Home > Result Summaries: Compounds > Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Result Summaries: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine GSKStudy ID Phase Title Summary (Download) 100382 phase 4 Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals’ Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines (1 citation(s)) 100386 (EXT Y5) phase 3 Evaluate the persistence of immune response of GSK Biologicals’ TWINRIX™ ADULT, administered according to 0,6 m schedule and 0,12 m schedule, in volunteers aged 12-15 y inclusive at the time of first vaccine dose (1 citation(s)) 100551 (EXT Y11) phase 3 Long-term persistence follow-up study to evaluate the immune persistence of GSK Biologicals' combined hepatitis A / hepatitis B vaccine in healthy adult volunteers (4 citation(s)) 100556 (Y11) phase 3 Long-term persistence follow-up study to evaluate the immune persistence of GSK Biologicals' combined hepatitis A / hepatitis B vaccine in healthy adult volunteers (4 citation(s)) 100559 Phase 3 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. (3 citation(s)) 100565 phase 3 An open study to evaluate immunogenicity & safety of GSK Biologicals'commercially available combined hepatitis A/B vaccine containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a 2-dose schedule in healthy children aged between 1 and 11 ye (2 citation(s)) 100566 phase 3 Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose (1 citation(s)) 101040 Phase 3 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. (1 citation(s)) 109063_1 phase 3 Non-Inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly in an Experimental co-Administration Versus 134612 Alone and the Experimental co-Administration Alone in Healthy Subjects Aged 11 Through 17 Years. (2 citation(s)) 110699 phase 4 Study to evaluate antibody persistence & immune memory in subjects vaccinated during adolescence with Twinrix™ (0 citation(s)) 110886_ phase 3 Immunogenicity and safety study of GSK Biologicals' HPV vaccine (GSK-580299) co-administered with a commercially available vaccine in healthy female adolescents (2 citation(s)) 111149 phase 4 Evaluate the effect of risk factors that influence the immunogenicity of GSK Bios' Twinrix compared to hepatitis A and hepatitis B vaccines given separately and to show the non-inferiority between the vaccines in adults (3 citation(s)) 112266 phase 4 Antibody persistence & immune memory in healthy adults previously vaccinated with TwinrixTM Adult (0 citation(s)) 112267 phase 4 An open, single centre study to evaluate the long-term antibody persistence and immune memory between 16 and 20 years after the primary study HAB-028 (208127/021) in which healthy adults were vaccinated with Twinrix™ Adult following a three-dose schedule (0 citation(s)) 208127/ 114 Phase 2 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. (0 citation(s)) 208127/021 Phase 3 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. (3 citation(s)) 208127/049 Phase 3 An open randomized study to evaluate the immunogenicity and reactogenicity of SB Bios' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with commercially available hepatitis A and hepatitis B vaccines of SB Bios, when injected in healthy adult volunteers (2 citation(s)) 208127/076 Phase 3 An open study to evaluate the immunogenicity, safety, and reactogenicity of SB Bios’ commercially available combined hepatitis A/hepatitis B vaccine containing 720 ELISA units of hepatitis A antigen and 20 mcg of hepatitis B surface antigen, admin following a 2 dose schedule in healthy children (2 citation(s)) 208127/082 phase 3 Phase III, open, randomised study, in two centers, to demonstrate the equivalence of the 0-12 mth schedule to the 0-6 mth schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of SB Bios’ combined hepatitis A/hepatitis B vac Twinrix™ in healthy volunteers(12-15Y) (3 citation(s)) 208127/084 Phase 3 An open, randomised study to compare the immunogenicity, safety and reactogenicity of SB combined hepatitis A/hepatitis B vac Twinrix. admin following a 2 dose schedule (0-6 mths) to that of Twinrix. Junior admin following a 3 dose schedule (0, 1, 6 months) in healthy volunteers aged 12-15 years (4 citation(s)) 208127/085 Phase 3 An open clinical study to evaluate the immunogenicity and reactogenicity of SB Bios’ combined hepatitis A/hepatitis B vac when admin, in opposite limbs, with SB Bios’ combined diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis vac mixed with Haemophilus influenzae type b conjugate vac (1 citation(s)) 208127/087 Phase 3 An open clinical study to evaluate the immunogenicity and reactogenicity of SB Bios’ combined hepatitis A/hepatitits B vaccine when administered following a 2 dose schedule (0-6 mth) and for the first dose, in opposite limbs at month 0, with SB Bios’ measles-mumps-rubella vaccine to healthy children (1 citation(s)) 208127/091 Phase 4 A phase IV, open, randomized, controlled, comparative, multicenter U.S. study of the safety of GSK Bios' 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 (0 citation(s)) 208127/097 Phase 4 An open, randomized, monocentric study to evaluate the immunogenicity, reactogenicity and safety of GSK Bios' 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. (1 citation(s)) 208127/098 Phase 4 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 (Mths 0-1-6) with the hepatitis A and B combination vaccine TWINRIX™ ADULT (1 citation(s)) 208127/100 and 208127/101 (Ext-HAB-075) Phase 3 A double-blind study to compare the immunogenicity, safety and reactogenicity of GSK Bios’ 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 admin following a 0-6 mth schedule in healthy adolescents (0 citation(s)) 208127/115 and 208127/119 (Ext-HAB-028 Month 108 and Month 120) Phase 3 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. (3 citation(s)) 208127/118 Phase 3 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. (3 citation(s)) 208127/120 phase 3 A phase III, open, randomized, multicenter, multicountry study to compare the reactogenicity and evaluate the safety and immunogenicity of GSK Bios’ combined hepatitis A/hepatitis B vac admin according to a 0-6 mth schedule by intramuscular injection versus TWINRIX™ JUNIOR admin in healthy children (4 citation(s)) 208127/121 Phase 3 An open, controlled, randomized, comparative, phase IIIb study to evaluate the immunogenicity, safety and reactogenicity of GSK Bios' combined hepatitis A and hepatitis B vac given on an accelerated schedule compared to separate vac with GSK Bios' monovalent hepatitis A vaccine in healthy adults (1 citation(s)) 208127/122 phase 3 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. (2 citation(s)) 208127/123 Phase 3 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 vac, in healthy subjects who have a previously documented seroprotective anti-HBs antibody response (0 citation(s)) 208127/125 Phase 3 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. (1 citation(s)) 208127/126 Phase 2 A phase II, open, randomized, multicentric study to evaluate the immunogenicity, reactogenicity and safety of an experimental vaccine to that of Twinrix™ Adult admin following an accelerated schedule (0-7-21 days + 12 mths) in healthy adults aged more than 16 years. (0 citation(s)) 208127/127 Phase 4 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. (1 citation(s)) 208127/129 Phase 3 A phase III, double-blind, controlled, multicentric randomized study, to evaluate the immunogenicity and reactogenicity of the combined hepatitis A/hepatitis B preservative-free thimerosal-free vac as compared to the combined hepatitis A/hepatitis B vac with preservative, admin at 0-1-6 Mth (0 citation(s)) 208127/130 Phase 4 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). (1 citation(s)) 208127/132 (EXT Y2) phase 3 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 (1 citation(s))
