Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 8:50 PM
Study NCT ID:
NCT07279766
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090983', 'term': '2019-nCoV Vaccine mRNA-1273'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 285000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-11-28', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'COVID-19-related hospitalization (alternate definition)', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Laboratory-confirmed COVID-19', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Total length of hospital stays due to COVID-19-related respiratory tract disease', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Composite of hospitalization for COVID-19 or pneumonia (ICD-10 codes only)', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Hospitalization for any cardiovascular disease', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Hospitalization due to any infectious disease', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Hospitalization requiring mechanical ventilation', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'In-hospital mortality', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Cardio-respiratory mortality', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Respiratory mortality', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Intensive care unit admission', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Laboratory-confirmed COVID-19 hospitalization', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'Any hospital contact associated with laboratory-confirmed COVID-19', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}], 'primaryOutcomes': [{'measure': 'Medically attended COVID-19', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date', 'description': 'Defined as a positive PCR test for SARS-CoV-2 or hospitalization for COVID-19-related respiratory tract disease'}], 'secondaryOutcomes': [{'measure': 'COVID-19-related hospitalization', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'COVID-19-related respiratory tract disease hospitalization', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'COVID-19-related cardio-respiratory disease hospitalization', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'All-cause respiratory tract disease hospitalization', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'All-cause cardio-respiratory hospitalization', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'All-cause lower respiratory tract disease hospitalization', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'All-cause hospitalization', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'COVID-19 death', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}, {'measure': 'All-cause death', 'timeFrame': '≥14 days after initially booked study visit date until 6 months after initially booked study visit date'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Vaccination', 'Pragmatic', 'Registry', 'Respiratory tract disease', 'Respiratory', 'Cardiovascular'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50-64 years\n* Informed consent form has been signed and dated\n\nExclusion Criteria:\n\n* Medical conditions that increase the risk of severe COVID-19, which will be assessed through self-reporting. These medical conditions include:\n\n 1. Asthma\n 2. Cancer (excluding non-melanoma skin cancer)\n 3. Cardiomyopathies\n 4. Cerebrovascular disease\n 5. Chronic kidney disease\n 6. Chronic lung disease\n 7. Cystic Fibrosis\n 8. Dementia\n 9. Diabetes\n 10. Down syndrome\n 11. Heart failure\n 12. Human Immunodeficiency Virus\n 13. Immunosuppressive therapy\n 14. Ischemic heart disease\n 15. Liver disease\n 16. Neurological/neuromuscular disease\n 17. Psychiatric disease (psychotic, schizophrenic, schizotypal, depressive, and bipolar (affective) disorders).\n 18. Severe obesity (body mass index \\>35 kg/m2)\n 19. Severe substance abuse\n 20. Short bowel syndrome\n 21. Solid organ transplant or hematological transplant\n* Apart from these, there are no specific exclusion criteria for this study'}, 'identificationModule': {'nctId': 'NCT07279766', 'acronym': 'DAN-COVID', 'briefTitle': 'Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'A Phase 4 Pragmatic, Randomized Trial to Evaluate the Effectiveness of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19', 'orgStudyIdInfo': {'id': 'DAN-COVID'}, 'secondaryIdInfos': [{'id': '2025-523841-82-00', 'type': 'OTHER', 'domain': 'EU Clinical Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mRNA-1273 (Spikevax)', 'description': 'COVID-19 vaccine single injection at day 0', 'interventionNames': ['Biological: mRNA-1273 (Moderna COVID-19 vaccine)']}, {'type': 'NO_INTERVENTION', 'label': 'No COVID-19 vaccine (control)', 'description': 'Control arm, no COVID-19 vaccine'}], 'interventions': [{'name': 'mRNA-1273 (Moderna COVID-19 vaccine)', 'type': 'BIOLOGICAL', 'description': 'For this arm, the current variant formulation of Spikevax (mRNA-1273) vaccine will be used.', 'armGroupLabels': ['mRNA-1273 (Spikevax)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne B Nielsen, MD', 'role': 'CONTACT', 'email': 'anne.bjerg.nielsen.01@regionh.dk', 'phone': '+4528453599'}, {'name': 'Tor Biering-Sørensen, MD, MSc, MPH, PhD', 'role': 'CONTACT', 'email': 'tor.biering-soerensen@regionh.dk', 'phone': '+4528933590'}, {'name': 'Tor Biering-Sørensen, MD, MSc, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '2860', 'city': 'Søborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Carsten S Larsen, MD, DMSc', 'role': 'CONTACT', 'email': 'carslars@rm.dk', 'phone': '+4540459708'}, {'name': 'Carsten S Larsen, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Danske Lægers Vaccinations Service', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}], 'centralContacts': [{'name': 'Anne B Nielsen, MD', 'role': 'CONTACT', 'email': 'anne.bjerg.nielsen.01@regionh.dk', 'phone': '+4528453599'}, {'name': 'Tor Biering-Sørensen, MD, MSc, MPH, PhD', 'role': 'CONTACT', 'email': 'tor.biering-soerensen@regionh.dk', 'phone': '+4528933590'}], 'overallOfficials': [{'name': 'Tor Biering-Sørensen, MD, MSc, MPH, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tor Biering-Sørensen', 'class': 'OTHER'}, 'collaborators': [{'name': 'ModernaTX, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, MSc, MPH, PhD', 'investigatorFullName': 'Tor Biering-Sørensen', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}