Superior Relative Efficacy of Live Attenuated Influenza Vaccine Compared With Inactivated Influenza Vaccine in Young Children With Recurrent Respiratory Tract Infections

TLDR

Young children have a high incidence of influenza and influenza‑related complications. This study compared the efficacy and safety of cold‑adapted trivalent influenza vaccine (CAIV‑T) with trivalent inactivated influenza vaccine (TIV) in children 6 to 71 months old with recurrent respiratory tract infections. Children were randomized to receive two doses of CAIV‑T (n = 1101) or TIV (n = 1086) 35 ± 7 days apart before the 2002‑2003 season and were followed for culture‑confirmed influenza, effectiveness outcomes, reactogenicity, and adverse events. CAIV‑T demonstrated superior relative efficacy versus TIV, reducing influenza by 52.7% overall, achieving 100% efficacy against A/H1N1 and 68% against B strains, lowering RTI‑related healthcare visits by 8.9% and missed school days by 16.2%, while only increasing mild symptoms such as rhinitis, otitis media, and decreased appetite, and was otherwise well tolerated.

Abstract

Young children have a high incidence of influenza and influenza-related complications. This study compared the efficacy and safety of cold-adapted influenza vaccine, trivalent (CAIV-T) with trivalent inactivated influenza vaccine (TIV) in young children with a history of recurrent respiratory tract infections (RTIs).Children 6 to 71 months of age were randomized to receive 2 doses of CAIV-T (n = 1101) or TIV (n = 1086), 35 +/- 7 days apart before the start of the 2002-2003 influenza season and were followed up for culture-confirmed influenza, effectiveness outcomes, reactogenicity, and adverse events.Overall, 52.7% (95% confidence interval [CI] = 21.6%-72.2%) fewer cases of influenza caused by virus strains antigenically similar to vaccine were observed in CAIV-T than in TIV recipients. Greater relative efficacy for CAIV-T was observed for the antigenically similar A/H1N1 (100.0%; 95% CI = 42.3%-100.0%) and B (68.0%; 95% CI = 37.3%-84.8%) strains but not for the antigenically similar A/H3N2 strains (-97.1%; 95% CI = -540.2% to 31.5%). Relative to TIV, CAIV-T reduced the number of RTI-related healthcare provider visits by 8.9% (90% CI = 1.5%-15.8%) and missed days of school, kindergarten, or day care by 16.2% (90% CI = 10.4%-21.6%). Rhinitis and rhinorrhea, otitis media, and decreased appetite were the only events that were reported more frequently in CAIV-T subjects. There was no difference between groups in the incidence of wheezing after vaccination.CAIV-T was well tolerated in these children with RTIs and demonstrated superior relative efficacy compared with TIV in preventing influenza illness.