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Smallpox vaccine, LISTER strain, from chick embryo cells

Phase 2

Smallpox | Vaccine | Infectious Disease |Sanofi|Last Updated: Feb 1, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment230

FDA Designations

No designations recorded

Clinical trial landscape

Smallpox vaccine, LISTER strain, from chick embryo cells · 1 trial · 2 indications

Phase 2 1
NCT00258947Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young AdultsSmallpox
COMPLETED230 Analytics
PHASE2COMPLETED
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
SmallpoxUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Smallpox vaccine, LISTER strain, from chick embryo cellsBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 25 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Aged 18 to 25 years on the day of screening * 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 serum pregnancy test performed at screening (Visit 01) * Subject entitl...

Countries:France
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Frequently asked questions about Smallpox vaccine, LISTER strain, from chick embryo cells

What is the smallpox vaccine, LISTER strain, from chick embryo cells used for?

It is a vaccine being developed for protection against smallpox, a serious infectious disease caused by the variola virus. It is based on the LISTER strain of vaccinia virus grown in chick embryo cells. It is intended for use in healthy adults and is currently in clinical development.

Who is developing the smallpox vaccine, LISTER strain, from chick embryo cells?

The vaccine is being developed by Sanofi, which trades under the ticker SNY. Sanofi is a global pharmaceutical company. The vaccine is in Phase 2 clinical development for smallpox.

What phase is the smallpox vaccine, LISTER strain, from chick embryo cells in?

It is in Phase 2 clinical development. One Phase 2 trial has been completed. The vaccine is investigational and has not been approved by the FDA. It is being studied for safety and its ability to produce a take response in healthy young adults.

What clinical trials is the smallpox vaccine, LISTER strain, from chick embryo cells in?

It has been studied in one completed Phase 2 trial, NCT00258947, titled Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults. The trial enrolled 230 healthy volunteers aged 18 years and older in France. It was randomized and double-blind.

How does the smallpox vaccine, LISTER strain, from chick embryo cells work?

It is a vaccine based on the LISTER strain of vaccinia virus, which is grown in chick embryo cells. Vaccinia virus is related to variola virus, the cause of smallpox, and vaccination induces an immune response that provides protection against smallpox. The vaccine is designed to produce a take response at the vaccination site.