Overview

This trial is active, not recruiting.

Condition antibody response after vaccination
Treatment combined vaccine against hepatitis a and b (twinrix)
Phase phase 4
Sponsor IDEWE Occupational Health Services
Collaborator GlaxoSmithKline
Start date September 2004
End date February 2006
Trial size 400 participants
Trial identifier NCT00216229, 04-033, IDEWE-301

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Anti-HBs antibodies concentration 1 month after 3th vaccine dose
time frame:

Secondary Outcomes

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

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by IDEWE Occupational Health Services.