NCT00696891CompletedPhase 3
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 380
- Locations
- 3
- Primary Endpoint
- Anti-HBs antibody concentrations
Study Overview
Brief Summary
This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population
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
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 50 to 70 years old.
- •Good physical condition as established by clinical examination and history taking at the time of entry.
- •Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
- •Written informed consent obtained from the subjects
Exclusion Criteria
- •Positive at screening for anti-HBV antibodies.
- •Elevated serum liver enzymes
- •History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- •Any acute disease at the moment of entry.
- •Chronic alcohol consumption.
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •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.
- •Simultaneous participation in any other clinical trial.
- •Previous vaccination with a recombinant hepatitis B vaccine.
- •Previous vaccination with an MPL containing vaccine.
- •Administration of immunoglobulins in the past 6 months and during the whole study period
- •Vaccination one week before and one week after each dose of the study vaccine
Outcomes
Primary Outcomes
Anti-HBs antibody concentrations
Time Frame: At Month 7
Secondary Outcomes
- Anti-HBs antibody concentrations(At Months 1, 2, 6, 7 and 12)
- Occurrence and intensity of solicited local symptoms(4-day follow-up after vaccination)
- Occurrence and intensity and relationship to vaccination of solicited general symptoms(4-day follow-up after vaccination)
- Occurrence and intensity of any symptoms (solicited/ unsolicited).(4-day follow-up after vaccination)
- Occurrence, intensity and causal relationship of unsolicited symptoms(Within 30 days after vaccination)
- Serious adverse events(Throughout study period)
Investigators
Study Sites (3)
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