Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT00161967
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Open-label Follow-up Study to Investigate the Seropersistence of TBE Antibodies and the Booster Response to a Tick-borne Encephalitis Vaccine in Children and Adolescents Aged 3 - 18 Years
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 the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the immune response to a booster vaccination with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third vaccination (in Study 209).
Protocol amendment of October 2006: The study has been prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations at approximately 3 years after the third vaccination and therefore did not receive a booster vaccination at this time point. Further follow-up of TBE antibody persistence is now included for these subjects at 46 and 58 months after the third vaccination (in Study 209), as well as a booster vaccination offered at either 48 or 60 months after the third vaccination (in Study 209), depending on individual TBE antibody levels.
Protocol amendment of October 2006: The study has been prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations at approximately 3 years after the third vaccination and therefore did not receive a booster vaccination at this time point. Further follow-up of TBE antibody persistence is now included for these subjects at 46 and 58 months after the third vaccination (in Study 209), as well as a booster vaccination offered at either 48 or 60 months after the third vaccination (in Study 209), depending on individual TBE antibody levels.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: