NCT01296360

Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country

Long-Term Immunity and Safety With or Without a Booster Dose Following Primary Vaccination With the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population in a JEV-Endemic Country. Open-Label, Randomized, Phase 3 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 9 Months – 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label Phase 3 study including children aged \>9 months to \<17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.

Detailed description

This is a randomized, open-label Phase 3 study including children aged \>9 months to \<17 years and 7 months who have been vaccinated with IXIARO in the previous study IC51-323.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	IXIARO	0.25 ml i.m. (milliliter, intramuscular)
BIOLOGICAL	IXIARO	0.5 ml i.m. (milliliter, intramuscular)

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-11-01
• Completion: 2013-10-01
• First posted: 2011-02-15
• Last updated: 2014-12-19
• Results posted: 2014-12-19

Locations

3 sites across 1 country: Philippines