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A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.

NCT00291980 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2008-08-28

No results posted yet for this study

Summary

The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this population.

Conditions

Interventions

BIOLOGICAL

HB-AS02V vaccine

HB-AS02V (20µg HBsAg) will be administered at Month 0

BIOLOGICAL

HBVAXPRO vaccine

HBVAXPRO vaccine (40µg HBsAg) will be administered at Month 0

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

More Related Trials

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 NCT00291980 on ClinicalTrials.gov