Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine in Healthy Adult Volunteers
1 other identifier
interventional
321
1 country
1
Brief Summary
The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 1993
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
November 1, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 1995
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 1995
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
1.4 years
June 12, 2008
June 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-HBs antibody concentrations
After two doses and after the booster dose
Secondary Outcomes (4)
Occurrence and intensity of local and general solicited symptoms
8 days after vaccination
Anti-HBs antibody concentrations
Screening, M1, 2, 3, 4, 6, 12, 13
Occurrence of unsolicited adverse events
30-day after vaccination
Occurrence of serious adverse events
During the study period and 30 days after the last vaccination
Study Arms (6)
Group A
EXPERIMENTALGroup B
EXPERIMENTALGroup C
EXPERIMENTALGroup D
EXPERIMENTALGroup E
EXPERIMENTALGroup F
ACTIVE COMPARATORInterventions
Intramuscular injection, 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:
- Pregnancy or lactation.
- Positivity for anti hepatitis 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.
- 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
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
November 1, 1993
Primary Completion
April 1, 1995
Study Completion
April 1, 1995
Last Updated
June 16, 2008
Record last verified: 2008-06