Combined diphtheria-tetanus-acellular pertussis, hepatitis B virus-inactivated poliovirus 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-acellular pertussis, hepatitis B virus-inactivated poliovirus and Haemophilus influenzae type b vac studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
217744/094 (DTPa-HBV-IPV-094) IV Single-blind, randomized, multicentric, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Sanofi-Pasteur’s (previously Aventis Pasteur MSD’s) DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as primary vaccination course at 3, 5 and 11-12 months of age.
101518 (DTPa-HBV-IPV-103) IV A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix?hexa) given as a booster at 18-24 months of age to children who have received a three-dose primary immunisation course with the same vaccine in a previous study.
213503/049 (DTPa-IPV-049) IV An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of GSK Biologicals’ combined Infanrix™-IPV+Hib (DTPa-IPV/Hib) vaccine in healthy children aged 17 to 20 months who completed a three-dose primary vaccination course. DTPa-HBV-IPV/Hib: Diphtheria, tetanus, acellular pertussis, hepatitis B recombinant, inactivated poliomyelitis and Haemophilus influenzae type b vaccine. DTPa-IPV/Hib: Diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b vaccine.
217744/076 (DTPa-HBV-IPV-076) IV An open, multicenter, phase IV clinical trial to assess the immunogenicity and reactogenicity of three doses of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) in healthy infants at 2, 4 and 6 months of age, when co-administered with Wyeth-Lederle’s meningococcal group C conjugate vaccine (Meningitec™) at a different injection site during the same visit or at separate visits.
217744/078 (DTPa-HBV-IPV-078) IV An open, multicentre, phase IV clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™), when co-administered at 3, 4 and 5 months of age with Wyeth-Lederle's seven-valent pneumococcal conjugate vaccine (Prevenar™) at a different injection site during the same visit.
217744/081 (DTPa-HBV-IPV-081) IV An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of a fourth dose of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™), co-administered with Wyeth's seven-valent Pneumococcal conjugate vaccine (Prevnar™) at a different injection site during the same visit in healthy children who previously participated in study 217744/078 (DTPa-HBV-IPV-078) and completed a three-dose primary vaccination course.
217744/083 (DTPa-HBV-IPV-083) IV An open, phase IV clinical study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in pre-term infants (< 37 weeks) in comparison with term infants, administered as a booster dose to children between 18 to 20 months of age who previously were primed with 3 doses of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) at 2, 4 and 6 month of age. DTPa-HBV-IPV/Hib: Diphtheria, tetanus, acellular pertussis, hepatitis B recombinant, inactivated poliovirus and conjugated Haemophilus influenzae type b vaccine.
217744/086 (DTPa-HBV-IPV-086) IV Single-blind, multicentre, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as a primary vaccination course at 2, 4 and 6 months of age.
217744/090 (DTPa-HBV-IPV-090) IV A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) given as a primary vaccination course at 2, 4 and 6 months of age to pre-term infants.
217744/095 (DTPa-HBV-IPV-095) IV Open, multicentric, phase IV clinical trial to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) when given as a booster dose to children aged 11 to 23 months previously primed at 2, 4 and 6 months of age either with Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) or GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in study DTPa-HBV-IPV-086.
105553 III A phase III randomised, controlled study to assess in a double blind manner the lot-to-lot consistency of three consecutive production lots of an investigational vaccination regimen and to evaluate the non-inferiority to Prevenar in a single blind design, when administered as a 3-dose primary immunization course before 6 months of age. 7Pn (Prevenar™ from Wyeth): 7-valent pneumococcal conjugate vaccine.
105554 III A phase IIIa randomized, controlled study to assess the immunogenicity of an investigational vaccination regimen when administered as a 3-dose primary immunization course before 6 months of age.
104005 (DTPa-HBV-IPV-106) III Phase III b, open, randomized, multicenter study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-conjugated Haemophilus influenzae type b vaccine (Infanrix hexa™) in Indian infants according to a 6-10-14 week schedule, when compared to Infanrix hexa™ given to Indian infants according to a 2-4-6 month schedule. Infanrix hexa™: DTPa-HBV-IPV/Hib: combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-conjugated Haemophilus influenzae type b vaccine.
217744/060 (DTPa-HBV-IPV-060) III Open, clinical study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV combined vaccine administered mixed in the same syringe with GlaxoSmithKline Biologicals’ Hib tetanus conjugate vaccine in the 3rd and 5th month of life to healthy infants, followed at the 11th month of life by a dose of the same GlaxoSmithKline Biologicals’ DTPa-HBV-IPV and Hib vaccines mixed in the same syringe and administered simultaneously with one dose of oral polio vaccine (OPV).
217744/063 (DTPa-HBV-IPV-063) III Open, clinical study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine (DTPa-HBV-IPV) administered mixed in the same syringe with GSK Biologicals’ Haemophilus influenzae type b (Hib), tetanus conjugate vaccine in the 3rd and 5th month of life healthy infants, followed at the 11th month of life by a dose of the same GSK Biologicals’ DTPa-HBV-IPV and Hib vaccines mixed in the same syringe and administered simultaneously with one dose of oral poliovirus vaccine (OPV).
217744/070 (DTPa-HBV-IPV-070) III An open clinical study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ DTPa HBV IPV vaccine mixed in one syringe with Hib vaccine, as a primary vaccination course to pre-term infants (<37 weeks) at 2, 4 and 6 months of age in comparison with infants born after normal gestation period (³ 37 weeks).
217744/074 (DTPa-HBV-IPV-074) III Open, randomized, multicenter, phase IIIb clinical trial to assess the incidence of high grade fever (=40.0°C) within 4 days following a booster dose in the second year of life of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) as compared to GSK Biologicals’ combined DTPa-IPV/Hib (Infanrix™-IPV+Hib) and HBV (Engerix-B™ Kinder) vaccines administered concomitantly in separate injections to children previously primed with licensed vaccines according to the vaccination recommendations currently in place in Germany.
217744/075 (DTPa-HBV-IPV-075) III Phase III, open, randomised immunogenicity and reactogenicity study to assess the interchangeability between GSK Biologicals' DTPa-HBV-IPV/Hib (mixed vaccine) and DTPa-IPV/Hib + HBV at third dose of primary vaccination course in children who received HBV vaccine at birth and one month of age and DTPa-IPV/Hib vaccine at 3 months and 4 months of age. The immunogenicity, safety and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV, DTPa-IPV, Hib conjugate and HBV vaccines will be evaluated.
217744/093 (DTPa-HBV-IPV-093) III Phase IIIb, multicenter, open label, non controlled, study to assess immunogenicity and reactogenicity of GSK Infanrix hexa® (DTPa-HBV-IPV/Hib) and Infanrix Quinta® (DTPa-IPV/Hib) vaccines co-administered with Wyeth Prevenar® vaccine at different injection sites, as primary vaccination and booster in healthy children, according to the French vaccine calendar. DTPa-HBV-IPV/Hib (Infanrix hexa®): a combined diphtheria, tetanus, acellular pertussis, inactivated poliovirus, hepatitis B and conjugated Haemophilus influenzae type b vaccine DTPa-IPV/Hib (Infanrix Quinta®): a combined diphtheria, tetanus, acellular pertussis, inactivated poliovirus and conjugated Haemophilus influenzae type b vaccine. 7Pn (Prevenar®): 7-valent pneumoccal vaccine.
217744/097 (DTPa-HBV-IPV-097) III An open, phase III clinical trial to assess the immunogenicity and reactogenicity of three doses of GSK Biologicals’ combined Hib-MenC vaccine co-administered with GSK Biologicals’ DTPa-HBV-IPV vaccine (Infanrix™ penta) and of two doses of Baxter’s meningococcal C conjugate vaccine (NeisVac-C™) co-administered with GSK Biologicals’ DTPa-HBVIPV/Hib vaccine (Infanrix™ hexa), as compared to Wyeth’s meningococcal C conjugate vaccine (Meningitec™) coadministered with Infanrix™ hexa in healthy infants at 2, 4 and 6 months of age. Hib-MenC: GSK Biologicals’ Haemophilus influenzae type b and meningococcal C tetanus toxoid conjugate vaccine NeisVac-C™: Baxter’s meningococcal C vaccine using tetanus toxoid as protein carrier (MenC-TT) Meningitec™: Wyeth’s meningococcal C vaccine using CRM197 as protein carrier (MenC-CRM) DTPa-HBV-IPV/Hib (Infanrix™ hexa): GlaxoSmithKline Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine
347414/010 III A phase III, double-blind, randomized, controlled study to assess, in young children, the efficacy in preventing acute otitis media (AOM) of an investigational vaccination regimen, when administered as a three-dose primary vaccination course during the first year of life with a booster dose in the second year of life.
347414/020 III A Phase III, randomized, single blind study to assess the immune response induced by Prevenar™ (7-valent pneumococcal conjugate vaccine, Wyeth Lederle Vaccines) when administered to healthy infants concomitantly with DTPa-HBV-IPV/Hib (Infanrix hexa™), compared to an investigational vaccination regimen as a three-dose primary vaccination course at a monthly interval starting at 8 – 16 weeks of age.
347414/026 III A phase-III, randomized, single-blind clinical trial to assess the immune memory induced by an investigational vaccination regimen in comparison with Prev(e)nar™ (7-valent pneumococcal conjugate vaccine, Wyeth-Lederle vaccines) and the immune response to a fourth dose of the pneumococcal vaccine and the investigational vaccination regimen, when administered to healthy children, 12 to 15 months old, previously vaccinated in infancy with the same vaccines in primary study 347414/020 in Belgium.
347414/035 III A phase-III, open, controlled, follow-up clinical trial, with Prevenar as control, to assess the safety of GSK Biologicals’ investigational vaccination regimen administered concomitantly with DTPa-HBV-IPV/Hib to healthy children, 11 to 15 months old, previously vaccinated in infancy with the investigational vaccination regimen in a primary study in the Netherlands.
101853 II A randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ investigational vaccination regimen, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age.
103488 II A randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ investigational vaccination regimen, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age.
105555 II A phase II, multicenter booster study to evaluate booster vaccination with an investigational vaccination regimen or to evaluate the immune memory following the administration of a single dose of 23-valent plain polysaccharide vaccine in healthy children, previously vaccinated in infancy in a primary study (103488).
106786 II A phase II, observer-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of an investigational vaccination regimen which is compared to the currently licensed GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) when administered to healthy infants at 2, 3 and 4 months of age. Infanrix hexa™ (DTPa-HBV-IPV/Hib): GlaxoSmithKline (GSK) Biologicals’ licensed combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine.
759348/001 II A randomised, controlled phase II study to evaluate the safety and immunogenicity of 7 different formulations of GlaxoSmithKline (GSK) Biologicals’ investigational vaccination regimen, when administered as a 3-dose primary immunisation schedule before 6 months of age, followed by a 4th dose during the second year of life.
759348/002 II A randomized, controlled, phase II study to evaluate the safety and immunogenicity of 7 different formulations of an investigational vaccination regimen, when administered as a 3-dose primary immunization schedule before 6 months of age, followed by a 4th dose during the second year of life.
759348/003 II A randomized, controlled, phase II study to evaluate the safety and immunogenicity of four different formulations of GlaxoSmithKline (GSK) Biologicals’ investigational vaccination regimen, when administered as a 3-dose primary immunization schedule beginning before 6 months of age.
759348/007 II A randomized, controlled, phase II study to evaluate the safety and immunogenicity of five formulations of GlaxoSmithKline Biologicals’ investigational vaccination regimen, when administered intramuscularly as a 3-dose primary immunization schedule (2-3-4 month schedule) before 6 months of age.