Effectiveness 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)

Tor Biering-Sørensen

Status and phase: Enrolling; Phase 4

Conditions: COVID-19

Treatments: Biological: mRNA-1273 (Moderna COVID-19 vaccine)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07279766

DAN-COVID

2025-523841-82-00 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 285,000 estimated patients

Sex: All

Ages: 50 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

285,000 participants in 2 patient groups

mRNA-1273 (Spikevax)

Experimental group

Description:

COVID-19 vaccine single injection at day 0

Treatment:

Biological: mRNA-1273 (Moderna COVID-19 vaccine)

No COVID-19 vaccine (control)

No Intervention group

Description:

Control arm, no COVID-19 vaccine