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IXIARO

Phase 3

Japanese Encephalitis | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: Dec 19, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

IXIARO · 1 trial · 1 indication

Phase 3 1
NCT01296360Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic CountryJapanese Encephalitis
COMPLETED300 Analytics
PHASE3COMPLETED
Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
Japanese EncephalitisUnlock trial analytics

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 to 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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Frequently asked questions about IXIARO

What is IXIARO used for?

IXIARO is a vaccine used for Japanese Encephalitis, a viral infection of the brain transmitted by mosquitoes. It is being developed for use in pediatric populations in endemic countries, with a completed Phase 3 trial in the Philippines involving 300 participants aged 9 months and older.

Who makes IXIARO?

IXIARO is developed by Valneva SE, a biopharmaceutical company traded on the stock exchange under the ticker VALN. The company conducted a Phase 3 clinical trial for the vaccine in a Japanese Encephalitis-endemic country.

What phase is IXIARO in?

IXIARO is in Phase 3 clinical development. A Phase 3 trial, NCT01296360, has been completed. The vaccine is investigational and not yet approved for use, as it is still undergoing clinical evaluation for pediatric populations.

What clinical trials is IXIARO in?

IXIARO has one completed Phase 3 clinical trial, NCT01296360, titled "Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country." The trial enrolled 300 participants in the Philippines and was active-controlled, though not double-blinded.

Is IXIARO the same as a Japanese Encephalitis vaccine?

IXIARO is a vaccine specifically designed to prevent Japanese Encephalitis, a mosquito-borne viral disease. It is being studied in pediatric populations in endemic regions, with a completed Phase 3 trial demonstrating its investigational use for this indication.