Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
This study has been completed.
Information provided by:
First received: April 3, 2006
Last updated: March 12, 2007
Last verified: March 2007
The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults
Biological: Tick-Borne Encephalitis vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase IV, Randomized, Open-Label, Multi-Center Study in Adults: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer) in Study V48P2E1, 5 Years After First Booster Immunization and Evaluation of Booster Kinetics in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer), 5 Years After First Booster Immunization|
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
Secondary Outcome Measures:
- Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.
|Study Start Date:||February 2006|
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