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Purified Vero Rabies Vaccine

Phase 3

Rabies | Vaccine | Infectious Disease |Sanofi|Trials Updated: Dec 3, 2014

Purified Vero Rabies Vaccine development status

Highest phase Phase 3 (NCT01339312)
Phase scored for SNYPhase 2
Registered trials 1 across 1 sponsor since Apr 2011

Purified Vero Rabies Vaccine target and mechanism

ModalityVaccine

Also known as Purified Vero Rabies Vaccine (VRVg)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment342

FDA Designations

No designations recorded

Purified Vero Rabies Vaccine clinical trials

Purified Vero Rabies Vaccine · 1 trial · 1 indication

Phase 2 1
NCT01877395Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure RegimenRabies
COMPLETED342 Analytics
PHASE2COMPLETED
Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen
RabiesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series).
Day 14 post-vaccination

Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)

Secondary Endpoints

Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
Day 0 up to 6 months post-vaccination
Geometric mean titer ratio (GMTR) following vaccination with either Purified Vero Rabies Vaccine, Serum Free or Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post exposure Regimen
Day 14 post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Purified Vero Rabies Vaccine GroupEXPERIMENTALParticipants will receive the Purified Vero Rabies Vaccine (VRVg)
Imovax® Rabies Vaccine GroupEXPERIMENTALParticipants will receive the Imovax® Rabies vaccine

Interventions

NameTypeDescription
Purified Vero Rabies Vaccine (VRVg)BIOLOGICAL0.5 mL, Intramuscular
Imovax® Rabies: inactivated rabies vaccineBIOLOGICAL1.0 mL, Intramuscular
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Aged 18 to \< 65 years on the day of inclusion * Informed consent form has been signed and dated - Able to attend all scheduled visits and comply with all trial procedures. Exclusion Criteria: * Subject is pregnant, or lactating, or of childbearing potential (to be considere...

Countries:United States
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Frequently asked questions about Purified Vero Rabies Vaccine

What is Purified Vero Rabies Vaccine?

Purified Vero Rabies Vaccine is an investigational vaccine developed by Sanofi for the prevention of rabies. It is designed to be given as a simulated rabies post-exposure regimen. The vaccine is in Phase 2 clinical development and has been studied in healthy adult volunteers.

What is Purified Vero Rabies Vaccine used for?

Purified Vero Rabies Vaccine is being developed for rabies, an infectious disease. It is intended for use in a rabies post-exposure regimen, meaning it is evaluated as a preventive treatment after potential exposure to the rabies virus. It is not yet approved and remains investigational.

Who makes Purified Vero Rabies Vaccine?

Sanofi develops Purified Vero Rabies Vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the clinical program evaluating this vaccine candidate for rabies prevention.

What phase is Purified Vero Rabies Vaccine in?

Purified Vero Rabies Vaccine is in Phase 2 clinical development. It is an investigational vaccine and is not FDA approved. The Phase 2 trial has been completed, and no active trials are currently listed for this vaccine candidate.

What clinical trials is Purified Vero Rabies Vaccine in?

Purified Vero Rabies Vaccine has been studied in one completed Phase 2 trial, NCT01877395, titled Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen. The trial enrolled 342 participants in the United States and was controlled and randomized.

Is Purified Vero Rabies Vaccine the same as VRVg?

Yes, Purified Vero Rabies Vaccine is also known as Purified Vero Rabies Vaccine (VRVg). VRVg is an abbreviation used for the same Sanofi vaccine candidate being studied for rabies prevention in a simulated post-exposure regimen.