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Study ID Status Title Patient Level Data
208109/232 Completed Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 months of Age Study Listed on ClinicalStudyDataRequest.com
208127/ 114 Completed A phase II, open, randomised, multicentric study to compare the immunogenicity, reactogenicity and safety of experimental vaccines to that of Twinrix (administered following a 3 dose schedule (0, 1, 6 months) in healthy adults aged 18-40 years. Study Listed on ClinicalStudyDataRequest.com
208127/021 Completed A double blind randomized, comparative study of the immunogenicity and reactogenicity of three different lots of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitis B vaccine when administered in healthy adults.
208127/049 Completed An open randomized study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with commercially available hepatitis A and hepatitis B vaccines of SmithKline Beecham Biologicals, when injected in healthy adult volunteers
208127/076 Completed An open study to evaluate the immunogenicity, safety, and reactogenicity of SmithKline Beecham Biologicals’ commercially available combined hepatitis A/hepatitis B vaccine containing 720 ELISA units of hepatitis A antigen and 20 mcg of hepatitis B surface antigen, administered following a 2 dose schedule in healthy children
208127/082 Completed Phase III, open, randomised study, in two centers, to demonstrate the equivalence of the 0-12 month schedule to the 0-6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitis B vaccine Twinrix™ in healthy volunteers (12-15Y)
208127/084 Completed An open, randomised study to compare the immunogenicity, safety and reactogenicity of SmithKline Beecham combined hepatitis A/hepatitis B vaccine Twinrix administered following a 2 dose schedule (0-6 mths) to that of Twinrix. Junior administered following a 3 dose schedule (0, 1, 6 months) in healthy volunteers aged 12-15 years
208127/085 Completed An open clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitis B vaccine when administered, in opposite limbs, with SmithKline Beecham Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis vaccine mixed with Haemophilus influenzae type b conjugate vaccine
208127/087 Completed An open clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitits B vaccine when administered following a 2 dose schedule (0-6 month) and for the first dose, in opposite limbs at month 0, with SmithKline Beecham Biologicals’ measles-mumps-rubella vaccine to healthy children
208127/091 Completed A phase IV, open, randomized, controlled, comparative, multicenter U.S. study of the safety of GSK Biologicals' combination hepatitis A and hepatitis B vaccine administered on a 0-1-6 mth schedule by intramuscular injection compared with concurrently administered monovalent vaccines in healthy adults Study Listed on ClinicalStudyDataRequest.com
208127/097 Completed An open, randomized, monocentric study to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with hepatitis A and hepatitis B vaccines of Chiron Behring/Aventis Pasteur in healthy adult volunteers Study Listed on ClinicalStudyDataRequest.com
208127/098 Completed Comparison of the immunogenicity and safety in healthy monozygotic and dizygotic twins, which have been grown up in the same environment, after having receipt three vaccinations (Months 0-1-6) with the hepatitis A and B combination vaccine TWINRIX™ ADULT Study Listed on ClinicalStudyDataRequest.com
208127/100 and 208127/101 (Ext-HAB-075) Completed A double-blind study to compare the immunogenicity, safety and reactogenicity of GSK Biologicals’ high-dose combined hepatitis A/B vaccine containing 1440 EL.U of hepatitis A antigen/40 mcg of hepatitis B surface antigen to that of Twinrix™, both administered following a 0-6 month schedule in healthy adolescents Study Listed on ClinicalStudyDataRequest.com
208127/115 and 208127/119 (Ext-HAB-028 Month 108 and Month 120) Completed A double-blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A – hepatitis B vaccine when administered in healthy adults. Study Listed on ClinicalStudyDataRequest.com
208127/118 Completed A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline (GSK) Biologicals' combined hepatitis A / hepatitis B vaccine in healthy adult volunteers. Study Listed on ClinicalStudyDataRequest.com
208127/120 Completed A phase III, open, randomized, multicenter, multicountry study to compare the reactogenicity and evaluate the safety and immunogenicity of GSK Biologicals’ combined hepatitis A/hepatitis B vaccine administered according to a 0-6 month schedule by intramuscular injection versus TWINRIX™ JUNIOR administered in healthy children Study Listed on ClinicalStudyDataRequest.com
208127/121 Completed An open, controlled, randomized, comparative, phase IIIb study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' combined hepatitis A and hepatitis B vaccine given on an accelerated schedule compared to separate vaccine with GSK Biologicals' monovalent hepatitis A vaccine in healthy adults Study Listed on ClinicalStudyDataRequest.com
208127/122 Completed An open study to evaluate the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A / hepatitis B vaccine (schedule 0, 1, 6 months) in healthy children aged 1 to 6 years. Study Listed on ClinicalStudyDataRequest.com
208127/123 Completed A phase III open study to assess the anamnestic response to a single injection of Twinrix vaccine, given approximately 44 months after primary vaccination with combined hepatitis A/ hepatitis B vaccine, in healthy subjects who have a previously documented seroprotective anti-HBs antibody response Study Listed on ClinicalStudyDataRequest.com
208127/125 Completed A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Study Listed on ClinicalStudyDataRequest.com
208127/126 Completed A phase II, open, randomized, multicentric study to evaluate the immunogenicity, reactogenicity and safety of an experimental vaccine to that of Twinrix™ Adult administered following an accelerated schedule (0-7-21 days + 12 months) in healthy adults aged more than 16 years. Study Listed on ClinicalStudyDataRequest.com
208127/127 Completed An open, multicentric, post-marketing surveillance study of GlaxoSmithKline Biologicals’ combined hepatitis A-hepatitis B vaccine (Twinrix™), injected as a three dose primary vaccination course according to the prescribing information, in healthy children and adults. Study Listed on ClinicalStudyDataRequest.com
208127/129 Completed A phase III, double-blind, controlled, multicentric randomized study, designed to evaluate the immunogenicity and reactogenicity of the combined hepatitis A/hepatitis B preservative-free thimerosal-free vaccine as compared to the combined hepatitis A/hepatitis B vaccine with preservative, administered according to a 3-dose schedule (0, 1, 6 months) to healthy adults aged 18 years or older
208127/130 Completed A phase IV open study to assess the persistence of anti-HBs and anti-HAV antibodies in older adults approximately 2 years after a primary 3-dose vaccination course with GlaxoSmithKline Biologicals’ combined hepatitis A/hepatitis B vaccine Twinrix™ (720/20) Study Listed on ClinicalStudyDataRequest.com
208127/132 (EXT Y2) Completed Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 month Schedule and a 0,1,6 month Schedule, in Healthy Children Aged Between 1-11 years at the Time of First Vaccine Dose 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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