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Study ID Status Title Patient Level Data
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
217744/094 Completed Study to assess and compare the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (INFANRIX™ HEXA) and Aventis Pasteur MSD’s DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) given at 3, 5 and 11-12 months of age Study Listed on ClinicalStudyDataRequest.com
217744/095 Completed Study to assess immunogenicity and reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine when given as a booster dose to children previously primed at 2-4-6 months of age either with Aventis Pasteurs' DTPa-HBV-IPV-Hib vaccine or GSK Biologicals' DTPa-HBV-IPV/Hib vaccine in study DTPa-HBV-IPV-086 Study Listed on ClinicalStudyDataRequest.com
217744/097 Study to assess immunogenicity and reactogenicity of three doses of GSK Bio’s combined Hib-MenC vaccine co-admind with GSK Bio’s DTPa-HBV-IPV vaccine and of two doses of Baxters meningococcal C conjugate vaccine co-admind with GSK Bio’s DTPa-HBV-IPV/Hib vaccine Study Listed on ClinicalStudyDataRequest.com
217744/099 Completed 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 Study Listed on ClinicalStudyDataRequest.com
217744/100 Completed Assess safety & reactogenicity of DTPa-IPV/Hib vaccine admnd at 3 & 4 mths & DTPa-HBV-IPV/Hib vaccine admnd at 5 mths, followed by DTPa-IPV/Hib vaccine at 18 mths in infants who received hepatitisB vaccine at birth & at one month of age Study Listed on ClinicalStudyDataRequest.com
218352/040 Completed Open immunization study to determine the reactogenicity and immunogenicity of Influsplit SSW® 1999/2000 (preservative-free) in persons as of 18 years of age.
218352/044 Completed Open immunization study to determine the reactogenicity and immunogenicity of Influsplit SSW® 2000/2001 in children aged from 6 months to less than 6 years
218352/047 Completed Open immunization study to determine the reactogenicity and immunogenicity of Influsplit SSW® 2001/2002 / Fluarix™ 2001/2002 in persons as of 18 years of age

 

 

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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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