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Japanese Encephalitis purified inactivated vaccine

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment389
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00595465Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51PHASE3 COMPLETED 389Dec 1, 2007Jun 1, 2008May 16, 20144 Austria, Germany
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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 — 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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