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Split virion, inactivated Influenza vaccine

Phase 2

Influenza | Vaccine | Infectious Disease |Sanofi|Last Updated: Jan 17, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

Split virion, inactivated Influenza vaccine · 1 trial · 2 indications

Phase 2 1
NCT00718146Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 FormulationInfluenza
COMPLETED130 Analytics
PHASE2COMPLETED
Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).
21 days post vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALAge 16 to 60 years
Group 2EXPERIMENTALAge over 60 years

Interventions

NameTypeDescription
Split virion, inactivated Influenza vaccineBIOLOGICAL0.5 mL, Intramuscular (IM)
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Eligibility Criteria

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

Inclusion Criteria : * Aged 18 to 60 years or 61 years and older 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 child-bearing potential: avoid becoming pregnant (use of an effective method ...

Countries:United Kingdom
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Frequently asked questions about Split virion, inactivated Influenza vaccine

What is the split virion, inactivated influenza vaccine?

The split virion, inactivated influenza vaccine is an injectable vaccine developed by Sanofi for the prevention of influenza. It is a split-virion formulation, meaning the virus is inactivated and broken apart so the vaccine can prompt an immune response without causing infection. It is being studied in adults.

What is the split virion, inactivated influenza vaccine used for?

It is used for the prevention of influenza, a respiratory infection caused by influenza viruses. The vaccine is designed to protect against seasonal influenza strains. Sanofi's Northern Hemisphere 2008-2009 formulation was tested in healthy adult volunteers aged 18 years and older in the United Kingdom.

Who makes the split virion, inactivated influenza vaccine?

Sanofi develops the split virion, inactivated influenza vaccine. Sanofi is a global pharmaceutical company that trades under the ticker SNY. The company's vaccine business is one of the largest in the world, and influenza vaccines are a core part of that portfolio.

What phase is the split virion, inactivated influenza vaccine in?

The split virion, inactivated influenza vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA for the formulation described here. The Phase 2 study evaluating this formulation has been completed.

What clinical trials is the split virion, inactivated influenza vaccine in?

The split virion, inactivated influenza vaccine was evaluated in one completed Phase 2 trial, NCT00718146, titled Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation. The trial enrolled 130 healthy adult volunteers aged 18 years and older in the United Kingdom and used a controlled design.