Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 466,320
- 试验地点
- 1
- 主要终点
- Hospitalization for influenza or pneumonia
研究概览
简要总结
This prespecified analysis will pool the datasets from two pragmatic randomized trials evaluating the relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against severe clinical outcomes: the DANFLU-2 (A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults) trial and the GALFLU (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) trial. The purpose of the pooled analysis is to ensure adequate statistical power for evaluating relative vaccine effectiveness against severe clinical outcomes and to increase generalizability of the results by combining data from two countries.
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
- 否
入选标准
- •Pragmatic trials conducted to estimate the relative vaccine effectiveness of high-dose influenza vaccine compared with standard-dose influenza vaccine using the DANFLU-2 protocol or a protocol developed based on the DANFLU-2 protocol
排除标准
- •Low data quality
- •Influenza circulation threshold was not met in any of the study seasons
- •Severe under-enrollment in all seasons
研究组 & 干预措施
High-Dose Influenza Vaccine
Single injection of high-dose influenza vaccine at Day 0
干预措施: High-Dose Influenza Vaccine (Biological)
Standard-Dose Influenza Vaccine
Single injection of standard-dose influenza vaccine at Day 0
干预措施: Standard-Dose 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
- All-cause mortality(≥14 days after vaccination up to 8 months)
- Hospitalization for any cardio-respiratory disease(≥14 days after vaccination up to 8 months)
- Laboratory-confirmed influenza hospitalization(≥14 days after vaccination up to 8 months)
- All-cause hospitalization(≥14 days after vaccination up to 8 months)
- Hospitalization for influenza(≥14 days after vaccination up to 8 months)
- Hospitalization for pneumonia(≥14 days after vaccination up to 8 months)
研究者
Tor Biering-Sørensen
Professor, MD, MSc, MPH, PhD
Herlev and Gentofte Hospital