A Phase 4, Pragmatic, Randomized Trial to Evaluate the Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years (DAN-COMBO)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 410,000
- 试验地点
- 3
- 主要终点
- The primary endpoints of the study are the occurrence of: (1) medically attended influenza and/or COVID-19; (2) influenza and/or COVID-19 hospitalization
研究概览
简要总结
The primary objectives of the study are to evaluate the comparative vaccine effectiveness (cVE) of mCombriax® (mRNA-1083) versus same day co-administration of the active comparators (i.e., high-dose influenza vaccine/Efluelda® and mRNA-1273/Spikevax®) among adults aged 65 years and older for prevention of: 1. Medically attended influenza and/or COVID-19, 2. Influenza and/or COVID-19 hospitalization
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 at the time of vaccination
- •Self-reported ability to understand written and spoken English or Danish (Denmark only) or Spanish or Galician (Spain only)
- •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
mCOMBRIAX dispersion for injection in pre-filled syringe Influenza and COVID-19, mRNA vaccine
干预措施: mCOMBRIAX dispersion for injection in pre-filled syringe Influenza and COVID-19, mRNA vaccine (Drug)
Efluelda Tetra, injektionsvæske, suspension i fyldt injektionssprøjte
干预措施: Efluelda Tetra, injektionsvæske, suspension i fyldt injektionssprøjte (Drug)
Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
干预措施: Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (Drug)
结局指标
主要结局
The primary endpoints of the study are the occurrence of: (1) medically attended influenza and/or COVID-19; (2) influenza and/or COVID-19 hospitalization
The primary endpoints of the study are the occurrence of: (1) medically attended influenza and/or COVID-19; (2) influenza and/or COVID-19 hospitalization
次要结局
- Medically attended influenza
- Influenza hospitalization
- Medically attended COVID-19
- COVID-19 hospitalization
- All-cause cardio-respiratory hospitalization
- All-cause hospitalization
- All-cause respiratory tract disease hospitalization
研究者
Tor Biering-Sørensen
Scientific
Gentofte Hospital