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Purified inactivated rabies vaccine

Phase 3

Rabies | Vaccine | Infectious Disease |Sanofi|Trials Updated: May 28, 2014

Purified inactivated rabies vaccine development status

Highest phase Phase 3
Registered trials 5 across 1 sponsor since Jul 2009

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

Purified inactivated rabies vaccine clinical trials

Purified inactivated rabies vaccine · 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

What is the purified inactivated rabies vaccine used for?

The purified inactivated rabies vaccine is used for immunization against rabies, a viral infection that affects the nervous system. It is being developed by Sanofi as a serum-free vaccine candidate for rabies prevention. The vaccine is intended to protect people from rabies virus infection.

Who makes the purified inactivated rabies vaccine?

Sanofi, which trades under the ticker SNY, is the developer of the purified inactivated rabies vaccine. Sanofi is a global pharmaceutical company, and this serum-free rabies vaccine candidate is part of its vaccine portfolio. The company conducted the clinical development of this vaccine in China.

What phase is the purified inactivated rabies vaccine in?

The purified inactivated rabies vaccine is in Phase 3 clinical development. It is an investigational vaccine candidate and is not approved. The Phase 3 trial has been completed, and the vaccine remains in clinical development for rabies prevention.

What clinical trials is the purified inactivated rabies vaccine in?

The purified inactivated rabies vaccine was studied in a completed Phase 3 trial, NCT01339312, titled Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine. The trial enrolled 816 participants in China, was randomized, double blind, and active controlled, and included healthy volunteers aged 10 years and older.

Is the purified inactivated rabies vaccine the same as the serum-free purified inactivated rabies vaccine?

Yes. The purified inactivated rabies vaccine is also known as the purified inactivated rabies vaccine, serum free. These names refer to the same Sanofi vaccine candidate, which is a serum-free formulation being developed for rabies prevention. The serum-free designation describes the formulation used in its clinical development.

How does the purified inactivated rabies vaccine work?

The purified inactivated rabies vaccine is a vaccine that uses inactivated rabies virus to stimulate an immune response against rabies. It is a serum-free formulation, meaning it does not contain serum components. The vaccine is designed to prompt the body to develop protection against rabies virus infection.