Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
Completed
- Conditions
- Japanese Encephalitis
- Registration Number
- NCT00596102
- Lead Sponsor
- Valneva Austria GmbH
- Brief Summary
The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3258
Inclusion Criteria
- Healthy subjects at least 18 years of age
- Written informed consent obtained prior to study entry
- Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination
Exclusion Criteria
- Inability or unwillingness to provide informed consent and to abide the requirements of the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) 24 months after the first vaccination first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers 6, 12, 36, 48 and 60 months Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) 6, 12, 36, 48 and 60 months after 1st vaccination Adverse Events 6, 12, 24, 36, 48 and 60 months after 1st vaccination