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临床试验/EUCTR2015-000177-12-Outside-EU/EEA
EUCTR2015-000177-12-Outside-EU/EEA进行中(未招募)不适用

An Observer-Blind, Randomized, Comparator-Controlled, Single-Centre Study to Evaluate the Tolerability, Safety, and Immunogenicity of Inactivated Influenza Vaccine, CSL Limited in a Healthy Pediatrics and Adult Population (aged =>3 years to =< 80 years)

CSL Limited0 个研究点目标入组 720 人开始时间: 2015年9月14日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
CSL Limited
入组人数
720

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Healthy subjects aged =>3 years to =< 80 years. Be able to provide a pre and post vaccination sample of up to 3 mL of venous blood. Females of reproductive age who are not pregnant must agree to use contraception.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 270
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 300
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 150

排除标准

  • Hypersensitivity to eggs, chicken protein, neomycin, polymyxin or any components of the vaccine. Influenza vaccination in the previous 6 months. Clinical signs of active infection and/or an axillary temperature of =>37.1°C at study entry. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving Study Vaccine.

研究者

发起方
CSL Limited

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