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

June 29, 2020 updated by: Valneva Austria GmbH

Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Queensland
      • Brisbane, Queensland, Australia, 4001
        • Dr. Deb - The Travel Doctor
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Travel Doctor - TMVC Australia
      • Soborg, Denmark, 2860
        • Danske Laegers Forsknings Center
      • Berlin, Germany, 10117
        • Berliner Zentrum für Reise- und Tropenmedizin
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Stockholm, Sweden, 11136
        • City Akuten Wasa Vaccination
    • Florida
      • Tampa, Florida, United States, 33624
        • Tampa Clinical Research Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21230
        • Passport Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • New York
      • New York, New York, United States, 10457
        • Bronx Lebanon Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: >=2 months to <3 years
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
0.25 ml, 2 i.m. vaccinations at Day 0 and 28
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Experimental: >=3 to <12 years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
0.25 ml, 2 i.m. vaccinations at Day 0 and 28
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Experimental: >=12 to <18 years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
0.25 ml, 2 i.m. vaccinations at Day 0 and 28
0.5 ml, 2 i.m. vaccinations at Day 0 and 28

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
Time Frame: up to Month 7
up to Month 7
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
Time Frame: 7 days
7 days
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
Time Frame: up to Day 56 and upt to Month 7
up to Day 56 and upt to Month 7
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Time Frame: 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.
up 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)
Time Frame: at Day 56 and Month 7
at Day 56 and Month 7
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Time Frame: at Day 56 and Month 7
at Day 56 and Month 7
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
Time Frame: at Day 56 and Month 7
at Day 56 and Month 7
GMTs at Day 56 and Month 7 Stratified According to Age Groups
Time Frame: at Day 56 and Month 7
at Day 56 and Month 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

June 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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