CTIS2023-503763-42-00进行中(未招募)1 期
A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a High-Dose MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc HD) in Comparison with a Non-adjuvanted Quadrivalent Recombinant Influenza Vaccine (QIVr) and an MF59-Adjuvanted Quadrivalent Subunit Egg-derived Influenza Vaccine (aQIV), in Adults Aged 50 Years and Older. - V201_03
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 6,300
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 至 65+(—)
- 性别
- All
入选标准
- •Individuals, aged 50 years and older, who are healthy or have stable comorbidities that increase their risk of complications from influenza infection, Individuals who can comply with all study procedures
排除标准
- •Progressive, unstable, or uncontrolled clinical conditions, Known hypersensitivity or allergy to any study vaccine component, Known history of Guillain-Barré syndrome or other demyelinating disease, Condition representing a contraindication to vaccination or blood draw, Abnormal function of immune system due to know disorder or medication, Influenza vaccination within 180 days prior to informed consent or plan to receive influenza vaccine within 9 months from study vaccination (all subjects) or within 12 months (subjects in the long-term subset for immunogenicity)..
研究者
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