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

NCT07279766 | Active Not Recruiting Phase 4

• 2 other identifiers: DAN-COVID2025-523841-82-00
• Study Type: interventional
• Target: 285,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; Vaccination; Pragmatic; Registry; Respiratory tract disease; Respiratory; Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Medically attended COVID-19

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

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

Secondary Outcomes (9)

• COVID-19-related hospitalization

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

• COVID-19-related respiratory tract disease hospitalization

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

• COVID-19-related cardio-respiratory disease hospitalization

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

• All-cause respiratory tract disease hospitalization

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

• All-cause cardio-respiratory hospitalization

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

Other Outcomes (14)

• COVID-19-related hospitalization (alternate definition)

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

• Laboratory-confirmed COVID-19

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

• Total length of hospital stays due to COVID-19-related respiratory tract disease

  ≥14 days after initially booked study visit date until 6 months after initially booked study visit date

Study Arms (2)

mRNA-1273 (Spikevax)

EXPERIMENTAL

COVID-19 vaccine single injection at day 0

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

No COVID-19 vaccine (control)

NO INTERVENTION

Control arm, no COVID-19 vaccine

Interventions

mRNA-1273 (Moderna COVID-19 vaccine) BIOLOGICAL

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

mRNA-1273 (Spikevax)

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 50-64 years
• Informed consent form has been signed and dated

You may not qualify if:

• Medical conditions that increase the risk of severe COVID-19, which will be assessed through self-reporting. These medical conditions include:
• Asthma
• Cancer (excluding non-melanoma skin cancer)
• Cardiomyopathies
• Cerebrovascular disease
• Chronic kidney disease
• Chronic lung disease
• Cystic Fibrosis
• Dementia
• Diabetes
• Down syndrome
• Heart failure
• Human Immunodeficiency Virus
• Immunosuppressive therapy
• Ischemic heart disease

Sponsors & Collaborators

• Tor Biering-Sørensen: lead
• ModernaTX, Inc.: collaborator

Study Sites (2)

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, 2900, Denmark

Location

Danske Lægers Vaccinations Service

Søborg, 2860, Denmark

Location

MeSH Terms

Conditions

COVID-19; Respiratory Tract Diseases

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Tor Biering-Sørensen, MD, MSc, MPH, PhD

  Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, MSc, MPH, PhD

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 12, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (2)