NCT00697931
Completed
Phase 3
Study to Compare the Immunogenicity and Reactogenicity of GSK Biologicals; (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine With That of Engerix™-B in an Adult Non-Responder Population
ConditionsHepatitis B
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatitis B
- Sponsor
- GlaxoSmithKline
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Anti-HBs antibody concentrations
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: older than 18 years of age.
- •Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
- •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 an MPL containing vaccine.
Outcomes
Primary Outcomes
Anti-HBs antibody concentrations
Time Frame: At month 7
Secondary Outcomes
- Anti-HBs antibody concentrations(At months 2, 6, 7 and 12)
- Occurrence and intensity of solicited local symptoms(4-day follow-up after vaccination)
- Occurrence, intensity and relationship of solicited general symptoms(4-day follow-up after vaccination)
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms(Within 30 days after vaccination)
- Incidence of serious AEs(Throughout the entire study up to and including 30 days after the last vaccination)
- Cell mediated immunity(At months 0, 2, 6, 7, 12)
Study Sites (1)
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