Navigation Links
FDA Accepts Sanofi Pasteur's Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers

SWIFTWATER, Pa., Aug. 26 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135.

Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States to help protect against meningococcal disease, a rare but serious disease that can take the life of a child within 24 hours.  Menactra vaccine is currently indicated for active immunization of individuals two through 55 years of age and is designed to help offer protection against four serogroups of Neisseria meningitidis (A, C, Y, and W-135), the bacterium that causes meningococcal infection.

The filing is based on results of one Phase II and three Phase III, open-label, controlled, multicenter trials, in which more than 3600 infants and toddlers from the United States received Menactra vaccine using a 2 dose schedule at 9 months and 12 months of age.  At 12 months Menactra vaccine was given concomitantly with either measles-mumps-rubella-varicella vaccine (MMRV), pneumococcal conjugate vaccine (PCV7), or Hepatitis A vaccine (HepA).  Results from the clinical studies show that a dose of Menactra vaccine at 9 and 12 months of age elicits a robust immune response against the serogroups included in the vaccine.  Responses to the concomitantly administered vaccines were equally robust.  Vaccine related reactions were similar to those described for other infant vaccines including swelling and tenderness at the site of vaccination, as well as irritability.  Most of these side effects were mild and of short duration.

"Sanofi Pasteur is committed to evaluating Menactra vaccine in different age groups in an effort to provide the broadest protection against meningococcal disease," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at sanofi pasteur. "Sanofi Pasteur's meningococcal vaccination approach, focusing on later infancy and the early second year of life, will require only half the doses of an early infant toddler strategy."

About Menactra® VaccineMenactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only U.S. licensed conjugate vaccine for persons two through 55 years of age for active immunization against invasive meningococcal disease caused by N meningitidis serogroups A, C, Y, and W-135.  Since 2005 when it was first licensed in the U.S., more than 32 million doses of Menactra vaccine have been distributed.

A vaccine industry leader, Sanofi Pasteur has a strong heritage of meningococcal vaccine development.  Meningococcal vaccines designed to help protect against serogroups A and C were introduced in the mid-1970s.  In 1981, Menomune®-A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined) became the first meningococcal vaccine available to help protect against meningococcal disease caused by four of the five most common serogroups (A, C, Y and W-135).

In 2005, Menactra vaccine was granted FDA licensure and became the first quadrivalent meningococcal conjugate vaccine available in the U.S. for those 11-55 years of age.  Two years later the age indication was extended down to the age of two years.

Side effects following administration of Menactra vaccine include: pain, redness, and swelling at the injection site, as well as headache and fatigue.  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.  Vaccination with Menactra vaccine may not protect all individuals.

For more information about Menactra vaccine, go to

About Meningococcal DiseaseMeningococcal disease, which includes meningitis, is a serious bacterial infection that strikes between 1,000 to 2,600 Americans each year.  Approximately 10 percent of individuals who contract meningococcal disease will die.  Of those who survive, up to one in five suffer permanent disabilities such as hearing loss, neurological damage and limb amputations.  Meningococcal disease can be hard to recognize, especially in its early stages, because symptoms are similar to those of more common viral illnesses.  Unlike more common illnesses, the disease can progress quickly and may cause death or disability in just a single day.

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).  For more information, please visit:

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2009, 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: or

Forward Looking StatementsThis 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-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 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 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, 2009.  Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.ContactsUS Media RelationsAmy BaTel:

SOURCE Sanofi Pasteur
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Talecris Biotherapeutics CEO Accepts 2010 Ernst & Young Entrepreneur Of The Year Award on Behalf of Employees and Patients
2. FDA Accepts Once Daily 23 mg Aricept(R) Extended Release NDA for Review
3. FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)
4. FDA Accepts Arno Therapeutics IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway
5. Food and Drug Administration Accepts Isolagens Biologics License Application for Full Review
6. FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)
7. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
8. FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
9. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
10. Sanofi-Aventis and Novalar File Marketing Authorization Application for OraVerse® in Five Key European Countries
11. Oramed Pharmaceuticals and sanofi-aventis Enter Into an Agreement for the Insulin Supply of Orameds Oral Insulin Capsules
Post Your Comments:
(Date:10/12/2015)... Va. , Oct. 12, 2015  Today, Divurgent is ... of Advisory Services. As a former CIO, Paul brings 15 ... not just understand or sympathize with today,s CIOs, he is ... the same challenges Paul has faced, and his new role ... in ensuring technology efficiencies across an organization. ...
(Date:10/12/2015)... DENVER , Oct. 12, 2015 Beginning ... ICD-10 Codes. Therapy Partner, the fastest growing practice management ... automated technology that easily converts all patient diagnostic codes ... --> --> ... Brief for all mental health practitioners to easily understand ...
(Date:10/12/2015)... INDIANAPOLIS , Oct. 12, 2015 Eli ... ACCELERATE study,s academic leadership have accepted the recommendation of ... 3 trial of the investigational medicine evacetrapib, due to ... the treatment of high-risk atherosclerotic cardiovascular disease and will ... --> --> The independent data ...
Breaking Medicine Technology:
(Date:10/13/2015)... ... October 13, 2015 , ... ... have developed valuable new strategies for enrolling and serving insurance consumers who do ... obtain health insurance and pay monthly premiums. In “Health Plan Engagement Strategies: The ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... ... smoke-free communities, and the Florida Apartment Association (FAA) has partnered with the Florida ... communities meet the demand. , The FAA Smoke-Free Multifamily Housing Program launched ...
(Date:10/13/2015)... ... 13, 2015 , ... Just under three months ago, eMarketing Concepts ... promotion – effectively offering all of their services for just a buck in the ... flooded with phone calls from interested buyers. As a genuine one-stop-shop for internet marketing, ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... a new PDF automation tool to batch conversions of CAD drawings, plans, ... 100% document fidelity. , CADConverter eliminates the complexity requirement of specialized applications to ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... The Bill ... in San Diego, also offering expert reconstruction and flood remediation services. Family-owned and operated ... They have been named the Best San Diego plumber two years in a row ...
Breaking Medicine News(10 mins):