Background: Acute otitis media (AOM) is a frequent complication of viral infections, including influenza, in young children. Live attenuated influenza vaccine (LAIV) has been shown to help protect against influenza-associated AOM by preventing influenza illness and decreasing the severity of breakthrough influenza illness. LAIV is approved for children 2–17 years of age and is not approved for use in children <24 months of age.
Objectives: To estimate the efficacy of LAIV against AOM due to all causes in young children during the influenza season compared with placebo and trivalent inactivated influenza vaccine (TIV)
Methods: All-cause AOM incidence for the entire influenza season was calculated for 5 randomized, double-blind, placebo-controlled trials in children 6–47 months of age (LAIV, n=6587; placebo, n=4905) and 2 randomized, double-blind, TIV-controlled trials in children 6–71 months of age (LAIV, n=4966; TIV, n=4971). AOM was diagnosed clinically by the demonstration of a visually abnormal tympanic membrane (with regard to color, position, and/or mobility) suggesting effusion, concomitantly with symptoms of an acute infection.
Results: All-cause AOM during the influenza season was diagnosed more frequently in placebo recipients 6–23 months of age than in those 24–47 months of age (15.4% vs 12.3%; P=0.002). The pooled efficacy of LAIV in children 6–71 months of age against all-cause AOM was 16.4% (P<0.001) vs placebo and 9.5% (P=0.02) vs TIV. In children ≥24 months of age, LAIV efficacy against all-cause AOM in the season following vaccination was 20.5% (P=0.007) vs placebo and 7.5% (P=0.29) vs TIV.
Conclusions: Among children 6–71 months of age, LAIV substantially reduced the incidence of all-cause AOM during the influenza season compared with placebo and TIV. Sponsored by MedImmune, LLC.