Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Popu… (NCT01041573) | Clinical Trial Compass
CompletedPhase 3
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Philippines1,869 participantsStarted 2010-03
Plain-language summary
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.
Who can participate
Age range2 Months – 18 Years
SexALL
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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.
Exclusion Criteria:
* Clinical manifestation of Japanese Encephalitis
* History of Flavivirus vaccination (including any investigational vaccines)
* History of vaccination with HAVRIX®720 and/or Prevnar®
* 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 2 weeks prior to the first IC51 vaccination and up to the second IC51 vaccination.
What they're measuring
1
Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination