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

Phase 3

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: IC51

• Registration Number: NCT00776230
• Lead Sponsor: Valneva Austria GmbH

Brief 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

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2013-12-05
• Results First Submitted QC: 2013-12-05
• Results First Posted: 2014-01-23
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test.

Exclusion Criteria

• History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IC51 (~18 months post filling)	IC51	6 mcg (\~18 months post filling)
IC51 (~12 months post filling)	IC51	6 mcg (\~12 months post filling)
IC51 (~24 months post filling)	IC51	6 mcg (\~24 months post filling)

Primary Outcome Measures

Name	Time	Method
Primary: 1. Geometric Mean Titers (GMT) at Day 56	56 days post 1st vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability	see above

Trial Locations

Locations (3)

Berliner Zentrum Reise- und Tropenmedizin; 🇩🇪 Berlin, Germany

Universitätsklinikum Rostock; 🇩🇪 Rostock, Germany

Zentrum für Reisemedizin; 🇦🇹 Vienna, Austria