Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291954
Status:
COMPLETED
Last Update Posted:
2008-08-28
First Post:
2006-02-14
Brief Title:
Compare the Immune Response Safety Elicited by Henogens Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSDs Hepatitis B Vaccine in Pre-Dialysis Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
Sponsor:
Henogen
Organization:
Henogen
Study Overview
Official Title:
A Multicentric Randomised Study Comparing the Immunogenicity and Safety of Henogens Adjuvanted Hepatitis B Vaccine Given at 0 1months to That of Aventis Pasteur MSDs Hepatitis B Given at 0 1 Months in Pre-Dialysis and Dialysis Patients Did Not Respond to Previous Hepatitis B Vaccination
Status:
COMPLETED
Status Verified Date:
2008-08
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:
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers A more immunogenic vaccine would be a benefit for this population
Detailed Description:
Study participants will receive either Henogens adjuvanted hepatitis B vaccine or Aventis Pasteurs hepatitis B vaccine The study involves a total of 4 visits and blood samples will taken at each of these visits
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