Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19
mRNA-1273 (Moderna COVID-19 vaccine): For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be used.
Study summary
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
64 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Medically attended COVID-19 — ≥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
Trial sites (2)
Facility
City
Region
Status
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
