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
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