Hepatitis B
Conditions
Keywords
Dialysis, Pre-dialysis, Hepatitis B vaccine, vaccine
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 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).
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 the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.
Interventions
BIOLOGICALHenogen HB vaccine
Month 12, 24 and 36
BIOLOGICALFendrix vaccine
Month 12, 24 and 36
Sponsors
Henogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent obtained from the subject/ from the parent/ guardian of the subject. * Subjects who completed the full course of primary vaccination.
Exclusion criteria
* Immunosuppression caused by the administration of parenteral steroids or chemotherapy. * Any confirmed or suspected human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody concentrations | Months 12, 24 and 36. |
Secondary
| Measure | Time frame |
|---|---|
| Quality of immune response | Month 12, 24 and 36 |
| SAEs retrospective reporting | 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). | Month 12, 24 and 36 |
Countries
Belgium, Czechia, Hungary
Outcome results
None listed