Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480116
Status:
COMPLETED
Last Update Posted:
2008-08-25
First Post:
2007-05-29
Brief Title:
Consistency Study of Three Lots of Henogens Adjuvanted Hepatitis B Vaccine When Given in 0 1 Month Schedule
Sponsor:
Henogen
Organization:
Henogen
Study Overview
Official Title:
Phase III Single Centre Double Blind Randomised Study Evaluating the Consistency of Three Lots of Henogens New Adjuvanted Hepatitis B Vaccine When Given at 0 1 Month Schedule in Healthy Volunteers Aged 18 Years to 40 Years
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 study vaccine has been developed for use in pre-dialysis haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines target population This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine
Detailed Description:
Double-blind randomised single centre study with three groups receiving three different lots of Henogens adjuvanted hepatitis B vaccine according to 0 1 months schedule Blood samples will be taken at Month 0 Months 1 and 2
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