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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523841-82-00 | Other Identifier | EU Clinical Trial Number |
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| Name | Class |
|---|---|
| ModernaTX, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1273 (Spikevax) | Experimental | COVID-19 vaccine single injection at day 0 |
|
| No COVID-19 vaccine (control) | No Intervention | Control arm, no COVID-19 vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1273 (Moderna COVID-19 vaccine) | Biological | For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Medical conditions that increase the risk of severe COVID-19, which will be assessed through self-reporting. These medical conditions include:
Apart from these, there are no specific exclusion criteria for this study
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte | Hellerup | 2900 | Denmark |
In this trial, baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
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| 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 |
| All-cause lower respiratory tract disease hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| All-cause hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| COVID-19 death | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| All-cause death | ≥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 |
| Composite of hospitalization for COVID-19 or pneumonia (ICD-10 codes only) | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Hospitalization for any cardiovascular disease | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Hospitalization due to any infectious disease | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Hospitalization requiring mechanical ventilation | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| In-hospital mortality | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Cardio-respiratory mortality | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Respiratory mortality | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Cardiovascular mortality | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Intensive care unit admission | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Laboratory-confirmed COVID-19 hospitalization | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Any hospital contact associated with laboratory-confirmed COVID-19 | ≥14 days after initially booked study visit date until 6 months after initially booked study visit date |
| Danske Lægers Vaccinations Service | Søborg | 2860 | Denmark |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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