Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-04-09 @ 1:58 PM
Study NCT ID:
NCT00774995
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2008-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Study to Evaluate the Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With GSK Biologicals' Engerix™-B Vaccine, Approximately 20 Years Ago.
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:
This study will evaluate the immune response of healthy subjects who received neonatal vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will be investigated by the administration of a challenge dose of hepatitis B vaccine and the comparison of their antibody concentration before and one month after vaccination.
This protocol posting deals with objectives \& outcome measures of the booster phase. No new subjects will be recruited during this booster phase of the study.
This protocol posting deals with objectives \& outcome measures of the booster phase. No new subjects will be recruited during this booster phase of the study.
Detailed Description:
None
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?: