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
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Forward-looking statements are generally identified by the words
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management believes that the expectations reflected in such
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that forward-looking information and statements are subject to
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predict and generally beyond the control of sanofi-aventis, that
could cause actual results and developments to differ materially
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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
