Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

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

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Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie, Vienna, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Japanese Encephalitis purified inactivated vaccine

Biological

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

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

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jan 16, 2008
Registry last updated: May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed