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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134,476
- 试验地点
- 1
- 主要终点
- Occurrence of a hospitalization due to influenza or pneumonia
研究概览
简要总结
This pragmatic randomized trial is designed to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia in adults 65-79 years of age in Galicia during 2023/2024 and 2024/2025 seasons.
详细描述
The study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial using the infrastructure of the Regional Vaccination Program of Galicia for patient recruitment, inclusion, randomization, and vaccine administration and the Galician health registries for data collection including baseline information, follow-up data and safety monitoring. Participants will have the opportunity of receiving all the information for the trial prior to the vaccination appointment. Informed consent will be obtained during the vaccination appointment by the study team prior to their vaccine administration. The participation in the study is voluntary, and only individuals who accept signing the informed consent will be recruited. Participants may withdraw from the study at any point.
The study aims to randomize at least 114.011 participants over 2 influenza seasons (2023/2024 and 2024/2025) with approximately 57,000 participants per season (pending any further potential sample size adjustments following interim analysis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 79 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
研究组 & 干预措施
QIV-HD vaccine
EFLUELDA, Suspension for injection, one dose
干预措施: Influenza vaccine (Drug)
QIV-SD vaccine
INFLUVAC TETRA, Suspension for injection, one dose
干预措施: Influenza vaccine (Drug)
结局指标
主要结局
Occurrence of a hospitalization due to influenza or pneumonia
时间窗: ≥14 days after vaccination and up to May 31 the following year
次要结局
- Hospitalization for any cardio-respiratory disease [composite endpoint](≥14 days after vaccination and up to May 31 the following year)
- Hospitalization for pneumonia(≥14 days after vaccination and up to May 31 the following year)
- All-cause hospitalization(≥14 days after vaccination and up to May 31 the following year)
- All-cause mortality(≥14 days after vaccination and up to May 31 the following year)
- Hospitalization for influenza(≥14 days after vaccination and up to May 31 the following year)
研究者
Federico Martinón Torres
Principal investigator
Hospital Clinico Universitario de Santiago