Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329576
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2006-05-23
Brief Title:
Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate the Anti-HBs Antibody Persistence in Subjects Who Received GSK Biologicals Preservative-free or Thiomersal-free Engerix-B or Engerix-B Containing Thiomersal Approximately 5 to 6 Yrs Earlier
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:
To evaluate the persistence of antibodies against hepatitis B approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study
Detailed Description:
All subjects who participated in the primary vaccination study where subjects who received GSK Biologicals hepatitis B vaccine and who will consent to participate in this long-term follow-up study approximately 5 to 6 years after the primary vaccination study The study will be conducted in only 3 centres out of the 4 centres in the primary vaccination study
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