NCT06684743进行中（未招募）4 期
A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 18 Years or Above
Tor Biering-Sørensen6 个研究点 分布在 2 个国家目标入组 690,000 人开始时间: 2024年11月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 690,000
- 试验地点
- 6
- 主要终点
- Hospitalization for RSV-related respiratory tract disease
研究概览
简要总结
The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in adults. Participants will be randomized 1:1 to either RSV vaccine or no RSV vaccine.
详细描述
The study is a pragmatic, registry-based, open-label, individually randomized trial. Administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize a total of 690,000 participants. Participants will be individually randomized 1:1 to receive either a bivalent RSV prefusion F vaccine (RSV vaccine) or no RSV vaccine. The trial is designed to assess the vaccine effectiveness of the RSV vaccine vs. no RSV vaccine on RSV-related and all-cause cardio-respiratory outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and above
- •Informed consent form has been signed and dated
排除标准
- •There are no specific exclusion criteria for this study
研究组 & 干预措施
RSV prefusion F protein-based vaccine (RSV vaccine)
Experimental
RSV vaccine single injection at day 0
干预措施: RSV prefusion F protein-based vaccine (Biological)
结局指标
主要结局
Hospitalization for RSV-related respiratory tract disease
时间窗: ≥14 days after initially booked vaccination/ information visit date up to 8 months
次要结局
- RSV-related hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause respiratory tract disease hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- RSV-related cardio-respiratory hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause cardio-respiratory hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause lower respiratory tract disease hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause mortality(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- RSV-related respiratory tract disease hospitalization(≥14 days after actual vaccination date/ booked information visit date up to 8 months)
- Hospitalization for RSV-related lower respiratory tract disease(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- Hospitalization for RSV-related respiratory tract disease by age groups(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- RSV-related respiratory tract disease hospitalization(≥14 days after actual vaccination date/ booked information visit date up to 8 months)
- Hospitalization for RSV-related lower respiratory tract disease(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- Hospitalization for RSV-related respiratory tract disease by age groups(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- Hospitalization for RSV-related respiratory tract disease in subsequent seasons(From September 1, 2025 up to 9 months (2025/2026 season) and September 1, 2026 up to 9 months (2026/2027 season))
- RSV-related hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause respiratory tract disease hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- RSV-related cardio-respiratory hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause cardio-respiratory hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause lower respiratory tract disease hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause mortality(≥14 days after initially booked vaccination/ information visit date up to 8 months)
研究者
Tor Biering-Sørensen
Professor
Herlev and Gentofte Hospital
研究点 (6)
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