2022-500657-17-00招募中4 期
A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
Gentofte Hospital, Sanofi Pasteur2 个研究点 分布在 1 个国家目标入组 339,700 人开始时间: 2022年6月28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
- 339,700
- 试验地点
- 2
- 主要终点
- Hospitalization due to influenza or pneumonia [composite endpoint]
研究概览
简要总结
The primary objective of the study is 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 older adults.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age 65 years and above (this inclusion criterion will be modified according to the Danish government’s official recommendations for the 2022/2023 and 2023/2024 influenza seasons – i.e. if the Danish government decides to offer QIV-HD to persons aged 80 and above, the trial will only recruit persons aged 65-79 years. If the Danish government does not offer QIV-HD to anyone, the trial will continue to recruit persons aged 65 and above with no upper limit to participation)
排除标准
- •There are no specific exclusion criteria for this study.
结局指标
主要结局
Hospitalization due to influenza or pneumonia [composite endpoint]
Hospitalization due to influenza or pneumonia [composite endpoint]
次要结局
- 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
Niklas Dyrby Johansen
Scientific
Gentofte Hospital
研究点 (2)
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