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临床试验/2023-506977-36-00
2023-506977-36-00招募中4 期

Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in adults aged 65 to 79 years in Galicia, Spain

Complexo Hospitalario Universitario De Santiago1 个研究点 分布在 1 个国家目标入组 114,011 人开始时间: 2023年9月13日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
114,011
试验地点
1
主要终点
The primary endpoint of the study is the occurrence of a hospitalization due to influenza or pneumonia [composite endpoint].

研究概览

简要总结

To evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia [composite endpoint] in adults aged 65 to 79 years.

入排标准

年龄范围
65 years 至 65+ years(65+ Years)
接受健康志愿者

入选标准

  • Age 65-79 years residing in the community (only individuals who are not eligible to receive QIV-HD as part of the standard of care).
  • Informed consent form has been signed and dated

排除标准

  • There are no specific exclusion criteria for this study

结局指标

主要结局

The primary endpoint of the study is the occurrence of a hospitalization due to influenza or pneumonia [composite endpoint].

The primary endpoint of the study is the occurrence of a hospitalization due to influenza or pneumonia [composite endpoint].

次要结局

  • The secondary endpoints of the study are as follows: 1. Hospitalization for any cardio-respiratory disease [composite endpoint] 2. All-cause hospitalization 3. All-cause mortality 4. Hospitalization for influenza 5. Hospitalization for pneumonia

研究者

发起方
Complexo Hospitalario Universitario De Santiago
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Federico Martinon Torres

Scientific

Complexo Hospitalario Universitario De Santiago

研究点 (1)

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