Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503529
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2007-07-17
Brief Title:
TBE Antibody Persistence and Booster Vaccination Study in Adults Follow-up to Study 223
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Open-label Phase IV Study to Investigate the Seropersistence of Tick Borne Encephalitis TBE Virus Antibodies After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 05ml in Adults Follow Up to Study 223
Status:
COMPLETED
Status Verified Date:
2015-05
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 purpose of this study is to assess
TBE antibody persistence 24 34 46 and 58 months as applicable after the first booster TBE vaccination with FSME-IMMUN 05ml given in Study 223 by means of ELISA IMMUNOZYM FSME IgG and Neutralization test NT
TBE antibody response to a second booster vaccination with FSME-IMMUN 05ml in the present study by means of ELISA and NT
Safety of FSME-IMMUN 05ml after the second booster vaccination
TBE antibody persistence 24 34 46 and 58 months as applicable after the first booster TBE vaccination with FSME-IMMUN 05ml given in Study 223 by means of ELISA IMMUNOZYM FSME IgG and Neutralization test NT
TBE antibody response to a second booster vaccination with FSME-IMMUN 05ml in the present study by means of ELISA and NT
Safety of FSME-IMMUN 05ml after the second booster vaccination
Detailed Description:
None
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 |
|---|---|---|---|
| EUDRACT 2007-000440-27 | None | None | None |