Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
NCT ID: NCT00697931
Last Updated: 2008-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
1997-05-31
1998-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group A
Recombinant MPL- adjuvanted hepatitis B vaccine
Intramuscular injection, 3 doses
Group B
Engerix™-B
Intramuscular injection, 3 doses
Interventions
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Recombinant MPL- adjuvanted hepatitis B vaccine
Intramuscular injection, 3 doses
Engerix™-B
Intramuscular injection, 3 doses
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Administration of immunoglobulins 6 months before and during the whole study period
* Vaccination one month before and one month after each dose of the study vaccine
18 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Clinical Trials Call Center
Leuven, , Belgium
Countries
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Other Identifiers
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208129/021
Identifier Type: -
Identifier Source: org_study_id