Twinrix Alternative Schedule Study
This trial is active, not recruiting.
|Condition||antibody response after vaccination|
|Treatment||combined vaccine against hepatitis a and b (twinrix)|
|Sponsor||IDEWE Occupational Health Services|
|Start date||September 2004|
|End date||February 2006|
|Trial size||400 participants|
|Trial identifier||NCT00216229, 04-033, IDEWE-301|
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.
|Endpoint classification||bio-equivalence study|
|Intervention model||parallel assignment|
Anti-HBs antibodies concentration 1 month after 3th vaccine dose
Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
Male or female participants at least 18 years old.
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
|Official title||A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)|
|Principal investigator||Antoon A De Schryver, M.D., PhD|
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