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

Japanese Encephalitis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00776230
Study type Interventional
Source Valneva Austria GmbH
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date June 2010
View Details
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