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Sanofi Pasteur Announces Results of U.S. Clinical Trials of Influenza A (H1N1) Vaccine in Infants and Children
Date:10/14/2009

SWIFTWATER, Pa., Oct. 14 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today an interim analysis of data from clinical trials of the U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine in infants and children 6 months through 9 years of age. The data indicate the vaccine is immunogenic and that one dose may protect many children. However, the study suggests that two doses of vaccine will be required for optimal protection of children under the age of 10 years. This is consistent with the recommendations for seasonal influenza immunization in children of this age. Clinical trials are ongoing to evaluate the immunogenicity and safety in children following two doses of vaccine.

"According to the Centers for Disease Control and Prevention young children are among those of highest priority for immunization with the Influenza A (H1N1) 2009 Monovalent Vaccine, given the relatively high disease incidence and potential for transmission in this population," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "As the only company licensed in the U.S. to produce a pediatric influenza vaccine which is licensed for children as young as 6 months of age, it was the highest priority for Sanofi Pasteur to conduct clinical trials to evaluate the safety and immunogenicity of the pandemic vaccine in children to support decisions on vaccine administration."

This randomized, placebo-controlled, multicenter trial was conducted by Sanofi Pasteur to determine the immunogenicity and safety of the vaccine, given as a two-dose schedule, 21 days apart. A total of 474 children were enrolled in the trial in two age cohorts: 229 children 6 months through 35 months of age; and 245 children 3 years through 9 years of age. The tr
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