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VLA1553 full dose

Phase 2

Chikungunya Virus Infection | Monoclonal antibody | Other |Valneva SE|Last Updated: Aug 8, 2025

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_CONTROLLEDDMC
Total Trials1
Total Enrollment304
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06106581A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 YearsPHASE2 COMPLETED 304Dec 18, 2023Jul 2, 2025Aug 8, 20253 Dominican Republic, Honduras
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Study Endpoints
Primary Endpoints
Frequency of solicited injection site reactions
within 14 days post-vaccination
Severity of solicited injection site reactions
within 14 days post-vaccination
Frequency of systemic reactions
within 14 days post-vaccination
Severity of systemic reactions
within 14 days post-vaccination
Secondary Endpoints
Frequency of any adverse event (AE)
within 28 days post-vaccination
Severity of any adverse event (AE)
within 28 days post-vaccination
Frequency of unsolicited AE
until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VLA1553 full doseEXPERIMENTAL -
VLA1553 half doseEXPERIMENTAL -
ControlACTIVE_COMPARATORSingle intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
Interventions
NameTypeDescription
VLA1553 full doseBIOLOGICALSingle intramuscular vaccination on Day 1 with VLA1553 full dose, a lyophilized live-attenuated Chikungunya vaccine candidate
VLA1553 half doseBIOLOGICALSingle intramuscular vaccination on Day 1 with VLA1553 half dose, a lyophilized live-attenuated Chikungunya vaccine candidate
ControlBIOLOGICALNimenrix
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Eligibility Criteria
Age Range1 Year — 11 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Male or female healthy children aged 7 to 11 years for Stratum A, 3 to 6 years for Stratum B and 1 to 2 years for Stratum C at the time of vaccination; 2. Written informed consent by the participant's parent(s)/Legally Acceptable Representative(s) ((LAR(s)), according to loca...

Countries:Dominican RepublicHonduras
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