IRCT20200318046812N4招募中3 期
Evaluation of the immunogenicity and safety of quadrivalent flu vaccine (Fluguard) manufactured by Nivad pharmed Salamat, in comparison with seasonal flu vaccine Vaxigrip, as a reference product made by Sanofi, France in healthy volunteers aged 18 to 49 years, study Clinical phase 3 random, double-blind, double-arm, parallel, active control, non-inferiority
ivad Pharmed Salamat Company0 个研究点目标入组 1,369 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,369
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
- •Age between 18-49
- •Have general health
- •Sign informed consent
- •Be able to accompany with the visit programs and study process
排除标准
- •History of previous vaccinations against influenza strains used in injectable vaccines during the previous 6 months
- •History of allergy to Vaxigrip
- •Received another vaccine during this study
- •Covid-19 infection (PCR confirmation)
- •Diagnosis of any disease, receiving medication or vaccine within 30 days before enrollment
- •Underlying disease or therapeutic intervention that may adversely affect the immune response
- •Participate in other clinical studies
- •Pregnancy, breastfeeding or pregnancy planning during the study period
- •Any conditions that prevent the study volunteer from enrollment, due to PI opinion such as: • Receiving immunomodulatory drugs or immunosuppressants • Receiving immunoglobulins • History of allergic reactions or Guillain-Barre syndrome • Autoimmune diseases
- •A history of previous hospitalization with flu-like symptoms or a proven flu illness
研究者
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