Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
NCT ID: NCT00699231
Last Updated: 2008-06-17
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
PHASE1
30 participants
INTERVENTIONAL
1992-02-29
1992-12-31
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
DOUBLE
Study Groups
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Group A1
Non-responders to vaccination after at least 7 previous injections
Engerix™-B
IM injection
Group A2
Non-responders to vaccination after at least 7 previous injections
HBV-MPL vaccine 208129
IM injection
Group B1
Vaccine-responders requiring a booster dose
Engerix™-B
IM injection
Group B2
Vaccine-responders requiring a booster dose
HBV-MPL vaccine 208129
IM injection
Group C1
Volunteers participating in the hospital's vaccination program
Engerix™-B
IM injection
Group C2
Volunteers participating in the hospital's vaccination program
HBV-MPL vaccine 208129
IM injection
Group D1
Unvaccinated haemodialysis patients
Engerix™-B
IM injection
Group D2
Unvaccinated haemodialysis patients
HBV-MPL vaccine 208129
IM injection
Interventions
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HBV-MPL vaccine 208129
IM injection
Engerix™-B
IM injection
Eligibility Criteria
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Inclusion Criteria
* A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
* Age: from 18 years onwards
* Seronegative for anti- hepatitis antibodies
Exclusion Criteria
* Any acute disease at the moment of entry into the study
* Chronic alcohol consumption
* Hepatomegaly, right upper quadrant pain or tenderness
* Any treatment with coticosteroids or immunomodulating drugs
* Known hypersensitivity to any component of the vaccine
* Simultaneous participation in any other clinical trial
18 Years
ALL
No
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
Brussels, , Belgium
Countries
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Other Identifiers
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208129/002
Identifier Type: -
Identifier Source: org_study_id