Twinrix Alternative Schedule Study
Phase 4
- Conditions
- Antibody Response After Vaccination
- Registration Number
- NCT00216229
- Lead Sponsor
- IDEWE Occupational Health Services
- 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.
1. To compare the seroconversion (\>= 1 IU/l) and seroprotection (\>= 10 IU/l) rate at month 6,7,12 and 13.
2. To compare the distribution of anti-HBs at these different moments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-HBs antibodies concentration 1 month after 3th vaccine dose
- Secondary Outcome Measures
Name Time Method Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
Trial Locations
- Locations (1)
IDEWE
🇧🇪Leuven, Belgium