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Split virion, inactivated Influenza vaccine

Phase 2

Influenza | Monoclonal antibody | 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 Split virion, inactivated Influenza vaccine used for?

Split virion, inactivated Influenza vaccine is used for influenza, specifically to prevent infection caused by the influenza virus. It is an inactivated vaccine that contains split virus particles, designed to elicit an immune response against the virus. The vaccine is being developed for use in adults, as studied in a clinical trial.

Who makes Split virion, inactivated Influenza vaccine?

Split virion, inactivated Influenza vaccine is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is responsible for the research and development of this vaccine candidate, which is currently in clinical trials for the prevention of influenza.

What phase is Split virion, inactivated Influenza vaccine in?

Split virion, inactivated Influenza vaccine is in Phase 2 of clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The vaccine is being studied for its immunogenicity and safety in adults, with one completed Phase 2 trial.

What clinical trials is Split virion, inactivated Influenza vaccine in?

Split virion, inactivated Influenza vaccine has one completed clinical trial, identified as NCT00718146. This Phase 2 study evaluated the immunogenicity and safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation, in 130 healthy adults aged 18 years and older in the United Kingdom.

How does Split virion, inactivated Influenza vaccine work?

Split virion, inactivated Influenza vaccine works by presenting inactivated, split virus particles to the immune system. This exposure triggers an immune response, including the production of antibodies, without causing the disease. The vaccine is designed to protect against influenza by priming the immune system to recognize and fight the virus upon future exposure.