A Phase 3 interventional study of Henogen HB vaccine and Fendrix vaccine in Hepatitis B, sponsored by Henogen. Completed at 23 sites in 3 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-11-19.
Sponsored by Henogen · Phase 3, Interventional, and Prevention
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).
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 the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.
1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.
This study's planned enrollment of 102 is below the median of 120 across 1,191 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Henogen is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Henogen Hepatitis B vaccine for uremic patients
Biological: Henogen HB vaccine
Fendrix hepatitis B vaccine for uremic patients
Biological: Fendrix vaccine
Month 12, 24 and 36
Month 12, 24 and 36
Anti-HBs antibody concentrations
Time frame: Months 12, 24 and 36.
Quality of immune response
Time frame: Month 12, 24 and 36
SAEs retrospective reporting
Time frame: Month 12, 24 and 36
RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001).
Time frame: Month 12, 24 and 36
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Henogen