MedImmune says its investigational vaccine 55% more effective than flu shot

By Elaine Rigoli

Tampa, Fla., May 1 - MedImmune, Inc. released data from a phase 3 study that showed its investigational influenza vaccine, CAIV-T (cold adapted influenza vaccine, trivalent), was 55% more effective than the trivalent injectable inactivated influenza vaccine in reducing influenza illness caused by any influenza strain in children six months to 59 months of age.

The influenza attack rate was 8.6% for study participants receiving the flu shot compared to 3.9% for those who received CAIV-T, according to a news release.

The data also showed that CAIV-T provided statistically significant improvements in reducing influenza illness caused by both matched and mismatched A strains as compared to the flu shot, the release said.

"The objective of this CAIV-T trial was to demonstrate better and broader protection against influenza illness compared to the flu shot in young children," said Robert Walker, vice president, clinical development, in a statement.

"We anticipate submitting these data to the Food and Drug Administration by the end of June 2006 to seek an expansion of our label to include children from five years down to six months of age. We continue to believe that our live, attenuated, needle-free influenza vaccine offers an important option to people wanting to protect themselves and their family against influenza disease."

The study included 8,475 children at 249 sites in 16 countries in North America, Europe, the Middle East and Asia. Study participants were randomized one-to-one to receive either CAIV-T or the flu shot during the 2004-2005 influenza season.

Each participant also received a placebo nasal spray or a placebo injection to preserve the double-blind design of the study. Participants were followed through the influenza season and evaluated to identify illnesses caused by influenza virus.

In the trial, CAIV-T was 44% more effective than the flu shot against illness caused by influenza strains matched to the vaccines, which was the primary endpoint for the trial, the release said.

Data also showed CAIV-T was 89% more effective than the flu shot in reducing influenza illness caused by the matched H1N1 A strain and 79% more effective than the flu shot against the circulating mismatched H3N2 A strain.

Gaithersburg, Md.-based MedImmune is focused on the areas of infectious diseases, cancer and inflammatory diseases.

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