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Influenza virus vaccine 2009-2010 formulation

Phase 2

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

Influenza virus vaccine 2009-2010 formulation development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2009

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment131

FDA Designations

No designations recorded

Influenza virus vaccine 2009-2010 formulation clinical trials

Influenza virus vaccine 2009-2010 formulation · 1 trial · 1 indication

Phase 2 1
NCT00945438Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route)Influenza
COMPLETED131 Analytics
PHASE2COMPLETED
Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route)
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.
21 days post-vaccination
To provide information concerning the safety of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.
21 days post-vaccination and entire study duration
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALParticipants aged 18 to 59 years at enrollment.
Group 2EXPERIMENTALParticipants aged 60 years or older at enrollment.

Interventions

NameTypeDescription
Influenza virus vaccine 2009-2010 formulationBIOLOGICAL0.1 mL, Intradermal
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 18 to 59 years (i.e., to the day before the 60th birthday) or 60 years or older (from the day of the 60th birthday) on the day of inclusion * Provision of a signed informed consent * Able to attend all scheduled visits and comply with all trial procedures * For a woman of...

Countries:France
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Frequently asked questions about Influenza virus vaccine 2009-2010 formulation

What is the influenza virus vaccine 2009-2010 formulation?

It is an inactivated, split virion influenza vaccine developed by Sanofi for the Northern Hemisphere 2009-2010 season. It is designed to protect against seasonal influenza and was studied for administration by the intradermal route. The vaccine is an infectious disease product in Sanofi's influenza vaccine portfolio.

What is the influenza virus vaccine 2009-2010 formulation used for?

It is used for the prevention of influenza, specifically the seasonal influenza strains circulating in the Northern Hemisphere during the 2009-2010 season. The clinical study enrolled healthy adult volunteers aged 18 years and older. It is given to reduce illness caused by influenza virus infection.

Who makes the influenza virus vaccine 2009-2010 formulation?

Sanofi develops the influenza virus vaccine 2009-2010 formulation. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is a major manufacturer of seasonal and pandemic influenza vaccines.

What phase is the influenza virus vaccine 2009-2010 formulation in?

The influenza virus vaccine 2009-2010 formulation is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. It is an investigational vaccine and is not described as approved.

What clinical trials is the influenza virus vaccine 2009-2010 formulation in?

The influenza virus vaccine 2009-2010 formulation was studied in one completed Phase 2 trial, NCT00945438, titled Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route). The trial enrolled 131 participants in France, used a controlled design, and included healthy volunteers aged 18 years and older.