Encephalitis, Tick-Borne Clinical Trial
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
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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