Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161967
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-09-08
Brief Title:
TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents Follow-up to Study 209
Sponsor:
Pfizer
Organization:
Pfizer
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 025 ml 3 vaccinations during the predecessor study 209 as well as the immune response to a booster vaccination with FSME-IMMUN 025 ml or FSME-IMMUN 05 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:
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