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

NCT00445185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2009-11-19

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

Henogen HB vaccine

Month 12, 24 and 36

BIOLOGICAL

Fendrix vaccine

Month 12, 24 and 36

Sponsors & Collaborators

  • Henogen

    lead INDUSTRY

Principal Investigators

  • Joëlle Nortier, MD, PhD · ULB Hôpital Erasme Département de Néphrologie

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-07-31
Completion
2009-11-30

Countries

  • Belgium
  • Czechia
  • Hungary

Study Locations

More Related Trials

Entities

Diseases

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 NCT00445185 on ClinicalTrials.gov