- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01047839
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
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
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Queensland
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Brisbane, Queensland, Australia, 4001
- Dr. Deb - The Travel Doctor
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Victoria
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Melbourne, Victoria, Australia, 3000
- Travel Doctor - TMVC Australia
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Soborg, Denmark, 2860
- Danske Laegers Forsknings Center
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Berlin, Germany, 10117
- Berliner Zentrum für Reise- und Tropenmedizin
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Stockholm, Sweden, 11136
- City Akuten Wasa Vaccination
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Florida
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Tampa, Florida, United States, 33624
- Tampa Clinical Research Inc.
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Maryland
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Baltimore, Maryland, United States, 21230
- Passport Health
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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New York
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New York, New York, United States, 10457
- Bronx Lebanon Hospital Center
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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
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0.25 ml, 2 i.m. vaccinations at Day 0 and 28
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
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Experimental: >=3 to <12 years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
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0.25 ml, 2 i.m. vaccinations at Day 0 and 28
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
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Experimental: >=12 to <18 years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
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0.25 ml, 2 i.m. vaccinations at Day 0 and 28
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
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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
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Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
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until Day 56
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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
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up to Month 7
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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
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7 days
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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
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up to Day 56 and upt to Month 7
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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
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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.
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up to Month 7
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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
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at Day 56 and Month 7
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GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Time Frame: at Day 56 and Month 7
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at Day 56 and Month 7
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SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
Time Frame: at Day 56 and Month 7
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at Day 56 and Month 7
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GMTs at Day 56 and Month 7 Stratified According to Age Groups
Time Frame: at Day 56 and Month 7
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at Day 56 and Month 7
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Keywords
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
- IC51-322
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
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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