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FLUZONE® HIGH-DOSE (INFLUENZA VACCINE): OVERVIEW OF EFFICACY AND SAFETY

THE ONLY HIGH-DOSE INFLUENZA VACCINE SHOWN TO PROTECT AGAINST FLU AND ITS COMPLICATIONS1-3*†

  
Fluzone High-Dose is among the flu vaccines preferentially recommended by ACIP for those aged 65+ vs unadjuvanted standard-dose flu vaccines.4

WHY CHOOSE FLUZONE HIGH-DOSE FOR YOUR OLDER PATIENTS AGED 65+

FLUZONE HIGH-DOSE PROVIDES 4x THE ANTIGEN

  • In studies of older patients, higher hemagglutinin (HA) content in influenza vaccines has been associated with higher protective influenza titers5
  • Fluzone High-Dose contains 60 micrograms (mcg) of HA per strain compared to 15 mcg of HA per strain in a standard-dose influenza vaccine5

MORE ANTIGEN, MORE PROTECTION

  • Compared to younger patients, adults aged 65+ are at increased risk for severe influenza-associated illness and hospitalization4
  • Higher dose flu vaccines are preferentially recommended by ACIP over unadjuvanted standard dose vaccines for eligible patients aged 65+4

Contains 4x THE ANTIGEN of standard-dose flu vaccines1,2†

The only flu vaccine to deliver SUPERIOR PROTECTION VS STANDARD DOSE in a randomized controlled trial of patients 65+1,2*

Real-world evidence in hospitalizations across 12 FLU SEASONS and 45+ MILLION PEOPLE in randomized and observational studies3‡

*In an RCT conducted in 2011-2012 and 2012-2013 in approximately 32,000 adults 65+, Fluzone High-Dose was 24% (95% CI: 10, 37) more effective (rVE) against influenza due to ANY lab-confirmed circulating strains than standard-dose Fluzone. The prespecified statistical superiority criterion for the primary endpoint (lower limit of 2-sided 95% CI of the vaccine efficacy of Fluzone High-Dose relative to Fluzone >9.1%) was met.1,2
†Fluzone High-Dose contains 60 mcg of HA per strain vs 15 mcg of HA per strain in a standard-dose influenza vaccine.2
‡Analysis included studies conducted over 12 influenza seasons (2009-2010 to 2019-2020, and 2021-2022) in adults 65+.3

PIVOTAL TRIAL:

FLUZONE HIGH-DOSE CONTAINS 4x THE ANTIGEN AND REDUCED FLU CASES BY 24% VS A STANDARD-DOSE FLU VACCINE IN A CLINICAL TRIAL OF ADULTS AGED 65+1,2*†

Study Design

  • 1:1 RCT to evaluate Fluzone High-Dose vs standard-dose Fluzone1,2
  • Study population: 31,803 adults aged 65+ during the influenza seasons 2011-2012 and 2012-20131,2
     
Mobile_FluzoneHD_PivotalTrial_Primary-Secondary-8.18.25 (1)

*Results from a study evaluating Fluzone High-Dose (trivalent formulation) vs Fluzone (standard-dose trivalent formulation). The prespecified statistical superiority criterion for the primary endpoint (lower limit of 2-sided 95% CI of the vaccine efficacy of Fluzone High-Dose relative to Fluzone >9.1%) was met.1,2
†Fluzone High-Dose contains 60 mcg of HA per strain vs 15 mcg of HA per strain in a standard-dose influenza vaccine.2
‡Modified CDC-defined influenza-like illness was based on the Centers for Disease Control and Prevention (CDC) surveillance network definition of an influenza-like illness and was defined as a respiratory illness with cough or sore throat, concurrent with a temperature above 37.2 °C. Influenza was culture-confirmed.2

ACIP=Advisory Committee on Immunization Practices; CI=confidence interval; RCT=randomized controlled trial; rVE=relative vaccine efficacy; RWE=real-world evidence.

REAL-WORLD EVIDENCE:

EVALUATED AGAINST STANDARD-DOSE FLU VACCINES OVER 12 SEASONS3

Study Design3* 

  • Systematic review and meta-analysis of randomized and observational studies to evaluate the rVE of Fluzone High-Dose vs standard-dose influenza vaccines against influenza-associated outcomes in more than 45 million adults aged 65+
  • Analysis included studies conducted over 12 influenza seasons (2009-2010 to 2019-2020, and 2021-2022)
    • The dominant strains were A/H3N2 and A/H1N1 in 8 and 4 of the seasons studied, respectively
    • In 8 of the 12 seasons, there was a mismatch between vaccine and circulating strains

Study Limitations3

  • High degree of statistical heterogeneity observed in several of the pooled rVE estimates
  • Inclusion of unmeasured confounders, such as health-seeking behavior or selection bias, that could affect the findings of the observational studies

*The study was supported by Sanofi; findings of the study were derived from manuscripts of 21 published studies in the public domain.3

FLUZONE HIGH-DOSE PREVENTED MORE INFLUENZA COMPLICATIONS VS STANDARD-DOSE VACCINES3

*Defined as visits with a rapid influenza diagnostic test followed by prescription of antiviral medication.3

ER=emergency room; rVE=relative vaccine effectiveness.

PHASE 3 IMMUNOGENICITY AND SAFETY STUDY

SAFETY PROFILE COMPARED TO STANDARD-DOSE FLU VACCINES5

Solicited systemic adverse reactions and solicited injection-site reactions were slightly more frequent after vaccination with Fluzone High-Dose as compared with a standard-dose influenza vaccine.5

Study Design

  • A Phase 3 controlled study in which 3876 adults aged 65+ were randomized 2:1 to receive Fluzone High-Dose or Fluzone (standard dose) during the influenza season of 2006-20075* 

Adverse Reactions (Within 7 Days)5

  • Study population values for each solicited adverse reaction are provided for the Fluzone High-Dose cohort, then the standard-dose Fluzone cohort
Mobile_FluzoneHD_Adverse-Reactions-7.28.25

*Fluzone High-Dose (trivalent formulation) was evaluated against Fluzone (standard-dose trivalent formulation).5

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Learn about Flublok® (Influenza Vaccine) for your patients aged 9+ years

Important Safety Information

Do not administer Fluzone, Flublok, or Fluzone High-Dose to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine (including egg protein for Fluzone and Fluzone High-Dose). Fluzone and Fluzone High-Dose should not be administered to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine.

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone, Flublok, or Fluzone High-Dose should be based on careful consideration of the potential benefits and risks.

If Fluzone, Flublok, or Fluzone High-Dose are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be attained.

Vaccination with Fluzone, Flublok, or Fluzone High-Dose may not protect all recipients.

Syncope (fainting) has been reported following vaccination with Fluzone, Flublok and Fluzone High-Dose. Procedures should be in place to avoid injury from fainting.

For Fluzone, in children 6 months through 8 years of age, the most common injection-site adverse reactions were pain or tenderness and redness; the most common solicited systemic adverse reactions were irritability, drowsiness (6 months through 35 months), and myalgia (3 years through 8 years). In adults 18 through 64 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache and myalgia. In adults over 65 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, myalgia, and malaise.

For Flublok, in children 9 through 17 years of age who received Flublok Quadrivalent, the most common solicited injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were myalgia, headache, and malaise. In adults 18 through 64 years of age who received Flublok, the most common injection site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, fatigue, and myalgia. In adults 65 years of age and older who received Flublok, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were fatigue and headache.

For Fluzone High-Dose, in adults 65 years of age and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, malaise, and headache.

For Fluzone, Flublok, and Fluzone High-Dose, other adverse reactions may occur.

Indications

Fluzone, Flublok, and Fluzone High-Dose are vaccines indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and type B virus contained in (or in the case of Flublok, represented by antigens contained in) the vaccine. Fluzone is approved for use in persons 6 months of age and older. Flublok is approved for use in persons 9 years of age and older. Fluzone High-Dose is approved for use in persons 65 years of age and older.

Before administration, please see the full Prescribing Information for Fluzone, Flublok, or Fluzone High-Dose. 

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Important Safety Information

Indications

References: 1. Fluzone High-Dose. Prescribing Information. Sanofi Pasteur Inc. 2. DiazGranados CA, et al. N Engl J Med. 2014;371(7):635-645. doi:10.1056/NEJMoa1315727 3. Lee JKH, et al. Vaccine X. 2023;14:100327. doi:10.1016/j.jvacx.2023.100327 4. Grohskopf LA, et al. MMWR Recomm Rep. 2024;73(5):1-25. doi:10.15585/mmwr.rr7305a1 5. Falsey AR, et al. J Infect Dis. 2009;200(2):172-180. doi:10.1086/599790

MAT-US-2508004-v1.0-08/2025

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