Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules
1 other identifier
interventional
99
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 1992
Longer than P75 for phase_2
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
September 1, 1992
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1998
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
3.7 years
June 11, 2008
June 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-hepatitis B surface antigen (HBs) antibody concentrations
One month after the full primary vaccination course and one month after the booster vaccination at 70 months
Secondary Outcomes (5)
Anti-HBs antibody concentrations
Months 1, 2, 3, 6, 12, 13, 42
Serious adverse experiences (SAE).
Throughout the study period
Occurrence and intensity of solicited local symptoms
8-day follow-up after vaccination
Occurrence, intensity and relationship of solicited general symptoms
8-day follow-up after vaccination
Incidence of unsolicited symptoms
During the 30-day follow-up after vaccination
Study Arms (8)
Group A
EXPERIMENTALSubjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Group B
EXPERIMENTALSubjects will receive HBV-MPL vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Group C
EXPERIMENTALSubjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Group D
EXPERIMENTALSubjects will receive Engerix™-B vaccine in the primary schedule 0, 2 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Group E
EXPERIMENTALSubjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Group F
EXPERIMENTALSubjects will receive HBV-MPL vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Group G
EXPERIMENTALSubjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months
Group H
EXPERIMENTALSubjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months
Interventions
Intramuscular injection, 1 or 3 doses
Eligibility Criteria
You may qualify if:
- Between 18 and 40 years old.
- Written informed consent will have been obtained from the subjects.
- Good physical condition as established by physical examination and history taking at the time of entry.
- Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.
You may not qualify if:
- Positive titres for anti hepatitis B antibodies.
- Any vaccination against hepatitis B in the past.
- Elevated serum liver enzymes.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Axillary temperature \> 37°C at the time of injection.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- History of allergic disease likely to be stimulated by any component of the vaccine.
- Administration of any other vaccine(s) or any immunoglobulin during the study period.
- 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
Wilrijk, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 13, 2008
Study Start
September 1, 1992
Primary Completion
May 1, 1996
Study Completion
December 1, 1998
Last Updated
June 13, 2008
Record last verified: 2008-06