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Inactivated Split-virion influenza vaccine

Phase 4

Orthomyxoviridae Infection | Vaccine | Infectious Disease |Sanofi|Trials Updated: Jan 14, 2014

Inactivated Split-virion influenza vaccine development status

Highest phase Phase 4 (NCT03266237)
Phase scored for SNYPhase 3
Registered trials 6 across 6 sponsors since Oct 2006

Inactivated Split-virion influenza vaccine target and mechanism

ModalityVaccine

Also known as Vaxigrip

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment2,256

FDA Designations

No designations recorded

Inactivated Split-virion influenza vaccine clinical trials

Inactivated Split-virion influenza vaccine · 1 trial · 3 indications

Phase 3 1
NCT00383539Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in AdultsOrthomyxoviridae Infection
COMPLETED2,256 Analytics
PHASE3COMPLETED
Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults
Orthomyxoviridae InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine
21 Days pot-vaccination

Secondary Endpoints

To provide information concerning the safety of an inactivated, split-virion influenza vaccine.
6 months post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLot 1
2EXPERIMENTALLot 2
3EXPERIMENTALLot 3
4ACTIVE_COMPARATORControl

Interventions

NameTypeDescription
Inactivated Split-virion influenza vaccineBIOLOGICALVaccine Lot 1
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria : * Aged 18 to 60 years on the day of inclusion. * Informed consent form signed. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman, inability to bear a child or negative urine pregnancy test at the first visit. Exclusion Criteria : * S...

Countries:FranceLithuaniaSpainUnited Kingdom
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Frequently asked questions about Inactivated Split-virion influenza vaccine

What is the Inactivated Split-virion influenza vaccine?

The inactivated split-virion influenza vaccine is a vaccine developed by Sanofi for protection against influenza, an infection caused by viruses in the Orthomyxoviridae family. It is an injectable vaccine that uses inactivated, split virus particles and is given to healthy adults. It is currently an investigational product in Phase 3 development.

What is the Inactivated Split-virion influenza vaccine used for?

It is used for the prevention of influenza, listed in development for Orthomyxoviridae infection. Influenza is a respiratory illness caused by influenza viruses. The vaccine is designed to stimulate an immune response against the virus in adults aged 18 years and older. Its clinical program enrolled healthy adult volunteers.

Who makes the Inactivated Split-virion influenza vaccine?

Sanofi develops the inactivated split-virion influenza vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the vaccine's clinical development program in infectious disease.

What phase is the Inactivated Split-virion influenza vaccine in?

The inactivated split-virion influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been established as approved. Its Phase 3 trial has been completed, and no trials for this asset are currently listed as active.

What clinical trials is the Inactivated Split-virion influenza vaccine in?

The vaccine has been studied in one completed Phase 3 trial, NCT00383539, titled a lot-to-lot consistency study of the investigational, inactivated, split-virion influenza vaccine in adults. That randomized, double-blind, active-controlled trial enrolled 2,256 healthy adults aged 18 years and older across France, Lithuania, Spain, and the United Kingdom.