Inhaled Laninamivir Octanoate as Prophylaxis for Influenza in Children

Pediatrics. 2016 Dec;138(6):e20160109. doi: 10.1542/peds.2016-0109. Epub 2016 Nov 2.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: A single 20-mg dose of inhaled laninamivir octanoate was effective and well tolerated as prophylaxis for influenza.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Age Factors
  • Antiviral Agents / administration & dosage*
  • Child
  • Child, Preschool
  • Communicable Disease Control / methods*
  • Confidence Intervals
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Family Characteristics
  • Follow-Up Studies
  • Guanidines
  • Humans
  • Influenza, Human / prevention & control*
  • Japan
  • Monitoring, Physiologic
  • Pyrans
  • Risk Assessment
  • Sialic Acids
  • Treatment Outcome
  • Zanamivir / administration & dosage
  • Zanamivir / analogs & derivatives*

Substances

  • Antiviral Agents
  • Guanidines
  • Pyrans
  • Sialic Acids
  • laninamivir
  • Zanamivir