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Sinovac rabies vaccine

Phase 3

Rabies (Healthy Volunteers) | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Feb 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment2,952

FDA Designations

No designations recorded

Clinical trial landscape

Sinovac rabies vaccine · 2 trials · 1 indication

Phase 3 2
NCT07416110Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies VaccineRabies (Healthy Volunteers)
NOT YET_RECRUITING912 Analytics
NCT07357545Immunogenicity and Safety Assessment of Rabies Vaccine (Vero Cell) for Human Use, Freeze-driedRabies (Healthy Volunteers)
COMPLETED2,040 Analytics
PHASE3NOT YET_RECRUITING
Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine
Rabies (Healthy Volunteers)Unlock trial analytics
PHASE3COMPLETED
Immunogenicity and Safety Assessment of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried
Rabies (Healthy Volunteers)Unlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Concentration (GMC) of rabies neutralizing antibodies among susceptible participants (RVNA titer <0.5 IU/mL before vaccination) in each group
Day 14 after the first-dose vaccination
Seroconversion rate of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Day 14 after the first dose vaccination
Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Day 42 after the first dose vaccination
GMC of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Day 14 after the first dose vaccination

Secondary Endpoints

GMC of rabies neutralizing antibody
Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Seroconversion Rate of rabies neutralizing antibody
Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Incidence of adverse reactions
Up to 30 days after the last-dose vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Sinovac rabies vaccine - Batch 1EXPERIMENTALSubjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 1) on Day 0,3,7,14,28
Sinovac rabies vaccine - Batch 2EXPERIMENTALSubjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 2) on Day 0,3,7,14,28
Sinovac rabies vaccine - Batch 3EXPERIMENTALSubjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 3) on Day 0,3,7,14,28
Sinovac rabies vaccine - 5 dosesEXPERIMENTALSubjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine on Day 0,3,7,14,28
Sinovac rabies vaccine - 4-1 dosesEXPERIMENTALSubjects will be randomly assigned to receive 4 doses of Sinovac rabies vaccine on Day 0,3,7,14
Sinovac rabies vaccine - 4-2 dosesEXPERIMENTALSubjects will be randomly assigned to receive 4 doses of Sinovac rabies vaccine on Day 0,3,7,28
Marketed rabies vaccine - 5 dosesACTIVE_COMPARATORSubjects will be randomly assigned to receive 5 doses of a marketed rabies vaccine in China on Day 0,3,7,14,28

Interventions

NameTypeDescription
Sinovac rabies vaccineBIOLOGICALThree batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules
Marketed rabies vaccineBIOLOGICALA markted Rabies Vaccine using 5 doses of PEP schedules
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Participants are able to understand and voluntarily sign the Informed Consent Form; 2. Able to provide legal identity documents; 3. Age 18 to 45 years; 4. Stable health status (defined as stable underlying disease status within 3 months prior to enrollment, i.e., no change in...

Countries:China
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Frequently asked questions about Sinovac rabies vaccine

What is Sinovac rabies vaccine used for?

Sinovac rabies vaccine is an investigational vaccine being studied for rabies prevention in healthy volunteers. It is currently in Phase 3 clinical development. The vaccine is being evaluated for immunogenicity and safety, meaning how well it triggers an immune response and its safety profile in humans.

Who makes Sinovac rabies vaccine?

Sinovac rabies vaccine is developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the NASDAQ under the ticker symbol SVA. The company is conducting clinical trials for this vaccine in China.

What phase is Sinovac rabies vaccine in?

Sinovac rabies vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been conducted or planned, with one completed and one not yet recruiting.

What clinical trials is Sinovac rabies vaccine in?

Sinovac rabies vaccine has two clinical trials. NCT07357545 is a completed Phase 3 study with 2,040 participants evaluating immunogenicity and safety. NCT07416110 is a Phase 3b trial not yet recruiting, with 912 participants, assessing lot-to-lot consistency. Both are conducted in China.

Is Sinovac rabies vaccine a monoclonal antibody?

Sinovac rabies vaccine is classified as a monoclonal antibody modality. However, it is being studied as a vaccine for rabies prevention. The trials focus on its immunogenicity and safety in healthy volunteers, with active-controlled, randomized, double-blind designs.