Haemophilus influenzae type b vaccine (Hib). Note: This study was conducted in 2 parts: the primary vaccination phase (759346/009) and the booster phase (104430).
347414/017 II A multinational, randomised, controlled, single-blind, phase-II study to evaluate the safety and immunogenicity of two investigational vaccination regimens versus a licensed Haemophilus influenzae type b (Hib) conjugate vaccine (Hiberix™) given concomitantly with DTPw-HBV vaccine in a separate injection to infants at 2, 4, and 6 months of age.
402764-003 II A phase II, open, randomized study to assess the immune memory induced by a primary vaccination course of an investigational vaccination regimen and the immunogenicity and reactogenicity of a fourth dose of an investigational vaccination regimen given to healthy toddlers primed in study 402764-001.
759346/001 II A phase II, open, randomized, controlled study to evaluate the immunogenicity of investigational vaccination regimens administered as a three dose primary vaccination course at 6, 10 and 14 weeks of age.
759346/002 II A phase II, open, randomized study to assess the immune memory induced by a primary vaccination course of an investigational vaccination in subjects primed in study 759346/001.
759346/009 II A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of an investigational vaccination regimen as compared to GSK Biologicals’ Hiberix vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age. DTPw-HBV (Tritanrix-HepB): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine; Hib (Hiberix): GSK Biologicals’ Haemophilus influenzae type b vaccine.