Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343915
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2005-09-14
Brief Title:
Immuno Safety Study of GSK Biologicals Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Long-term Study of Immune Response Persistence of GSK Biologicals 2-dose Thiomersal-free Engerix-B and 3-dose Preservative-free Engerix-B Vaccines in Subjects Aged 11-15 Yrs
Status:
COMPLETED
Status Verified Date:
2019-02
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 at 30 42 54 and 66 months after the first dose of the hepatitis B primary vaccination course
Subjects were aged 11 to 15 years at the time of the primary vaccination course
At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Subjects were aged 11 to 15 years at the time of the primary vaccination course
At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
All subjects who participated in the primary study in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators
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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001531-20 | EUDRACT_NUMBER | GSK | None |
| 101696 | OTHER | None | None |
| 101697 | OTHER | None | None |
| 101698 | OTHER | None | None |