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Japanese Encephalitis purified inactivated vaccine

Phase 3

Japanese Encephalitis | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: May 16, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment389

FDA Designations

No designations recorded

Clinical trial landscape

Japanese Encephalitis purified inactivated vaccine · 1 trial · 1 indication

Phase 3 1
NCT00595465Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51Japanese Encephalitis
COMPLETED389 Analytics
PHASE3COMPLETED
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Japanese EncephalitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
Day 56

Secondary Endpoints

Seroconversion Rate
Day 56
Safety and Adverse Events
Day 56
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
IC51 Batch AACTIVE_COMPARATOR -
IC51 Batch BACTIVE_COMPARATOR -
IC51 Batch CACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Japanese Encephalitis purified inactivated vaccineBIOLOGICALIC51 6 mcg i.m. injection on Day 0 and Day 28
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites4

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...

Countries:AustriaGermany
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Frequently asked questions about Japanese Encephalitis purified inactivated vaccine

What is Japanese Encephalitis purified inactivated vaccine used for?

Japanese Encephalitis purified inactivated vaccine is used for the prevention of Japanese Encephalitis, a viral infection transmitted by mosquitoes that can cause inflammation of the brain. It is an investigational vaccine intended to protect individuals aged 18 years and older from this disease.

Who makes Japanese Encephalitis purified inactivated vaccine?

Japanese Encephalitis purified inactivated vaccine is being developed by Valneva SE, a biopharmaceutical company. Valneva's stock is traded under the ticker symbol VALN. The vaccine is currently in clinical development for the prevention of Japanese Encephalitis.

What phase is Japanese Encephalitis purified inactivated vaccine in?

Japanese Encephalitis purified inactivated vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine remains under evaluation for its intended use in preventing Japanese Encephalitis.

What clinical trials is Japanese Encephalitis purified inactivated vaccine in?

Japanese Encephalitis purified inactivated vaccine has been studied in one completed Phase 3 clinical trial, identified as NCT00595465. This trial compared three commercial batches of the vaccine in 389 healthy adult volunteers aged 18 years and older, conducted in Austria and Germany.

Is Japanese Encephalitis purified inactivated vaccine the same as IC51?

Yes, Japanese Encephalitis purified inactivated vaccine is also known as IC51. The Phase 3 clinical trial NCT00595465 is titled 'Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51,' confirming that IC51 is an alternative name for this vaccine.