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Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

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

NCT00594958•Valneva Austria GmbH

View on ClinicalTrials.gov

Summary

The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male and female subjects 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, drug addiction including alcohol dependence

Key Dates

Start Date

September 1, 2006

Primary Completion Date

April 1, 2007

Completion Date

September 1, 2007

Last Updated

March 21, 2024

Enrollment

639

ACTUAL participants

Conditions

Japanese Encephalitis

Interventions

IC51

BIOLOGICAL

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

NCT06372665

Japanese Encephalitis

View study

UNKNOWNPHASE4

Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province

NCT04817917

Japanese EncephalitisVaccine Preventable Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Inclusion Criteria

Exclusion Criteria

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province

Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age

Post-licensure Safety Study of IMOJEV® in Thailand

Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines