Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
1 other identifier
interventional
23
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2010
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 6, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
April 29, 2015
CompletedMarch 18, 2020
March 1, 2020
2 years
October 6, 2010
April 13, 2015
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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)
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)
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).
Months 12, 24 and 36
Study Arms (1)
No treatment
OTHERsubjects will be followed up on immunity (analysis of blood samples) and safety
Interventions
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.
Eligibility Criteria
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 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Brisbane, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
Berlin, Germany
Unknown Facility
Hamburg, Germany
Related Publications (1)
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.
PMID: 32156630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Scientist Clinical Research
- Organization
- Valneva Austria GmbH
Study Officials
- STUDY CHAIR
Andrea Ayad, Dr.
Valneva Austria GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2010
First Posted
November 23, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2012
Study Completion
September 1, 2014
Last Updated
March 18, 2020
Results First Posted
April 29, 2015
Record last verified: 2020-03