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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:October 2010
End Date:November 2014
Contact:Andrea Ayad
Phone:+43 1 206 20

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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


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


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).
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