NCT01047839

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 2 Months – 17 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	IC51	0.25 ml, 2 i.m. vaccinations at Day 0 and 28
BIOLOGICAL	IC51	0.5 ml, 2 i.m. vaccinations at Day 0 and 28
BIOLOGICAL	IC51	0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-01-13
• Last updated: 2020-06-30
• Results posted: 2014-12-19

Locations

10 sites across 5 countries: United States, Australia, Denmark, Germany, Sweden