跳至主要内容
临床试验/JPRN-jRCT2080222627
JPRN-jRCT2080222627已完成3 期

A Phase 3 Study of CS-8958 (Prophylaxis for children) - A randomized, double-blind, placebo-controlled study to evaluate the efficacy for the prevention of influenza virus infection in children under 10 years

DAIICHI SANKYO CO., LTD.0 个研究点目标入组 343 人开始时间: 2014年10月16日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
343

研究概览

简要总结

Single 20-mg dose of inhaled CS-8958 20 mg was effective as post-exposure prophylaxis to protect against influenza in pediatric (<10 years of age) household members of index cases for prophylaxis of influenza. Adverse events in CS-8958 20 mg single-dose group did not differ significantly from those in the placebo-group. No abnormal behaviors were observed, and there were no other major safety issues.

研究设计

研究类型
Interventional

入排标准

年龄范围
ot applicable 至 <= 9age old(—)
性别
All

入选标准

  • Household contact of a patient with influenza virus infection
  • Body temperature (axillary) at informed consent =< 36.9 degrees C
  • No influenza symptoms
  • Be capable of inhaling drug judged by investigator

排除标准

  • Persons who are unable to cohabit with an index patient
  • Persons who cannot start study treatment within 48 hours after the initial onset of any influenza symptom in the index patient
  • Persons receiving corticosteroids or immunosuppressants
  • Persons who have a history of hypersensitivity to a neuraminidase inhibitor

研究者

相似试验