Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

Valneva Austria GmbH389 enrolled

Overview

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

389

Conditions

Japanese Encephalitis

Interventions

Japanese Encephalitis purified inactivated vaccineBIOLOGICAL

IC51 6 mcg i.m. injection on Day 0 and Day 28

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main 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 Main Exclusion Criteria: * History of immunodeficiency or immunosuppressive therapy, * Known Human Immunodeficiency Virus (HIV); OR * Drug addiction including alcohol dependence

Locations (4)

Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Vienna, Austria

Berliner Zentrum Reise- und Tropenmedizin

Berlin, Germany

Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin

Munich, Germany

Klinik und Poliklinik für Innere Medizin der Universität Rostock

Rostock, Germany

Outcomes

Primary Outcomes

Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody

Time frame: Day 56

Secondary Outcomes

Seroconversion Rate

Time frame: Day 56

Safety and Adverse Events

Time frame: Day 56

Data from ClinicalTrials.gov

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