Twinrix Alternative Schedule Study
Overview
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.
Full Title of Study: “A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
Interventions
- Biological: Combined vaccine against hepatitis A and B (Twinrix)
Clinical Trial Outcome Measures
Primary Measures
- Anti-HBs antibodies concentration 1 month after 3th vaccine dose
Secondary Measures
- Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- IDEWE Occupational Health Services
- Collaborator
- GlaxoSmithKline
- Overall Official(s)
- Antoon A De Schryver, M.D., PhD, Principal Investigator, IDEWE Occupational Health Services
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