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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.

NCT00291941 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2008-08-28

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Henogen HBV vaccine

20µg, Month 0, 2 and 6

BIOLOGICAL

FENDRIX

20 µg,Months 0, 1, 2 and 6

Sponsors & Collaborators

Principal Investigators

  • Christian Tielemans, MD, PhD · ULB Hôpital Erasme Département de Néphrologie

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Belgium
  • Czechia
  • Hungary

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00291941 on ClinicalTrials.gov