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

Completed · Phase 3

Conditions studied: Encephalitis

In brief

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

Key facts

Study ID

NCT01047839

Run by

Valneva Austria GmbH

People needed

100

Starts

2010-01-01

Expected to finish

2013-08-01

Last updated by the study team

2020-06-30

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tampa Clinical Research Inc. — Tampa, Florida, United States
• Passport Health — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, 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
• Danske Laegers Forsknings Center — Søborg, Denmark
• Berliner Zentrum für Reise- und Tropenmedizin — Berlin, Germany
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
• City Akuten Wasa Vaccination — Stockholm, Sweden

Full record on ClinicalTrials.gov

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