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Clinical Trials/NCT00216229
NCT00216229UnknownPhase 4

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

IDEWE Occupational Health Services2 sites in 1 country400 target enrollmentStarted: September 1, 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
400
Locations
2
Primary Endpoint
Anti-HBs antibodies concentration 1 month after 3th vaccine dose
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Anti-HBs antibodies concentration 1 month after 3th vaccine dose

Secondary Outcomes

  • Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)

Investigators

Sponsor
IDEWE Occupational Health Services
Sponsor Class
Other

Study Sites (2)

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