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

Launched by HENOGEN · Feb 14, 2006

Keywords

ClinConnect Summary

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 these visits.

Gender

ALL

Eligibility criteria

• • 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