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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
102
Month 12, 24 and 36
Month 12, 24 and 36
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium
RHMS La Madeleine ATH
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ath, Belgium
RHMS Clinique Louis Caty Baudour
Baudour, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
Brussels, Belgium
ULB Hôpital Erasme Département de Néphrologie
Brussels, Belgium
AZ -VUB Dienst Nefrologie
Brussels, Belgium
Cliniques universitaires Saint Luc
Brussels, Belgium
CHU Hôpital civil de
Charleroi, Belgium
UZ Gent
Ghent, Belgium
CHU Tivoli
La Louvière, Belgium
...and 13 more locations