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Study ID Status Title Patient Level Data
209762/150 Completed Double blind, randomized sequential study to compare immunogenicity and reactogenicity of current formulations of GSK Biologicals’ measles-mumps-rubella vaccine and GSK Biologicals’ varicella vaccine to investigational vaccination regimens Study Listed on ClinicalStudyDataRequest.com
209762/151 Completed Phase II study to evaluate immunogenicity, reactogenicity and safety of GSK Biologicals’ investigational vaccination regimen compared to the currently licensed GSK Biologicals’ Priorix™ and Merck and Co.’s M-M-R®II vaccines when administered as a primary vaccination to healthy children aged 12-24 months Study Listed on ClinicalStudyDataRequest.com
210602-002 Completed Assess the feasibility of an investigational vaccination regimen, compared to a 3-dose primary vaccination with GSK Biologicals' Infanrix hexa™ (DTPa-HBV-IPV/Hib vaccine) following hepatitis B vaccination at birth. Primary vaccination is followed in the 2nd year of life by a booster dose of Infanrix-hexa Study Listed on ClinicalStudyDataRequest.com
213501/016 Completed 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. Study Listed on ClinicalStudyDataRequest.com
213501/018 Completed Study to evaluate 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 GSK Biologicals hepatitis B Study Listed on ClinicalStudyDataRequest.com
213501/019 Completed Study to assess immunogenicity and reactogenicity of GSK Biologicals’ quadrivalent diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus influenzae type b conjugate vaccines when mixed extemporaneously and given in a single injection to healthy infants Study Listed on ClinicalStudyDataRequest.com
213503/044 Completed Open study to assess the immunogenicity after two and three doses of GSK Biologicals’ Hib vaccine combined with GSK Biologicals’ DTPa-IPV vaccine given to Swedish infants in a 3, 5, 12 month schedule Study Listed on ClinicalStudyDataRequest.com
213503/045 Completed Study to compare immunogenicity and reactogenicity of GSK Bio’s DTPa-IPV vaccine, with GSK Bio’s DTPa (Infanrix) and Aventis MSDs IPV vaccine (Imovax Polio) administered separately to healthy children 4 to 6 years of age Study Listed on ClinicalStudyDataRequest.com
213503/046 Completed Open, randomised phase IIIb, clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ DTaP-IPV vaccine, with GSK Biologicals’ DTaP and Aventis Pasteur MSD’s IPV vaccines administered to healthy children, previously vaccinated with 4 doses of DTaP and polio vaccines, and co-administered with GSK Biologicals’ MMR vaccine Study Listed on ClinicalStudyDataRequest.com
213503/047 Completed Open, randomized, phase II, clinical trial to compare the immunogenicity and safety of a booster dose of GSK Biologicals' DTaP-IPV vaccine (Infanrix®-IPV) co-administered with a booster dose of Merck and Company's M-M-R®II, to that of separate injections of GSK Biologicals' DTaP vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II administered as booster doses to healthy children 4 to 6 years of age. Study Listed on ClinicalStudyDataRequest.com
213503/048 Completed Safety, immunogenicity&consistency of 3 manufacturing lots of DTaP-IPV vaccine vs separate injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV admd as booster doses to healthy children 4-6 yrs, each co-admd with Merck's MMR vaccine Study Listed on ClinicalStudyDataRequest.com
213503/049 Completed An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of GSKBiologicals combined Infanrix-IPV+Hib (DTPa-IPV/Hib) vaccine in healthy children aged 17 to 20 months whocompleted a three-dose primary vaccination course Study Listed on ClinicalStudyDataRequest.com
213503/050 Completed Study to evaluate safety and immunogenicity of a booster dose of DTPa-IPV/Hib at 18 months of age with GSK Biologicals DTPa-IPV/Hib compared to Aventis Pasteurs Pentacel, after an initial primary vaccination series administered at 2, 4, and6 months of age with Aventis Pasteurs Pentacel
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
217744/060 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 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 Bio’s 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 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 v Study Listed on ClinicalStudyDataRequest.com
217744/075 Completed 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

 

 

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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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