ONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY - IC51-303
- Conditions
- Japanese encephalitis. This study is a follow-up to the pivotal immunogenicity and safety studies IC51-301 and IC51-302.
- Registration Number
- EUCTR2005-000253-29-GB
- Lead Sponsor
- Intercell AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 4333
-Subjects correctly included in and having completed clinical studies IC51-301 or
IC51-302 with at least one vaccination.
-Written informed consent for study IC51-303.
Only for the immunogenicity part:
-Subjects correctly included in and having completed study IC51-301 or IC51-302 according to the protocol with the required amount of injections (IC51-301: 3 / IC51-302: 2).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Inability or unwillingness to provide informed consent and to abide by the requirements of the study.
Only for the immunogenicity part:
-Known negative (< 1:10) anti-JEV neutralizing antibody titer (PRNT) 28 days after the last vaccination in the preceding study or thereafter.
-Subjects with any condition which in the opinion of the Investigator makes the subject unsuitable for inclusion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method