Status:
COMPLETED
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
Lead Sponsor:
Henogen
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief 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 po...
Detailed Description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of...
Eligibility Criteria
Inclusion
- Inclusion criteria
- A male or female subject greater than or equal to 15 years of age at the time of study entry
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Seronegative for anti-HBc antibodies and for HBsAg at screening.
- Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients
- Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine.
- The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
- Documented evidence of non-response to previous hepatitis B vaccination after at least one to maximum three months after the last vaccine dose.
- Exclusion criteria
- Subject included on HN014/HBV-001 study. History of Hepatitis B infection Use of immunoglobulins within six months preceding the first study vaccination.
- Any confirmed or suspected human immunodeficiency virus (HIV) infection. Pregnant or lactating female
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00291954
Start Date
March 1 2006
End Date
October 1 2007
Last Update
August 28 2008
Active Locations (25)
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1
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
2
RHMS La Madeleine ATH
Ath, Belgium, 7800
3
RHMS Clinique Louis Caty Baudour
Baudour, Belgium, 7331
4
Cliniques universitaires Saint Luc
Brussels, Belgium, 1200