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Study ID Status Title Patient Level Data
217744/028 Completed Study to assess the safety and reactogenicity of SB Biologicals DTPa vaccine, co-administered with commercial Hib vaccine as compared to SB Biologicals' DTPa vaccine-SB Biologicals' DTPa-IPV vaccine each time mixed with SB Biologicals’ Hib vaccine, and to SB Biologicals’ DTPa-HBV-IPV vaccine co-administered with SB Biologicals’ Hib vaccine
217744/030 Completed 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
217744/035 Completed A booster vaccination study of one dose of GSK’s DTPa HBV IPV vaccine, coadministered with 2 formulations of GSK’s Hib conjugate vaccine, either mixed or injected in 2 concomitant injections, in healthy children who participated in Study 217744/011 (DTPa-HBV-IPV-011) or 217744/016 (DTPa-HBV-IPV-016)
217744/049 Completed Immunogenicity and reactogenicity of GSK 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 Study Listed on ClinicalStudyDataRequest.com
217744/054 Completed Study to assess the immunogenicity and reactogenicity of DTPa-HBV-IPV vaccine mixed with Hib vaccine to healthy infants at 3, 5 and 11 months of age, compared to each vaccine administered separately
217744/060 Completed Study to assess the immunogenicity and reactogenicity of DTPa-HBV-IPV mixed with Hib vaccine in healthy infants, followed by a dose of the same vaccine administered simultaneously with one dose of oral polio vaccine (OPV) Study Listed on ClinicalStudyDataRequest.com
217744/061 Completed 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 Infanrix™ when both vaccines are co-administered with OmniHIB™ 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 (217744/044) Study Listed on ClinicalStudyDataRequest.com
217744/063 Completed 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 Study Listed on ClinicalStudyDataRequest.com
217744/066 Completed 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 (Havrix™), in children in their second year of life. Study Listed on ClinicalStudyDataRequest.com
217744/068 Completed Study to assess immunogenicity, safety and reactogenicity of 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 Study Listed on ClinicalStudyDataRequest.com
217744/069 Completed Immunogenicity and safety of GSK Biological’s DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib co-administered with HBV vaccine as primary and booster vaccination in healthy infants born to hepatitis B surface antigen negative mothers Study Listed on ClinicalStudyDataRequest.com
217744/070 Completed An open clinical study to assess the immunogenicity and safety of 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 (=>37 weeks) Study Listed on ClinicalStudyDataRequest.com
217744/074 Completed 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’ com bined 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. Study Listed on ClinicalStudyDataRequest.com
217744/075 Phase III, open, randomised immunogenicity and reactogenicity study to assess the interchangeability between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd dose of primary vac. course in children who received HBV vac. at birth and one month of age and DTPa-IPV/Hib vac at 3-4 Mth of age Study Listed on ClinicalStudyDataRequest.com
217744/076 Completed An open, multicenter, phase IV clinical trial to assess the immunogenicity and reactogenicity of three doses of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy infants at 2, 4 and 6 months of age, when co-administered with Wyeth-Lederle’s meningococcal group C conjugate vaccine. Study Listed on ClinicalStudyDataRequest.com
217744/077 Completed 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 Study Listed on ClinicalStudyDataRequest.com
217744/078 Completed An open, multicentre, phase IV clinical trial to assess the immunogenicity and reactogenicity of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, when co-administered at 3-4-5 Mth of age with Wyeth-Lederle's seven-valent pneumococcal conjugate vaccine at a different injection site during the same visit Study Listed on ClinicalStudyDataRequest.com
217744/081 Completed An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of a 4th dose of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, co-administered with Wyeth's seven-valent Pneumococcal conjugate vaccine at a different injection site during the same visit in healthy children Study Listed on ClinicalStudyDataRequest.com
217744/083 Completed Study to assess immunogenicity and reactogenicity of GSK Bio’s combined DTPa-HBV-IPV/Hib vaccine in pre-term infants in comparison with term infants, administered as a booster dose to children who previously were primed with 3 doses of GSK Biologicals combined DTPa-HBV-IPV/Hib vaccine Study Listed on ClinicalStudyDataRequest.com
217744/084 Completed 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 Study Listed on ClinicalStudyDataRequest.com
217744/085 Completed A phase III, open labeled, randomized, multicenter, clinical study of the safety and immunogenicity of a primary series of GlaxoSmithKline Biologicals' (GSK Biologicals') DTaP-HepBIPV 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 Study Listed on ClinicalStudyDataRequest.com
217744/086 Completed 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. Study Listed on ClinicalStudyDataRequest.com
217744/088 Completed Phase IV, prospective study of the safety of GSK Biologicals' Pediarix administered to a cohort of infants in a US Health Maintenance Organization (HMO). (Post-Marketing PEDIARIX Safety Study)
217744/090 Completed 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. Study Listed on ClinicalStudyDataRequest.com
217744/093 Completed 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 in healthy children

 

 

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GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.
GSK-sponsored clinical trials are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.

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