Fluzone High-Dose Quadrivalent Influenza Vaccine

FLUZONE HIGH-DOSE IS THE FIRST AND ONLY INFLUENZA VACCINE WITH SUPERIOR FLU
PROTECTION a

and 10 years of real-world evidence b in preventing flu-related hospitalizations in adults aged 65+ 2-4

aProven superiority in a clinical trial between Fluzone High-Dose (Influenza Vaccine) trivalent formulation and a standard-dose influenza vaccine. 2
bIncludes 10 years of evidence (2009-2019) with Fluzone High-Dose (trivalent formulation). 3

Fluzone High-Dose Quadrivalent 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 Quadrivalent is approved for use in persons 65 years of age and older.

IMMUNO-BRIDGING AND SAFETY STUDY

IN AN IMMUNO-BRIDGING STUDY, FLUZONE HIGH-DOSE QUADRIVALENT (INFLUENZA VACCINE) INDUCED A NON-INFERIOR IMMUNE RESPONSE COMPARED TO 2 FLUZONE HIGH-DOSE (INFLUENZA VACCINE) FORMULATIONS CONTAINING EITHER INFLUENZA B VICTORIA OR B YAMAGATA LINEAGES 2

GEOMETRIC MEAN TITERS
(GMT) RATIO2

Predefined Non-inferiority Criterion:

lower limit of the 95% confidence interval must be >0.667

SEROCONVERSION
RATES2

Predefined Non-inferiority Criterion:

lower limit of the 95% confidence interval must be >-10%

INFLUENZA STRAIN

GMT RATIO (95% CI)

NON-INFERIORITY ACHIEVED?

SEROCONVERSION RATE DIFFERENCE (95% CI)

NON-INFERIORITY ACHIEVED?

A (H1N1)

0.83

(0.744 to 0.932)
YES

-3.27%

(-7.37 to 0.86)
YES
A (H3N2)

0.95

(0.842 to 1.066)
YES

-0.71%

(-4.83 to 3.42)
YES
B1 (Victoria)

1.08

(0.958 to 1.224)
YES

-2.41%

(-7.66 to 2.70)
YES
B2 (Yamagata)

1.00

(0.881 to 1.129)
YES

-1.75%

(-7.04 to 3.53)
YES

STUDY DESIGN 2,5

4:1:1 randomized controlled trial | Fluzone High-Dose Quadrivalent (Influenza Vaccine) vs 2 Fluzone High-Dose trivalent formulations | Subjects: 2670 adults aged 65+ | Influenza season: 2017-2018

FLUZONE HIGH-DOSE QUADRIVALENT (INFLUENZA VACCINE) EXHIBITED A SIMILAR SAFETY PROFILE COMPARED TO FLUZONE HIGH-DOSE (INFLUENZA VACCINE) FORMULATIONS 2,6

SOLICITED INJECTION-SITE REACTIONS (WITHIN 7 DAYS)

Pain
Erythema
Swelling
Induration
Bruising

SYSTEMIC ADVERSE REACTIONS (WITHIN 7 DAYS)

Myalgia
Headache
Malaise
Shivering
Fever (≥99.5°F)5
0%
20%
40%
60%
80%
100%

Rates of any solicited local and systemic reaction, including grade 3 reactions, were similar among Fluzone High-Dose Quadrivalent and Fluzone High-Dose trivalent formulations recipients in adults 65+ years of age.

Onset usually occurred within the first 3 days after vaccination, and the majority of solicited adverse reactions resolved within 3 days of vaccination.

Fluzone High-Dose n=885-889
Fluzone High-Dose Quadrivalent n=1761-1768
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EFFICACY AND SAFETY STUDY

EFFICACY STUDY

PRIMARY ENDPOINT Relative vaccine efficacy (rVE) against influenza due to ANY lab-confirmed circulating strains2,7

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 strains2,7

Standard-dose
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Fluzone High-Dose

51%

(95% CI: 17-72)

FEWER INFLUENZA CASES

Number of influenza cases
syringe

4X

THE ANTIGEN

60 micrograms (mcg) hemagglutinin (HA) vs 15 mcg HA in a standard-dose influenza vaccine 7

STUDY DESIGN 2

1:1 randomized controlled trial | Fluzone High-Dose (Influenza Vaccine) trivalent formulation vs standard-dose inactivated Fluzone (Influenza Vaccine) | Subjects: 31803 adults aged 65+ | Influenza season: 2011-2012, 2012-2013

The efficacy of the Fluzone High-Dose is relevant to Fluzone High-Dose Quadrivalent since both vaccines are manufactured according to the same process and have overlapping compositions. 2

The pre-specified 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

Graphical representation is for illustrative purposes only.

CI=confidence interval.

SAFETY PROFILE COMPARED TO A STANDARD-DOSE INFLUENZA VACCINE 6

ADVERSE REACTIONS (WITHIN 7 DAYS)

SYSTEMIC

Any
Myalgia
Malaise
Headache
Fever (≥99.5°F)

SOLICITED INJECTION-SITE

Pain
Erythema
Swelling
0%
20%
40%
60%
80%
100%

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. 6

Fluzone n=1258-1260
Fluzone High-Dose n=2569-2572

STUDY DESIGN 6

2:1 randomized controlled trial | Fluzone High-Dose (Influenza Vaccine) trivalent formulation vs standard-dose Fluzone (Influenza Vaccine) | Subjects: ~3850 adults aged 65+ | Influenza season: 2006-2007

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REAL-WORLD EVIDENCE

META-ANALYSIS

10 YEARS OF REAL-WORLD EVIDENCE IN PREVENTING MORE INFLUENZA COMPLICATIONS THAN STANDARD-DOSE INFLUENZA VACCINES 3

POOLED RELATIVE VACCINE EFFECTIVENESS (95% CI) AGAINST INFLUENZA-RELATED OUTCOMES 3,a

heart

PNEUMONIA/INFLUENZA HOSPITALIZATION

13.4%

(95% CI: 7.3 to 19.2)

PNEUMONIA/INFLUENZA MORTALITY

39.9%

(95% CI: 18.6 to 55.6)

PNEUMONIA HOSPITALIZATION

27.3%

(95% CI: 15.3 to 37.6)
realheart

CARDIORESPIRATORY HOSPITALIZATION

17.9%

(95% CI: 15.0 to 20.8)

CARDIORESPIRATORY MORTALITY

27.7%

(95% CI: 13.2 to 32.0)
virus

INFLUENZA HOSPITALIZATION

11.7%

(95% CI: 7.0 to 16.1)

POST-INFLUENZA MORTALITY

22.2%

(95% CI: -18.2 to 48.8)

aSelect endpoints are presented here. Influenza-like illness, all-cause hospitalizations, and all-cause mortality were also evaluated.

STUDY DESIGN 3

FLUZONE HIGH-DOSE (INFLUENZA VACCINE) TRIVALENT FORMULATION VS STANDARD-DOSE INFLUENZA VACCINES

SUBJECTS
~34 million adults aged 65+ included in 15 published studies

10 INFLUENZA SEASONS
Identified studies were conducted over 2009-2010 to 2018-2019 influenza seasons

  • 7 seasons were A (H3N2) predominant
  • 3 seasons were A (H1N1) predominant
  • 3 seasons were antigenically mismatched

Study funding was provided by Sanofi Pasteur and the authors were employees of Sanofi Pasteur

LIMITATIONS

  • High degree of statistical heterogeneity observed
  • Unmeasured confounders could affect the results
  • Most outcomes of the reviews were not lab-confirmed and do not necessarily represent strain-specific vaccine effectiveness
  • The between-studies weighting may lead to overall results that are statistically significant while sub-analyses have wider CI
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Fluzone High-Dose is the only influenza vaccine with:

good

UNIQUE COMPOSITION7

with 4X the antigen as compared to a standard-dose influenza vaccine.

Click here for more information.

good

PROVEN EFFICACY2,7,a

in preventing more influenza than a standard-dose influenza vaccine in a randomized controlled efficacy trial.

Click here for full data.

good

1O YEARS OF REAL-WORLD EVIDENCE3,b

demonstrating a reduction in influenza-related complications, including hospitalizations.

Click here for full data.

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

aProven superiority in a clinical trial between Fluzone High-Dose (Influenza Vaccine) trivalent formulation and a standard-dose influenza vaccine. 2

bIncludes 10 years of evidence (2009-2019) with Fluzone High-Dose (trivalent formulation). 3

TO ORDER FLUZONE HIGH-DOSE QUADRIVALENT,

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

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INDICATIONS

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

IMPORTANT SAFETY INFORMATION

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

Appropriate medical treatment and supervision must be available to manage possible 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 Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent should be based on careful consideration of the potential benefits and risks.

If Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be lower than expected.

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

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

For Fluzone Quadrivalent, in children 6 months through 35 months of age, the most common injection-site reactions were pain or tenderness, erythema, and swelling; the most common solicited systemic adverse reactions were irritability, abnormal crying, malaise, drowsiness, appetite loss, myalgia, vomiting, and fever. In children 3 years through 8 years of age, the most common injection-site reactions were pain, erythema, and swelling; the most common solicited systemic adverse reactions were myalgia, malaise, and headache. In adults 18 years and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, headache, and malaise.

For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common injection-site reactions were tenderness and pain; the most common solicited systemic adverse reactions were headache, fatigue, myalgia, and arthralgia. In adults 50 years of age and older, the most common injection-site reactions were tenderness and pain; the most common solicited systemic adverse reactions were headache and fatigue.

For Fluzone High-Dose Quadrivalent, 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, headache, and malaise.

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

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

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