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Inactivated Split-virion influenza vaccine

Phase 3

Orthomyxoviridae Infection | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 14, 2014

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

Clinical trial landscape

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 Inactivated Split-virion influenza vaccine used for?

Inactivated Split-virion influenza vaccine is an investigational vaccine being studied for the prevention of Orthomyxoviridae infection, which includes influenza and myxovirus infection. It is designed to protect against these viral infections and is currently in clinical development.

Who makes Inactivated Split-virion influenza vaccine?

Sanofi (ticker: SNY) is developing Inactivated Split-virion influenza vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing Orthomyxoviridae infection.

What phase is Inactivated Split-virion influenza vaccine in?

Inactivated Split-virion influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed to assess its performance.

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

Inactivated Split-virion influenza vaccine has one completed Phase 3 trial, NCT00383539, titled "Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults." This randomized, double-blind, active-controlled study enrolled 2,256 healthy adults aged 18 years and older across France, Lithuania, Spain, and the United Kingdom.

How does Inactivated Split-virion influenza vaccine work?

Inactivated Split-virion influenza vaccine is a vaccine that contains inactivated, split influenza virus particles. It works by exposing the immune system to these viral components, prompting an immune response that prepares the body to fight off future influenza infections.

Is Inactivated Split-virion influenza vaccine the same as a flu shot?

Inactivated Split-virion influenza vaccine is an investigational influenza vaccine designed to prevent flu caused by Orthomyxoviridae viruses. It is similar in concept to seasonal flu shots, but it is still in clinical development and not yet commercially available.