Clinical trial NCT01246479: Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2010-11-23
Enrollment: 23
Sex: ALL
Minimum age (years): 9
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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).

Primary outcomes:
measure: Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)
timeFrame: Month 12
Secondary outcomes:
measure: GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
timeFrame: Month 12, 24 and 36
measure: Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
timeFrame: Month 24, 36
measure: Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
timeFrame: Months 12, 24 and 36
measure: 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).
timeFrame: Months 12, 24 and 36
Other outcomes:
Locations:
city: Tampa
country: United States
state: Florida
city: Brisbane
country: Australia
city: Melbourne
country: Australia
city: Berlin
country: Germany
city: Hamburg
country: Germany
Study officials:
affiliation: Valneva Austria GmbH
name: Andrea Ayad, Dr.
role: STUDY_CHAIR
References:
citation: Taucher C, Barnett ED, Cramer JP, Eder-Lingelbach S, Jelinek T, Kadlecek V, Kiermayr S, Mills DJ, Pandis D, Reiner D, Dubischar KL. Neutralizing antibody persistence in pediatric travelers from non-JE-endemic countries following vaccination with IXIARO(R) Japanese encephalitis vaccine: An uncontrolled, open-label phase 3 follow-up study. Travel Med Infect Dis. 2020 Mar-Apr;34:101616. doi: 10.1016/j.tmaid.2020.101616. Epub 2020 Mar 7.