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Low-dose RSV mRNA vaccine

Phase 1

RSV | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Feb 18, 2026

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07418229Study to Evaluate the Safety of a Lyophilized RSV mRNA VaccinePHASE1 NOT YET_RECRUITING 60Mar 9, 2026May 30, 2027Feb 18, 20261 China
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Study Endpoints
Primary Endpoints
Incidence of adverse events
Up to 30 days after vaccination
Secondary Endpoints
Incidence of adverse events
Up to 14 days after vaccination
Incidence of serious adverse events and adverse events of special interest
Up to 12 months after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Sinovac RSV mRNA vaccine low-dose groupEXPERIMENTALParticipants will receive one dose of low-dose lyophilized RSV mRNA vaccine.
Sinovac RSV mRNA vaccine high-dose groupEXPERIMENTALParticipants will receive one dose of high-dose lyophilized RSV mRNA vaccine.
Placebo control groupPLACEBO_COMPARATORParticipants will receive one dose of normal saline.
Interventions
NameTypeDescription
Low-dose RSV mRNA vaccineBIOLOGICALOne dose of RSV mRNA vaccine in low dosage
High-dose RSV mRNA vaccineBIOLOGICALOne dose of RSV mRNA vaccine in high dosage
PlaceboOTHERParticipants will receive one dose of normal saline.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Participants can understand and voluntarily sign the informed consent form; 2. Able to provide legal identity documents; 3. Healthy individuals aged 18 years and above; 4. Participants of childbearing potential and their sexual partners voluntarily adopt effective contracepti...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07418229primaryCompletionDate: changed
LOWMay 24, 2026NCT07418229studyFirstPostDate: changed