Status:
COMPLETED
Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™
Lead Sponsor:
Henogen
Conditions:
Hepatitis B
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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 wit...
Detailed Description
Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after t...
Eligibility Criteria
Inclusion
- Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
- Subjects who completed the full course of primary vaccination.
Exclusion
- Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
- Any confirmed or suspected human immunodeficiency virus (HIV) infection.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00445185
Start Date
March 1 2007
End Date
November 1 2009
Last Update
November 19 2009
Active Locations (23)
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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
CHU Brugmann (site V Horta) Service de néphrologie
Brussels, Belgium, 1020