Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19
NCT ID: NCT07279766
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
285000 participants
INTERVENTIONAL
2025-12-11
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mRNA-1273 (Spikevax)
COVID-19 vaccine single injection at day 0
mRNA-1273 (Moderna COVID-19 vaccine)
For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be used.
No COVID-19 vaccine (control)
Control arm, no COVID-19 vaccine
No interventions assigned to this group
Interventions
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mRNA-1273 (Moderna COVID-19 vaccine)
For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be used.
Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated
Exclusion Criteria
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
50 Years
64 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Tor Biering-Sørensen
OTHER
Responsible Party
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Tor Biering-Sørensen
Professor, MD, MSc, MPH, PhD
Principal Investigators
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Tor Biering-Sørensen, MD, MSc, MPH, PhD
Role: STUDY_CHAIR
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-523841-82-00
Identifier Type: OTHER
Identifier Source: secondary_id
DAN-COVID
Identifier Type: -
Identifier Source: org_study_id
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