Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

Phase 3

Completed

• Conditions: Encephalitis
• Interventions: Biological: IC51

• Registration Number: NCT01047839
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2014-09-25
• Results First Submitted QC: 2014-12-10
• Results First Posted: 2014-12-19
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination
• Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
• Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception.
• The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.

Exclusion Criteria

• Clinical manifestation or history of any Flavivirus disease
• Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
• History of immunodeficiency or immunosuppressive therapy
• Known HIV, HBV or HCV infection
• History of hypersensitivity reactions to other vaccines
• Acute febrile infection at each visit during which the subject receives a vaccination
• Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
>=12 to <18 years	IC51	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
>=2 months to <3 years	IC51	IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
>=3 to <12 years	IC51	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Primary Outcome Measures

Name	Time	Method
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination	until Day 56	Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.

Secondary Outcome Measures

Name	Time	Method
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination	up to Month 7
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination	up to Month 7	Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7	at Day 56 and Month 7
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination	7 days
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination	up to Day 56 and upt to Month 7
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)	at Day 56 and Month 7
GMTs at Day 56 and Month 7 Stratified According to Age Groups	at Day 56 and Month 7
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups	at Day 56 and Month 7

Trial Locations

Locations (10)

Berliner Zentrum für Reise- und Tropenmedizin; 🇩🇪 Berlin, Germany

Tampa Clinical Research Inc.; 🇺🇸 Tampa, Florida, United States

Passport Health; 🇺🇸 Baltimore, Maryland, United States

Bronx Lebanon Hospital Center; 🇺🇸 New York, New York, United States

Dr. Deb - The Travel Doctor; 🇦🇺 Brisbane, Queensland, Australia

Travel Doctor - TMVC Australia; 🇦🇺 Melbourne, Victoria, Australia

City Akuten Wasa Vaccination; 🇸🇪 Stockholm, Sweden

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Danske Laegers Forsknings Center; 🇩🇰 Soborg, Denmark

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States