Navigation Links
FDA Accepts Sanofi Pasteur's Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers
Date:8/26/2010

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 vac
'/>"/>

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

Page: 1 2 3 4 5

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:
*Name:
*Comment:
*Email:
(Date:7/2/2015)... DALLAS , July 2, 2015 ... Market by Technology (Deep Brain Stimulation, Spinal Cord Stimulation, Transcranial ... Trends & Global Forecast to 2020", published by MarketsandMarkets, the ... and is projected to reach $6.20 Billion by 2020, at ... Browse 8 4 market ...
(Date:7/2/2015)... , July 2, 2015  The Green Exchange, Inc., ... world,s first HIPAA compliant mobile app that connects cannabis ... fresh medical marijuana, announced today that their service provides ... Eaze, Meadow and more than half a dozen other ... year, Loud Cannabis is unique in that it ...
(Date:7/2/2015)... DURHAM, N.C. , July 2, 2015 ... its acquisition of assets related to the ion channel ... that had previously been obtained as part of Pfizer,s ... all of Pfizer,s rights to the "Icagen" name and ... will provide comprehensive services for ion channel and transporter ...
Breaking Medicine Technology:Neuromodulation Market Worth $6.20 Billion by 2020 2Neuromodulation Market Worth $6.20 Billion by 2020 3Neuromodulation Market Worth $6.20 Billion by 2020 4New Cannabis Delivery App Gets Product to Patient in Under 7 Minutes 2Icagen Re-launched through XRpro Sciences Acquisition of Pfizer Team and Technology for Ion Channel and Transporter Drug R&D 2Icagen Re-launched through XRpro Sciences Acquisition of Pfizer Team and Technology for Ion Channel and Transporter Drug R&D 3Icagen Re-launched through XRpro Sciences Acquisition of Pfizer Team and Technology for Ion Channel and Transporter Drug R&D 4
(Date:7/3/2015)... Buffalo, NY (PRWEB) , ... July 03, 2015 ... ... Noonday Learning Lecture took place on June 25, 2015 at 1:00pm. The Association ... presentation explored issues pertaining to injured bicyclists and practical points of investigating these ...
(Date:7/3/2015)... ... 2015 , ... " Selfie on a Stick ” was featured on NewsWatch ... products available to consumers. Amanda Forstrom, a technology expert and special reporter for NewsWatch, ... documenting memories. , Almost every smartphone has an incredibly powerful camera built into it. ...
(Date:7/2/2015)... ... ... Enterprises, LLC. is pleased to announce the opening of its newest location in Dallas, Texas. ... premium frozen yogurt chain was listed as #22 on the Inc. 500 list of fastest ... Bachman Lake, is located at:, 3701 W. Northwest Highway, STE 430, Dallas, TX 75220 , ...
(Date:7/2/2015)... ... ... Many Fourth of July celebrations will include fireworks this summer, so it’s important ... tips to promote the proper use of fireworks. , According to the U.S. Consumer ... fireworks-related injuries in the month surrounding the Fourth of July. Amica is sharing the ...
(Date:7/2/2015)... (PRWEB) , ... July 02, 2015 , ... ... the newest shades of the SIGVARIS PERFORMANCE SOCKS. Since the socks were first ... and athletic trainers. Their significant popularity has inspired four new, fun shades including: ...
Breaking Medicine News(10 mins):Health News:Attorney from William Mattar Leads Discussion on Bicycle Accidents 2Health News:Learn How to Take Selfies like Kendall Jenner 2Health News:sweetFrog Opens 18th Location in the Lone Star State 2Health News:6 Fireworks Safety Tips from Amica Insurance 2Health News:SIGVARIS is Sporting Four Brand New Colors in the Popular PERFORMANCE SOCK Product Line 2
... SOMERSET, N.J., Jan. 5 Alfacell Corporation (Nasdaq: ... on January 2, 2009 that the NASDAQ Listing Qualifications ... The NASDAQ Stock Market, effective with the open of ... the result of the Company,s non-compliance with the $35 ...
... Jan. 5 New York Blood Center (NYBC) ... recognition of National Blood Donor Month , ... fallen sharply over the recent holiday period. Supplies of ... with distribution restrictions placed on Type O, Rh negative blood.Ordinarily, ...
... April 2009 Interoperability Showcase at HIMSS09 Conference for ... Four leading healthcare industry organizations announced today ... and Medicaid Services (CMS) on the formation of ... of the new X12 HIPAA 5010 transactions implementation. ...
... falls short, study finds, , , MONDAY, Jan. 5 (HealthDay News) ... older ages, thanks to medical advances. But the long-term facilities, ... not be ready for the additional challenges that come with ... time to think of a way to successfully provide care ...
... Jan. 5 Robbins & Myers, Inc.,(NYSE: ... of its first quarter,fiscal 2009 ending November 30, 2008, ... The live webcast/conference call will be held on Thursday, ... will be Peter C. Wallace,President and Chief Executive Officer, ...
... Mobile Massage Team ( www.mobilemassageteam.com ), a leading provider ... promotional events, and special affairs, welcomes eleven new team ... region."We are very pleased to welcome these new team ... Massage Team. "They reflect the continued growth of our ...
Cached Medicine News:Health News:Alfacell Announces Receipt of NASDAQ Panel Decision 2Health News:Alfacell Announces Receipt of NASDAQ Panel Decision 3Health News:Donate Blood Today -- Save Up to Three Lives 2Health News:Donate Blood Today -- Save Up to Three Lives 3Health News:Healthcare Organizations Launch Collaborative Initiative to Test HIPAA Transactions Against Proposed 5010 Standards 2Health News:Healthcare Organizations Launch Collaborative Initiative to Test HIPAA Transactions Against Proposed 5010 Standards 3Health News:Healthcare Organizations Launch Collaborative Initiative to Test HIPAA Transactions Against Proposed 5010 Standards 4Health News:Healthcare Organizations Launch Collaborative Initiative to Test HIPAA Transactions Against Proposed 5010 Standards 5Health News:Diabetes Epidemic Now Poses Challenges for Nursing Homes 2Health News:Diabetes Epidemic Now Poses Challenges for Nursing Homes 3Health News:Mobile Massage Team Announces Eleven New Therapist Members in the Northeast U.S. Region 2Health News:Mobile Massage Team Announces Eleven New Therapist Members in the Northeast U.S. Region 3
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: