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Sanofi Pasteur Announces Results of U.S. Clinical Trials in Adults Following One Dose of Influenza A (H1N1) Vaccine
Date:10/1/2009

Interim Results 21 Days Following the Initial Dose of Vaccine

Interim results announced today are from serum samples taken from all participants 21 days after the first dose. These data indicate that all doses administered in the trial are immunogenic and, based on the dose responses in this study, that one 15 mcg dose of Sanofi Pasteur's Influenza A (H1N1) 2009 Monovalent Vaccine would be expected to induce a strong immune response in adults 18 years of age and older. A 15 mcg dose is the standard dose for each influenza strain in the seasonal influenza vaccine.

In adults 18 years of age through 64 years of age, 98 percent of participants achieved seroprotective antibody titers at 21 days with the dose formulated to be 15 mcg used in the study. In adults 65 years of age and older, who received the same formulation, 93 percent achieved seroprotective titers.

No serious adverse events have been observed to date in this clinical trial. Local injection site redness, swelling and pain and systemic complaints of mild fever, headache and fatigue were reported. Overall, the safety profile observed to date is very similar to that of the seasonal influenza vaccine.

About Influenza A (H1N1) 2009 Monovalent Vaccine

The 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.

The Influenza A (H1N1) 2009 Monovalent Vaccine is manufactured by the same process as Sanofi Pasteur's seasonal trivalent influenza virus vaccine licensed in the U.S. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like virus. Influenza A (H1N1) 2009 Monovalent Vaccine is licensed for single-dose presentations in syringes a
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SOURCE Sanofi Pasteur
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