Hepatitis B Vaccine, Recombinant 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).

The summaries are in PDF format. If you do not have Adobe® Acrobat® Reader™ installed, you can download it for free.


Hepatitis B Vaccine, Recombinant studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
103860/128 (HBV-128) IV A study to evaluate antibody responses to 10 and 20 µg of licensed recombinant hepatitis B vaccine among elderly patients
103860/283 (HBV-283) IV A phase IV, single-blind, randomised, single centre study to demonstrate the non-inferiority in terms of immunogenicity of multidose ENGERIX-B with 2-phenoxyethanol as preservative to that elicited by multidose ENGERIX™-B with thiomersal as preservative, when administered according to a 0, 1, 6 month schedule in healthy adults aged ł 18 years.
104387 (HBV-308) IV A phase IV, single-blinded, randomized, single centre study to demonstrate the non-inferiority of immunogenicity elicited by GSK Biologicals’ hepatitis B vaccine, Engerix™-B in multidose presentation to that elicited by Engerix™-B in monodose presentation when administered according to 0, 1, 6 months schedule in healthy adults aged = 18 years.
106640 (HBV-312 Ext 269 Year 6) IV A phase IV, open, multicentric study to evaluate the anti-HBs antibody persistence, in subjects (aged 18 to 50 years at the time of primary vaccination), who received GlaxoSmithKline (GSK) Biologicals’ preservative-free Engerix™-B or thiomersal-free Engerix™-B vaccines or Engerix™-B containing 50 µg thiomersal/ dose, intramuscularly, approximately five to six years earlier.
106744 (DTPa-HBV-IPV-110) IV An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children 7 to 9 years old, previously vaccinated with 4 doses of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine or 4 doses of GSK Biologicals’ HBV vaccine, in clinical trials conducted by GSK Biologicals. Infanrix hexa™: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) Engerix™-B Kinder: GSK Biologicals’ hepatitis B vaccine (HBV)
106745 (DTPa-HBV-IPV-111) IV An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children 4-6 years old, previously vaccinated with 4 doses of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine, in clinical trials conducted by GSK Biologicals. DTPa-HBV-IPV/Hib (Infanrix hexa™): GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine.
106789 (DTPa-HBV-IPV-112) IV An open, phase IV, single-group multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in children at 4-5 years of age, previously primed and boosted in the first two years of life with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine. Infanrix hexa™ (DTPa-HBV-IPV/Hib): GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine. Engerix™-B Kinder: Hepatitis B vaccine: GSK Biologicals hepatitis B vaccine.
103860/015 (HBV-015) III A study of the reactogenicity, immunogenicity, and protective efficacy of three doses (20mcg or 40mcg) of the Smith Kline – RIT recombinant DNA yeast-derived hepatitis B vaccine in homosexual males.
103860/064 (HBV-064) III Immunogenicity and protective efficacy of SmithKline Beecham Biological’s r-DNA hepatitis B vaccine (10µg) in newborns of HbeAg+ and HbsAg+ mothers in comparison with a historical control group
103860/215 (HBV-215) III Assessment of the clinical acceptability and immunogenicity of SmithKline Biologicals’ recombinant DNA hepatitis B vaccine in HIV seropositive (HIV+) and HIV seronegative (HIV-) subjects. Extensive searching has revealed that no clinical study report is available for this study. The clinical trial results were reported via publication; see citation below.
103860/277 (HBV-277) III A phase III, double-blind, randomized, comparative, multicenter study of the immunogenicity and safety of three doses of GlaxoSmithKline Biologicals' thimerosal-free hepatitis B vaccine (10 mg/0.5 mL) compared to the US-licensed GlaxoSmithKline Biologicals' preservative-free hepatitis B vaccine (Engerix-BŇ, 10 mg/0.5 mL) when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life
103860/280 (HBV-280) III A phase III, single-blinded, randomized, multicentric study to compare the immunogenicity of GlaxoSmithKline (GSK) Biologicals' thiomersal-free 2-dose ENGERIX™-B (20mg) and 3-dose preservative-free ENGERIX™-B (10mg) vaccines administered intramuscularly according to a 0, 6 month and 0, 1, 6 month schedule, respectively, and to evaluate safety and reactogenicity of each vaccine in healthy adolescent volunteers (11 to 15 years).
103860/280 (HBV-280) – 101695 (Ext HBV-280 M30) – 101696 (Ext HBV-280 M42) III A phase III, single-blinded, randomized, multicentric study to compare the immunogenicity of GlaxoSmithKline (GSK) Biologicals' thiomersal-free 2-dose ENGERIX™-B (20 µg) and 3-dose preservative-free ENGERIX™-B (10 µg) vaccines administered intramuscularly according to a 0, 6 month and 0, 1, 6 month schedule, respectively, and to evaluate safety and reactogenicity of each vaccine in healthy adolescent volunteers (11 to 15 years). Engerix™-B: GSK Biologicals’ commercially available recombinant hepatitis B vaccine (HBV).
103860/280 (HBV-280) – 101695 (Ext HBV-280 M30) – 101696 (Ext HBV-280 M42) – 101697 (Ext HBV-280 M54) III A phase III, single-blinded, randomized, multicentric study to compare the immunogenicity of GlaxoSmithKline (GSK) Biologicals' thiomersal-free 2-dose ENGERIX™-B (20 µg) and 3-dose preservative-free ENGERIX™-B (10 µg) vaccines administered intramuscularly according to a 0, 6 month and 0, 1, 6 month schedule, respectively, and to evaluate safety and reactogenicity of each vaccine in healthy adolescent volunteers (11 to 15 years). Engerix™-B: GSK Biologicals’ commercially available recombinant hepatitis B vaccine (HBV).
103860/282 (HBV-282) III A phase III double-blind, randomized, controlled, monocenter study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline preservative free Engerix™-B comparing aged lot (>24 months) and, as reference, new lot (<12 months) when administered intramuscularly according to a 0,1,6 month schedule in healthy volunteers (18 to 50 years).
103860-046 (HBV-046) III Assessment of the clinical acceptability, immunogenicity and long-term preventive efficacy of GlaxoSmithKline (previously SmithKline Beecham and SmithKline-Rit) Biologicals’ recombinant DNA anti-hepatitis B vaccine in hemophiliacs.
103860-115 (HBV-115 bis) III Immunogenicity and protective efficacy of SmithKline Beecham Biologicals’ hepatitis B vaccine (10 mg) in newborns of HBeAg and HBsAg positive mothers compared with a historical control group.
103860-115 (HBV-115) III Immunogenicity and protective efficacy of GlaxoSmithKline (previously SmithKlineBeecham) Biologicals’ hepatitis B vaccine (10mg) in newborn of HBeAg and HBsAg positive mothers compared with a historical control group.
103860-143 (HBV-143) III Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (previously SmithKline Beecham and SmithKline-Rit) Biologicals’ recombinant DNA hepatitis B vaccine with or without hepatitis B immune globulins (HBIg) in newborns of HBeAg-positive mothers.
103860-270 (HBV-270) III A phase III, double-blind, randomized, multicentric study to evaluate the safety and consistency of 3 consecutive lots of GlaxoSmithKline Biologicals’ thiomersal-free Engerix-B™ vaccine containing 20 µg of hepatitis B surface antigen (HbsAg) per 1 ml dose, when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers aged from 18 to 40 years.
208129/032 (HBV-MPL-032) - 208129/042 (EXT:HBV-MPL-032) - 208129/047 (EXT:HBV-MPL-032) III 208129/032: A phase III, multinational, controlled, open, randomized clinical trial comparing the immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals’ new adjuvanted hepatitis B vaccine to that of a double dose of ENGERIX™-B (20 ?g), administered according to a 0, 1, 2, 6 month schedule in pre-haemodialysis/haemodialysis patients (? 15 years of age). 208129/042 & 208129/047: A phase III, multinational study comparing the persistence of anti-Hepatitis B surface antigen (HBs) antibodies at months 24, 30, 36 in pre-haemodialysis/ haemodialysis patients (= 15 years of age) who had previously received a primary vaccination course of either GlaxoSmithKline Biologicals new adjuvanted hepatitis B vaccine (HB-AS04C) or Engerix™-B. This study will also evaluate the anti-HBs anamnestic response to HB-AS04C booster doses in pre-haemodialysis/ haemodialysis patients (= 15 years of age) who have previously received a primary vaccination course of either GlaxoSmithKline Biologicals new adjuvanted hepatitis B vaccine (HB-AS04C) or Engerix™-B and whose anti-HBs titres have fallen below 10 mIU/ ml. Note: A booster dose of GSK Biologicals’ new adjuvanted hepatitis B vaccine, HB-AS04C, was administered to all subjects who returned approximately 3.5 years (Month 42) after primary vaccination with either HB-AS04C or Engerix™-B. Engerix™-B (HBV): GlaxoSmithKline (GSK) Biologicals’ recombinant hepatitis B vaccine. FendrixTM: GSK Biologicals’ adjuvanted hepatitis B vaccine (HB-AS04C
208129/032 (HBV-MPL-032) and 208129/042 (EXT:HBV-MPL-032) III A phase III, multinational, controlled, open, randomized clinical trial comparing the immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals’ new adjuvanted hepatitis B vaccine to that of a double dose of ENGERIXä-B (20 µg), administered according to a 0, 1, 2, 6 month schedule in pre-haemodialysis/haemodialysis patients (ł 15 years of age).
208129/033 (HBV-MPL-033) and 208109/038 (Ext-HBV-MPL-033) III A phase III, multinational, single-blind, randomized, controlled clinical study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals novel adjuvanted hepatitis B vaccine containing 20 mg of HBsAg on AS04 per 0.5 ml dose to ENGERIX™-B 20 mg, in a non-responder population ł 15 years of age, when administered intramuscularly, according to a 0, 1, 2, 12 month schedule.
208129/034 (HBV-MPL-034) III A phase III, open, controlled, randomised clinical study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (previously SmithKline Beecham) Biologicals’ novel adjuvanted hepatitis B vaccine containing 20 mcg of hepatitis B surface antigen (HBsAg) on SBAS4 per 0.5 ml dose, administered intramuscularly, according to a 0, 6 month schedule, to Engerix™-B 20 mcg administered according to a 0,1,6 month schedule in healthy volunteers (= 15 years) positive for the HLA-DQ2 genotype.
208129/036 (HBV-MPL-036) III Phase III, open, controlled-randomised clinical study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ novel adjuvanted hepatitis B vaccine containing 20µg of HBsAg on AS04C per 0.5ml dose, administered intramuscularly according to a 0, 21-day schedule, to a double dose of Engerix ™-B (2 x 20µg) when administered according to a 0, 7, 21-day schedule, in pre-liver transplant patients =18 years of age, with an additional dose administered at Month 6-12.
208129-037 (HBV-MPL-037). III A phase III, double-blind, randomized, multicentre study to evaluate the consistency of 3 consecutive lots of GlaxoSmithKline Biologicals' novel adjuvanted hepatitis B vaccine containing 20mg of HBsAg on AS04 per 0.5ml dose, with single-blind safety evaluation using Engerixä-B, 20mg HBsAg as a control, when administered intramuscularly according to a 0, 1, 2 month schedule in healthy volunteers aged from 15 to 50 years.
213501/019 (DTPw-HBV-Hib-019) III Phase III, primary vaccination study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ quadrivalent diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B (DTPw-HBV) and Haemophilus influenzae type b conjugate (Hib) vaccines when mixed extemporaneously and given in a single injection at 2, 4 and 6 months of age to healthy infants previously primed at birth with GSK Biologicals’ hepatitis B vaccine.
759346/007 III A phase III, open, randomized, controlled primary vaccination study to demonstrate the non-inferiority of an investigational vaccination regimen as compared to Tritanrix™-HepB/Hiberix™ with respect to the immunogenicity of the hepatitis B antigen, when administered to healthy infants at 6, 10 and 14 weeks of age after a birth dose of hepatitis B vaccine. DTPw-HBV/Hib (Tritanrix™-HepB/Hiberix™): GlaxoSmithKline (GSK) Biologicals’ combined diphtheria, tetanus, whole cell pertussis and hepatitis B vaccine mixed with Haemophilus influenzae type b vaccine (Hib). HBV (Engerix™-B): GSK Biologicals’ hepatitis B vaccine
104297 II An open follow-up study for a 2-year period (extending from 21 to 45 months post Dose 1) of the safety and immunogenicity of an investigational vaccination regimen in children enrolled to study 257049/026 - a randomised controlled phase IIb study in children aged 1 to 4 years in Mozambique.
103860/269 (HBV-269) II A phase II double-blind, randomized, controlled, multicenter study to evaluate the immunogenicity of GlaxoSmithKline Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers (18 to 50 years).
103860/271 (Ext-HBV-064 Y14-Y15) II Immunogenicity and protective efficacy of GlaxoSmithKline (GSK) r-DNA hepatitis B vaccine (10 mg) in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.
103860/275 (HBV-275) II A phase II, open, randomized, single center study to compare the immunogenicity, reactogenicity and safety of three different experimental formulations of GlaxoSmithKline (GSK) Biologicals’ hepatitis B vaccine compared to that of Engerix™-B administered following a 3 dose schedule (0, 1, 6 months) in healthy adults aged 18-40 years.
210602/002 & 105752 II Randomized, phase II, double blind, controlled study to 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 second year of life by a booster dose of Infanrix hexa™. Infanrix hexa™ (DTPa-HBV-IPV/Hib): GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine.
257049/026 II A double-blind randomised controlled Phase IIb study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals’ candidate vaccine RTS,S/AS02A, administered IM according to a 0, 1 and 2 month vaccination schedule in toddlers and children aged 1 to 4 years in a region of Mozambique.
580299 (HPV) 011 II A phase I/II, observer-blind, randomized, controlled study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy male subjects aged 10-18 years. HPV: human papillomaviruses
257049-025 I A phase I, double-blind, randomized, controlled, study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate vaccine, administered intramuscularly according to a 0, 1, 2-month vaccination schedule in children aged 1 through 4 years in Mozambique.