NCT00776230

Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

Immunogenicity of a Commercial Batch of the Japanese Encephalitis Vaccine IC51 up to Twenty-four Months Post Filling. An Open-label, Multicenter, Phase 3 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

Detailed description

Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years. The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	IC51	6 mcg im. at day 0 and day 28

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-10-21
• Last updated: 2016-05-04
• Results posted: 2014-01-23

Locations

3 sites across 2 countries: Austria, Germany