NCT01041573

Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,869 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 2 Months – 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Open-label, randomized, active controlled Phase 3 study in children aged ≥ 2 months to \< 18 years. Subjects aged ≥ 2 months to \< 12 months were randomized in a 2:1 ratio to receive IC51 (0.25 ml dose) or Prevnar® as a safety comparator. Children aged ≥ 12 months to \< 3 years and ≥ 12 years to \< 18 years were randomized in a 3:1 ratio to receive IC51 (0.25 ml dose \< 3 years, 0.5 ml ≥ 12 years) or HAVRIX®720 as safety comparator. For subjects aged ≥ 3 years to \< 12 years, a dose finding run-in phase was performed. A total of 200 subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of IC51, and the appropriate dose was determined based on an interim analysis. After this run-in phase, 300 further children in this age group were randomized 2:1 to receive either 0.5 ml of IC51 or HAVRIX®720. Immunogenicity was be studied in a subgroup of 30 children aged ≥ 2 months to \< 12 months; 125 children aged ≥ 12 months to \< 3 years and 140 children ≥ 12 years to \< 18 years. For the age group of ≥ 3 to \< 12 years immunogenicity was assessed in the 200 children enrolled during the dose-finding run-in phase.

Conditions

• Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	IC51 Japanese Encephalitis	6 mcg or 3 mcg im. at day 0 and day 28
BIOLOGICAL	Havrix®720	0.5 ml im. at day 0 and month 7
BIOLOGICAL	Prevnar	0.5 ml im. at day 0 and day 56 and month 7

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-02-01
• Completion: 2011-07-01
• First posted: 2009-12-31
• Last updated: 2021-07-27
• Results posted: 2014-02-27

Locations

2 sites across 1 country: Philippines