TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)
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|ClinicalTrials.gov Identifier: NCT00161967|
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Encephalitis, Tick-Borne||Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||November 2008|
- Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Subjects receive one vaccination with either FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml, depending on their age.
- Seropositivity rate measured by ELISA and/or NT according to Adner et al., 2001 at each available time point after the third vaccination in study 209 and separately at each available time point after the booster vaccination in this study [ Time Frame: TBE virus antibody tests at pre-determined intervals with the last test at 21-35 days after the booster vaccination in this study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161967
|Grieskirchner Strasse 17|
|Wels, Upper Austria, Austria, 4600|
|Kehl, Germany, 77694|
|Zamosc, Poland, 22-400|
|Principal Investigator:||Baxter BioScience Investigator||Baxter BioScience|