NCT00161967

TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Encephalitis, Tick-Borne

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-07-01
• Completion: 2008-11-01
• First posted: 2005-09-13
• Last updated: 2015-05-21

Locations

3 sites across 3 countries: Austria, Germany, Poland