Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
NCT00697125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2008-06-13
Summary
The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
Conditions
Interventions
- BIOLOGICAL
-
Engerix™-B
Intramuscular injection, 3 doses
- BIOLOGICAL
-
HBV-MPL vaccine (208129)
- BIOLOGICAL
-
Hepatitis B vaccine, experimental formulation
Intramuscular injection, 3 doses
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 1993-06-30
- Primary Completion
- 1994-07-31
- Completion
- 1994-07-31
Countries
- Belgium
Study Locations
More Related Trials
-
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
NCT00698087 ·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 Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults
NCT00697242 ·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 and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
NCT00696917 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
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
-
Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y
NCT00698061 ·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
-
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
-
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
-
Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
NCT00697866 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine
NCT00329576 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
NCT00697775 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
NCT00697749 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
NCT00805389 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
NCT00699231 ·Status: COMPLETED ·Phase: PHASE1
-
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
NCT00343915 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age
NCT00697554 ·Status: COMPLETED ·Phase: PHASE3
-
Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
NCT00984139 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
NCT00440531 ·Status: COMPLETED ·Phase: PHASE3
-
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
NCT00289744 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
NCT02153320 ·Status: COMPLETED ·Phase: PHASE1