Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Status and phase
Completed
Phase 3
Conditions
Hepatitis B
Treatments
Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
Biological: Engerix™-B
Details and patient eligibility
About
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
Full description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Enrollment
60 patients
Sex
All
Ages
18 to 40 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
60 participants in 3 patient groups
Group A
Experimental group
Treatment:
Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
Group B
Active Comparator group
Treatment:
Biological: Engerix™-B
Group C
Experimental group
Treatment:
Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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