Trial | NCT00216229  Report issue

Title

Twinrix Alternative Schedule Study
A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    400
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.

To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month 6,7,12 and 13.
To compare the distribution of anti-HBs at these different moments.
Study Started
Sep 30
2004
Study Completion
Feb 28
2006
Last Update
Dec 14
2005
Estimate

Biological Combined vaccine against hepatitis A and B (Twinrix)

Criteria 

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
No Results Posted