Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

Study Overview
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Brief Summary
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The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.

Official Title
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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

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Procedure: Blood draw
* Biological: IC51 has given in the parent study IC51-322


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322. Male or female healthy subjects aged ≥ 9 months to < 21 years at the time of enrolment into this study. 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. Exclusion Criteria: History of or clinical manifestation of any Flavivirus disease during study IC51-322. Vaccination against JE virus (JEV) (except with IC51) at any time prior or planned during this study. Participation in another study with an investigational product during study IC51-322 or IC51-324. History of or development of any immunodeficiency including post-organtransplantation after inclusion into study IC51-322. History of or development of an autoimmune disease during study IC51-322. Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during study IC51-322 up to first visit of study IC51-324. (For corticosteroids this means prednisone or equivalent at >= 0.05 mg/kg/day. Topical or inhaled steroids are allowed). Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction. 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 the study. Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No treatment<br>subjects will be followed up on immunity (analysis of blood samples) and safety | Procedure: Blood draw<br>* blood draw at Month 12, Month 24 and Month 36.<br>Biological: IC51 has given in the parent study IC51-322<br>* No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322) | Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322) | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) | GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322) | Month 12, 24 and 36 | 
| Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322) | Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322) | Month 24, 36 | 
| Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) | Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322) | Months 12, 24 and 36 | 
| Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). | Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322). | Months 12, 24 and 36 |