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

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.

Study Overview

• Status: Completed
• Conditions: Japanese Encephalitis
• Intervention / Treatment: Procedure: Blood draw; Biological: IC51 has given in the parent study IC51-322

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
  • Melbourne, Australia
• Germany
  • Berlin, Germany
  • Hamburg, Germany
• United States
  • Florida
    • Tampa, Florida, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: No treatment; subjects will be followed up on immunity (analysis of blood samples) and safety	Procedure: Blood draw; blood draw at Month 12, Month 24 and Month 36.; Biological: IC51 has given in the parent study IC51-322; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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).	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

Collaborators and Investigators

• Sponsor: Valneva Austria GmbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 23, 2010

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis
• Other Study ID Numbers: IC51-324

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No