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

Phase 4Active Not RecruitingNCT07279766

Tor Biering-Sørensen285,000 enrolled

Overview

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.

The study is a pragmatic, registry-based, open-label, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize a total of 285,000 participants. Participants will be individually randomized 1:1 to receive either a COVID-19 vaccine or no COVID-19 vaccine. The study is designed to assess the vaccine effectiveness of the COVID-19 vaccine vs. no COVID-19 vaccine on the risk of medically attended COVID-19 infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

285,000

Conditions

COVID-19

Interventions

mRNA-1273 (Moderna COVID-19 vaccine)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Medically attended COVID-19

Defined as a positive PCR test for SARS-CoV-2 or hospitalization for COVID-19-related respiratory tract disease