Sanofi Pasteur Presents New Data Confirming Fluzone® High-Dose (Influenza Virus Vaccine) Produces Higher Antibody Response in the Age 65+ Population

SWIFTWATER, Pa., Oct. 21, 2011 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN andNYSE: SNY), announced today data from a new study examining the immunogenicity and safety profiles of Fluzone High-Dose vaccine as compared with the responses of elderly and younger adults to a standard dose of Fluzone vaccine. The data were presented at the 49th Annual Meeting of the Infectious Diseases Society of America on October 21, 2011.

"The results further support the immunogenicity advantages of Fluzone High-Dose vaccine as compared to Fluzone vaccine, the standard dose comparator, in seniors 65 years of age and older," said Peter Tsang, M.D., Ph.D., Director Clinical Development, Sanofi Pasteur.

Fluzone High-Dose vaccine was licensed by the U.S. Food and Drug Administration (FDA) in December 2009 for adults 65 years of age and older. The vaccine was reviewed and licensed by the FDA via the accelerated approval pathway because the vaccine addressed an unmet medical need in the 65+ population. People over 65 years of age have the highest rates of hospitalization and death from influenza and its complications despite having among the highest immunization rates against influenza. As people age, the immune system typically weakens, and the body is less able to trigger an immune response to infection or vaccine. The immune response of people 65 years of age and older to the traditional flu shot is substantially lower than that of younger people. Thus, Fluzone High-Dose vaccine was developed to generate a more robust immune response in the senior population.  

Study Design

The primary study objective was to describe post-vaccination immunogenicity of Fluzone High-Dose vaccine in the elderly and of Fluzone vaccine, the standard dose (SD), in the elderly and in younger adults as assessed by geometric mean titers (GMTs) and seroconversion and seroprotection rates.  

A secondary study objective was to describe the safety profile of Fluzone High-Dose vaccine in the elderly and of Fluzone vaccine in the elderly and younger adults as assessed by solicited reactions collected for seven days post-vaccination, and unsolicited adverse events collected for 28 days post-vaccination and serious adverse events collected through six months post-vaccination. The data were collected as part of a Phase II study for Fluzone Intradermal vaccine.

In the multicenter trial, 639 subjects between the ages of 65 and 96 were randomized to receive one standard dose of Fluzone vaccine (SD) (15 µg HA per strain) or Fluzone High-Dose vaccine (HD) (60 µg HA per strain) and 186 younger adults ages 18 through 49 years of age received Fluzone vaccine (SD) (15 µg HA per strain). Both influenza vaccines were formulated with the influenza virus strains for the 2007-2008 season and contained A/Solomon (H1N1), A/Wisconsin (H3N2) and B/Malaysia.

Hemagglutination Immunization (HI) antibody titers were measured before and 28 days post-vaccination.  

Fluzone High-Dose Elicits Enhanced Immune Response in Elderly

Among those 65 years of age and older, statistically significantly higher antibody responses were induced by Fluzone High-Dose vaccine compared to Fluzone vaccine (SD). Immunogenicity measured by seroconversion and GMTs was higher for all three strains and seroprotection was higher for the H1N1 and B strains.  

Administration of Fluzone High-Dose vaccine in people over the age of 65 years enhanced the antibody response to levels similar to, and for some parameters higher than, those observed in younger adults receiving the standard dose of Fluzone vaccine.

Safety Profile

Injection site reactions were more frequent in elderly subjects who received Fluzone High-Dose vaccine compared to those who received the standard dose of Fluzone vaccine. Reactions were mild to moderate and resolved within three to seven days.

Solicited reactions and unsolicited events were reported more frequently in younger adults receiving Fluzone vaccine than in either of the two elderly groups receiving Fluzone High-Dose vaccine or the standard dose of Fluzone vaccine.  

About Fluzone Vaccines

Fluzone and Fluzone High-Dose vaccines are inactivated influenza virus vaccines given for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.  

Fluzone vaccine is intended for persons 6 months of age and older.  

Fluzone High-Dose vaccine is intended for persons 65 years of age and older. Approval of Fluzone High-Dose vaccine is based on superior immune response relative to Fluzone vaccine. Data demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine relative to Fluzone vaccine are not available.

Safety Information for Fluzone and Fluzone High-Dose Vaccines

Side effects to Fluzone and Fluzone High-Dose vaccines are soreness, pain, and swelling at the injection site; fever, headache, fatigue, and muscle aches. Other side effects may occur. Fluzone and Fluzone High-Dose vaccines should not be administered to anyone with a severe allergic reaction to any vaccine component, including eggs, egg products, or thimerosal (the only Fluzone vaccine product containing thimerosal is the multi-dose vial), or to a previous dose of any influenza vaccine. Tell the doctor if you/your child has ever experienced Guillain-Barre syndrome (severe muscle weakness) after a previous dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact your health-care professional immediately. The tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. Vaccination with Fluzone or Fluzone High-Dose vaccine may not protect all individuals.

For more information about Fluzone vaccine, talk to your health-care professional and see complete Patient Information. Prescribing Information is available at www.vaccineshoppe.com.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. 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 the broadest 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.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Sanofi Pasteur

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