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 · Type: INTERVENTIONAL · Enrollment: 163
Last updated 2008-06-17
Summary
This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months
Conditions
Interventions
- BIOLOGICAL
-
HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
- BIOLOGICAL
-
Engerix™-B
3-dose intramuscular injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 1997-03-31
- Primary Completion
- 1998-05-31
Countries
- Belgium
Study Locations
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