Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Valneva Austria GmbH
Age
0–17
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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.
Clareo Health | Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
