Hepatitis B
Conditions
Keywords
Hepatitis B, Engerix™-B, Adjuvanted recombinant hepatitis B vaccine
Brief summary
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary
Detailed description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Interventions
BIOLOGICALMPL-Adjuvanted recombinant hepatitis B vaccine
Intramuscular injection, 2 or 3 doses, 2 different formulations
BIOLOGICALEngerix™-B
Intramuscular injection, 2 or 3 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
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
* Pregnancy or lactation. * Positive titres for anti hepatitis B antibodies * Any vaccination against hepatitis B in the past. * Any previous administration of MPL. * Elevated serum liver enzymes. * History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * Axillary temperature \> 37.5°C at the time of injection. * Any acute disease at the moment of entry. * Chronic alcohol consumption. * Any treatment with immunosuppressive or immunostimulant therapy. * Any chronic drug treatment, 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. * Simultaneous administration of any other vaccine(s). * Administration of any immunoglobulin during the study period. * Simultaneous participation in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody concentrations | At M3 and M13 |
| Occurrence of local and general solicited symptoms | 4-day follow-up after vaccination |
| Occurrence of unsolicited symptoms | 30-day follow-up after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| SAEs | Throughout the study up to 30 days after last vaccination |
| Anti-HBs antibody concentrations | Months 2, 3, 6, 9, 12, 13 |
Countries
Austria
Outcome results
None listed