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Home » Directories » FDA Approved Drugs » Fluzone, FluBlok Quadrivalent Influenza Vaccines

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Fluzone, FluBlok Quadrivalent Influenza Vaccines

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Profile

Contact Information

Contact: sanofi pasteur
Website: https://www.fluzone.com/

Currently Enrolling Trials

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    General Information

    Fluzone Quadrivalent is indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses for use in persons 6 months of age and older

    Flublok Quadrivalent is indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine for use in persons 18 years of age and older

    Fluzone High-Dose Quadrivalent is indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for use in persons 65 years of age and older.

    Fluzone Quadrivalent

    The recommended dose and schedule is as follows:

    Age Vaccination Status Dose Schedule
    6 months through 35 months

    Not previously vaccinated with influenza vaccine or unknown vaccination history

    Previously vaccinated with influenza vaccine

    Two doses, either 0.25 mL or 0.5 mL*

     

    One or two doses , either 0.25 mL or 0.5 mL*

    Administer at least 4 weeks apart

    If two doses, administer at least 4 weeks apart

    36 months through 8 years

    Not previously vaccinated with influenza vaccine or unknown vaccination history

    Previously vaccinated with influenza vaccine

     

    Two 0.5 mL doses

    One or two 0.5 mL doses

    Administer at least 4 weeks apart

    If two doses, administer at least 4 weeks apart

    9 years and older   One 0.5 mL dose  

    Flublok Quadrivalent:

    Administer Flublok Quadrivalent as a single 0.5 mL dose

    Fluzone High-Dose Quadrivalent

    Should be administered as a single 0.7 mL injection by the intramuscular route in adults 65 years of age and older..

    Side Effects

    Adverse effects may include, but are not limited to, the following:

    • injection-site reactions
    • pain
    • erythema
    • swelling
    • myalgia
    • malaise
    • headache
    • fatigue

    Clinical Trial Results

    Fluzone High-Dose Quadrivalent

    FDA approval was based on data from a Phase 3 immunogenicity and safety study, in which Fluzone High-Dose Quadrivalent achieved the primary endpoint of non-inferior immunogenicity compared to two trivalent formulations of Fluzone High-Dose, each containing one of the two influenza B strains recommended for inclusion in the vaccine for the 2017-2018 influenza season. In a secondary endpoint of the trial, each B strain in Fluzone High-Dose Quadrivalent induced a superior immune response compared to the trivalent formulation not containing the corresponding B strain.

    Fluzone Quadrivalent

     

    Flublok Quadrivalent

     

    Approval Date: 2002-09-01
    Company Name: Sanofi Pasteur
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