AVAILABLE FOR THE 2020-2021 FLU SEASON

In a head-to-head randomized controlled trial, FLUZONE HIGH-DOSE VACCINE was proven to provide superior protection compared to Fluzone® (Influenza Vaccine).1,2

Primary Endpoint
24
(95% CI: 10-37)
%
Better Protection
from Influenza
due to any strain1,2
Primary Endpoint Definition:
The occurrence of laboratory-confirmed, protocol-defined, influenza-like illness caused by viral strains regardless of their antigenic similarity to vaccine components.1,2
Secondary Endpoint
51
(95% CI: 17-72)
%
Better Protection
from Influenza
due to strains antigenically similar to those contained in the vaccine1,2
Secondary Endpoint Definition:
The occurrence of culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations in association with a modified Centers for Disease Control and Prevention (CDC)–defined influenza-like illness.1,2

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.

Based on data from Fluzone High-Dose, solicited injection site reactions and systemic adverse reactions were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.1

FLUZONE HIGH-DOSE: a selection of Demonstrated Real-WORLD Evidence from Every Year Since Launch3-7

a FDA = Food and Drug Administration. b CDC = Centers for Disease Control and Prevention. c CMS = Centers for Medicare and Medicaid Services.

a PERR = Previous event rate ratio.

a FFS = Fee-for-service.

Safety Profile of Fluzone High-Dose Quadrivalent is similar to Fluzone High-Dose Trivalent Formulation1

within 7 days of vaccination, RATES OF ANY SOLICITED local and systemic adverse reactions, as well as any grade 3 local and systemic adverse reactions, were similar among Fluzone High-Dose and Fluzone High-Dose Quadrivalent recipients.8


Fluzone High-Dose Vaccine Injection-Site and System Reactions Fluzone High-Dose Vaccine Injection-Site and System Reactions

FLUZONE HIGH-DOSE QUADRIVALENT

  • Helps to protect against 2 influenza A strains and BOTH INFLUENZA B LINEAGES that unpredictably co-circulate each season1
  • 4X THE AMOUNT OF ANTIGEN of standard-dose quadrivalent inactivated influenza vaccine1
  • 0.7-mL dose for intramuscular injection1
  • Approved for use in adults 65+1

BASIS OF LICENSURE

Primary Endpoint
Fluzone High-Dose Quadrivalent generated a similar immune response against influenza strains contained in trivalent formulations of Fluzone High-Dose, achieving non-inferiority criteria as assessed by Geometric Mean Titers (GMTs) and seroconversion rates.1
Secondary Endpoint
Fluzone High-Dose Quadrivalent induced a superior immune response to that of Fluzone High-Dose that did not contain the corresponding B strain, as assessed by HAI GMTs and seroconversion rates.1