NCT00445185

Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™

A Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12, 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogen's HBV Vaccine, HB-AS02V or GSK Biological's Fendrix™

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Henogen · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives \& outcome measures of the extension phase at Months 12, 24 and 36. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).

Detailed description

Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Henogen HB vaccine	Month 12, 24 and 36
BIOLOGICAL	Fendrix vaccine	Month 12, 24 and 36

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-07-01
• Completion: 2009-11-01
• First posted: 2007-03-08
• Last updated: 2009-11-19

Locations

23 sites across 3 countries: Belgium, Czechia, Hungary