Hepatitis A Inactivated and Hepatitis B Recombinant vaccine has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Hepatitis A Inactivated and Hepatitis B Recombinant vaccine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
100382 (HAB-160) IV A phase IV, open, randomized, multicentre, multicountry study to evaluate the effect of several risk factors likely to influence the immunogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A and hepatitis B vaccine Twinrix™ according to a 0, 1 and 6 month schedule, as compared to separately administered monovalent hepatitis A (0, 6 months) and hepatitis B vaccines (0, 1, 6 months) from different manufacturers, as well as to demonstrate the non-inferiority of Twinrix™ to the monovalent vaccines, in healthy and non-healthy adults aged 41 years or older.
208127/091 (HAB-091) IV A phase 4, open, randomized, controlled, comparative, multicenter U.S. study of the safety of GlaxoSmithKline Biologicals' combination hepatitis A and hepatitis B vaccine (Twinrix®: 720 EL.U of hepatitis A antigen and 20 mg of hepatitis B surface antigen per ml) administered on a 0, 1, 6 month schedule by intramuscular injection compared with concurrently administered monovalent vaccines (Havrix®: 1440 EL.U/ml on a 0, 6 month schedule and Engerix-B®: 20 mg/ml on a 0, 1, 6 month schedule) in healthy adults 18 years of age and older.
208127/097 (HAB-097) IV An open, randomized, monocentric study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals' combined hepatitis A/ hepatitis B vaccine compared to separate vaccinations with hepatitis A and hepatitis B vaccines of Chiron Behring/ Aventis Pasteur, when injected according to a 0, 1, 6 month schedule (0, 6 months respectively for the monovalent hepatitis A vaccine) in healthy adult volunteers.
208127/098 (HAB-098) IV 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. Evaluation of the influence of the anti-HBs and anti-HAV immune response by single major histocompatibility complex (MHC) encoded genes and examination of other potential candidate genes with the aid of microsatellite and cytokine polymorphisms.
208127/127 (HAB-127) IV 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.
208127/130 (EXT:HAB-098) IV 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).
100386 (HAB-158 Ext- 082) Y5/ 100387 (HAB-159 Ext- 082) Y6 III Phase III, open, randomised study, in two centres, 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 GlaxoSmithKline Biologicals’ Twinrix™ Adult vaccine (720 EL. U. of hepatitis A antigen/ 20 µg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive.
101040 (HAB-164 Ext-038 Y10) III 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.
101377 (HAB-166) III A phase III, open, randomized, multicentre study to demonstrate the non-inferiority of GlaxoSmithKline Biologicals’ combined hepatitis A and hepatitis B vaccine Twinrix™ (720/20) according to a 0, 1 and 6 month schedule, to the monovalent hepatitis A vaccine Havrix™ 1440 (0, 6 months) and hepatitis B vaccine Engerix™-B 20 µg (0, 1, 6 months) separately administered, in healthy adults aged between 18 and 40 years.
208127/021(HAB-028) III 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 (HAB-049) III 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 according to a 0, 7, 21 day schedule in healthy adult volunteers.
208127/076 (HAB-076) III An open study to evaluate the immunogenicity, safety, and reactogenicity of SmithKline Beecham Biologicals’ commercially available combined hepatitis A / hepatitis B vaccine (Twinrix Ô) containing 720 ELISA units of hepatitis A antigen and 20 mcg of hepatitis B surface antigen, administered following a 2 dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years included.
208127/082 (HAB-082) III 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™ (720 EL. U. of hepatitis A antigen / 20 mcg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. Twinrix is a registered trademark of the GlaxoSmithKline group of companies.
208127/084 (HAB-084) III An open, randomised study to compare the immunogenicity, safety and reactogenicity of SmithKline Beecham’s combined hepatitis A / hepatitis B vaccine TwinrixÔ (720 EL. U. of hepatitis A antigen / 20 mcg of recombinant hepatitis B surface antigen) administered following a 2 dose schedule (0, 6 months) to that of TwinrixÔ Junior (360 EL. U. of hepatitis A antigen / 10 mcg of recombinant hepatitis B surface antigen) administered following a 3 dose schedule (0, 1, 6 months) in healthy volunteers aged 12-15 years.
208127/085 (HAB-085) III An open clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitis B (TwinrixÔ) vaccine when administered following a 2 dose schedule (0 and 6 months) and concomitantly, in opposite limbs, at month 0 with SmithKline Beecham Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis vaccine mixed with Haemophilus influenzae type b conjugate vaccine (InfanrixÔ-IPV/Hib) to healthy children ± 18 months of age.
208127/087 (HAB-087) III An open clinical study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ combined hepatitis A/hepatitits B (TwinrixÔ) vaccine when administered following a 2 dose schedule (0 and 6 months) and concomitantly for the first dose, in opposite limbs at month 0, with SmithKline Beecham Biologicals’ measles-mumps-rubella vaccine (Priorix Ô) to healthy children 12-15 months of age.
208127/100 and 208127/101 (Ext-HAB-075) III A double-blind study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ high-dose combined hepatitis A/B (HAB) vaccine containing 1440 EL.U of hepatitis A antigen/40 mcg of hepatitis B surface antigen to that of Twinrix™ (containing 720 EL.U of hepatitis A antigen/20 mcg of hepatitis B surface antigen), both administered following a 0, 6 month schedule in healthy adolescents (11-18 years of age).
208127/115 and 208127/119 (Ext-HAB-028 Month 108 and Month 120) III 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.
208127/118 (Ext-HAB-032 Month 120) III 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 (HAB-120) III A phase III, open, randomized, multicenter, multicountry study to compare the reactogenicity and evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A / hepatitis B vaccine (at least 720 EL.U of hepatitis A antigen and 20 mg of hepatitis B surface antigen per dose of 1 ml) administered according to a 0, 6 month schedule by intramuscular injection versus TWINRIX™ JUNIOR (at least 360 EL.U of hepatitis A antigen and 10 mg of hepatitis B surface antigen per dose of 0.5 ml) administered according to a 0, 1, 6 month schedule by intramuscular injection in healthy children between 1 to 11 years old.
208127/121 (HAB-121) III An open, controlled, randomized, comparative, phase IIIb study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine [Twinrix® (=720 EL.U of hepatitis A antigen and 20 mg of hepatitis B surface antigen per ml)] given on an accelerated schedule (0, 7, and 21 to 30 days followed by a booster at Month 12), compared to separate vaccinations with GlaxoSmithKline Biologicals' monovalent hepatitis A vaccine (Havrix®, =1440 EL.U/1 ml) given on a 0, 12-month schedule and hepatitis B vaccine (Engerix-B®, 20 mg /1 ml) given on a 0, 1, 2, 12-month schedule) in healthy adults 18 years of age or older.
208127/122 (Ext-HAB-039 Month 90) III 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.
208127/123 (HAB-123) III A phase III open study to assess the anamnestic response to a single injection of TwinrixÔ (720/20) vaccine, given approximately 44 months after primary vaccination with combined hepatitis A/ hepatitis B vaccine (HAB 720/20 or experimental vaccine), in healthy subjects who have a previously documented seroprotective anti-HBs antibody response following the 2-dose primary vaccination but have anti-HBs antibody titer below the seroprotective level at the study onset. Twinrix is a registered trademark of the GlaxoSmithKline group of companies.
208127/125 (Ext-HAB-038 Month 90) III 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
208127/129 (HAB-129) III 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.
208127-082 EXT M24 & EXT M36, 100386, 100387 (HAB-103, HAB-104, HAB-158, HAB-159) III Phase III, open, randomised study, in two centres, 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 GlaxoSmithKline Biologicals’ Twinrix™ Adult vaccine (720 EL. U. of hepatitis A antigen/ 20 ?g of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. Twinrix™ Adult (HAB): GlaxoSmithKline (GSK) Biologicals’ commercially available combined hepatitis A/ hepatitis B vaccine.
208127/ 114 (HAB-114) II 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. Twinrix is a registered trademark of the GlaxoSmithKline group of companies.
208127/126 (HAB-126) II 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. Twinrix is a registered trademark of the GlaxoSmithKline group of companies.