title: The safety and efficacy of live attenuated influenza vaccine in young children with asthma or prior wheezing.
abstract: In the European Union and Canada, an Ann Arbor strain live attenuated influenza vaccine (LAIV) is approved for use in children aged 2-17 years, including those with mild to moderate asthma or prior wheezing. The safety and efficacy of LAIV versus trivalent inactivated influenza vaccine (TIV) in children with asthma aged 6-17 years have been demonstrated. However, few data are available for children younger than 6 years of age with asthma or prior wheezing. Safety and efficacy data were collected for children aged 2-5 years with asthma or prior wheezing from two randomized, multinational trials of LAIV and TIV (N = 1,940). Wheezing, lower respiratory illness, and hospitalization were not significantly increased among children receiving LAIV compared with TIV. Increased upper respiratory symptoms and irritability were observed among LAIV recipients (p < 0.05). Relative efficacies were consistent with the results observed in the overall study populations, which demonstrated fewer cases of culture-confirmed influenza illness in LAIV compared with TIV recipients. Study results support the safety and efficacy of LAIV among children aged 2-17 years with mild to moderate asthma or a history of wheezing. Data regarding LAIV use are limited among individuals with severe asthma or active wheezing within the 7 days before vaccination.
authors.affiliation: Medical and Scientific Affairs, MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA. ambrosec@medimmune.com
authors.forename: C S
authors.initials: CS
authors.lastname: Ambrose
authors.forename: F
authors.initials: F
authors.lastname: Dubovsky
authors.forename: T
authors.initials: T
authors.lastname: Yi
authors.forename: R B
authors.initials: RB
authors.lastname: Belshe
authors.forename: S
authors.initials: S
authors.lastname: Ashkenazi
mesh_terms: D000293:Adolescent; D001249:Asthma / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D012135:Respiratory Sounds / Q000276:immunology*; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D007252:Influenza Vaccines; D014613:Vaccines, Attenuated; D015164:Vaccines, Inactivated