Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus vaccine combined has been approved in the United States and 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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Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus vaccine combined studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
217744/088 (DTPa-HBV-IPV-088) IV Phase IV, prospective, study of the safety of GSK Biologicals' Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined) administered to a cohort of infants in a US Health Maintenance Organization (HMO). (Post-Marketing PEDIARIX Safety Study) Pediarix®: GlaxoSmithKline (GSK) Biologicals' diphtheria, tetanus, acellular pertussis, hepatitis B and inactivated poliovirus combined vaccine (DTPa-HBV-IPV)
105910 III A phase III, partially double-blind clinical trial to evaluate the immunogenicity and reactogenicity of an investigational vaccination regimen as compared with GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine administered in healthy infants at 3, 4 and 5 months of age. The immunogenicity, safety and reactogenicity of the DTPa-HBV-IPV vaccine will also be evaluated in a third group of subjects. DTPa-HBV-IPV/Hib: GSK Biologicals’ Infanrix hexa™: current formulation of the combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine. DTPa-HBV-IPV: GSK Biologicals’ Infanrix penta™: preservative-free formulation of the combined diphtheria, tetanus, acellular pertussis, hepatitis B and inactivated poliovirus vaccine.
107531 (Rota-060) III A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals’ two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age). Pediarix®: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio vaccine. Prevnar®: Wyeth’s pneumococcal polysaccharide conjugate vaccine (7-valent). ActHIB®: Sanofi Pasteur’s Haemophilus influenzae type b (Hib) conjugate vaccine. Note: Pediarix®, Prevnar® and ActHIB® will henceforth be referred to as routine infant vaccines.
217744/001 (DTPa-HBV-IPV-001) III Open randomised clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine in comparison to SmithKline Beecham Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B vaccine when co-administered with inactivated poliovirus vaccine as two separate injections in opposite limbs and administered as primary vaccinations to healthy infants at 3, 4 and 5 months of age
217744/002 (DTPa-HBV-IPV-002) III Open clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine. The vaccines will be administered as primary vaccinations to healthy infants at 2, 4, and 6 months of age
217744/004 (DTPa-HBV-IPV-004) III Open clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine, co-administered with commercially available Hib vaccine as two separate injections in opposite limbs. The vaccines will be administered as primary vaccination to healthy infants at 2, 4 and 6 months of age
217744/011 (DTPa-HBV-IPV-011) III Randomised clinical study to assess the safety and reactogenicity of SB Biologicals' DTPa-HBV-IPV vaccine, when co-administered with Hib vaccine in two concomitant injections into opposite limbs, as a primary vaccination course to healthy infants at the age of 3, 4 and 5 months
217744/012 (DTPa-HBV-IPV-012) III Randomised clinical study to assess the immunogenicity and reactogenicity of SB Biologicals' DTPa-HBV-IPV vaccine, when co-administered with Hib vaccine in two concomitant injections into opposite limbs, as a primary vaccination course to healthy infants at the age of 3, 4˝ and 6 months
217744/028 (DTPa-HBV-IPV-028) III Open clinical study to assess the safety and reactogenicity of SB Biologicals DTPa vaccine, co-administered with commercial Hib vaccine into opposite limbs, as compared to SB Biologicals' DTPa vaccine mixed with SB Biologicals’ Hib vaccine, to SB Biologicals' DTPa-IPV vaccine mixed with SB Biologicals’ Hib vaccine, and to SB Biologicals’ DTPa-HBV-IPV vaccine co-administered with SB Biologicals’ Hib vaccine into opposite limbs, when given as a booster dose to healthy children in their second year of life, previously primed with three doses of SB Biologicals' DTPa-HBV-IPV vaccine
217744/030 (DTPa-HBV-IPV-030) III A phase III open randomised primary vaccination study of three doses of SB Biologicals’ DTPa-HBV-IPV vaccine co-administered with SB Biologicals’ Hib vaccine into opposite limbs, compared to commercially available DTPw-IPV/Hib vaccine co-administered with hepatitis B vaccine, in healthy children
217744/049 (DTPa-HBV-IPV-049) III Open clinical study to evaluate the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV and Hib vaccines when administered concomitantly to healthy infants administered as a three-dose primary vaccination course at the age of 1.5, 3.5 and 6 months
217744/054 (DTPa-HBV-IPV-054) III A phase III, open, randomised, primary vaccination clinical study to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV combined vaccine mixed extemporaneously and administered in a single injection with GSK Biologicals’ Hib conjugate vaccine to healthy infants at 3, 5 and 11 months of age, compared to GSK Biologicals’ DTPa-HBV-IPV combined vaccine and Hib conjugate vaccine administered separately.
217744/066 (DTPa-HBV-IPV-066) III Open, randomized, multicentre, phase III clinical trial to assess the reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine, co-administered during the same visit with GSK Biologicals’ HAV vaccine (HavrixÔ), in children in their second year of life.
217744/077 (DTPa-HBV-IPV-077) III A phase III, double-blind, randomized, multicenter primary vaccination study to bridge the DTPa-HBV-IPV vaccine manufactured according to the large scale manufacturing process with the DTPa-HBV-IPV vaccine manufactured by the small scale manufacturing process when administered intramuscularly to infants at 2, 4 and 6 months of age, co-administered with Merck's Hib conjugate vaccine (Liquid PedvaxHIB®) in a separate injection at 2 and 4 months of age
217744/084 (DTPa-Hep B-IPV-084) III A phase III, open labeled, randomized, multicenter, clinical study of the safety of a primary series of GlaxoSmithKline Biologicals' (GSK Biologicals') DTaP-HepB-IPV combined candidate vaccine coadministered with HibTITER® and Prevnar® to healthy infants at 2, 4, and 6 months of age as compared to the separate administration of Infanrix® + Engerix-B®+ IPOL® + HibTITER + Prevnar.
217744/085 (DTPa-Hep B-IPV-085) III A phase III, open labeled, randomized, multicenter, clinical study of the safety and immunogenicity of a primary series of GlaxoSmithKline Biologicals' (GSK Biologicals') DTaP-HepB-IPV candidate vaccine coadministered with HibTITER® and Prevnar® to healthy infants at 2, 4, and 6 months of age as compared to the separate administration of Infanrix® + Engerix-B® + IPOL® + HibTITER + Prevnar and to GSK Biologicals' DTaP-HepB-IPV candidate vaccine coadministered with HibTITER.
Hib-MenC-TT-014 (106388) III A phase III, open, randomized, controlled, multicentre, primary and booster vaccination study to demonstrate the non-inferiority of the meningococcal serogroup C and the Haemophilus influenzae type b immune response of GlaxoSmithKline (GSK) Biologicals’ Hib-MenC vaccine co-administered with Infanrix™ penta versus NeisVac-C™ co-administered with Infanrix™ hexa when given as two primary doses at 3 and 5 months of age as well as the immunogenicity of the Hib-MenC vaccine when given as a booster at 11 months of age and the persistence of antibodies prior to the administration of the booster dose. Menitorix™ (Hib-MenC): GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b (Hib) - meningococcal serogroupC (MenC) - tetanus toxoid conjugate vaccine. Infanrix™ penta (DTPa-HBV-IPV): GSK Biologicals’ combined diphtheria-tetanus-acellular pertussis (DTPa) - hepatitis B - inactivated polio vaccine. NeisVac-C™ (MenC): Baxter’s meningococcal serogroup C tetanus toxoid conjugate vaccine. Infanrix™ hexa (DTPa-HBV-IPV/Hib): GSK Biologicals’ combined DTPa - hepatitis B - inactivated polio - Haemophilus influenzae type b vaccine. Note: This study was conducted in two parts: the primary vaccination phase 106388 (Hib-MenC-TT-014) and the booster vaccination phase 106390 (Hib-MenC-TT-015 BST:014). This CTRS presents the results of the primary vaccination phase of the study only. Results from the booster vaccination phase were not available at the time this CTRS was posted; the data will be added as soon as they are available.
Hib-MenC-TT-014 (106388) & Hib-MenC-TT-015 (106390) III A phase III, open, randomized, controlled, multicentre, primary and booster vaccination study to demonstrate the non-inferiority of the meningococcal serogroup C and the Haemophilus influenzae type b immune response of GlaxoSmithKline (GSK) Biologicals’ Hib-MenC vaccine co-administered with Infanrix™ penta versus NeisVac-C™ co-administered with Infanrix™ hexa when given as two primary doses at 3 and 5 months of age as well as the immunogenicity of the Hib-MenC vaccine when given as a booster at 11 months of age and the persistence of antibodies prior to the administration of the booster dose. Menitorix™ (Hib-MenC): GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b (Hib) - meningococcal serogroupC (MenC) - tetanus toxoid conjugate vaccine. Infanrix™ penta (DTPa-HBV-IPV): GSK Biologicals’ combined diphtheria-tetanus-acellular pertussis (DTPa) - hepatitis B - inactivated polio vaccine. NeisVac-C™ (MenC): Baxter’s meningococcal serogroup C tetanus toxoid conjugate vaccine. Infanrix™ hexa (DTPa-HBV-IPV/Hib): GSK Biologicals’ combined DTPa - hepatitis B - inactivated polio - Haemophilus influenzae type b vaccine. Note: This study was conducted in two parts: the primary vaccination phase 106388 (Hib-MenC-TT-014) and the booster vaccination phase 106390 (Hib-MenC-TT-015 BST: 014).
100381 II A Phase II open controlled, multicentre, booster vaccination study to assess the safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals’ Hib-MenC vaccine (co-administered with Infanrix™ penta) compared to a booster dose of Menjugate™ (co-administered with Infanrix™ hexa) when given to toddlers primed in infancy in a primary study. Hib-MenC vaccine (Menitorix): GSK Biologicals’ combined Haemophilus influenzae type b-meningococcal serogroups C-TT conjugate vaccine. DTPa-HBV-IPV (Infanrix™ penta): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus (poliovirus types 1, 2 and 3) vaccine. MenC-CRM197 (Novartis’ Menjugate™): licensed meningococcal serogroup C - CRM197 vaccine. DTPa-HBV-IPV/Hib (Infanrix™ hexa): GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus (types 1, 2 and 3) and Haemophilus influenzae type b vaccine.
101858 II A phase II, single-blinded, randomized, controlled, multicenter primary and booster vaccination study to evaluate the immunogenicity, reactogenicity and safety of an investigational vaccination regimen compared to ActHIB, each co-administered with Pediarix and Prevnar, in healthy infants at 2, 4, and 6 months of age and in healthy toddlers at 12 to 15 months of age (booster dose), when co-administered with Prevnar.
102370 & 102371 II A phase II, open, randomized, controlled, multicentre primary and booster vaccination study of an investigational vaccination regimen versus Hib and MenC conjugate licensed vaccines when given according to the 2-4-6 month schedule to healthy infants with a booster dose at 12 to 15 months of age. Note: This study was conducted in two parts: the primary vaccination phase (102370) and the booster phase (102371).
217744/015 (DTPa-HBV-IPV-015) II An open study of the safety and immunogenicity of DTPa-HBV-IPV vaccine administered as a three dose series or in a sequential IPV/OPV schedule at 2, 4, and 6 months of age
217744/061 (DTPa-HBV-IPV-061) II A phase II, single-blinded, randomized comparative study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals' DTPa-HBV-IPV vaccine compared with Infanrixâ when both vaccines are co-administered with OmniHIBâ between 15 and 18 months of age following primary immunization at the age of 2, 4 and 6 months in the study DTPa-HBV-IPV-044 (CPMS N° 217744/044)
217744/099(DTPa-HBV-IPV-099) II A phase II, randomized, partially blinded clinical trial to evaluate the immunogenicity and reactogenicity of an investigational vaccine regimen of GSK Biologicals as compared to GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) and to the concomitant administration of GSK Biologicals’ DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines, when given as a primary vaccination to healthy infants at 2, 3 and 4 months of age
347414/016 II A phase II, single-blind, randomised, controlled, multicentre study to evaluate the safety, reactogenicity and immunogenicity of two experimental formulations versus a licensed Haemophilus influenzae type b (Hib) conjugate vaccine (Hiberix™ or HibTiter™) administered as primary vaccination to infants in their 3rd, 4th and 5th months of life, with concomitant administration of GSK Bio’s DTPa-HBV-IPV vaccine.
347414/028 II A randomized, controlled, open, phase-II clinical study to evaluate the safety and immunogenicity of an experimental formulation extemporaneously mixed with SB Biologicals' Haemophilus influenzae type b (Hib) vaccine (HiberixÔ), administered as a booster dose concomitantly with DTPa-HBV-IPV to healthy children 12 to 18 months old, previously vaccinated in infancy with two Haemophilus influenzae type b (Hib)-containing experimental formulations in study 347414/016.
711202/001 II A phase II, open, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of investigational vaccination regimens and GSK Biologicals’ Hib MenC-TT conjugate vaccine given concomitantly with Infanrix penta®, to infants in their 3rd, 4th and 5th months of life. Hib-MenC-TT (Menitorix): GSK Biologicals’ combined Haemophilus influenzae type b polysaccharide-Neisseria meningitidis polysaccharide C conjugated vaccine using tetanus toxoid as carrier protein. Infanrix penta®: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio vaccine (DTPa-HBV-IPV).
792014/001 II A phase II, open (partially double-blind), randomised, controlled, multicentre, primary vaccination study to evaluate the immunogenicity (including immune memory), reactogenicity and safety of three investigational vaccine regimens versus ActHIB® and Meningitec®# given concomitantly with Infanrix® penta and versus ActHIB® given concomitantly with Infanrix® penta and Prevenar® in infants according to a 2-4-6 month schedule. Due to the availability of Menjugate® and according to protocol, Menjugate® was used in this clinical trial instead of Meningitec®.
792014/002 II A phase II, open (partially double-blind), randomized, controlled, multicentre, primary vaccination study to evaluate the immunogenicity (including immune memory), reactogenicity and safety of an investigational vaccination regimen versus ActHIB® and Menjugate® given concomitantly with Infanrix® penta and Prevenar® in infants according to a 2-4-6 month schedule. DTPa-HBV-IPV (Infanrix® penta): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine. Prevenar®: (7-Pn) heptavalent conjugate pneumococcal vaccine from Wyeth. ActHIB®: (Hib) conjugate Haemophilus influenzae type b-tetanus toxoid vaccine from Sanofi Pasteur. Menjugate®: (MenC) meningococcal serogroup C oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein vaccine from Novartis. Note: This study was conducted in 2 parts: the primary vaccination phase (792014/001) and the booster phase (792014/002) This CTRS presents the results of the booster vaccination phase.
792014/003 II A phase II, open randomised, controlled, multicentre, primary vaccination study to evaluate the immunogenicity, reactogenicity and safety of an investigational vaccination regimen and of GSK Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine given concomitantly with Infanrix™ penta, versus Menjugate™ given concomitantly with Infanrix™ hexa in infants according to a 2-3-4 month schedule. MenC-CRM197 (MenjugateTM) Novartis’ meningococcal serogroup C-CRM197 conjugate vaccine. Hib-MenC (Menitorix): GlaxoSmithKline (GSK) Biologicals’ combined Haemophilus influenzae type b-meningococcal serogroups C-TT conjugate vaccine. DTPa-HBV-IPV (Infanrix™ penta): GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine. DTPa-HBV-IPV/Hib (Infanrix™ hexa): GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B virus, inactivated poliovirus and Haemophilus influenzae type b vaccine.