New Analysis Reports Lower Rates of Serious Cardio-Respiratory Events Among Study Participants Administered Higher-Dose Influenza Vaccine

Aug 03, 2015, 08:00 ET from Sanofi Pasteur

SWIFTWATER, Pa., Aug. 3, 2015 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi, announced that Vaccine published positive results from a new analysis of data from a large-scale, multi-center efficacy trial. In this new analysis, researchers observed significantly fewer serious cardio-respiratory events possibly related to influenza ("the flu") in study participants 65 years of age and older who received a higher-dose split-virus inactivated influenza vaccine (IIV-HD) compared to a standard-dose split-virus inactivated influenza vaccine (IIV-SD).

In the efficacy trial, a total of 31,989 adults 65 years of age and older were randomly assigned in a 1:1 ratio to receive either IIV-HD (Fluzone® High-Dose vaccine, Sanofi Pasteur, Swiftwater, PA) or IIV-SD (Fluzone vaccine, Sanofi Pasteur) and followed for six to eight months post-vaccination for the occurrence of influenza and serious events, including events leading to death or hospitalization (or its prolongation), or events considered life-threatening or medically important, or resulting in disability. For the supplementary analysis reported in Vaccine, cardio-respiratory events were grouped into seven categories: pneumonia, asthma, chronic obstructive pulmonary disease (COPD) or bronchial events, influenza (laboratory-confirmed influenza diagnosed outside of normal study procedures), other respiratory events, coronary artery events, congestive heart failure, and cerebrovascular events.

The primary results from the efficacy trial were published in The New England Journal of Medicine, which reported that IIV-HD was 24.2 percent (95% confidence interval [CI], 9.7 to 36.5) more effective in preventing laboratory-confirmed influenza-like illness compared to IIV-SD.i In the current supplementary analysis of the trial, investigators reported that the rate of serious cardio-pulmonary events possibly related to influenza was 17.7% lower in the IIV-HD group (26.7 cases per 1000 person-seasons) compared to the IIV-SD group (32.5 cases per 1000 person-seasons). In addition, serious pneumonia was observed at a 39.8% lower rate among IIV-HD recipients (4.4 cases per 1000 person-seasons) compared to IIV-SD recipients (7.4 cases per 1000 person-seasons). The rate of hospitalization (any cause) was 6.9% lower in the IIV-HD group (95.7 cases per 1000 person-seasons) compared to the IIV-SD group (102.7 cases per 1000 person-seasons). 

"Influenza and pneumonia combined is the seventh leading cause of death in older adults in this country," ii said David P. Greenberg, MD, Vice President, Scientific & Medical Affairs, and Chief Medical Officer, Sanofi Pasteur US. "The results of this analysis focused on serious cardio-respiratory events and hospitalizations, and support the previously reported findings of the large efficacy study, in which lower rates of laboratory-confirmed influenza were observed following use of the higher-dose vaccine compared to the standard-dose vaccine among the seniors who participated."

The findings of this supplementary analysis were published in Vaccine as "Prevention of serious events in adults 65 years of age or older: a comparison between high-dose and standard-dose inactivated influenza vaccines" (DOI: http://dx.doi.org/10.1016/j.vaccine.2015.07.006) by Carlos A. DiazGranados, MD, Corwin A. Robertson, MD, H. Keipp Talbot, MD, MPH, Victoria Landolfi, MSc, Andrew J. Dunning, PhD, David P. Greenberg, MD, appears in Vaccine, Volume 33, Issue 32 (2015), published by Elsevier.

Copies of this paper are available to credentialed journalists upon request; please contact Elsevier's Newsroom at newsroom@elsevier.com or +31 20 4853564.

About Fluzone High-Dose (Influenza Vaccine) Indication
Fluzone High-Dose vaccine is indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.

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

Safety Information
The most common local and systemic adverse reactions to Fluzone High-Dose vaccine include pain, erythema, and swelling at the injection site; myalgia, malaise, headache, and fever. Other adverse reactions may occur. Fluzone High-Dose vaccine should not be administered to anyone with a known hypersensitivity (eg, anaphylaxis) to any vaccine component, including egg protein, or to a previous dose of any influenza vaccine.

If Guillain-Barre syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone High-Dose vaccine should be based on careful consideration of the potential benefits and risks.  Vaccination with Fluzone High-Dose vaccine may not protect all individuals.

Before administering Fluzone High-Dose vaccine, please see accompanying full Prescribing Information.

About Vaccine
Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society, The International Society for Vaccines and The Japanese Society for Vaccinology and is published by Elsevier. www.elsevier.com/locate/vaccine

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us

_______________________________ i DiazGranados CA, Dunning AJ, Kimmel M, et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med 2014; 371:635-645.   ii Heron M. Deaths: Leading Causes for 2010. Natl Vital Stat Rep. 2013 Dec 20;62(6):1-96.

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