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Sanofi Pasteur Announces Final Results Of U.S. Clinical Trials Of Influenza A (H1N1) Vaccine In Adults And Children

Posted on 15 November 2009 - 02:11 by Alfie

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Story Summary: The adult trial was conducted in 849 individuals divided into two age cohorts: 18 through 64 years of age; and 65 years of age and older. 5 mcg and 15 mcg of HA antigen in each of two cohorts, with a third group receiving a placebo (ClinicalTrials. Sanofi Pasteur previously reported interim data showing that an immune response considered seroprotective was achieved following one 15 mcg dose of the vaccine in 50 percent of children 6 months through 35 months of age, 76 percent of children 3 through 9 years of age, 98 percent of adults 18 through 64 years of age and 92 percent of adults age 65 and older. A rise in antibody titers lower than 1:40 following vaccination may minimize the occurrence of disease and its consequences but is not considered seroprotective. About Influenza A (H1N1) 2009 Monovalent VaccineThe U. S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine manufactured by Sanofi Pasteur is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. Influenza A (H1N1) 2009 Monovalent Vaccine was licensed by the U. S. Food and Drug Administration on September 15 as a monovalent strain change to Sanofi Pasteurs licensed seasonal influenza vaccine. Influenza A (H1N1) 2009 Monovalent Vaccine is licensed for single-dose presentations in syringes and vials and in multi-dose vials. Safety Information for Influenza A (H1N1) 2009 Monovalent VaccineInfluenza vaccine should not be administered to anyone with a known severe hypersensitivity to egg proteins, any vaccine component or life-threatening reactions after previous administration of any influenza vaccine. Recurrence of Guillain-Barre syndrome(GBS) has been temporally associated with the administration of influenza vaccine. Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals. Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide and more than 45 percent of the influenza vaccines distributed in the U. S. for the 2008-2009 influenza season. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. Project FundingThis project has been funded with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. The views expressed do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices or organizations imply endorsement by the U. S. Government. 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. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements. Source: Sanofi Aventis Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. Contact Our News EditorsFor any corrections of factual information, or to contact the editors please use our feedback form. Please send any medical news or health news press releases to: These are the most read articles from this news category for the last 6 months: H1N1 Swine Flu Map Of Confirmed Outbreaks To-Date09 Jun 2009Featured below is an interactive Google map pinpointing outbreaks of H1N1 swine flu in 2009, together with source attributions, report dates, and current known statuses. Please send any medical news or health news press releases to: These are the most read articles from this news category for the last 6 months: H1N1 Swine Flu Map Of Confirmed Outbreaks To-Date09 Jun 2009Featured below is an interactive Google map pinpointing outbreaks of H1N1 swine flu in 2009, together with source attributions, report dates, and current known statuses….Read the Full Story

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