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VLA1553 full dose

Phase 2

Chikungunya Virus Infection | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: Aug 13, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment304

FDA Designations

No designations recorded

Clinical trial landscape

VLA1553 full dose · 1 trial · 1 indication

Phase 2 1
NCT06106581A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 YearsChikungunya Virus Infection
COMPLETED304 Analytics
PHASE2COMPLETED
A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years
Chikungunya Virus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Solicited Injection Site Reactions
within 14 days post-vaccination

Frequency and severity of solicited injection site and solicited systemic reactions within 14 days post-vaccination.

Severity of Solicited Injection Site Reactions
within 14 days post-vaccination
Number of Participants With Solicited Systemic Reactions
within 14 days post-vaccination
Severity of Solicited Systemic Reactions
within 14 days post-vaccination

Secondary Endpoints

Number of Participants With Any Adverse Event (AE)
within 28 days post-vaccination
Severity of Any Adverse Event (AE)
within 28 days post-vaccination
Number of Participants With 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 to 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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Frequently asked questions about VLA1553 full dose

What is VLA1553 full dose used for?

VLA1553 full dose is an investigational drug being studied for the prevention of Chikungunya Virus Infection. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in healthy children aged 1 to 11 years.

What does VLA1553 full dose target?

VLA1553 full dose is a monoclonal antibody. The specific molecular target of VLA1553 full dose has not been disclosed in the available information. It is being studied for its potential to prevent Chikungunya Virus Infection.

Who makes VLA1553 full dose?

VLA1553 full dose is being developed by Valneva SE, a biopharmaceutical company. Valneva SE is publicly traded under the ticker symbol VALN. The company is conducting clinical trials to evaluate the safety and efficacy of VLA1553 full dose.

What phase is VLA1553 full dose in?

VLA1553 full dose is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the prevention of Chikungunya Virus Infection in pediatric populations.

What clinical trials is VLA1553 full dose in?

VLA1553 full dose has one completed Phase 2 clinical trial registered as NCT06106581. This trial, titled 'A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years', enrolled 304 participants in the Dominican Republic and Honduras. The trial was randomized, double-blind, and active-controlled.

Is VLA1553 full dose the same as VLA1553?

VLA1553 full dose is a specific formulation or dosing regimen of the drug VLA1553. The full dose designation distinguishes it from other potential doses of the same drug. Both refer to the same investigational product being developed by Valneva SE for Chikungunya Virus Infection.