SEE THE STUDIES
Real results for flu protection you can count on
FLUZONE® HIGH-DOSE QUADRIVALENT (INFLUENZA VACCINE)
FLUZONE® HIGH-DOSE (INFLUENZA VACCINE) is a
flu vaccine approved by the Food and Drug Administration (FDA) to
provide superior flu protection compared to a standard-dose flu shot
in adults 65 and older. But at Sanofi, we don’t just stop there. In
addition to a clinical trial, the effectiveness of FLUZONE®
HIGH-DOSE was also judged by data from general day-to-day medical
practice amongst 34 million 65+ adults spanning 10 years.
FLUZONE® HIGH-DOSE has been shown to provide
adults 65+ better protection from flu-related complications compared
The efficacy of the trivalent and quadrivalent formulations of FLUZONE® HIGH-DOSE (INFLUENZA VACCINE) are related because both are made using the same process and have overlapping compositions.
Superior protection compared to standard-dose FLUZONE® (INFLUENZA VACCINE)
Study Design: Based on a clinical trial of ~32,000 adults 65+ conducted during 2 flu seasons, 2011-2012 and 2012-2013, where an influenza case was laboratory tested.
Compared with FLUZONE®, the most common side effects were slightly more frequent and included pain and redness where you got the shot, muscle ache, and headache.
The immune response and side effects of FLUZONE® HIGH-DOSE QUADRIVALENT were similar to the trivalent formulation in a 2017-2018 clinical study in 2,679 adults 65+. FLUZONE® HIGH-DOSE QUADRIVALENT is expected to provide better protection against the flu compared with standard-dose quadrivalent flu vaccines.
In an analysis of published studies, people vaccinated with Fluzone® High-Dose experienced fewer flu-related hospitalizations and deaths compared with those vaccinated with standard-dose flu shots.
Select endpoints are presented here. Influenza-like illness, all-cause hospitalizations, and all-cause mortality were also evaluated. Individual results may vary.
Study Design: Association of these clinical events with Fluzone® High-Dose was based on a group analysis of 15 published studies in ~34 million adults 65+ conducted during 10 flu seasons from 2009-2010 through 2018-2019.
Study funding was provided by Sanofi and the authors were employees of Sanofi.
Study Limitations: Percentages are approximate and results may have been influenced by other variables. Results shown are pooled analysis from multiple studies; individual study results may vary.
FLUBLOK® QUADRIVALENT (INFLUENZA VACCINE)
In a clinical trial in adults 50 years and older, vaccination with FLUBLOK® QUADRIVALENT was compared to FLUARIX® QUADRIVALENT. The effectiveness of FLUBLOK® QUADRIVALENT was also judged by data from general day-to-day medical practice amongst more than 12 million adults 65 years and older, vaccination with FLUBLOK® QUADRIVALENT was compared to standard-dose vaccines. The results were:
Better protection against the flu compared to FLUARIX® QUADRIVALENT in adults 50+
Study Design: Randomized, controlled clinical trial of ~9,000 adults 50+ conducted during 2014-2015 flu (or influenza) season.
In adults 50 years of age and older, the most common side effects were pain and/or tenderness at the injection site, headache, and tiredness.
13% fewer flu-related hospitalizations and emergency room visits compared to standard-dose flu shots in adults 65+
The data shown is 1 of 3 primary analyses. Two additional primary analyses were conducted: 2 vaccine analyses comparing FLUCELVAX® QUADRIVALENT with standard-dose quadrivalent and FLUBLOK® QUADRIVALENT with standard-dose quadrivalent.
Study Design: Analysis of data captured during day-to-day medical practice of Medicare fee-for-service claims collected from 12.7 million adults aged 65+ during the 2019-2020 influenza season. Specific characteristics of 2019-2020 season, such as varied strain circulation, may have impacted results.
Study conducted by the FDA and Centers for Medicare and Medicaid Services.
Study Limitations: Lack of access to information to confirm specific viral cases may have reduced the impact of comparisons made in the study.
Distortion caused by unlimited variables could have affected results.
The study period was cut off at the end of February 2020 to avoid potential bias from the overlap between influenza season and the escalation of the COVID-19 pandemic in the US.
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