Clinical Trial: An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

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

Official Title: A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescen

Brief Summary: This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome:

  • Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination [ Time Frame: 3 years after vaccination ]
  • Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination [ Time Frame: 4 years after vaccination ]
  • Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination [ Time Frame: 5 years after vaccination ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination [ Time Frame: 3 years after vaccination ]
  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination [ Time Frame: 4 years after vaccination ]
  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination [ Time Frame: 5 years after vaccination ]


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: April 12, 2010
Date Started: May 2009
Date Completion:
Last Updated: December 7, 2011
Last Verified: December 2011