Clinical Trial: TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary:

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.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: 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 [ Time Frame: 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) ]

Original Primary Outcome: 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

Current Secondary Outcome:

Original Secondary Outcome:

  • Seropositivity rate measured by ELISA 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study
  • Seropositivity rate measured by NT 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study
  • Antibody concentration 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study measured by ELISA
  • Antibody titers 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study measured by NT
  • Fold increase in antibody concentration after the booster vaccination as compared to before the booster vaccination in this study measured by ELISA
  • Fold increase in antibody concentration after the booster vaccination as compared to before the booster vaccination in this study measured by NT
  • Injection site reactions and systemic reactions after the booster vaccination in this study


Information By: Pfizer

Dates:
Date Received: July 17, 2007
Date Started: July 2007
Date Completion:
Last Updated: May 20, 2015
Last Verified: May 2015