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Purified inactivated rabies vaccine, serum free

Phase 3

Rabies | Monoclonal antibody | Other |Sanofi|Last Updated: May 28, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment816
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01339312Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies VaccinePHASE3 COMPLETED 816Apr 1, 2011Sep 1, 2012May 28, 20141 China
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Study Endpoints
Primary Endpoints
Information on the rabies virus neutralizing antibody (RVNA) titer post vaccination
Day 14

Rabies virus neutralizing antibody (RVNA) titer as determined by rapid fluorescent focus inhibition test (RFFIT)

Secondary Endpoints
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination.
Day 1 up to 6 months post last vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VRVg Vaccine Group 1EXPERIMENTALParticipants aged 18 years or older will receive Purified Vero Rabies Vaccine Serum Free (VRVg)
VRVg Vaccine Group 2EXPERIMENTALParticipants aged 10 to 17 years will receive Purified Vero Rabies Vaccine Serum Free (VRVg)
Verorab Vaccine Group 1ACTIVE_COMPARATORParticipants aged 18 years or older will receive Verorab Vaccine
Verorab Vaccine Group 2ACTIVE_COMPARATORParticipants aged 10 to 17 years will receive Verorab Vaccine
Interventions
NameTypeDescription
Purified inactivated rabies vaccine, serum freeBIOLOGICAL0.5 mL, Intramuscular
Purified Vero Rabies VaccineBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria
Age Range10 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Adults (≥ 18 years) * Aged ≥ 18 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception or ...

Countries:China
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