Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced that a single dose of influenza A (H1N1) 2009 monovalent vaccines, Panenza (15 mcg dose, non-adjuvanted) or Humenza (3.8 mcg dose, adjuvanted), administered to children (three years of age and older) and adults induces a robust immune response, according to results from clinical trials conducted in Europe.

One dose of Panenza or Humenza Influenza A (H1N1) 2009 monovalent vaccine induces a robust antibody response that is considered protective in 93 per cent or more of adults 18 to 59 years old and in 83 percent or more of adults 60 years of age and older. In children three years of age through 17 years of age, 94 percent or more of study participants achieved seroprotective antibody response. Both vaccines tested met the three European Medicines Agency's (EMEA) criteria.

"These significant clinical data concerning Sanofi Pasteur's pandemic influenza vaccines will help build public confidence in the vaccine and will support efforts by health authorities to face the challenge posed by pandemic influenza," said Wayne Pisano, president and chief executive officer of Sanofi Pasteur. "Humenza and Panenza vaccines are effective answers to different public health needs. Humenza, a low-dose adjuvanted vaccine, has the potential to expand pandemic production capacities and to increase the number of doses of vaccine available, making it possible to immunize more people; Panenza, standard-dose non-adjuvanted vaccine, may be considered by European authorities as the vaccine of choice to protect specific at-risk populations."

Results announced today are based on interim analysis following the first vaccination dose from clinical trials conducted in France and Finland. These data, from serum samples taken from all participants 21 days after the first dose, indicate that adjuvanted and non-adjuvanted vaccines administered in the trial induce a strong immune response in most participants. No serious adverse events have been observed to date in these clinical trials. Safety and tolerability profiles were as expected. Local injection site (redness, swelling and pain) and systemic complaints of mild fever, headache and fatigue were reported.

Panenza and Humenza are registered trademarks of Sanofi Pasteur's influenza A(H1N1) vaccines in EU and other countries.

Sanofi Pasteur's influenza A (H1N1) 2009 monovalent inactivated influenza virus vaccines, Panenza and Humenza, are manufactured at Sanofi Pasteur's facility in Val de Reuil, France, using the same process as Sanofi Pasteur's seasonal trivalent influenza virus vaccine licensed in Europe.