A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 332,438
- 试验地点
- 2
- 主要终点
- Hospitalization for influenza or pneumonia
研究概览
简要总结
The purpose of this pragmatic randomized trial is to evaluate the relative vaccine effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) in older adults. Participants will be randomized 1:1 to either QIV-HD or QIV-SD.
详细描述
The study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize 339,700 participants over 3 influenza seasons. In each season, participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD. During the 2023/2024 and 2024/2025 seasons, up to 12,000 participants will be enrolled in a sub-cohort where participants are asked to perform home self-swabs and answer symptom questionnaires in case of influenza-like illness to enable further assessment of the impact of QIV-HD vs. QIV-SD on patient-reported outcomes among individuals with influenza-like illness and laboratory-confirmed influenza.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 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)
- •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
High-Dose Quadrivalent Influenza Vaccine
QIV-HD single injection at Day 0
干预措施: High-Dose Quadrivalent Influenza Vaccine (Biological)
Standard-Dose Quadrivalent Influenza Vaccine
QIV-SD single injection at Day 0
干预措施: Standard-Dose Quadrivalent Influenza Vaccine (Biological)
结局指标
主要结局
Hospitalization for influenza or pneumonia
时间窗: ≥14 days after vaccination up to 8 months
次要结局
- Hospitalization for pneumonia(≥14 days after vaccination up to 8 months)
- Hospitalization for any cardio-respiratory disease(≥14 days after vaccination up to 8 months)
- All-cause hospitalization(≥14 days after vaccination up to 8 months)
- All-cause mortality(≥14 days after vaccination up to 8 months)
- Hospitalization for influenza(≥14 days after vaccination up to 8 months)
研究者
Tor Biering-Sørensen
Professor, MD, PhD, MPH
Herlev and Gentofte Hospital