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

Completed · Phase 3

Conditions studied: Japanese Encephalitis

In brief

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

Key facts

Study ID

NCT01246479

Run by

Valneva Austria GmbH

People needed

23

Starts

2010-10-01

Expected to finish

2014-09-01

Last updated by the study team

2020-03-18

Who can join

Age: 1 and older, up to 20. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Tampa, Florida, United States
• Study site — Brisbane, Australia
• Study site — Melbourne, Australia
• Study site — Berlin, Germany
• Study site — Hamburg, Germany

Full record on ClinicalTrials.gov

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