Fluzone High-Dose Quadrivalent Influenza Vaccine
IN A RANDOMIZED CONTROLLED TRIAL OF ADULTS AGED 65+

THE FIRST AND ONLY FLU VACCINE TO DELIVER SUPERIOR FLU PROTECTION VS STANDARD
DOSE2,3*

Fluzone High-Dose is the first and only influenza vaccine proven superior to a standard-dose flu vaccine in adults aged 65+ and has more than 12 years of real-world evidence (2009-2010 to 2019-2020, and 2021-2022) in the prevention of influenza outcomes including influenza hospitalization. 2-4

*Results from a study (2011-2012, 2012-2013) 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 2,3

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

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

More Antigen, More Protection
  • Compared to younger patients, adults aged 65+ are at increased risk for severe influenza-associated illness and hospitalization1
  • Higher dose flu vaccines are preferentially recommended by ACIP as an option to offer eligible patients aged 65+ who may be at a higher risk of flu-related complications, compared to standard-dose vaccines1
FLUZONE HIGH-DOSE PROVIDES 4x THE ANTIGEN
  • In studies of older patients, higher hemagluttinin (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
The #1 Flu Vaccine administered in patients aged 65+6*
More healthcare providers vaccinated their older patients with Fluzone High-Dose than any other flu vaccine to protect against influenza and its complications
THE FIRST AND ONLY INFLUENZA VACCINE PROVEN SUPERIOR TO A STANDARD-DOSE2,3†
In a phase 3b-4 randomized control trial in adults aged 65+, Fluzone High-Dose provided 24% greater protection against laboratory-confirmed influenza than a standard-dose flu vaccine
More than a decade of real-world evidence4‡
12 years of RWE in >45 million people comparing Fluzone High-Dose to standard-dose flu vaccines against influenza-related complications

*Internal calculations by Sanofi based on IQVIA database of total flu vaccines administered from 7/23 to 4/24 in people aged 65+. Not inclusive of all federal payers. Study details and information maintained by Sanofi.6

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.2,3

Analysis included studies conducted over 12 influenza seasons (2009-2010 to 2019-2020, and 2021-2022).4

RANDOMIZED CONTROLLED TRIAL

MORE ANTIGEN, MORE PROTECTION

Fluzone HD contains 4x the antigen and reduced flu cases by 24% vs a standard-dose flu vaccine in a clinical trial of adults aged 65+2,3*

STUDY DESIGN

  • 1:1 randomized, controlled trial to evaluate Fluzone High-Dose vs standard-dose Fluzone2,3
  • Study population: 31,803 adults aged 65+ during the influenza seasons 2011-2012 and 2012-20132,3

PRIMARY ENDPOINT Relative vaccine efficacy (rVE) against influenza due to ANY lab-confirmed circulating strains2,3

Standard dose
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Fluzone High-Dose

24%

(95% CI: 10, 37)

FEWER INFLUENZA CASES

Number of influenza cases

SECONDARY ENDPOINT rVE against
influenza due to antigenically matched strains2,3‡

Standard dose
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Fluzone High-Dose

51%

(95% CI: 17, 72)

FEWER INFLUENZA CASES

Number of influenza cases

Standard-dose Fluzone

Fluzone High-Dose


*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.2,3

Fluzone High-Dose contains 60 micrograms (mcg) of hemagglutinin (HA) per strain vs 15 mcg of HA per strain in a standard-dose influenza vaccine.3

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.3

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REAL-WORLD EVIDENCE

META-ANALYSIS: THROUGH 12 YEARS OF REAL-WORLD EVIDENCE IN >45 MILLION PEOPLE, FLUZONE HIGH-DOSE PROVIDED:

Greater protection against influenza complications, including influenza hospitalizations, compared to standard-dose flu vaccines4

STUDY DESIGN*

  • Systematic review and meta-analysis of randomized and observational studies to evaluate the relative vaccine effectiveness of Fluzone High-Dose vs standard-dose influenza vaccines against influenza-associated outcomes in more than 45 million adults aged 65+4
  • Analysis included studies conducted over 12 influenza seasons (2009-2010 to 2019-2020, and 2021-2022)4
  • The dominant strains were A/H3N2 and A/H1N1 in 8 and 4 of the seasons studied, respectively4
  • In 8 of the 12 seasons, there was a mismatch between vaccine and circulating strains4

STUDY LIMITATIONS

  • High degree of statistical heterogeneity observed in several of the pooled rVE estimates4
  • Inclusion of unmeasured confounders, such as health-seeking behavior or selection bias, that could affect the findings of the observational studies4

*This study was supported by Sanofi.

PRIMARY OBJECTIVE: POOLED RELATIVE VACCINE EFFECTIVENESS (95% CI) AGAINST INFLUENZA-RELATED OUTCOMES4

Flu virus icon

INFLUENZA-LIKE ILLNESS*

14.3% rVE

(95% CI: 4.2, 23.3)

INFLUENZA-RELATED HOSPITALIZATIONS

11.2% rVE

(95% CI: 7.4, 14.8)

INFLUENZA-RELATED HOSPITALIZATIONS/ER VISITS

10.4% rVE

(95% CI: 6.8, 13.9)
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CARDIOVASCULAR-RELATED HOSPITALIZATIONS

12.8% rVE

(95% CI: 10.2, 15.3)

CARDIORESPIRATORY-RELATED HOSPITALIZATIONS

16.7% rVE

(95% CI: 13.8, 19.5)
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RESPIRATORY-RELATED HOSPITALIZATIONS

14.7% rVE

(95% CI: 8.5, 20.4)

PNEUMONIA HOSPITALIZATIONS

27.8% rVE

(95% CI: 12.5, 40.5)

PNEUMONIA/INFLUENZA HOSPITALIZATIONS

14.4% rVE

(95% CI: 6.8, 20.6)

Select endpoints are presented here; all-cause hospitalization and pneumonia were also evaluated.4

* Defined as visits with a rapid influenza diagnostic test followed by prescription of antiviral medication.4

ER=emergency room; rVE=relative vaccine effectiveness.

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PHASE 3 IMMUNOGENICITY AND SAFETY STUDY

SAFETY PROFILE COMPARED TO A STANDARD-DOSE INFLUENZA VACCINE

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*

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

ADVERSE REACTIONS (WITHIN 7 DAYS) 5

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

SOLICITED SYSTEMIC REACTIONS

Any
(n=1260, n=2572)
Myalgia
(n=1260, n=2572)
Malaise
(n=1259, n=2570)
Headache
(n=1260, n=2572)
Fever (≥99.5°F)
(n=1258, n=2569)

SOLICITED INJECTION-SITE REACTIONS

Pain
(n=1260, n=2572)
Erythema
(n=1260, n=2572)
Swelling
(n=1260, n=2572)
0%
20%
40%
60%
80%
100%

Standard-dose Fluzone

Fluzone High-Dose

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TO ORDER FLUZONE HIGH-DOSE,

CALL 1-800-VACCINE (1-800-822-2463) OR CLICK BELOW

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INDICATIONS

Fluzone, Flublok, and Fluzone High-Dose are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older. Flublok is approved for use in persons 18 years of age and older. Fluzone High-Dose is approved for use in persons 65 years of age and older.

IMPORTANT SAFETY INFORMATION

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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 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, fatigue, and myalgia. In adults 65 years of age and older, 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.

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

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