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ACTIVE NOT RECRUITING
NCT07279766
PHASE4

Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19

Sponsor: Tor Biering-Sørensen

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

285000

Start Date

2025-12-11

Completion Date

2026-08

Last Updated

2026-03-16

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

mRNA-1273 (Moderna COVID-19 vaccine)

For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be used.

Locations (2)

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