[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653754":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":77,"studyPopulation":19,"armGroups":78,"interventions":91,"overallOfficials":97,"centralContacts":102,"locations":111,"responsibleParty":161,"collaborators":164,"id":168,"slug":169,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":176,"sex":177,"minAge":178,"maxAge":19,"enrollmentInfo":179,"targetDuration":19,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":197,"whyStopped":19,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"Herlev and Gentofte Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"Medically attended influenza and\u002For COVID-19","Defined as a laboratory-confirmed positive influenza A\u002FB test or positive SARS-CoV-2 test, regardless of healthcare setting, or influenza-related or COVID-19-related hospitalization, defined by ICD-10 codes.","From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination",{"measure":14,"description":15,"timeFrame":12},"Influenza and\u002For COVID-19 hospitalization","Defined as hospitalization with a relevant ICD-10 code for influenza or COVID-19 infection or any hospitalization with a laboratory-confirmed positive influenza A\u002FB test or SARS-CoV-2 test performed within 7 days prior to hospitalization or within 48 hours of hospital admission.",[17,20,22,24,26,28,30],{"measure":18,"description":19,"timeFrame":12},"Medically attended influenza",null,{"measure":21,"description":19,"timeFrame":12},"Influenza hospitalization",{"measure":23,"description":19,"timeFrame":12},"Medically attended COVID-19",{"measure":25,"description":19,"timeFrame":12},"COVID-19 hospitalization",{"measure":27,"description":19,"timeFrame":12},"All-cause cardio-respiratory hospitalization",{"measure":29,"description":19,"timeFrame":12},"All-cause respiratory tract disease hospitalization",{"measure":31,"description":19,"timeFrame":12},"All-cause hospitalization",[33,35,37,39,41,43,45,47,49,51,53,55,57,59,61,63,65,67,69],{"measure":34,"description":19,"timeFrame":12},"Influenza-related cardio-respiratory hospitalization",{"measure":36,"description":19,"timeFrame":12},"COVID-19-related cardio-respiratory hospitalization",{"measure":38,"description":19,"timeFrame":12},"Influenza-related respiratory tract disease hospitalization",{"measure":40,"description":19,"timeFrame":12},"COVID-19-related respiratory tract disease hospitalization",{"measure":42,"description":19,"timeFrame":12},"All-cause death",{"measure":44,"description":19,"timeFrame":12},"Influenza death",{"measure":46,"description":19,"timeFrame":12},"COVID-19 death",{"measure":48,"description":19,"timeFrame":12},"Laboratory-confirmed influenza",{"measure":50,"description":19,"timeFrame":12},"Laboratory-confirmed COVID-19",{"measure":52,"description":19,"timeFrame":12},"Total length of hospital stays due to influenza-related respiratory tract disease",{"measure":54,"description":19,"timeFrame":12},"Total length of hospital stays due to COVID-19-related respiratory tract disease",{"measure":56,"description":19,"timeFrame":12},"Composite of hospitalization for COVID-19 or pneumonia",{"measure":58,"description":19,"timeFrame":12},"Composite of hospitalization for influenza or pneumonia",{"measure":60,"description":19,"timeFrame":12},"Composite of hospitalization for influenza or COVID-19 (ICD-10 codes only)",{"measure":62,"description":19,"timeFrame":12},"Hospitalization for any cardiovascular disease",{"measure":64,"description":19,"timeFrame":12},"Hospitalization due to any infectious disease",{"measure":66,"description":19,"timeFrame":12},"Hospitalization requiring mechanical ventilation",{"measure":68,"description":19,"timeFrame":12},"Intensive care unit admission",{"measure":70,"description":19,"timeFrame":12},"The burden and outcomes of influenza virus type and subtype (e.g., influenza A and B, including H1 and H3)",{"allocation":72,"interventionModel":73,"interventionModelDescription":19,"primaryPurpose":74,"observationalModel":19,"timePerspective":19,"maskingInfo":75},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":76,"maskingDescription":19,"whoMasked":19},"NONE","This Phase 4 randomized, active-comparator, pragmatic trial is designed to evaluate the effectiveness of a seasonal variant-containing formulation of mCombriax® (mRNA-1083) compared with same-day co-administration of authorized standalone enhanced influenza and COVID-19 vaccines in adults aged ≥65 years. The trial is designed to be conducted over two consecutive respiratory virus seasons to account for potential seasonal variation in virus circulation, vaccine composition, and effectiveness. The primary objective is to evaluate the comparative vaccine effectiveness (cVE) of the combination vaccine with respect to clinically relevant outcomes, including severe influenza and COVID-19. Demonstration of non-inferior protection in real-world setting, in combination with the potential programmatic advantages of a single-dose strategy, may support policy recommendations, reimbursement decisions, and broader implementation of combined seasonal respiratory vaccination strategies.",[79,85],{"label":80,"type":81,"description":82,"interventionNames":83},"mCombriax® (mRNA-1083)","EXPERIMENTAL","An authorized mRNA-based multicomponent vaccine encoding antigens targeting both seasonal influenza and SARS-CoV-2 viruses.",[84],"Biological: mCombriax® (mRNA-1083)",{"label":86,"type":87,"description":88,"interventionNames":89},"Efluelda® (TIV-HD) and Spikevax® (mRNA-1273)","ACTIVE_COMPARATOR","Same-day co-administration of an authorized high-dose trivalent influenza vaccine (TIV-HD; Efluelda®) and an authorized COVID-19 mRNA vaccine (Spikevax®, mRNA-1273)",[90],"Biological: Efluelda® (TIV-HD) and Spikevax® (mRNA-1273)",[92,95],{"type":93,"name":80,"description":82,"armGroupLabels":94,"otherNames":19},"BIOLOGICAL",[80],{"type":93,"name":86,"description":88,"armGroupLabels":96,"otherNames":19},[86],[98],{"name":99,"affiliation":100,"role":101},"Tor Biering-Sørensen","Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte","STUDY_CHAIR",[103,108],{"name":104,"role":105,"phone":106,"phoneExt":19,"email":107},"Lisa S Duus","CONTACT","+4540639843","lisa.steen.duus@regionh.dk",{"name":99,"role":105,"phone":109,"phoneExt":19,"email":110},"+4528933590","tor.biering-soerensen@regionh.dk",[112,126,143],{"facility":100,"status":19,"city":113,"state":19,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"Hellerup","2900","Denmark","DK",{"type":118,"coordinates":119},"Point",[120,121],12.57093,55.73204,{"lat":121,"lon":120},[124,125],{"name":104,"role":105,"phone":106,"phoneExt":19,"email":107},{"name":99,"role":105,"phone":109,"phoneExt":19,"email":110},{"facility":127,"status":19,"city":128,"state":19,"zip":129,"country":115,"countryCode":116,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Danske Lægers Vaccinations Service","Søborg","2860",{"type":118,"coordinates":131},[132,133],12.31803,56.08481,{"lat":133,"lon":132},[136,140],{"name":137,"role":105,"phone":138,"phoneExt":19,"email":139},"Carsten S Larsen","+4540459708","carslars@rm.dk",{"name":141,"role":142,"phone":19,"phoneExt":19,"email":19},"Carsten S Larsen, MD, DMSc","PRINCIPAL_INVESTIGATOR",{"facility":144,"status":19,"city":145,"state":146,"zip":19,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"General Public Health Directorate of Galician Health Service","Santiago de Compostela","A Coruña","Spain","ES",{"type":118,"coordinates":150},[151,152],-8.54569,42.88052,{"lat":152,"lon":151},[155,159],{"name":156,"role":105,"phone":157,"phoneExt":19,"email":158},"Carmen Rodríguez-Tenreiro-Sánche","655 299 502","carmentenreiro@hotmail.es",{"name":160,"role":142,"phone":19,"phoneExt":19,"email":19},"Federico M Torres, MD, PhD",{"type":162,"investigatorFullName":99,"investigatorTitle":163,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Professor, MD, MSc, MPH, PhD",[165],{"name":166,"class":167},"ModernaTX, Inc.","INDUSTRY","100653754","phase-4-effectiveness-of-an-influenzacovid-19-vaccine-mcombriax-mrna-1083-in-adults--65-years-100653754",false,"NCT07790523","Effectiveness of An Influenza\u002FCOVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years","A Phase 4, Pragmatic, Randomized Trial to Evaluate the Effectiveness of An Influenza\u002FCOVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years","DAN-COMBO","Inclusion Criteria:\n\n1. Age ≥65 years at the time of vaccination\n2. Self-reported ability to understand written and spoken English or Danish (Denmark only) or Spanish or Galician (Spain only)\n3. Informed consent form has been signed and dated\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria for this study",true,"ALL","65 Years",{"count":180,"type":181},410000,"ESTIMATED","INTERVENTIONAL",[184],"PHASE4","The purpose of this pragmatic randomized trials is to evaluate the comparative vaccine effectiveness (cVE) of mCombriax® (mRNA-1083) versus same day co-administration of the active comparators (i.e., high-dose influenza vaccine\u002FEfluelda® and mRNA-1273\u002FSpikevax®) among adults aged 65 years and older.",[187,188],"COVID-19","Influenza",[187,188,190,191,192,193,194,195,196],"mCombriax","Pragmatic","Registry","Respiratory tract disease","Cardiovascular","Hospitalization","Vaccination","NOT_YET_RECRUITING","2026-08-25",{"date":200,"type":201},"2026-08-27","ACTUAL",{"date":203,"type":181},"2026-09-01",{"date":205,"type":181},"2028-09-30",{"name":99,"class":6},3]