NCT00291941

A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.

A Multicentric, Randomised Study Comparing the Immunogenicity and Safety of Henogen's Adjuvanted Hepatitis B Vaccine Given at 0, 1, 6 Months to That of GSK Biologicals' Adjuvanted Hepatitis B Vaccine Given at 0, 1, 2, 6 Moths in Pre-Dialysis, and Dialysis Patients Who Are Hepatitis B Naive.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Henogen · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.

Detailed description

Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Henogen HBV vaccine	20µg, Month 0, 2 and 6
BIOLOGICAL	FENDRIX	20 µg,Months 0, 1, 2 and 6

Timeline

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

Locations

24 sites across 3 countries: Belgium, Czechia, Hungary