Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 1995
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1995
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 1996
CompletedFirst Submitted
Initial submission to the registry
June 12, 2008
CompletedFirst Posted
Study publicly available on registry
June 16, 2008
CompletedJune 16, 2008
June 1, 2008
1.1 years
June 12, 2008
June 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Anti-HBs antibody concentrations
At M3 and M13
Occurrence of local and general solicited symptoms
4-day follow-up after vaccination
Occurrence of unsolicited symptoms
30-day follow-up after vaccination
Secondary Outcomes (2)
SAEs
Throughout the study up to 30 days after last vaccination
Anti-HBs antibody concentrations
Months 2, 3, 6, 9, 12, 13
Study Arms (3)
Group A
EXPERIMENTALGroup B
ACTIVE COMPARATORGroup C
EXPERIMENTALInterventions
Intramuscular injection, 2 or 3 doses, 2 different formulations
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:
- Pregnancy or lactation.
- Positive titres for anti hepatitis B antibodies
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL.
- Elevated serum liver enzymes.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Axillary temperature \> 37.5°C at the time of injection.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- Any treatment with immunosuppressive or immunostimulant therapy.
- History of allergic disease likely to be stimulated by any component of the vaccine.
- Simultaneous administration of any other vaccine(s).
- Administration of 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
Vienna, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 12, 2008
First Posted
June 16, 2008
Study Start
January 1, 1995
Primary Completion
February 1, 1996
Study Completion
February 1, 1996
Last Updated
June 16, 2008
Record last verified: 2008-06