A Phase 4 Pragmatic, Randomized Trial to Evaluate the Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 285,000
- 试验地点
- 2
- 主要终点
- Medically attended COVID-19
研究概览
简要总结
The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of the COVID-19 vaccine, mRNA-1273, in adults aged 50-64 years without known risk factors for severe COVID-19 infection. Participants will be randomized 1:1 to either COVID-19 vaccine or no COVID-19 vaccine.
详细描述
The study is a pragmatic, registry-based, open-label, 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 a total of 285,000 participants. Participants will be individually randomized 1:1 to receive either a COVID-19 vaccine or no COVID-19 vaccine. The study is designed to assess the vaccine effectiveness of the COVID-19 vaccine vs. no COVID-19 vaccine on the risk of medically attended COVID-19 infection.
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
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50-64 years
- •Informed consent form has been signed and dated
排除标准
- •Medical conditions that increase the risk of severe COVID-19, which will be assessed through self-reporting. These medical conditions include:
- •Cancer (excluding non-melanoma skin cancer)
- •Cardiomyopathies
- •Cerebrovascular disease
- •Chronic kidney disease
- •Chronic lung disease
- •Cystic Fibrosis
- •Down syndrome
- •Heart failure
- •Human Immunodeficiency Virus
- •Immunosuppressive therapy
- •Ischemic heart disease
- •Liver disease
- •Neurological/neuromuscular disease
- •Psychiatric disease (psychotic, schizophrenic, schizotypal, depressive, and bipolar (affective) disorders).
- •Severe obesity (body mass index >35 kg/m2)
- •Severe substance abuse
- •Short bowel syndrome
- •Solid organ transplant or hematological transplant
- •Apart from these, there are no specific exclusion criteria for this study
研究组 & 干预措施
mRNA-1273 (Spikevax)
COVID-19 vaccine single injection at day 0
干预措施: mRNA-1273 (Moderna COVID-19 vaccine) (Biological)
No COVID-19 vaccine (control)
Control arm, no COVID-19 vaccine
结局指标
主要结局
Medically attended COVID-19
时间窗: ≥14 days after initially booked study visit date until 6 months after initially booked study visit date
Defined as a positive PCR test for SARS-CoV-2 or hospitalization for COVID-19-related respiratory tract disease
次要结局
- All-cause death(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
- COVID-19-related cardio-respiratory disease hospitalization(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
- All-cause cardio-respiratory hospitalization(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
- All-cause lower respiratory tract disease hospitalization(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
- COVID-19-related hospitalization(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
- COVID-19 death(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
- COVID-19-related respiratory tract disease hospitalization(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
- All-cause respiratory tract disease hospitalization(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
- All-cause hospitalization(≥14 days after initially booked study visit date until 6 months after initially booked study visit date)
研究者
Tor Biering-Sørensen
Professor, MD, MSc, MPH, PhD
Herlev and Gentofte Hospital