Sanofi Pasteur Presents Safety Data on Menactra Vaccine Given to Infants at Infectious Disease Society Meeting

The two-dose meningococcal quadrivalent conjugate vaccine was generally well-tolerated

PHILADELPHIA, Nov. 2 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), presented Safety of a Quadrivalent (A,C,Y,W-135) Meningococcal Vaccine When Given to Infants with Other Pediatric Vaccines at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) this past weekend. The annual meeting of physicians, scientists, and other health-care professionals who specialize in infectious diseases was held from October 29 through November 1 in Philadelphia, PA.
 

In the phase III, open-label, controlled, multicenter safety study, infants from the United States were enrolled to receive the quadrivalent, meningococcal conjugate vaccine (MCV4) at 9 months of age and then MCV4 concomitantly with the measles-mumps-rubella vaccine (MMRV), pneumococcal conjugate vaccine (PCV7), and a Hepatitis A (HepA) vaccine at 12 months of age. In the control group, 12-month-olds received only MMRV, PCV7, and HepA.
 

"The investigators concluded that the two-dose Menactra vaccine was generally well-tolerated by the infants in the study," said Miriam Pina, M.D., Sanofi Pasteur's clinical director who presented the data at IDSA. According to Pina, the most common side effects experienced in this study were minor and short-term, including injection site pain, redness, swelling and irritability.
 

About Menactra Vaccine
 

Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only licensed conjugate vaccine in the U.S. for persons 2 through 55 years of age for active immunization against invasive meningococcal disease caused by N meningitidis serogroups A, C, Y, and W-135. Since it was first licensed in the U.S. by the Food & Drug Administration in 2005, more than 28 million doses of Menactra vaccine have been distributed.
 

Side effects to Menactra vaccine include headache, fatigue, and injection site pain, redness, and swelling. Other side effects may occur. Vaccination should be avoided by persons with known hypersensitivity (severe allergic reaction) to any ingredient of the vaccine, including latex (which is used in the vial stopper), or by any persons previously diagnosed with Guillain-Barre syndrome. There is a potential for an increased chance of getting Guillain-Barre syndrome following vaccination. Vaccination with Menactra vaccine may not protect all individuals.
 

For more information about Menactra vaccine, talk to your health-care professional or go to www.menactra.com.
 

About sanofi-aventis
 

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY) .
 

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2008, 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 product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, 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-aventis' 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-aventis, 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 EMEA, 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 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-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
 

  Contact:
    Susan Watkins
    T. +1-570-957-2563
    susan.watkins@sanofipasteur.com
    www.sanofipasteur.us

Source: Sanofi Pasteur

CONTACT: Susan Watkins, +1-570-957-2563,
susan.watkins@sanofipasteur.com
 

Web Site: http://www.sanofipasteur.com/
 

Posted: November 2009

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