Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
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|ClinicalTrials.gov Identifier: NCT00311493|
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : March 13, 2007
|Condition or disease||Intervention/treatment||Phase|
|Encephalitis, Tick-Borne||Biological: Tick-Borne Encephalitis vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||179 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2006|
- Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311493
|Study Director:||Drug Information Services||Chiron Corporation|