SWIFTWATER – Sanofi Pasteur, the vaccines division of the sanofi-aventis Group announced Thursday the final analyses of data from clinical trials of the U.S. licensed Influenza 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 of follow-up in the two trials.

“These are extremely important data,” said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur, “because they once again make clear not only the immunogenicity of the Influenza A (H1N1) 2009 Monovalent Vaccine manufactured by Sanofi Pasteur, but also the fact that this vaccine has a safety profile similar to that typically observed with seasonal influenza vaccine in all age groups studied.”

The trials confirm that one dose of Influenza A (H1N1) 2009 Monovalent Vaccine induces a robust antibody response in adults – but two doses of vaccine are needed to assure a robust antibody response in children 9 years of age and younger. The two-dose regimen for these younger children is similar to the recommendations for seasonal influenza immunization in this age group.