Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445185
Status:
COMPLETED
Last Update Posted:
2009-11-19
First Post:
2007-03-07
Brief Title:
Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogens HBV Vaccine or Fendrix
Sponsor:
Henogen
Organization:
Henogen
Study Overview
Official Title:
A Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogens HBV Vaccine HB-AS02V or GSK Biologicals Fendrix
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current extension study will assess the persistence of anti-HBs antibodies at Months 12 24 and 36 after primary vaccination with Henogens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None