Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

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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

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy subjects at least 18 years of age
Written informed consent obtained prior to study entry
Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

Exclusion criteria

Inability or unwillingness to provide informed consent and to abide the requirements of the study

Treatment and study plan

Japanese Encephalitis purified inactivated vaccine

Biological

Japanese Encephalitis purified inactivated vaccine

Primary outcomes

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

Time frame: 24 months after the first vaccination

first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302

Secondary outcomes

Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

Time frame: 6, 12, 36, 48 and 60 months after 1st vaccination
Geometric Mean Titers

Time frame: 6, 12, 36, 48 and 60 months
Adverse Events

Time frame: 6, 12, 24, 36, 48 and 60 months after 1st vaccination

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study

Important dates

Study start: 2005
Primary completion: 2011
First posted: Jan 16, 2008
Registry last updated: Jul 30, 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