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Rabies vaccine

Phase 3

Rabies (Healthy Volunteers) | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Jul 9, 2025

Target and mechanism

ModalityMonoclonal antibody

Also known as Rabies Vaccine (Serum-free Vero Cell), Freeze-dried, Rabies Vaccine, Freeze-dried

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment390

FDA Designations

No designations recorded

Clinical trial landscape

Rabies vaccine · 1 trial · 1 indication

Phase 3 1
NCT07055893Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis RegimenRabies (Healthy Volunteers)
NOT YET_RECRUITING390 Analytics
PHASE3NOT YET_RECRUITING
Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen
Rabies (Healthy Volunteers)Unlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL
Day 14 and Day 28 after the first dose vaccination

Secondary Endpoints

Geometric mean concentrations (GMCs) of RVNA titers
Day 14, Day 28 and Day 42 after the first dose vaccination
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL
Day 42 after the first dose vaccination
Incidence of adverse reactions
Up to 28 days after the last-dose vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Sinovac rabies vaccineEXPERIMENTALParticipants will be randomly assigned to receive Sinovac rabies vaccine.
Sanofi Pasteur Verorab®ACTIVE_COMPARATORParticipants will be randomly assigned to receive the marketed rabies vaccine Verorab®

Interventions

NameTypeDescription
Rabies vaccineBIOLOGICALReceiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule
Verorab®BIOLOGICALReceiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule
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Eligibility Criteria

Age Range1 Year to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Populations aged ≥1 years old; 2. Participants and/or participants' parents/legal guardians are able to understand and sign the informed consent form (ICF) voluntarily; 3. Participants are able to comply with the study procedures based on the investigator's assessment; 4. In ...

Countries:Pakistan
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Frequently asked questions about Rabies vaccine

What is Rabies vaccine used for?

Rabies vaccine is used for rabies prophylaxis in healthy volunteers, specifically evaluated in a simulated post-exposure prophylaxis regimen. It is an investigational vaccine being studied for its immunogenicity and safety in preventing rabies infection.

Who makes Rabies vaccine?

Rabies vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the stock exchange under the ticker SVA. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is Rabies vaccine in?

Rabies vaccine is currently in Phase 3 clinical development. It is an investigational product and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to assess its immunogenicity and safety in a simulated post-exposure prophylaxis setting.

What clinical trials is Rabies vaccine in?

Rabies vaccine is being studied in a Phase 3 clinical trial with the identifier NCT07055893. This trial, titled 'Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen', is not yet recruiting and aims to enroll 390 participants in Pakistan.

Is Rabies vaccine the same as Rabies Vaccine (Serum-free Vero Cell), Freeze-dried?

Yes, Rabies vaccine is also known as Rabies Vaccine (Serum-free Vero Cell), Freeze-dried, and Rabies Vaccine, Freeze-dried. These names refer to the same investigational vaccine product being developed by Sinovac Biotech.

How does Rabies vaccine work?

Rabies vaccine is a monoclonal antibody modality, though its specific molecular target is not detailed. As a vaccine, it is intended to stimulate the immune system to produce protective antibodies against the rabies virus, providing immunity when used in a post-exposure prophylaxis regimen.