Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
1 other identifier
interventional
380
3 countries
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
3 active sites
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
June 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 1999
CompletedFirst Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 13, 2008
CompletedJune 13, 2008
June 1, 2008
1.9 years
June 11, 2008
June 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-HBs antibody concentrations
At Month 7
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALGroup B
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
GSK Clinical Trials Call Center
Wilrijk, Belgium
GSK Clinical Trials Call Center
Toronto, Canada
GSK Clinical Trials Call Center
Gothenburg, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 13, 2008
Study Start
June 1, 1997
Primary Completion
May 1, 1999
Last Updated
June 13, 2008
Record last verified: 2008-06