Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240526
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2005-10-13
Brief Title:
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B WithWithout HBIg in Newborns to HBeAg Mothers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Comparative Study of the Immunogenicity and Protective Efficacy of GlaxoSmithKline Biologicals Rec-DNA Hepatitis B Vaccine With or Without Hepatitis B Immunoglobulins HBIg in Newborns of HBeAg Mothers
Status:
COMPLETED
Status Verified Date:
2016-10
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:
To evaluate the persistence of anti-HBs antibodies up to 16 17 18 19 and 20 years after administration of the first dose of the study vaccine The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered
No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered
Detailed Description:
The primary study was to evaluate the reactogenicity immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination
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