跳至主要内容
临床试验/IRCT20080901001165N61
IRCT20080901001165N61尚未招募3 期

Investigating the comparative preventive efficacy and safety of FluGaurd® (a 4-valent recombinant influenza vaccine, produced by Niwad-Pharmed-Salamat company, I.R.Iran), to Vaxigrip® (produced by Sanofi company, France) as the reference product in Healthy volunteers

iwad-Pharmed-Salamat company0 个研究点目标入组 200 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 49 years(—)
性别
All

入选标准

  • The age of the volunteer is between 18 and 49 years.
  • The volunteer has general health (through clinical examinations and medical records).
  • The volunteer or his/her legal guardian must have signed the informed consent form.
  • The volunteer must be able to keep up with the monitoring programs.

排除标准

  • Have a history of previous vaccinations against influenza strains used in injectable vaccines;
  • Have a history of allergy to Vaxigrip;
  • History of chronic use (more than 14 days) immunosuppressive drugs in the last 6 months (in the case of corticosteroids, prednisolone (or its equivalents) in the amount of 0.5 mg per kg of volunteer weight per day. Topical or inhaled steroids usage are free.)
  • History of any immune system disorders such as Guillain-Barré syndrome and other Masculoscletal disorders;
  • History of chronic diseases such as cancer, liver and kidney disease, neurological disorders, diabetes;
  • History of receiving immunoglobulins or other blood products 90 days before the vaccine injection;

研究者

发起方
iwad-Pharmed-Salamat company

相似试验