The purpose of this pragmatic randomized trial is to evaluate the vaccine effectivenessof the COVID-19 vaccine, mRNA-1273, in adults aged 50-64 years without known risk factorsfor severe COVID-19 infection. Participants will be randomized 1:1 to either COVID-19vaccine or no COVID-19 vaccine.
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.
Biological: mRNA-1273 (Moderna COVID-19 vaccine)
For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be
used.
Inclusion Criteria:
- Age 50-64 years
- Informed consent form has been signed and dated
Exclusion Criteria:
- Medical conditions that increase the risk of severe COVID-19, which will be assessed
through self-reporting. These medical conditions include:
1. Asthma
2. Cancer (excluding non-melanoma skin cancer)
3. Cardiomyopathies
4. Cerebrovascular disease
5. Chronic kidney disease
6. Chronic lung disease
7. Cystic Fibrosis
8. Dementia
9. Diabetes
10. Down syndrome
11. Heart failure
12. Human Immunodeficiency Virus
13. Immunosuppressive therapy
14. Ischemic heart disease
15. Liver disease
16. Neurological/neuromuscular disease
17. Psychiatric disease (psychotic, schizophrenic, schizotypal, depressive, and
bipolar (affective) disorders).
18. Severe obesity (body mass index >35 kg/m2)
19. Severe substance abuse
20. Short bowel syndrome
21. Solid organ transplant or hematological transplant
- Apart from these, there are no specific exclusion criteria for this study
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Denmark
Danske Lægers Vaccinations Service
Søborg, Denmark
Tor Biering-Sørensen, MD, MSc, MPH, PhD, Study Chair
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte