SANNV Sanofi NV25

SWIFTWATER, Pa., May 1, 2012 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today new Phase III data for its investigational quadrivalent influenza vaccine (QIV) in children 6 months through 8 years of age. This pediatric study evaluated the safety and immunogenicity of QIV compared to currently licensed Fluzone^® (Influenza Virus Vaccine). Results of the study were presented today at the Annual Meeting of the Pediatric Academic Societies in Boston.

The data from this pediatric study of QIV support the results of prior studies in adults. The non-inferiority comparisons demonstrate that the addition of a fourth influenza strain (a second B strain) to the investigational vaccine does not adversely affect the safety and immunogenicity profiles of QIV compared to those of licensed Fluzone vaccine. 

"Fluzone vaccine is the only influenza vaccine licensed and available in the U.S. for use in children as young as 6 months of age along with formulations of Fluzone vaccine available for the full spectrum of the population through the oldest adults," said David Greenberg, M.D., Senior Director, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "We believe that a quadrivalent Fluzone vaccine could provide an important public health benefit for people of all ages by providing coverage against an extra B virus strain of influenza. Influenza B is responsible for a substantial burden of disease and influenza-associated complications and hospitalizations in children."

Currently, seasonal influenza vaccines contain the three influenza virus strains anticipated to circulate in a given year based on global surveillance of influenza virus activity during the prior year. The annual trivalent inactivated influenza vaccine (TIV) formulation includes two A strains and one B strain. However, for over a decade, two distinct influenza B families (lineages) have co-circulated with varying prevalence, making it difficult to predict which B-lineage strain will predominate in a given year. In fact, approximately half of the time, the B-lineage strain selected for the annual vaccine has not matched the B-lineage strain that predominately circulated in a given season. Even in years where the predominant B-lineage strain is selected for the vaccine, some influenza disease occurs from the other circulating B-lineage strain not in the vaccine. Inclusion of a strain from each of the two B lineages is a public health measure that can help reduce unnecessary cases of influenza disease that could be vaccine-preventable if the additional strain were in the vaccine.

Study Design

In this randomized, observer-blinded, active-controlled, three-arm, multicenter study, more than 4,300 children 6 months through 8 years of age were randomized approximately 4:1:1 to receive investigational QIV containing the two licensed influenza A strains plus strains from both B lineages, the 2010-2011 licensed TIV (Fluzone vaccine, containing a Victoria-lineage B strain) or TIV containing the two licensed influenza A strains plus the alternate (Yamagata) B lineage strains.

The objectives of the study included demonstration of non-inferiority of antibody responses to each influenza strain in QIV compared with responses to each respective strain in the TIV comparators. Non-inferiority was measured in children 6 months through 8 years of age for the study population overall and separately for the youngest children 6 months through 35 months of age and older children 3 years through 8 years of age.

Additional objectives of the study were to demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that did not contain the corresponding B strain. Antibody responses were assessed by both geometric mean titers (GMTs) and seroconversion rates.

Immunogenicity was assessed before and 28 days post-vaccination. Safety was assessed throughout the duration of the study.

Study Data

In this investigational study, all non-inferiority criteria were met for all four strains in QIV compared with the two control TIV formulations for the study group overall and separately for children in the sub-groups 6 months through 35 months of age and 3 years through 8 years of age. Superiority criteria were met for each B strain in QIV compared with each TIV that did not contain the corresponding B strain.

The safety profiles of the QIV and the TIV formulations in the study did not materially differ. Across all three vaccine groups, the most frequently reported solicited injection-site reaction was pain or tenderness. Across all groups, the most frequently reported systemic reactions were irritability in the younger children and myalgia (muscle ache) and malaise (feeling unwell) in the older children. Rates of unsolicited adverse events and serious adverse events were similar among the study groups.

Important Safety Information

Fluzone vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

The most common local and systemic adverse reactions to Fluzone vaccine include soreness, pain and swelling at the vaccination site, fever, malaise and myalgia. Other adverse reactions may occur. Fluzone vaccine should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein or thimerosal (the multi-dose vial of Fluzone vaccine is the only presentation that contains thimerosal), or to a previous dose of any influenza vaccine.

The decision to give Fluzone vaccine should be based on the potential benefits and risks, especially if Guillain-Barre syndrome has occurred within six weeks of receipt of a prior influenza vaccine. The tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. Vaccination with Fluzone vaccine may not protect all individuals.

Before administering Fluzone vaccine, please see full Prescribing Information available at www.sanofipasteur.us or 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, consumer healthcare, emerging markets, animal health and the new 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 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 labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product 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, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding 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, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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