Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289770
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2006-02-09
Brief Title:
Long-term Immune Persistence of GSK Biologicals Combined Hepatitis A B Vaccine Injected According to a 016 Mth Schedule in Healthy Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Double Blind Randomised Comparative Study of the Immunogenicity and Reactogenicity of Three Different Lots of GlaxoSmithKline Biologicals Combined Hepatitis A - Hepatitis B Vaccine When Administered in Healthy Adults
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:
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11 12 13 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis Ahepatitis B vaccine The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
This protocol posting deals with objectives outcome measures of the extension phase at Year 11-15
This protocol posting deals with objectives outcome measures of the extension phase at Year 11-15
Detailed Description:
This is a long-term follow-up study at Years 11 12 13 14 and 15 after primary vaccination with GSK Biologicals hepatitis Ahepatitis B vaccine three-dose schedule with 3 different lots To evaluate the long-term antibody persistence volunteers will be bled at Years 11 12 13 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations
No additional subjects will be recruited in the course of this extension study If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point ie Years 11 12 13 14 or 15 he she will be offered an additional vaccine dose
No additional subjects will be recruited in the course of this extension study If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point ie Years 11 12 13 14 or 15 he she will be offered an additional vaccine dose
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 |
|---|---|---|---|
| 100555 EXT Y15 | OTHER | GSK | None |
| 100552 EXT Y12 | OTHER | None | None |
| 100553 EXT Y13 | OTHER | None | None |
| 100554 EXT Y14 | OTHER | None | None |