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:8/29/2014)... NEW YORK , Aug. 29, 2014 ... EDAP TMS S.A. ("EDAP" or the "Company") (NASDAQ: ... action, filed in United States District Court, Southern District ... under 14-cv-6069, is on behalf of a class consisting ... between February 1, 2013 and July 30, 2014, inclusive ...
(Date:8/29/2014)... WEST JORDAN, Utah , Aug. 29, 2014 /PRNewswire/ ... Imaging Solutions, has acquired Polaris Medical Imaging, a leader ... CT scanners. This strategic acquisition allows BC Technical to ... their capabilities, specifically within MR and CT modalities. ... lower cost service," said Mark Alvarez , president ...
(Date:8/29/2014)... Does your doctor know what you,re smoking?  Chances ... marijuana to the over 112,000 currently registered patients under ... the other roughly 20,300+ active physicians listed with the Colorado ... – even though a poll in February 2014 showed 51% ... tried it. "With marijuana legalization underway, every ...
Breaking Medicine Technology:SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 3BC Technical Acquires Polaris Medical Imaging 2Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 2Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 3Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 4
... of the Creighton University School of Medicine presented a ... of Clinical Oncology (ASCO) Annual Symposium, June 5th in ... in Gynecologic Cancer Detected by an In Vitro Assay, ... Drug Response Marker test results taken in the primary ...
... Ill., June 6, 2011 As part of its ... misuse, and diversion of prescription medications, the National Association ... the NABP PMP InterConnect. NABP will now focus on ... and their software vendors to finalize the software interface, ...
Cached Medicine Technology:Precision Therapeutics Presents Clinical Study Emphasizing the Role of ChemoFx® in Directing Chemotherapy in Gynecological Cancers 2NABP PMP InterConnect Development Complete; PMPs Continue to Sign on to Participate in National System for Tracking Drug Abuse and Diversion 2
(Date:8/30/2014)... (PRWEB) August 30, 2014 According to ... a decision that requires Takeda Pharmaceutical Co. and Eli ... damages for claims that the drugmakers concealed information about ... medication Actos. The case, Allen v. Takeda Pharmaceuticals North ... Court, Western District of Louisiana (Lafayette).* , According to ...
(Date:8/30/2014)... Hands On Mobile Massage and ... complete spa experience combining elegant decor, soothing music, ... important ingredient of all, states Marla Kaplan-Pelle, Director ... will enjoy the get-away feel, without leaving the ... "Step into the spacious, luxurious spa and leave ...
(Date:8/30/2014)... (PRWEB) August 30, 2014 The Plastic ... in New Jersey and even in the U.S. to ... takes inches off of patients’ waists with deep-tissue heating. ... in small sections, Vanquish is more inclusive to target ... Patients lay comfortably under panels about one inch away ...
(Date:8/30/2014)... After offering hyperbaric oxygen therapy ... past several years, Dr. Roy Schmidt and the ... a scholarship program for veterans who have been ... held this summer to discuss veterans’ needs ( ... shed light on the large number of veterans ...
(Date:8/30/2014)... Insomnia causes disturbances in every aspect of ... unknowingly developed insomnia and the steps often used to return ... in to the show at this link: Dr. Carol ... August 30, and will be podcasted at this link ... DrCarolFrancisTalkRadio.com. , "Insomnia causes countless unrecognized complications. ...
Breaking Medicine News(10 mins):Health News:The Law Office of Melinda J. Helbock A.P.C. Comments on Decision to Uphold $9 Billion Actos Award 2Health News:Hands On Mobile Massage and Spa of Long Island Now Offers a Spa-on-wheels 2Health News:NJ Top Docs Presents, The Plastic Surgery Group 2Health News:Tennessee Hyperbaric Center Offering HBOT Scholarships to Veterans 2Health News:Sleepless Nights, Exhausting Days, Mental Fog – Relief for Insomnia With Clinical Psychologist Dr. Carol Francis 2
... developments regarding,North Carolina,s organ and tissue donation protocol ... hire Corder Philips to aid in the,campaign to ... include a grant received from the License to ... their online,registry and increase outreach efforts by allowing ...
... Members ... -, ... Education Coalition,s Supporting the Children of the,National Guard and Reserve Institute (GRI) ... Emergency,Assistance Fund. The contribution will help support the needs of more than,8,300 ...
... DEERFIELD, IL, Dec. 11 /PRNewswire-FirstCall/ - Cardiome,Pharma Corp. ... partner,Astellas Pharma US, Inc. ("Astellas") today announced that ... U.S. Food and Drug,Administration (FDA) has recommended that ... hydrochloride, an investigational,new drug for rapid conversion of ...
... feelings, study shows , TUESDAY, Dec. 11 (HealthDay ... of the brain, says a University of California, Los ... of Neurology . , The study included 14 adults ... imaging (fMRI) while they evaluated a series of statements ...
... have identified a genetic variant of the DAB2IP ... aggressive prostate cancer. Research teams from the Translational ... of Medicine, the Karolinska Institute in Stockholm, Sweden, ... jointly. , Researchers suspect that the DAB2IP gene ...
... small islands of genes within the human genome is a ... DNA is junk, some of it is used to help ... in Genome Research, Hopkins researchers have now found that this ... to inherited diseases like Parkinsons or mental disorders, may be ...
Cached Medicine News:Health News:North Carolina Coalition on Donation Selects Corder Philips for Newest Campaign 2Health News:TriWest Contributes $25,000 to Washington National Guard Fund and Sponsors Education for Teachers of Military Children 2Health News:FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation 2Health News:FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation 3Health News:FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation 4Health News:FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation 5Health News:FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation 6Health News:Personal Convictions May Control Both Behavior and Emotions 2Health News:Study finds gene linked to aggressive prostate cancer 2Health News:Study finds gene linked to aggressive prostate cancer 3Health News:More 'functional' DNA in genome than previously thought 2
... Thru-the-Lens Headlight Video Camera System ... Source. Provides surgeon's eye view ... or edit tapes or digital files ... sharp focus from 8" to 36". ...
... automated system that enables you to perform ... hemostatic disordersincluding D-Dimer, Von Willebrand Antigen and ... rerun testing for greater efficiency in your ... service to help your lab increase uptime ...
... Studies have shown that the best, least ... to warm the OR to 72-75 degrees, eliminating ... operating room, though, can cause the surgical team ... can help keep surgeons cool regardless of OR ...
... Embolic Protection System is designed to provide ... when performing carotid stenting interventions. The ACCUNET ... system that utilizes rapid exchange technology so ... filter during catheter manipulations. It is available ...
Medicine Products: