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Sinovac rabies vaccine

Phase 3

Rabies (Healthy Volunteers) | Monoclonal antibody | Other |Sinovac Biotech, Ltd|Last Updated: Feb 17, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment2,952
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07416110Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies VaccinePHASE3 NOT YET_RECRUITING 912 — — Mar 4, 2026Jun 30, 2027Feb 17, 20262 China
NCT07357545Immunogenicity and Safety Assessment of Rabies Vaccine (Vero Cell) for Human Use, Freeze-driedPHASE3 COMPLETED 2,040 — — Aug 27, 2021Jun 21, 2023Jan 22, 20262 China
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07416110primaryCompletionDate: changed
LOWMay 24, 2026NCT07416110studyFirstPostDate: changed