Open-label Phase IV Study to Investigate the Seropersistence of Tick Borne Encephalitis (TBE) Virus Antibodies After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults (Follow Up to Study 223)

NCT00503529 Phase 4 COMPLETED

The purpose of this study is to assess: * TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first booster TBE vaccination with FSME-IMMUN 0.5ml given in Study 223, by means of ELISA (IMMUNOZYM FSME IgG) and Neutralization test (NT), * TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the present study, by means of ELISA and NT, * Safety of FSME-IMMUN 0.5ml after the second booster vaccination.

Details

Lead sponsor	Pfizer
Phase	Phase 4
Status	COMPLETED
Enrolment	314
Start date	2007-07
Completion	2010-09

Conditions

• Encephalitis, Tick-Borne

Interventions

• Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Primary outcomes

• Seropositivity rate measured by Enzyme-Linked Immunosorbent Assay (ELISA) and/or Neutralization test (NT) 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study — 24, 34, 46 and 58 months after the the first booster TBE vaccination in Study 223 and after the booster vaccination in this study (study ID 690701)

Countries

Poland