Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
NCT00697749 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230
Last updated 2016-09-16
Summary
This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype
Conditions
Interventions
- BIOLOGICAL
-
HBV-MPL vaccine 208129
2-dose intramuscular injection
- BIOLOGICAL
-
Engerix™-B
3-dose intramuscular injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 1999-04-30
- Primary Completion
- 2000-01-31
- Completion
- 2000-01-31
More Related Trials
-
Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
NCT00697229 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
NCT00696917 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
NCT00697931 ·Status: COMPLETED ·Phase: PHASE3
-
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
NCT00696891 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B
NCT00697840 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
NCT00698087 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
NCT00697125 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
NCT00697775 ·Status: COMPLETED ·Phase: PHASE2
-
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
NCT01777295 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
NCT00805389 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y
NCT00698906 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y
NCT00698555 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection
NCT03866187 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine
NCT00657657 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
NCT00508833 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults
NCT00603252 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
NCT00699231 ·Status: COMPLETED ·Phase: PHASE1
-
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
NCT00774995 ·Status: COMPLETED ·Phase: PHASE4
-
Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B
NCT02901951 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults
NCT00697242 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
NCT00880477 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response
NCT00197158 ·Status: COMPLETED ·Phase: PHASE4
-
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
NCT01627340 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
NCT00697970 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
NCT00289731 ·Status: COMPLETED ·Phase: PHASE4