Status:
UNKNOWN
Twinrix Alternative Schedule Study
Lead Sponsor:
IDEWE Occupational Health Services
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Antibody Response After Vaccination
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months...
Eligibility Criteria
Inclusion
- 18 years or older;
- a good physical condition as confirmed by history and physical examination at entry of the study;
- for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen;
- all participants have provided written informed consent.
Exclusion
- Employees occupationally exposed to hepatitis B virus
- Other exclusion criteria listed for the vaccine (licensed vaccine):
- Each acute disease at the inclusion in the study;
- A history of hypersensibility to one of the components of the vaccine;
- Simultaneous participation in another clinical trial
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00216229
Start Date
September 1 2004
End Date
February 1 2006
Last Update
December 14 2005
Active Locations (1)
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1
IDEWE
Leuven, Belgium, B-3001