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Inactivated, split-virion influenza vaccine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment4,787

FDA Designations

No designations recorded

Clinical trial landscape

Inactivated, split-virion influenza vaccine · 3 trials · 4 indications

Phase 3 1Phase 2 2
NCT00383526Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip® in the ElderlyOrthomyxoviridae Infection
COMPLETED3,707 Analytics
PHASE3COMPLETED
Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip® in the Elderly
Orthomyxoviridae Infection
NCT003835263,707
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Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza vaccine
21 days post-vaccination
To provide information concerning the immunogenicity of influenza vaccination.
21 Days and 2 Years post-vaccination 1

Secondary Endpoints

To provide information concerning the safety of Inactivated, Split-Virion Influenza vaccine
Entire study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Study Group 1EXPERIMENTAL -
Study Group 2ACTIVE_COMPARATOR -
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Inactivated, split-virion influenza vaccineBIOLOGICALVaccine
Inactivated, split-virion, influenza virusBIOLOGICAL0.5 mL single annual dose
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Aged over 60 years on the day of inclusion. * Informed Consent Form signed. * Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in pa...

Countries:BelgiumFranceItalyLithuaniaAustraliaNew ZealandGermanySwitzerland
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Frequently asked questions about Inactivated, split-virion influenza vaccine

What is Inactivated, Split-Virion Influenza Virus used for?

Inactivated, Split-Virion Influenza Virus is an investigational vaccine being developed for influenza and orthomyxoviridae infections. It is designed to prevent illness caused by influenza viruses. The vaccine is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Inactivated, Split-Virion Influenza Virus?

Sanofi (ticker: SNY) is developing Inactivated, Split-Virion Influenza Virus. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in various populations, including adults, elderly subjects, and renal transplant recipients.

What phase is Inactivated, Split-Virion Influenza Virus in?

Inactivated, Split-Virion Influenza Virus is in Phase 2 clinical development. It is an investigational vaccine and has not received regulatory approval. Four Phase 2 trials have been completed, with a total enrollment of 4,787 participants across multiple countries.

What clinical trials is Inactivated, Split-Virion Influenza Virus in?

Inactivated, Split-Virion Influenza Virus has completed four Phase 2 trials: NCT00524940, NCT00606359, NCT00703651, and NCT00776438. These trials assessed safety and immunogenicity in healthy volunteers and specific populations, including renal transplant subjects, across the United States, France, Belgium, Czechia, and Lithuania.

Is Inactivated, Split-Virion Influenza Virus the same as Fluzone or Vaxigrip?

Inactivated, Split-Virion Influenza Virus is compared against Fluzone and Vaxigrip in clinical trials, but it is not stated to be the same product. The trials reference these as comparators or alternative vaccines, indicating they are distinct formulations being evaluated for immunogenicity.