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.

Long 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022266-27-DE

Enrollment

Registered

2010-10-07

Start date

2010-12-13

Completion date

Unknown

Last updated

2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 17.0 Level: LLT Classification code 10023123 Term: Japanese encephalitis System Organ Class: 10021881 - Infections and

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: - To assess long-term immunity following vaccination with purified inactivated Japanese Encephalitis (JE) vaccine IC51 in terms of geometric mean titers (GMTs) and rate of subjects with a PRNT50 = 1:10 in a pediatric population from regions where JE is not endemic.;Secondary Objective: - To assess the long-term safety profile of IC51 in a pediatric population from regions where JE is not endemic. - To assess age-dependent differences in persistence of immunity and the long- 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)	—

Measure

Time frame

Main Objective: - To assess long-term immunity following vaccination with purified inactivated Japanese Encephalitis (JE) vaccine IC51 in terms of geometric mean titers (GMTs) and rate of subjects with a PRNT50 = 1:10 in a pediatric population from regions where JE is not endemic.;Secondary Objective: - To assess the long-term safety profile of IC51 in a pediatric population from regions where JE is not endemic. - To assess age-dependent differences in persistence of immunity and the long- 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)

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Countries

Germany

Contacts

Public ContactClinical Operations

Valneva Austria GmbH

info@valneva.com00431206200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026