MedImmune announced today that interim data from human studies of its nasal spray vaccine for the 2009 novel Influenza A (H1N1) virus demonstrate a similar clinical profile in children and adults 2 to 49 years of age as previously studied seasonal formulations of the vaccine. The live attenuated influenza vaccine (LAIV) for the 2009 novel Influenza A (H1N1) virus received approval from the U.S. Food and Drug Administration (FDA) on September 15, 2009.
"MedImmune is pleased to report these findings that demonstrate that the safety profile and immunogenicity of our nasal spray vaccine for the 2009 H1N1 virus is, as expected, similar to our seasonal influenza vaccine," said Filip Dubovsky, M.D., vice president, clinical development, vaccines. "It is rewarding for all of us at MedImmune to see the vaccine being used to help protect the U.S. population from this novel strain of influenza."
Two randomized, double-blind, placebo-controlled trials are ongoing in children (2-17 years) and adults (18-49 years) to evaluate the safety, tolerability, and immunogenicity of vaccine. A total of 326 children and 300 adults were randomly assigned to receive 2 doses of 2009 H1N1 LAIV or placebo 28 days apart. Both clinical trials are collecting data following a second dose of the vaccine.
LAIV for 2009 H1N1 is made using the same process as LAIV for seasonal influenza. The safety of the 2009 H1N1 vaccine was evaluated in the same way that the safety of new seasonal LAIV strains is assessed every year. The H1N1 vaccine was also evaluated in children to further establish its safety profile.