NCT01246479

Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

Long Term Immunity and Safety Following Vaccination With the Japanese Encephalitis Vaccine IC51(IXIARO®, JESPECT®) In a Pediatric Population in Non Endemic Countries. Uncontrolled, Phase 3 Follow-up Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 9 Months – 20 Years
• Healthy volunteers: Accepted

Summary

The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
PROCEDURE	Blood draw	blood draw at Month 12, Month 24 and Month 36.
BIOLOGICAL	IC51 has given in the parent study IC51-322	No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-10-01
• Completion: 2014-09-01
• First posted: 2010-11-23
• Last updated: 2020-03-18
• Results posted: 2015-04-29

Locations

5 sites across 3 countries: United States, Australia, Germany