A study to find out in the long run if the medicine called IC51 (IXIARO®, JESPECT®) is safe and works well to help children and young people not to get Japanese Encephalitis.

• Conditions: JE can be fatal or lead to long-term disability. Vaccination should therefore be considered for people who are at risk of exposure to JEV by travelling to endemic regions. The study within which no IMP will be administered, will benefit the pediatric population as it will provide information on potential need of booster doses of IC51 in children and adolescents.; MedDRA version: 17.0Level: LLTClassification code 10023123Term: Japanese encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.0Level: LLTClassification code 10023120Term: Japanese B viral encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.0Level: LLTClassification code 10023122Term: Japanese B virus encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.0Level: LLTClassification code 10023119Term: Japanese B encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.0Level: PTClassification code 10014596Term: Encephalitis Japanese BSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2010-022266-27-DE
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-07
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To assess long-term immunity following vaccination with purified inactivated <br> Japanese Encephalitis (JE) vaccine IC51 in terms of geometric mean titers (GMTs) <br> and rate of subjects with a PRNT50 = 1:10 in a pediatric population from regions <br> where JE is not endemic.;Secondary Objective: - To assess the long-term safety profile of IC51 in a pediatric population from <br> regions where JE is not endemic.<br>- To assess age-dependent differences in persistence of immunity and the long- <br> term safety profile of IC51.;Primary end point(s): Rate of subjects with PRNT50 titers of = 1:10  at month 12 after the first IC51 vaccination (in study IC51-322)