Sanofi Pasteur Announces Final Results of U.S. Clinical Trials ofH1N1 Vaccine in Adults and Children
Thu, 11/12/2009 - 4:11am
-Sanofi Pasteur, the vaccinesdivision of the sanofi-aventis Group, has announced the final analyses of data from clinical trials of the U.S. licensedInfluenza A (H1N1) 2009 Monovalent Vaccine in adults and children. The data confirm the immunogenicity and safety profile of the vaccine,with no serious vaccine-related adverse events reported during the 42 days offollow-up in the two trials. "These are extremely important data," said Wayne Pisano, President andChief Executive Officer of Sanofi Pasteur, "because they once again make clearnot only the immunogenicity of the Influenza A (H1N1) 2009 Monovalent Vaccinemanufactured by Sanofi Pasteur, but also the fact that this vaccine has asafety profile similar to that typically observed with seasonal influenzavaccine in all age groups studied." The trials confirm that one dose of Influenza A (H1N1) 2009 MonovalentVaccine induces a robust antibody response in adults -- but two doses ofvaccine are needed to assure a robust antibody response in children 9 years ofage and younger. The two-dose regimen for these younger children is similar tothe recommendations for seasonal influenza immunization in this age group.