Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-28 @ 4:12 AM
Study NCT ID:
NCT03183492
Status:
WITHDRAWN
Last Update Posted:
2018-03-02
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Persistence of GlaxoSmithKline (GSK) Biologicals' Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Long-term Persistence of Hepatitis A Immunity in Healthy Adults Vaccinated as Part of a Hepatitis A Universal Mass Vaccination Program
Status:
WITHDRAWN
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor cancelled the study as real life impact data has already shown the value of HepA vaccination \& as no critical need to gather additional data in Israel.
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 persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. In the present study, the anamnestic response will be assessed 30 days after the challenge dose.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: