ong term immunity and safety following vaccination with the Japanese Encephalitis vaccine IC51 (IXIARO®, JESPECT®) in a pediatric population in non-endemic countries. Uncontrolled, Phase 3 Follow-up study. - IC51-324

Valneva Austria GmbH0 个研究点目标入组 80 人开始时间: 2010年10月7日最近更新: 2015年11月16日

适应症

试验速览

暂无简介。

•1. Subjects who have received two vaccinations of IC51 in study IC51-322.
•2. Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322.
•3. Male or female healthy subjects aged = 9 months to < 21 years at the time of enrolment into this study.*
•4. Written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
•*Date and time of enrolment will be defined as the time point at which the investigator confirms eligibility of the subject for inclusion in the study, i.e., all of the inclusion criteria and none of the exclusion criteria are fulfilled (to be checked at visit 1).
•Are the trial subjects under 18? yes
•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) no
•F.1.3.1 Number of subjects for this age range

•1. History of or clinical manifestation of any Flavivirus disease during study IC51-322.
•2. Vaccination against JE virus (except with IC51) at any time prior or planned during this study.
•3. Participation in another study with an investigational product during study IC51-322 or IC51-324.
•4. History of development of an immunodeficiency including post-organ-transplantation after inclusion into study IC51-322.
•5. History of an development of an autoimmune disease during study IC51-322.
•6. Administration of chronic immunosuppresants (>14 days) or other immune-modifying medications started during study IC51-322 up to first visit of study IC51-324.
•7. Known infection with HIV, HBV or HCV.
•8. Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction.
•9. Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of this study.
•10. Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

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