Hepatitis B
Conditions
Keywords
Hepatitis B, Engerix™-B, Recombinant hepatitis B vaccine
Brief summary
The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months
Detailed description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Interventions
BIOLOGICALEngerix™-B
Intramuscular injection, 1 or 3 doses
BIOLOGICALHBV-MPL vaccine
Intramuscular injection, 1 or 3 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 40 years old. * Written informed consent will have been obtained from the subjects. * Good physical condition as established by physical examination and history taking at the time of entry. * Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.
Exclusion criteria
* Positive titres for anti hepatitis B antibodies. * Any vaccination against hepatitis B in the past. * Elevated serum liver enzymes. * History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * Axillary temperature \> 37°C at the time of injection. * Any acute disease at the moment of entry. * Chronic alcohol consumption. * Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. * History of allergic disease likely to be stimulated by any component of the vaccine. * Administration of any other vaccine(s) or any immunoglobulin during the study period. * Simultaneous participation in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-hepatitis B surface antigen (HBs) antibody concentrations | One month after the full primary vaccination course and one month after the booster vaccination at 70 months |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody concentrations | Months 1, 2, 3, 6, 12, 13, 42 |
| Serious adverse experiences (SAE). | Throughout the study period |
| Occurrence and intensity of solicited local symptoms | 8-day follow-up after vaccination |
| Occurrence, intensity and relationship of solicited general symptoms | 8-day follow-up after vaccination |
| Incidence of unsolicited symptoms | During the 30-day follow-up after vaccination |
Countries
Belgium
Outcome results
None listed