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Study ID Status Title Patient Level Data
208108/087 Completed Phase 2 open randomized primary vaccination study to assess the immunogenicity and reactogenicity of GSK Biologicals' Haemophilus influenzae type b conjugate vaccine administered with commercially available DTPw vaccine as compared to GSK Biologicals' Hib administered mixed with GSK Biologicals' DTPw vaccine in healthy infants Study Listed on ClinicalStudyDataRequest.com
208108/091 Completed A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB/Hib2.5 to GSK Biologicals’ Tritanrix™-HepB/Hiberix™ when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects Study Listed on ClinicalStudyDataRequest.com
208108-083 Completed A phase IV, open, multicentric, post-marketing surveillance study to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals’ Haemophilus influenzae type b vaccine (Hiberix™) in Korean subjects administered according to the Prescribing Information. Study Listed on ClinicalStudyDataRequest.com
208109/210 Completed A Phase 4, open, comparative, multicenter study of the immunogenicity and safety of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine (Havrix) 720 EL.U/ 0.5 ml on a 0, 6-month schedule, administered by intramuscular injection, either to children aged (1) 15 to 18 months old or (2) 11 to 13 months old, when compared to 23 to 25 month-old children; and to determine the immune responses following co-administration of routine childhood vaccines, DTPa and Hib in the 15 to 18 month age g Study Listed on ClinicalStudyDataRequest.com
208109/220 Completed A Phase IIIb, open, randomized, controlled, multicenter study of the immunogenicity and safety of GSK Biologicals' inactivated hepatitis A vaccine administered on a 0-6 mth schedule concomitantly with Wyeth Lederle's pneumococcal conjugate vaccine in healthy children 15 months of age Study Listed on ClinicalStudyDataRequest.com
208109/228 Completed A phase IV open study to assess the anamnestic response to a single intramuscular injection of GSK Biologicals’ hepatitis A vaccine, Havrix™ Junior in healthy adult subjects who have had a previously documented seropositive status following a full course of primary vaccination with GSK Biologicals’ hepatitis A vaccine Study Listed on ClinicalStudyDataRequest.com
208109/229 Completed A Phase IIIb, open, multicenter study of the immunogenicity and safety of one dose of GSK Biologicals' inactivated hepatitis A vaccine administered to healthy children who were seropositive for anti-HAV Study Listed on ClinicalStudyDataRequest.com
208109/231 Completed Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age Study Listed on ClinicalStudyDataRequest.com
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.
208127/076 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
208127/091 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
208127/118 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.
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
208127/122 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.
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

 

 

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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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