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IXIARO

Phase 3

Japanese Encephalitis | Monoclonal antibody | Other |Valneva SE|Last Updated: Dec 19, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01296360Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic CountryPHASE3 COMPLETED 300 — — Dec 1, 2010Oct 1, 2013Dec 19, 20143 Philippines
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Study Endpoints
Primary Endpoints
SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose
1 month post booster
Secondary Endpoints
Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose
1 month
GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose
1 month
GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination
36 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
>14 months to <2 yearsACTIVE_COMPARATORIXIARO 0.25 ml i.m. (milliliter, intramuscular)
>3 years - <18 yearsACTIVE_COMPARATORIXIARO 0.5 ml i.m (milliliter, intramuscular)
Interventions
NameTypeDescription
IXIAROBIOLOGICAL0.25 ml i.m. (milliliter, intramuscular)
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Eligibility Criteria
Age Range9 Months — 18 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Children and adolescents who have completed study IC51-323 and received both IXIARO vaccinations according to protocol. * Children who have received the dose confirmed for their age group. * Male or female healthy children and adolescents aged ≥9 months to \<17 years and 7 mon...

Countries:Philippines
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