Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT00197158
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Demonstrate the Non-inferiority of Immunogenicity Elicited by GSK Biologicals' Hepatitis B Vaccine, Multidose Engerix™-B to That of Monodose Engerix™-B When Administered According to 0,1,6 Mths Schedule in Healthy Adults Aged ≥ 18 Yrs
Status:
COMPLETED
Status Verified Date:
2016-09
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:
GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine (Belgium).
Detailed Description:
Randomized study with two groups. One group will receive GSK's multidose hepatitis B vaccine and the other group will receive GSK's monodose hepatitis B vaccine
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: