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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 64
Healthy Volunteers: t
View:
• Age 50-64 years
• Informed consent form has been signed and dated
Locations
Other Locations
Denmark
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
NOT_YET_RECRUITING
Hellerup
Danske Lægers Vaccinations Service
RECRUITING
Søborg
Contact Information
Primary
Anne B Nielsen, MD
anne.bjerg.nielsen.01@regionh.dk
+4528453599
Backup
Tor Biering-Sørensen, MD, MSc, MPH, PhD
tor.biering-soerensen@regionh.dk
+4528933590
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2026-08
Participants
Target number of participants: 285000
Treatments
Experimental: mRNA-1273 (Spikevax)
COVID-19 vaccine single injection at day 0
No_intervention: No COVID-19 vaccine (control)
Control arm, no COVID-19 vaccine
Related Therapeutic Areas
Sponsors
Collaborators: ModernaTX, Inc.
Leads: Tor Biering-Sørensen