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Purified Vero Rabies Vaccine

Phase 2

Rabies | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Dec 3, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment342

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Purified Vero Rabies Vaccine is an investigational vaccine being studied for rabies prevention. It is being evaluated in a simulated rabies post-exposure regimen, meaning it is tested for use after potential exposure to the rabies virus. The vaccine is currently in Phase 2 clinical development and is not yet approved.

Who makes Purified Vero Rabies Vaccine?

Purified Vero Rabies Vaccine is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy volunteers.

What phase is Purified Vero Rabies Vaccine in?

Purified Vero Rabies Vaccine is currently in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. The vaccine is being studied in a completed Phase 2 trial that evaluated its use in a simulated rabies post-exposure regimen.

What clinical trials is Purified Vero Rabies Vaccine in?

Purified Vero Rabies Vaccine has been studied in one clinical trial with the identifier NCT01877395. This Phase 2 trial, titled 'Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen,' was completed in the United States and enrolled 342 participants aged 18 years and older.

How does Purified Vero Rabies Vaccine work?

Purified Vero Rabies Vaccine is a vaccine, not a monoclonal antibody, despite the modality classification. It is designed to stimulate the immune system to produce antibodies against the rabies virus. The vaccine is being studied for use in a post-exposure regimen to prevent rabies after a potential exposure.