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Purified inactivated rabies vaccine, serum free

Phase 3

Rabies | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: May 28, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment816

FDA Designations

No designations recorded

Clinical trial landscape

Purified inactivated rabies vaccine, serum free · 1 trial · 2 indications

Phase 3 1
NCT01339312Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies VaccineRabies
COMPLETED816 Analytics
PHASE3COMPLETED
Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine
RabiesUnlock trial analytics

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 to 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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Frequently asked questions about Purified inactivated rabies vaccine, serum free

What is Purified inactivated rabies vaccine, serum free used for?

Purified inactivated rabies vaccine, serum free is an investigational vaccine being developed for rabies prevention. It is designed to protect against rabies virus infection. The vaccine is currently in Phase 3 clinical development and is being studied in healthy volunteers aged 10 years and older.

Who makes Purified inactivated rabies vaccine, serum free?

Purified inactivated rabies vaccine, serum free is being developed by Sanofi, a company traded on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and efficacy for rabies prevention.

What phase is Purified inactivated rabies vaccine, serum free in?

Purified inactivated rabies vaccine, serum free is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine remains under evaluation for rabies prevention.

What clinical trials is Purified inactivated rabies vaccine, serum free in?

Purified inactivated rabies vaccine, serum free has one completed Phase 3 clinical trial registered as NCT01339312. This study compared the vaccine with a reference purified Vero rabies vaccine in 816 participants in China. The trial was randomized, double-blind, and active-controlled, enrolling healthy volunteers aged 10 years and older.

Is Purified inactivated rabies vaccine, serum free the same as a purified Vero rabies vaccine?

Purified inactivated rabies vaccine, serum free is a vaccine developed using a serum-free manufacturing process. In clinical trials, it has been compared with a reference purified Vero rabies vaccine. The vaccine is being studied as a potential alternative to existing rabies vaccines, but it is not the same as the reference vaccine.