Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291876
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2006-02-14
Brief Title:
Long-Term Immune Persistence of GlaxoSmithKline Biologicals Inactivated Hepatitis A Vaccine Injected According to a 0 12-month Schedule
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals Inactivated Hepatitis A Vaccine Containing 1440 ELU of Antigen Per mL and Injected According to a 0 12 Month Schedule in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2017-01
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 persistence of hepatitis A antibodies at 138 150 162 174186 198 210 222 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine
This protocol posting deals with objectives outcome measures of the extension phase at year 11 to 20
No additional subjects will be recruited during this long-term follow-up
This protocol posting deals with objectives outcome measures of the extension phase at year 11 to 20
No additional subjects will be recruited during this long-term follow-up
Detailed Description:
This is a long-term follow-up study at Years 11 12 13 14 15 16 17 18 19 and 20 after primary vaccination with GSK Biologicals hepatitis A vaccine two-dose schedule To evaluate the long-term antibody persistence volunteers will donate a blood sample at Years 11 12 13 14 15 16 17 18 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A anti-HAV antibody concentrations
If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point ie Months 138 150 162 174186 198 210 222 234 and 246 he she will be offered an additional vaccine dose A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007 and to extend the follow up until Year 20
The study has 10 phases 100571 100572 100573 100574 100575 110677 110678 110679 110680 110681
If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point ie Months 138 150 162 174186 198 210 222 234 and 246 he she will be offered an additional vaccine dose A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007 and to extend the follow up until Year 20
The study has 10 phases 100571 100572 100573 100574 100575 110677 110678 110679 110680 110681
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 |
|---|---|---|---|
| 100572 M150 | OTHER | None | None |
| 100573 M162 | OTHER | None | None |
| 100574 M174 | OTHER | None | None |
| 100575 M186 | OTHER | None | None |
| 110677 M198 | OTHER | None | None |
| 110678 M210 | OTHER | None | None |
| 110679 | OTHER | None | None |
| 110680 | OTHER | None | None |
| 110681 | OTHER | GSK | None |