GlaxoSmithKline: Hepatitis B trials

The registry lists 144 Hepatitis B studies with GlaxoSmithKline as lead sponsor. 2 are open to participants now and 69 have results posted.

Phase 1 11Phase 2 36Phase 3 56Phase 4 36No phase 7(a study in two phases counts in both)

Studies

Page 2 of 2. Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as ControlCompletedNCT00697866Phase 3
• Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy AdultsCompletedNCT00697853Phase 2
• Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-BCompletedNCT00697840Phase 3
• Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy AdolescentsCompletedNCT00697775Phase 2
• Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 GenotypeCompletedNCT00697749Phase 3
• Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of AgeCompletedNCT00697554Phase 3
• Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older AdultsCompletedNCT00697242Phase 3
• Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different SchedulesCompletedNCT00697229Phase 2
• Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).CompletedNCT00697216Phase 3
• Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different AdjuvantsCompletedNCT00697125Phase 2
• Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15yCompletedNCT00696917Phase 3
• Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in AdultsCompletedNCT00696891Phase 3
• Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in AdultsCompletedNCT00603252Phase 4
• Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)CompletedNCT00508833Phase 1/2
• Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy InfantsCompletedNCT00429481Phase 2
• Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine ChallengeCompletedNCT00411697Phase 4
• Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsCompletedNCT00383591Phase 3
• Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsCompletedNCT00383383Phase 3
• Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 YearsCompletedNCT00383227Phase 3
• Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of AgeCompletedNCT00376779Phase 2
• To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV VaccinesCompletedNCT00366366Phase 3
• Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/HibCompletedNCT00356564Phase 4
• Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).CompletedNCT00352963Phase 3
• Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/HibCompletedNCT00335881Phase 4
• Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/HibCompletedNCT00332566Phase 3
• Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B VaccineCompletedNCT00329576Phase 4
• Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy InfantsCompletedNCT00320463Phase 3
• Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.CompletedNCT00317187Phase 3
• A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.CompletedNCT00317174Phase 2
• Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.CompletedNCT00317161Phase 3
• Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.CompletedNCT00317135Phase 3
• Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at BirthCompletedNCT00317122Phase 3
• Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.TerminatedNCT00316680Phase 3
• Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination SchedulesCompletedNCT00316147Phase 3
• Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488CompletedNCT00307567Phase 2
• Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to InfantsCompletedNCT00291967Phase 2
• Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy InfantsCompletedNCT00290303Phase 3
• Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib VaccineCompletedNCT00289796Phase 2
• Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in InfantsCompletedNCT00197275Phase 3
• Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B VaccineCompletedNCT00197171Phase 3
• Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune ResponseCompletedNCT00197158Phase 4
• Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 MthsCompletedNCT00158808Phase 2
• Post-marketing Safety Study of GSK Biological's Pediarix™ VaccineCompletedNCT00146835
• Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)CompletedNCT00140725Phase 3