title: Safety of the intranasal, trivalent, live attenuated influenza vaccine (LAIV) in children with intermittent wheezing in an open-label field trial.
abstract: BACKGROUND
  Safety of the intranasal, trivalent, live attenuated influenza vaccine (LAIV) in children with asthma is unknown. A previous report showed an "asthma signal" in children aged 18-35 months.
  
  
  METHODS
  Healthy children aged 1.5-18 years with history of intermittent wheezing received single annual LAIV doses during a 4-year trial. Rates of medically-attended acute respiratory illnesses, including acute asthma exacerbation, during 0-14 and 0-42 days post-LAIV were compared with respective reference periods (before day 0 and after 14 or 42 days). To assess the risk of new-onset asthma, LAIV recipients without history of wheezing were analyzed.
  
  
  RESULTS
  During each of the 4 years, 454, 656, 656, and 430 children, respectively, with intermittent wheezing who received LAIV had no increased risk for medically-attended acute respiratory illnesses, including asthma exacerbation. First-dose LAIV recipients, including those aged 1.5-4 years, and those receiving 2-4 consecutive annual doses had no increased risk. Children with parents' report of intermittent wheezing and those with administrative database codes for asthma during 2 prior years had no increased risk. During the 4 years, 2952, 3092, 2953, and 2478 children without history of wheezing had no increased risk of new-onset asthma.
  
  
  CONCLUSIONS
  LAIV administration in children aged 1.5-18 years with history of intermittent wheezing was safe, and was not associated with increased risk for medically-attended acute respiratory illnesses, including acute asthma exacerbation. This was true for the first and 2-4 consecutive annual doses. Parents' report of intermittent wheezing was reliable. First-dose LAIV was not associated with new-onset asthma in children without history of wheezing.
authors.affiliation: Section of Pediatric Infectious Diseases, Department of Pediatrics, Scott & White Memorial Hospital and Clinic, Texas A&M University Health Science Center College of Medicine, Temple, TX 76508, USA. mgaglani@swmail.sw.org
authors.forename: Manjusha J
authors.initials: MJ
authors.lastname: Gaglani
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Piedra
authors.forename: Mark
authors.initials: M
authors.lastname: Riggs
authors.forename: Gayla
authors.initials: G
authors.lastname: Herschler
authors.forename: Charles
authors.initials: C
authors.lastname: Fewlass
authors.forename: W Paul
authors.initials: WP
authors.lastname: Glezen
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D001249:Asthma / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control*; D012135:Respiratory Sounds / Q000209:etiology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D007252:Influenza Vaccines; D014613:Vaccines, Attenuated