Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197158
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-09-15
Brief Title:
Comparison of Monodose and Multidose Presentations of GSK Biologicals Hepatitis B Vaccine in Terms of Immune Response
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
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 016 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 GSKs multidose hepatitis B vaccine and the other group will receive GSKs monodose hepatitis B vaccine
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