NCT00291954

Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination

A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1months to That of Aventis Pasteur MSD's Hepatitis B Given at 0, 1 Months in Pre-Dialysis, and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Henogen · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.

Detailed description

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	HB-AS02V	HB-AS02V (20µg HBsAg) will be administered at Month 0 and 1
BIOLOGICAL	HBVAXPRO vaccine	HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0 and 1

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-02-15
• Last updated: 2008-08-28

Locations

25 sites across 3 countries: Belgium, Czechia, Hungary