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Influenza virus vaccine 2009-2010 formulation

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment131

FDA Designations

No designations recorded

Clinical trial landscape

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 Influenza virus vaccine 2009-2010 formulation used for?

Influenza virus vaccine 2009-2010 formulation is used for the prevention of influenza. It is a seasonal influenza vaccine developed for the 2009-2010 Northern Hemisphere season. The vaccine is administered via the intradermal route and is intended for use in adults aged 18 years and older.

Who makes Influenza virus vaccine 2009-2010 formulation?

Influenza virus vaccine 2009-2010 formulation is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is responsible for the research, development, and manufacturing of this seasonal influenza vaccine.

What phase is Influenza virus vaccine 2009-2010 formulation in?

Influenza virus vaccine 2009-2010 formulation is in Phase 2 clinical development. It is an investigational vaccine and has not been approved for commercial use. The Phase 2 trial has been completed, and the vaccine is no longer in active clinical testing.

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

Influenza virus vaccine 2009-2010 formulation has been studied in one clinical trial, identified as NCT00945438. This Phase 2 study, titled 'Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route)', was conducted in France and enrolled 131 participants. The trial has been completed.

Is Influenza virus vaccine 2009-2010 formulation FDA approved?

Influenza virus vaccine 2009-2010 formulation is not FDA approved. It is an investigational vaccine that has completed a Phase 2 clinical trial. The vaccine is still in clinical development and has not received regulatory approval for marketing in the United States or elsewhere.