NCT00698087CompletedPhase 3
Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Anti-HBs antibody concentrations
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Group A
Experimental
Intervention: MPL-Adjuvanted recombinant hepatitis B vaccine (Biological)
Group B
Active Comparator
Intervention: Engerix™-B (Biological)
Group C
Experimental
Intervention: MPL-Adjuvanted recombinant hepatitis B vaccine (Biological)
Outcomes
Primary Outcomes
Anti-HBs antibody concentrations
Time Frame: At M3 and M13
Occurrence of local and general solicited symptoms
Time Frame: 4-day follow-up after vaccination
Occurrence of unsolicited symptoms
Time Frame: 30-day follow-up after vaccination
Secondary Outcomes
- Anti-HBs antibody concentrations(Months 2, 3, 6, 9, 12, 13)
- SAEs(Throughout the study up to 30 days after last vaccination)
Investigators
Study Sites (1)
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