title: Inhaled Laninamivir Octanoate as Prophylaxis for Influenza in Children.
abstract: A single 20-mg dose of inhaled laninamivir octanoate is an effective treatment of influenza. However, the efficacy of laninamivir octanoate for the prevention of influenza in children <10 years of age has not yet been established.
  
  
  
  We conducted a double-blind, multicenter, randomized, placebo-controlled study to determine whether the efficacy of a single 20-mg dose of inhaled laninamivir octanoate to prevent the development of influenza was superior to that of placebo as prophylaxis for influenza in pediatric (<10 years) household members of index cases. Eligible subjects without influenza, in contact with an influenza-infected index case living in the same household, were blindly randomly assigned in a 1:1 ratio to receive 20 mg of laninamivir octanoate or placebo. The primary end point was the proportion of subjects who developed clinical influenza during a 10-day period.
  
  
  
  A total of 343 subjects were randomly assigned, with 341 subjects included in the full analysis set for the primary analysis. The proportions of subjects who developed clinical influenza were 11% (18/171) in the laninamivir octanoate group and 19% (33/170) in the placebo group (P = .02). The relative risk reduction was 45.8% (95% confidence interval, 7.5% to 68.2%). The incidence of adverse events was similar in both groups.
  
  
  
  A single 20-mg dose of inhaled laninamivir octanoate was effective and well tolerated as prophylaxis for influenza.
authors.affiliation: Department of Pediatrics, Kawasaki Hospital, Kawasaki Medical School, Okayama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakano
authors.affiliation: Department of Infectious Diseases Medical Mycology Research Center, Chiba University, Chiba, Japan; and.
authors.forename: Naruhiko
authors.initials: N
authors.lastname: Ishiwada
authors.affiliation: Clinical Development Department and.
authors.forename: Tokuhito
authors.initials: T
authors.lastname: Sumitani
authors.affiliation: Clinical Data and Biostatistics Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.
authors.forename: Mitsutoshi
authors.initials: M
authors.lastname: Uemori
authors.affiliation: Clinical Development Department and isobe.koji.di@daiichisankyo.co.jp.
authors.forename: Koji
authors.initials: K
authors.lastname: Isobe
mesh_terms: D000280:Administration, Inhalation; D000367:Age Factors; D000998:Antiviral Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003140:Communicable Disease Control / Q000379:methods*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005191:Family Characteristics; D005500:Follow-Up Studies; D006146:Guanidines; D006801:Humans; D007251:Influenza, Human / Q000517:prevention & control*; D007564:Japan; D008991:Monitoring, Physiologic; D011714:Pyrans; D018570:Risk Assessment; D012794:Sialic Acids; D016896:Treatment Outcome; D053243:Zanamivir / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D000998:Antiviral Agents; D006146:Guanidines; D011714:Pyrans; D012794:Sialic Acids; C546918:laninamivir; D053243:Zanamivir