Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

The objective is to demonstrate equivalence of three 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

About this study

This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.

Who can participate

Healthy volunteers accepted: Yes

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

Main Inclusion Criteria:

Male and female subjects 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 HIV, drug addiction including alcohol dependence

Treatment and study plan

IC51

Biological

6 mcg, intramuscularly [i.m.], 0.5 mL

Other names: Japanese Encephalitis purified inactivated vaccine

Primary outcomes

GMT for Anti-JEV Neutralizing Antibody

Time frame: day 56

Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.

Secondary outcomes

Safety

Time frame: study duration

Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
SCR for Anti-JEC Neutralizing Antibody Titer

Time frame: day 56

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Jan 16, 2008
Registry last updated: Mar 21, 2024

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