NCT00311493
Completed
Phase 4
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
ConditionsEncephalitis, Tick-Borne
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Encephalitis, Tick-Borne
- Sponsor
- Novartis
- Enrollment
- 179
- Primary Endpoint
- Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
- Status
- Completed
- Last Updated
- 19 years ago
Overview
Brief Summary
The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers of both sexes aged \>18 who participated in another study on TBE vaccination
Exclusion Criteria
- •Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Outcomes
Primary Outcomes
Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
Secondary Outcomes
- 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.
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