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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Low-dose RSV mRNA vaccine · 1 trial · 2 indications

Phase 1 1
NCT07418229Study to Evaluate the Safety of a Lyophilized RSV mRNA VaccineRSV
NOT YET_RECRUITING60 Analytics
PHASE1NOT YET_RECRUITING
Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine
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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 to 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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Frequently asked questions about Low-dose RSV mRNA vaccine

What is Low-dose RSV mRNA vaccine used for?

Low-dose RSV mRNA vaccine is an investigational vaccine being developed for the prevention of respiratory syncytial virus (RSV) infection. It is currently in Phase 1 clinical development and is not yet approved for use. The vaccine is designed to elicit an immune response against RSV.

Who makes Low-dose RSV mRNA vaccine?

Low-dose RSV mRNA vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded on the stock exchange under the ticker symbol SVA. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational RSV vaccine.

What phase is Low-dose RSV mRNA vaccine in?

Low-dose RSV mRNA vaccine is currently in Phase 1 clinical development. It is an investigational vaccine and has not received regulatory approval. The Phase 1 trial is designed to assess the safety of the vaccine in healthy volunteers.

What clinical trials is Low-dose RSV mRNA vaccine in?

Low-dose RSV mRNA vaccine is being evaluated in a Phase 1 clinical trial registered as NCT07418229, titled 'Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine'. This randomized, double-blind, placebo-controlled trial is enrolling 60 participants in China and is currently not yet recruiting.

Is Low-dose RSV mRNA vaccine FDA approved?

No, Low-dose RSV mRNA vaccine is not FDA approved. It is an investigational vaccine currently in Phase 1 clinical trials. The vaccine has not yet completed the clinical development process required for regulatory approval.