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 Adolescents Previously Immunized Against TBE

Novartis Vaccines10 sites in 1 country126 target enrollmentMay 2009

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Tick Borne Encephalitis (TBE)
Sponsor: Novartis Vaccines
Enrollment: 126
Locations: 10
Primary Endpoint: Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
Status: Completed
Last Updated: 14 years ago

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

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

May 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Novartis Vaccines

Responsible Party

Sponsor

•Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent

•Subjects who did not receive complete schedule of primary vaccination in the parent study
•Subjects enrolled in other investigational studies at the same time and within the last three months
•Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

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

Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination(3 years after vaccination)
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination(4 years after vaccination)
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination(5 years after vaccination)