SAN FRANCISCO, May 1 (UPI) -- MedImmune said Monday phase 3 data indicate its potential flu vaccine CAIV-T provides broader protection in infants than flu shots.
The company said it plans to submit the data to the Food and Drug Administration by the end of June to expand the label indication to include children as young as 6 months of age.
"We discovered that CAIV-T was significantly more effective in protecting children against influenza infection," Dr. Robert Belshe, director of the Center for Vaccine Development at Saint Louis University School of Medicine and chair of the study's advisory committee, said in a statement released by MedImmune. "This is especially important because this age group is among the most vulnerable to influenza infection, and they tend to spread influenza to other family members."
In the study, which was presented at the Pediatric Academic Societies meeting in San Francisco, CAIV-T was 55-percent more effective in reducing any flu illness in children 6 to 59 months of age than the trivalent injectable inactivated influenza vaccine.
The overall incidence of adverse events in children receiving CAIV-T was similar to that of the children who received the flu shot.