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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

NCT00291954 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2008-08-28

No results posted yet for this study

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.

Conditions

Interventions

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

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
2006-03-31
Primary Completion
2007-10-31
Completion
2007-10-31

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 NCT00291954 on ClinicalTrials.gov