National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7,600
- 试验地点
- 10
- 主要终点
- Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines
研究概览
简要总结
National cohort study of effectiveness and safety of SARS-CoV-2 vaccines (ENFORCE is an equivalence trial to evaluate the effectiveness and safety of multiple new SARS-CoV-2 vaccines approved for use in the EU, and which are being offered at participating units.
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).
详细描述
First phase will enrol 10,000 persons initiating vaccination (assuming 4 vaccines). If more vaccines become available additional 2,500 persons per vaccine will be included. Subsequent phases with larger sections of the population included may be implemented.
Participants will have 6 study visits and be followed for 2 years after the first vaccination, which offers the participants an extra close follow up on vaccine effectiveness. Safety data will be collected at study visits until 3 months after the first vaccination. Research samples will be collected at each study visit during the two year follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Written informed consent obtained before any trial related procedures are performed
- •Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan)
- •The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
排除标准
- •Male and female under the age of 18
- •Any subgroup of individuals for which the vaccines are contraindicated
- •Previous SARS-CoV-2 vaccination
结局指标
主要结局
Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines
时间窗: The change from Base-line in MPNAT measured via profiling of antibodies against SARS-CoV-2 Spike epitopes at 24 month
Primary outcome is the minimal protective neutralising antibody titre (MPNAT); i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected.
次要结局
- Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines(The change from first vaccination until 24 month)
- Assessment of any Adverse Event from the vaccines will be compared between groups(From first vaccine until Day 90)
- Assessment of the safety of the vaccines will be compared between groups(From first vaccine until Day 90)
研究者
Jens D Lundgren, MD
Professor
Rigshospitalet, Denmark