Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-03 @ 11:04 PM
Study NCT ID:
NCT07266558
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)
Sponsor:
Organization:
Raw JSON
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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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection', 'timeFrame': 'Day 1 through Day 181', 'description': 'The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).'}, {'measure': 'Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection', 'timeFrame': 'Day 1 through Day 181', 'description': 'The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).'}, {'measure': 'Number of Participants with Unsolicited Adverse Events (AEs)', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation', 'timeFrame': 'Day 1 through Day 181'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with a First Event of Severe COVID-19 after Study Injection', 'timeFrame': 'Day 1 through Day 181'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mRNA-1273', 'mRNA-1283', 'SARS-CoV-2', 'mRNA vaccine', 'Coronavirus', 'Messenger RNA', 'COVID-19', 'COVID-19 Vaccine', 'Moderna'], 'conditions': ['SARS-CoV-2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of mRNA-1283 and mRNA-1273 (variant formulations) in adults 50 to 64 years of age without high risk factors for severe COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy and without underlying medical conditions that may put them at higher risk of experiencing severe outcomes of COVID-19, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n\nKey Exclusion Criteria:\n\n* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.\n* Acutely ill or febrile within 72 hours prior to or at the Screening Visit or Day 1.\n* Receipt of any of the following:\n\n * COVID-19 vaccine within 3 months prior to enrollment,\n * Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention,\n * Corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for \\>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study or,\n * Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.\n* Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study injection.\n* Has participated in an investigational clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.\n\nNote: Additional inclusion/exclusion criteria may apply, per protocol.'}, 'identificationModule': {'nctId': 'NCT07266558', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Phase 4, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of mRNA-1283 And mRNA-1273 Variant-Containing Formulation in Adults 50 to 64 Years of Age Without Underlying Conditions That Put Them at High Risk for Severe Outcomes From COVID-19', 'orgStudyIdInfo': {'id': 'mRNA-1273_1283-P401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mRNA-1273 (Variant Formulation)', 'description': 'Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.', 'interventionNames': ['Biological: mRNA-1273']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1283 (Variant Formulation)', 'description': 'Participants will receive a single IM injection of mRNA-1283 on Day 1.', 'interventionNames': ['Biological: mRNA-1283']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single IM injection of placebo on Day 1.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'mRNA-1273', 'type': 'BIOLOGICAL', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1273 (Variant Formulation)']}, {'name': 'mRNA-1283', 'type': 'BIOLOGICAL', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1283 (Variant Formulation)']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% sodium chloride (normal saline) injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': 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