Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
Study to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine Versus Engerix™-B, in Haemodialysis Patients
1 other identifier
interventional
30
1 country
1
Brief Summary
This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 1992
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1992
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 1992
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1992
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedJune 17, 2008
June 1, 2008
10 months
June 13, 2008
June 16, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Occurrence and intensity of solicited local and general symptoms
4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events
During the course of the study
Occurrence of serious adverse events
During the course of the study
Anti-HBs antibody concentrations
Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation
Study Arms (8)
Group A1
ACTIVE COMPARATORNon-responders to vaccination after at least 7 previous injections
Group A2
EXPERIMENTALNon-responders to vaccination after at least 7 previous injections
Group B1
ACTIVE COMPARATORVaccine-responders requiring a booster dose
Group B2
EXPERIMENTALVaccine-responders requiring a booster dose
Group C1
ACTIVE COMPARATORVolunteers participating in the hospital's vaccination program
Group C2
EXPERIMENTALVolunteers participating in the hospital's vaccination program
Group D1
ACTIVE COMPARATORUnvaccinated haemodialysis patients
Group D2
EXPERIMENTALUnvaccinated haemodialysis patients
Interventions
Eligibility Criteria
You may qualify if:
- Dialysis patients
- 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
You may not qualify if:
- History of persistent hepatic, cardiac or respiratory disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Clinical Trials Call Center
Brussels, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
February 1, 1992
Primary Completion
December 1, 1992
Study Completion
December 1, 1992
Last Updated
June 17, 2008
Record last verified: 2008-06