Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y
Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 18-40 Years
1 other identifier
interventional
163
1 country
1
Brief Summary
This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at 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
March 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 1998
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
1.2 years
June 13, 2008
June 16, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-HBs antibody concentrations
Month 7
Secondary Outcomes (5)
Anti-HBs antibody concentrations
Month 1, 2, 6 and 12
Cell mediated immunity
Month 1, 2, 6, 7 and 12
Occurrence and intensity and relationship to vaccination of solicited local and general symptoms
4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of unsolicited symptoms
31-day follow-up after vaccination
Incidence of SAE
Throughout the study period
Study Arms (6)
Group A
EXPERIMENTALGroup B
EXPERIMENTALGroup C
EXPERIMENTALGroup D
EXPERIMENTALGroup E
EXPERIMENTALGroup F
ACTIVE COMPARATORInterventions
5 different formulations, 2-dose intramuscular injection
Eligibility Criteria
You may qualify if:
- Age: between 18 and 40 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 titres at screening for anti-hepatitis 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 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 month before and one month after each dose of the study vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Clinical Trials Call Center
Ghent, 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
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
March 1, 1997
Primary Completion
May 1, 1998
Last Updated
June 17, 2008
Record last verified: 2008-06