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Purified Vero Rabies Vaccine

Phase 2

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

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment342
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01877395Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure RegimenPHASE2 COMPLETED 342Jun 1, 2013Sep 1, 2014Dec 3, 20145 United States
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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 — 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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