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Purified vero rabies vaccine - serum free - VRVg-2

Phase 3

Rabies | Monoclonal antibody | Other |Sanofi|Last Updated: Feb 10, 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 Trials1
Total Enrollment1,708
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04127786Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of AdultsPHASE3 COMPLETED 1,708 — — Oct 21, 2019Apr 24, 2025Feb 10, 20264 Thailand
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Study Endpoints
Primary Endpoints
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL
Day 42 (post-vaccination)

RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.

Secondary Endpoints
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population
Cohort 1: Day 0 (pre-vaccination), Day 28 (post-vaccination); Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis
Pooled Groups 1 and 4: Day 28 (post-vaccination) and Primary Series: Cohort-1 Group 3: Day 42 (post-vaccination)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group1:VRVg2 Cohort1(C1)-1ry Series:pediatric&adult participants-Booster:102 adult participantsEXPERIMENTALVRVg-2, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 102 adult participants at Month 12
Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participantsACTIVE_COMPARATORVerorab, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12
Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participantsACTIVE_COMPARATORImovax Rabies, 3 injections at Day 0, Day 7, and Day 28 Booster dose of VRVg-2 for a subset of 34 adult participants at Month 12
Group 4:VRVg-2 Cohort 2(C2)-1ry Series:Adult participants-Booster Phase:138 adult participantsEXPERIMENTALVRVg-2, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 138 adult participants between Month 24 up to Month 36
Group 5:Verorab C2-1ry Series:adult participants-Booster Phase:46 adult participantsACTIVE_COMPARATORVerorab, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36
Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participantsACTIVE_COMPARATORImovax Rabies, 2 injections at Day 0 and Day 7 Booster dose of VRVg-2 for a subset of 46 adult participants between Month 24 up to Month 36
Interventions
NameTypeDescription
Purified vero rabies vaccine - serum free - VRVg-2BIOLOGICALPharmaceutical form: Freeze-dried Route of administration: Intramuscular
Purified inactivated rabies vaccine - Verorab®BIOLOGICALPharmaceutical form:Freeze-dried Route of administration: Intramuscular
Purified inactivated rabies vaccine - Imovax® RabiesBIOLOGICALPharmaceutical form: Freeze-dried Route of administration: Intramuscular
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Eligibility Criteria
Age Range1 Year — N/A
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Aged ≥1 year on the day of inclusion * Cohort 1 - pediatrics (\>1 to 17 years old) and adult (≥18 years old) * Cohort 2 - all adults (≥18 years old) * Informed consent form has been signed and dated by the participant and /or and parent(s) or legally acceptable representa...

Countries:Thailand
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