Status:
COMPLETED
Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
Lead Sponsor:
Valneva Austria GmbH
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
9-20 years
Phase:
PHASE3
Brief Summary
The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01246479
Start Date
October 1 2010
End Date
September 1 2014
Last Update
March 18 2020
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Tampa, Florida, United States
2
Brisbane, Australia
3
Melbourne, Australia
4
Berlin, Germany