Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291980
Status:
COMPLETED
Last Update Posted:
2008-08-28
First Post:
2006-02-14
Brief Title:
A Study to Compare the Immune Response and Safety Elicited by Henogens Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSDs Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody
Sponsor:
Henogen
Organization:
Henogen
Study Overview
Official Title:
A Phase III Multicentric Multinational Controlled Randomised Open Study Comparing the Immunogenicity Reactogenicity and Safety of Henogens New Adjuvanted Hepatitis B Vaccine HB-AS02V to That of Aventis Pasteur MSDs Hepatitis B Vaccine HBVAXPRO Administered as a Booster Dose in Pre-Dialysis Peritoneal Dialysis and Haemodialysis Subjects ³ 15 Years of Age Who Previously Responded to Hepatitis B Primary Vaccination But Have Lost Antibody
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:
The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects After vaccination anti-HBs peak antibody concentrations are reduced As the persistence of anti-HBs is closely related to the initial anti-HBs peak a more immunogenic vaccine allowing higher antibody concentrations 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 3 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