Sanofi Pasteur this week reported the results of a Phase III clinical trial comparing its investigational Fluzone intradermal candidate with Fluzone administered by the traditional intramuscular method. Study results showed that the Fluzone intradermal has a lower antigen content and injection volume.
The multicenter, double-blind Phase III trial was conducted in the U.S. during the 2008-2009 influenza season and involved 4,292 adults, 18 through 64 years of age. Study participants were randomized to receive either the Fluzone intradermal or the licensed Fluzone vaccine administered intramuscularly.
Earlier this year, Sanofi Pasteur announced that it had filed an sBLA with the FDA for Fluzone intradermal. The file has been accepted for review by the FDA and an action date is anticipated in the first half of 2011, the company says in a statement.
"The results from this large Phase III study in adults show that administration of influenza vaccine with an intradermal microinjection system may reduce the amount of antigen required for an immune response similar to that seen with Fluzone vaccine," says St. Louis University's Geoffrey Gorse. "The reduced amount of antigen, smaller volume of vaccine administered and shorter needle associated with intradermal microinjection compared with traditional intramuscular injection are attractive attributes for health-care providers and their patients that are likely to lead to increased acceptance of influenza vaccination and increase population coverage."
- see the Sanofi release
ALSO: Citing cost and possible confusion for consumers, metro Detroit health departments have decided against buying a flu vaccine designed for senior citizens. The vaccine, Fluzone High-Dose, has four times the number of antigens in it than the regular Fluzone vaccine, which triggers the body to make more antibodies, according to its French manufacturer, Sanofi Pasteur, and the CDC. Report