Back to resultsLong Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
Primary Purpose
Japanese Encephalitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blood draw
IC51 has given in the parent study IC51-322
Sponsored by
About this trial
This is an interventional other trial for Japanese Encephalitis
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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
No treatment
Arm Description
subjects will be followed up on immunity (analysis of blood samples) and safety
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)
Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01246479
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No treatment
Arm Type
Other
Arm Description
subjects will be followed up on immunity (analysis of blood samples) and safety
Intervention Type
Procedure
Intervention Name(s)
Blood draw
Intervention Description
blood draw at Month 12, Month 24 and Month 36.
Intervention Type
Biological
Intervention Name(s)
IC51 has given in the parent study IC51-322
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)
Description
Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Description
GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
Time Frame
Month 12, 24 and 36
Title
Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Description
Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)
Time Frame
Month 24, 36
Title
Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Description
Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
Time Frame
Months 12, 24 and 36
Title
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).
Description
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).
Time Frame
Months 12, 24 and 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Ayad, Dr.
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Chair
Facility Information:
City
Tampa
State/Province
Florida
Country
United States
City
Brisbane
Country
Australia
City
Melbourne
Country
Australia
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
32156630
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.
Results Reference
derived
Learn more about this trial
Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
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