Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
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 Jun 1993
Shorter than P25 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
June 1, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 1994
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 1994
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
1.1 years
June 11, 2008
June 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence and intensity of solicited local and general symptoms
8 days follow-up after vaccination
Secondary Outcomes (3)
Anti-HBs antibody concentrations
Months 0, 1, 3, 6, 7, 8 and 12
Occurrence, intensity of unsolicited adverse events
30-day follow-up after vaccination
Occurrence of serious adverse events
During the study period up to 30 days after last vaccination
Study Arms (3)
Group A
ACTIVE COMPARATORGroup B
EXPERIMENTALGroup C
EXPERIMENTALInterventions
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.
- Serological signs of HBV infection
- Elevated serum liver enzymes
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL.
- 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.
- 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
Ghent, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- 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, 1993
Primary Completion
July 1, 1994
Study Completion
July 1, 1994
Last Updated
June 13, 2008
Record last verified: 2008-06