LYON, France Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Thursday 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 (3 years of age and older) and adults just one time induces a robust immune response that is considered protective in 93% or more of adults 18 to 59 years old and in 83% or more of adults 60 years of age and older, according to results from clinical trials conducted in Europe.
In children 3 years of age through 17 years of age, 94% or more of study participants achieved seroprotective antibody response.
“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,” stated Wayne Pisano, president and CEO of Sanofi Pasteur.
The results are based on interim analysis following the first vaccination dose from clinical trials conducted in France and Finland. No serious adverse events have been observed to date in these clinical trials. Local injection site (redness, swelling and pain) and systemic complaints of mild fever, headache and fatigue were reported.