A Phase 4 Pragmatic, Randomized Trial to Evaluate the Effectiveness and Safety of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19 (DAN-COVID)

Condition studied

SARS-CoV-2 infection

Investigational medicinal product(s)

Eligibility

Primary endpoint

Medically attended COVID-19, defined as a positive PCR test for SARS-CoV-2 or hospitalization for COVID-19-related respiratory tract disease. The prespecified registry-based definition of the primary endpoint is as follows: Medically attended COVID-19 (ICD-10 codes: B342, B972, U071) diagnosis type: A. Requires either a positive SARS-CoV-2 PCR test from the Danish Microbiology Database OR COVID-19-related hospitalization

Endpoint detail

1. COVID-19-related hospitalization, 2. COVID-19-related respiratory tract disease hospitalization, 3. COVID-19-related cardio-respiratory disease hospitalization, 4. All-cause respiratory tract infection hospitalization, 5. All-cause cardio-respiratory hospitalization, 6. All-cause lower respiratory tract disease hospitalization, 7. All-cause hospitalization, 8. COVID-19 death, 9. All-cause death