En undersøgelse af mRNA-1010 sammenlignet med en licenseret influenzavaccine hos voksne ≥50 år
20. august 2026 opdateret af: ModernaTX, Inc.
Et fase 3, randomiseret, observatørblindt, aktivt kontrolleret, case-drevet studie for at undersøge sikkerheden, effektiviteten og immunogeniciteten af mRNA-1010 kandidat for sæsoninfluenzavaccine sammenlignet med en licenseret inaktiveret sæsonbestemt influenzavaccine hos voksne ≥50 år.
De primære formål med denne undersøgelse er at evaluere sikkerheden og reaktogeniciteten af mRNA-1010 og at evaluere relativ vaccineeffektivitet (rVE) af mRNA-1010 versus en aktiv komparator mod protokoldefineret influenzalignende sygdom (ILI) forårsaget af enhver influenza A- eller B-stammer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40805
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alken, Belgien, 3570
- Anima Research Center
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Ghent, Belgien, 10 - 9000
- Universitair Ziekenhuis Gent
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Mechelen, Belgien, 435 2800
- AZ Sint Maarten
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Wilrijk, Belgien, 663 2650
- University of Antwerpen - Vaccinopolis
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Burgas, Bulgarien
- Medical center "Dr. Staykov" Ltd.
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Kozloduy, Bulgarien
- MHAT "Sveti Ivan Rilski"
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Lovech, Bulgarien
- Medical Center Medconsult Pleven, Lovech branch
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Montana, Bulgarien
- Medical Center Hera - Montana branch
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Montana, Bulgarien
- MHAT "Dr. Stamen Iliev"
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Pleven, Bulgarien
- Medical Center Medconsult Pleven
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Plovdiv, Bulgarien
- AIPPMP Dr. Levena Kireva
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Plovdiv, Bulgarien
- MHAT "Sv. Panteleymon" Ltd.
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Sliven, Bulgarien
- DCC-1 Sliven Lts.
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Sliven, Bulgarien
- MHAT Sliven to MMA Sofia
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Sofia, Bulgarien
- Diagnostic & Consultancy Center Ascendent, Sofia
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Sofia, Bulgarien
- Medical Center "Hera" EOOD
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Sofia, Bulgarien
- Medical Center Excelsior - Base 2
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Sofia, Bulgarien
- Medical Center Excelsior OOD, Base1
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Sofia, Bulgarien
- Medical Centre "Sirtuin" Ltd
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Stamboliyski, Bulgarien
- AIPPMP D-r Zhaneta Demireva Ltd.
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Burlington, Canada
- Aviva Medical Diagnostics and Specialists Clinic and Heart & Vascular Centre
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Calgary, Canada
- CARe Clinic, Calgary, AB
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London, Canada
- Milestone Research Inc.
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Lévis, Canada
- Centricity Research Quebec City
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Ottawa, Canada
- Red Maple Trials
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Pointe-Claire, Canada
- Centricity Research Pointe-Claire
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Québec, Canada
- Clinique de Lebourgneuf
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Red Deer, Canada
- CARe , Red Deer, AB.
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Sarnia, Canada
- Bluewater Clinical Research Group Inc.
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Stouffville, Canada
- Stouffville Medical Research Institute
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Toronto, Canada
- Canadian Phase Onward Inc.
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Toronto, Canada
- Centricity Research Toronto LMC
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Trois-Rivières, Canada
- Diex Recherche
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Truro, Canada
- Colchester Research Group
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Victoriaville, Canada
- Diex Recherche Victoriaville
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Acomb, York, Det Forenede Kongerige
- Panthera Biopartners site - York
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Birmingham, Det Forenede Kongerige
- University Hospitals Birmingham NHS Foundation Trust
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Birmingham, Det Forenede Kongerige
- FutureMeds Birmingham
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Blackpool, Det Forenede Kongerige
- Layton Medical Centre
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Corby, Det Forenede Kongerige
- Lakeside Healthcare
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Edinburgh, Det Forenede Kongerige
- NHS Lothian - Western General Hospital
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Enfield, Det Forenede Kongerige
- Panthera Biopartners site - Enfield
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Exeter, Det Forenede Kongerige
- Royal Devon University Healthcare NHS Foundation Trust
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Glasgow, Det Forenede Kongerige
- FutureMeds - Glasgow
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Glasgow, Det Forenede Kongerige
- Glasgow Panthera Biopartners Site
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London, Det Forenede Kongerige
- Chelsea and Westminster Hospital NHS Foundation Trust
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London, Det Forenede Kongerige
- Guy's and St Thomas's NHS Foundation Trust
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London, Det Forenede Kongerige
- Barts Health NHS Trust - Mile End Hospital
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London, Det Forenede Kongerige
- HMC Research Group
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London, Det Forenede Kongerige
- St George's University Hospitals (NHS Foundation Trust)
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London, Det Forenede Kongerige
- Velocity Clinical Research - North London
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Manchester, Det Forenede Kongerige
- Manchester University NHS Foundation Trust
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Metropolitan Borough of Wirral, Det Forenede Kongerige
- FutureMeds Wirral
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Newcastle upon Tyne, Det Forenede Kongerige
- Infectious Diseases Research - Clinical Research Facility
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Norwich, Det Forenede Kongerige
- Norfolk nand Norwich University Hospital
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Nottingham, Det Forenede Kongerige
- University of Nottingham Health Service
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Peterborough, Det Forenede Kongerige
- Wansford Research Limited
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Plymouth, Det Forenede Kongerige
- University Hospitals Plymouth NHS Trust
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Portsmouth, Det Forenede Kongerige
- Portsmouth Hospitals University NHS Trust - Portsmouth Research Hub
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Rochdale, Det Forenede Kongerige
- Panthera Biopartners - Manchester
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Sheffield, Det Forenede Kongerige
- Sheffield Panthera Biopartners Site
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Southampton, Det Forenede Kongerige
- Southampton General Hospital
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Stockton-on-Tees, Det Forenede Kongerige
- Future Meds - Teesside
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Paide, Estland, 6
- Vee Family Doctors' Center
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Tallinn, Estland, 4
- Center of Clinical and Basic Research
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Tallinn, Estland, 68A
- Merelahe Family Doctors Centre
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Tallinn, Estland, 7
- Innomedica OU
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Tartu, Estland, 54
- Clinical Research Center
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Espoo, Finland
- FVR - Finnish Vaccine Research Ltd - Espoo
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Kokkola, Finland
- FVR - Finnish Vaccine Research Ltd - Kokkola
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Oulu, Finland
- FVR - Finnish Vaccine Research Ltd - Oulu
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Tampere, Finland
- FVR - Finnish Vaccine Research Ltd - Tampere
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Turku, Finland
- FVR - Finnish Vaccine Research Ltd - Järvenpää
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Alabama
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Anniston, Alabama, Forenede Stater, 36207
- Pinnacle Research Group, LLC
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Athens, Alabama, Forenede Stater, 35611
- North Alabama Research Center, LLC
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Birmingham, Alabama, Forenede Stater, 35209
- Flourish Research
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Birmingham, Alabama, Forenede Stater, 35210
- EmVenio Research Brimingham, AL
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Cullman, Alabama, Forenede Stater, 35055
- Cullman Clinical Trials
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Huntsville, Alabama, Forenede Stater, 35802
- Optimal Research
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Mobile, Alabama, Forenede Stater, 36608
- Velocity Clinical Research
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Arizona
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Glendale, Arizona, Forenede Stater, 85308
- Lenzmeier Family Medicine
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Phoenix, Arizona, Forenede Stater, 85012
- DM Clinical Research
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Phoenix, Arizona, Forenede Stater, 85028
- Helios Clinical Research
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Tempe, Arizona, Forenede Stater, 85283
- Fiel Family and Sports Medicine
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Tucson, Arizona, Forenede Stater, 85711
- Arizona Liver Health
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Baptist Health Center for Clinical Research
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Rogers, Arkansas, Forenede Stater, 72758
- Woodland Research
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California
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Colton, California, Forenede Stater, 92324
- Benchmark Research - Colton
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Covina, California, Forenede Stater, 91723
- Flourish Research
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Huntington Park, California, Forenede Stater, 90255
- Velocity Clinical Research - Huntington Park
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La Mesa, California, Forenede Stater, 91942
- Velocity Clinical Research, San Diego
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Long Beach, California, Forenede Stater, 90805
- Long Beach Research Institute LLC
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Los Angeles, California, Forenede Stater, 90057
- Velocity Clinical Research - Westlake
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Newport Beach, California, Forenede Stater, 92660
- M3 Wake Research/PRI, LLC
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North Hollywood, California, Forenede Stater, 91606
- Carbon Health North Hollywood
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Northridge, California, Forenede Stater, 91325
- Valley Clinical Trials, Inc.
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Redding, California, Forenede Stater, 96001
- Paradigm Research
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Riverside, California, Forenede Stater, 92503
- Artemis Institute for Clinical Research
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Rolling Hills Estates, California, Forenede Stater, 90274
- Peninsula Research Associates (PRA)
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San Bernardino, California, Forenede Stater, 92408
- Velocity Clinical Research - Banning
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San Diego, California, Forenede Stater, 92120
- Wr-McCr, Llc
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San Diego, California, Forenede Stater, 92103
- Artemis Institute for Clinical Research - Research Site
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San Diego, California, Forenede Stater, 92111
- WHCR- M3 Wake Research
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Santa Ana, California, Forenede Stater, 92704
- Velocity Clinical Research
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Walnut Creek, California, Forenede Stater, 94598
- Diablo Clinical Research
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Colorado
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Fort Collins, Colorado, Forenede Stater, 80525
- Tekton Research - Fort Collins
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Longmont, Colorado, Forenede Stater, 80501
- Tekton Research, Inc - Longmont Center
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Connecticut
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Stamford, Connecticut, Forenede Stater, 06905
- Stamford Therapeutics Consortium
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Waterbury, Connecticut, Forenede Stater, 06708
- Chase Medical Research, LLC
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Florida
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Atlantis, Florida, Forenede Stater, 33462
- JEM Research Institue
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Crystal River, Florida, Forenede Stater, 34429
- Nature Coast Clinical Research, LLC - Crystal River
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Hialeah, Florida, Forenede Stater, 33016
- Homestead Associates in Research,Inc
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Hollywood, Florida, Forenede Stater, 33024
- CenExel RCA
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Inverness, Florida, Forenede Stater, 34452
- Nature Coast Clinical Research, LLC - Inverness
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Jacksonville, Florida, Forenede Stater, 32216
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Forenede Stater, 32205-4785
- Westside Center for Clinical Research
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Jupiter, Florida, Forenede Stater, 33458
- Health Awareness INC
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Lake City, Florida, Forenede Stater, 32055
- M3 Wake Research/MSRA,LLC
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Lake Mary, Florida, Forenede Stater, 32746
- Accel Clinical Research
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Leesburg, Florida, Forenede Stater, 34748
- Clinical Site Partners - Leesburg
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Maitland, Florida, Forenede Stater, 32751
- K2 Medical Research
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Maitland, Florida, Forenede Stater, 32751
- ARS - Meridien Research
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Miami, Florida, Forenede Stater, 33155
- Miami Clinical Research
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Miami, Florida, Forenede Stater, 33173
- Suncoast Research Associates, LLC
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Miami, Florida, Forenede Stater, 33135
- South Florida Research Center, Inc.
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Miami Lakes, Florida, Forenede Stater, 33016
- Floridian Clinical Research
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Orlando, Florida, Forenede Stater, 32819
- Headlands Research
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Pembroke Pines, Florida, Forenede Stater, 33024
- Suncoast Research Associates
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Port Saint Lucie, Florida, Forenede Stater, 34952
- Health Awareness INC
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St. Petersburg, Florida, Forenede Stater, 33704
- IMA Clinical Research Warren
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Tampa, Florida, Forenede Stater, 33613
- Forward Clinical Trials - Dermatology
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Winter Park, Florida, Forenede Stater, 32789
- Clinical Site Partners, LLC
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Georgia
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Albany, Georgia, Forenede Stater, 31707
- Javara
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Columbus, Georgia, Forenede Stater, 31904
- IACT Health
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Decatur, Georgia, Forenede Stater, 30030
- CenExel iResearch , LLC
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Savannah, Georgia, Forenede Stater, 31405
- CenExel iResearch Savannah
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Savannah, Georgia, Forenede Stater, 31406-2675
- Velocity Clinical Research-Savannah
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Savannah, Georgia, Forenede Stater, 31406
- Javara - Privia Medical Group Georgia, LLC
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Stockbridge, Georgia, Forenede Stater, 30281
- Clinical Research Atlanta/Headlands
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96814-4526
- East-West Medical Research Institute
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Idaho
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Blackfoot, Idaho, Forenede Stater, 83221
- Bingham Memorial Hospital
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Meridian, Idaho, Forenede Stater, 83642
- Velocity Clinical Research - Boise
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
- Great Lakes Clinical Trials
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Chicago, Illinois, Forenede Stater, 60608
- EmVenio Research
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Melrose Park, Illinois, Forenede Stater, 60160
- DM Clinical Research- River Forest
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Indiana
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Valparaiso, Indiana, Forenede Stater, 46383
- Velocity Clinical Research - Valparaiso
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Iowa
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Sioux City, Iowa, Forenede Stater, 51106
- Velocity Clinical Research-Sioux City
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Kansas
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Augusta, Kansas, Forenede Stater, 67010
- Alliance for Multispecialty Research
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Lenexa, Kansas, Forenede Stater, 66219-1376
- Johnson County Clin-Trials (JCCT)
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Overland Park, Kansas, Forenede Stater, 66209
- DelRicht Research - Overland Park
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Wichita, Kansas, Forenede Stater, 67207
- AMR
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Velocity Clinical Research - Baton Rouge
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Lafayette, Louisiana, Forenede Stater, 70508
- Velocity Clinical Research - Lafayette
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Monroe, Louisiana, Forenede Stater, 71201
- IMA Clinical Research Monroe
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New Orleans, Louisiana, Forenede Stater, 70115
- DelRicht Research
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New Orleans, Louisiana, Forenede Stater, 70119
- Velocity Clinical Research
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Prairieville, Louisiana, Forenede Stater, 70769-4212
- DelRicht Research @ Neighborhood Health
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Privia Medical Group
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Gaithersburg, Maryland, Forenede Stater, 20877
- Cenexel CBH (CBH Health)
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Rockville, Maryland, Forenede Stater, 20852
- Matthew Mintz Clinic
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Rockville, Maryland, Forenede Stater, 20854
- Velocity Clinical Research - Covington
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Massachusetts
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Brookline, Massachusetts, Forenede Stater, 02446
- DM Clinical Research - Brookline
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Michigan
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Southfield, Michigan, Forenede Stater, 48076
- DM Clinical Research
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Southfield, Michigan, Forenede Stater, 48075-5400
- Great Lakes Research Institute
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Southfield, Michigan, Forenede Stater, 48034
- Headlands Research - Detroit
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Mississippi
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Gulfport, Mississippi, Forenede Stater, 39503
- DELRICHT RESEARCH at GULFPORT MEMORIAL
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Missouri
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Chesterfield, Missouri, Forenede Stater, 63005
- Clinical Research Professionals
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Springfield, Missouri, Forenede Stater, 65807
- Clinvest
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Springfield, Missouri, Forenede Stater, 65807
- DelRicht Research
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St Louis, Missouri, Forenede Stater, 63141
- Sundance Clinical Research, LLC
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Town and Country, Missouri, Forenede Stater, 63017
- Delricht
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Montana
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Missoula, Montana, Forenede Stater, 59804
- Boeson Research MSO
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Missoula, Montana, Forenede Stater, 59808
- Elias Research Associates
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Nebraska
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Grand Island, Nebraska, Forenede Stater, 68803
- Velocity Clinical Research-Grand Island
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Lincoln, Nebraska, Forenede Stater, 68510
- Platinum Research Network, LLC
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Norfolk, Nebraska, Forenede Stater, 68701
- Velocity Clinical Research-Norfolk
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Omaha, Nebraska, Forenede Stater, 68134
- Velocity Clinical Research-Omaha
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Nevada
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Henderson, Nevada, Forenede Stater, 89052
- Henderson Clinical Trials
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Las Vegas, Nevada, Forenede Stater, 89106
- M3 Wake Research/CRCN, LLC
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Las Vegas, Nevada, Forenede Stater, 89119
- Office of Michael B. Jacobs, MD
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New Jersey
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Jersey City, New Jersey, Forenede Stater, 07306
- DM Clinical Research - New Jersey
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Warren Township, New Jersey, Forenede Stater, 07059
- IMA Clinical Research Warren
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
- DM Clinical Research-Albuquerque
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Albuquerque, New Mexico, Forenede Stater, 87109
- AXCES Research Group - Sante Fe
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New York
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Binghamton, New York, Forenede Stater, 13905
- Velocity Clinical Research - Binghamton
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Brooklyn, New York, Forenede Stater, 11220
- DM Clinical
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Buffalo, New York, Forenede Stater, 14217
- RCR Buffalo
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East Syracuse, New York, Forenede Stater, 13057
- Velocity Clinical Research, Syracuse
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Hartsdale, New York, Forenede Stater, 10530
- IMA Clinical Research
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New York, New York, Forenede Stater, 10036
- IMA Research
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Rochester, New York, Forenede Stater, 14609
- Rochester Clinical Research, Inc
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Vestal, New York, Forenede Stater, 13850
- Velocity Clinical Research-Vestal
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Asheville Clinical Research
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Charlotte, North Carolina, Forenede Stater, 28205
- DelRicht Research, LLC
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Morehead City, North Carolina, Forenede Stater, 23730
- Lucas Research
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Raleigh, North Carolina, Forenede Stater, 27612
- M3 Wake Research, Inc.
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Raleigh, North Carolina, Forenede Stater, 27607
- Eximia Clinical Research
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Salisbury, North Carolina, Forenede Stater, 28144
- Accellacare US Inc.
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Wilmington, North Carolina, Forenede Stater, 28403
- Trial Management Associates, LLC
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Wilmington, North Carolina, Forenede Stater, 28401
- Accellacare Research Wilmington
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Javara - Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45242
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45212
- Community Research
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Cincinnati, Ohio, Forenede Stater, 45219
- Velocity Clinical Research-Mt. Auburn
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Columbus, Ohio, Forenede Stater, 43213
- Centricity Research Columbus
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Dayton, Ohio, Forenede Stater, 45417
- Midwest Clinical Research Center
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73013
- Tekton Research, Inc - Edmond
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Tulsa, Oklahoma, Forenede Stater, 74133
- Delricht Tate
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Yukon, Oklahoma, Forenede Stater, 73099
- Tekton Research, Inc - Yukon Location
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Oregon
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Corvallis, Oregon, Forenede Stater, 97330
- The Corvallis Clinic
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Portland, Oregon, Forenede Stater, 97210
- Summit Research
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- DM Clinical Research - Philadelphia
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Uniontown, Pennsylvania, Forenede Stater, 15401
- Preferred Primary Care Physicians
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02886
- Velocity Clinical Research - Providence
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South Carolina
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Anderson, South Carolina, Forenede Stater, 29621
- Velocity Clinical Research - Anderson
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Charleston, South Carolina, Forenede Stater, 29407
- DelRicht Research
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Charleston, South Carolina, Forenede Stater, 29414
- Charleston Clinical Trials, LLC
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Columbia, South Carolina, Forenede Stater, 29204
- Velocity Clinical Research, Spartanburg
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Gaffney, South Carolina, Forenede Stater, 29340
- Velocity Clinical Research, Gaffney
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Carolina Health Specialists
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Research
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Union, South Carolina, Forenede Stater, 29379
- Velocity Clinical Research- UNION
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Black Hills Center for American Indian Health
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37421
- M3 Wake Research/ClinSearch, LLC
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Jackson, Tennessee, Forenede Stater, 38305
- Helios Clinical Research
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Johnson City, Tennessee, Forenede Stater, 37601
- MultiSpeciality Clinical Research
-
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Texas
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Austin, Texas, Forenede Stater, 78745
- Tekton Research, Inc
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Austin, Texas, Forenede Stater, 78745
- Avant Reseach Associates
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Beaumont, Texas, Forenede Stater, 78705
- Tekton Research, LLC
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Brownsville, Texas, Forenede Stater, 78526
- Headlands Research Brownsville
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El Paso, Texas, Forenede Stater, 79225
- 3A Research, LLC
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Fort Worth, Texas, Forenede Stater, 76135
- Benchmark Research
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Fort Worth, Texas, Forenede Stater, 76104
- Helios
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Houston, Texas, Forenede Stater, 77065
- DM Clinical Research - CyFair
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Houston, Texas, Forenede Stater, 77008-1374
- Helios Clinical Research
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Houston, Texas, Forenede Stater, 77081
- DM Clinical Research- Bellaire
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Keller, Texas, Forenede Stater, 76248
- Helios CR, Inc. Keller Tx
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Plano, Texas, Forenede Stater, 75093
- Research Your Health
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Prosper, Texas, Forenede Stater, 75078
- DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
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San Antonio, Texas, Forenede Stater, 78207
- DM Clinical Research
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San Antonio, Texas, Forenede Stater, 78229
- IMA Clinical Research
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San Antonio, Texas, Forenede Stater, 78229
- Tekton Research Inc - San Antonio
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San Marcos, Texas, Forenede Stater, 78666
- San Marcos Family Medicine
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Stephenville, Texas, Forenede Stater, 76401
- Stephenville Medical & Surgical Clinic, PA
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Sugar Land, Texas, Forenede Stater, 77478
- DM Clinical Research - Sugarland
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Sugar Land, Texas, Forenede Stater, 77478
- Breco Research - A Tarheel Clinical Research Site
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Tomball, Texas, Forenede Stater, 77375
- DM Clinical Research
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Tomball, Texas, Forenede Stater, 77375
- DM Clinical Research - Tomball
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Utah
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Salt Lake City, Utah, Forenede Stater, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Forenede Stater, 84121
- J. Lewis Research, Inc.
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Salt Lake City, Utah, Forenede Stater, 84107
- CenExel - JBR
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Salt Lake City, Utah, Forenede Stater, 84106
- Synexus Clinical Research US, Inc.
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South Jordan, Utah, Forenede Stater, 84095
- J. Lewis Research, Inc/Jordan River Family Medicine
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Virginia
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Alexandria, Virginia, Forenede Stater, 22311
- Javara
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Hampton, Virginia, Forenede Stater, 23666-5843
- Velocity Clinical Research-Hampton
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Newport News, Virginia, Forenede Stater, 23606-4537
- Health Research of Hampton Roads, Inc.
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Portsmouth, Virginia, Forenede Stater, 23702
- Velocity Clinical Research-Portsmouth
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Richmond, Virginia, Forenede Stater, 23226
- Clinical Research Partners, LLC
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Winchester, Virginia, Forenede Stater, 22601
- Amherst Family Practice
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Washington
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Spokane, Washington, Forenede Stater, 99218
- Velocity Clinical Research- Spokane
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Wenatchee, Washington, Forenede Stater, 98801
- Confluence Health
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Batumi, Georgien
- Unimed Adjara Ltd - Batumi Referral Hospital
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Kutaisi, Georgien
- LTD "Hospital service"
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Rustavi, Georgien
- LTD Clinic Rustavi
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Tbilisi, Georgien
- Emergency Cardiology Center named by acad. G. Chapidze
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Tbilisi, Georgien
- Eristavi National Center of Experimental and Clinical Surgery
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Tbilisi, Georgien
- LTD Israel-Georgian Medical Research Clinic Helsicore
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Ansan-si, Sydkorea
- Korea University Ansan Hospital
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Bucheon-si, Sydkorea
- Soon Chun Hyang University Hospital Bucheon
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Daejeon, Sydkorea
- Chungnam National University Hospital
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Incheon, Sydkorea
- Inha University Hospital
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Seoul, Sydkorea
- Seoul National University Hospital
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Seoul, Sydkorea
- Severance Hospital, Yonsei University Health System
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Seoul, Sydkorea
- Hallym University Kangnam Sacred Heart Hospital
-
Suwon, Sydkorea
- Ajou University Hospital
-
Wŏnju, Sydkorea
- Yonsei University, Wonju Severance Christian Hospital
-
-
-
-
-
Kaohsuing City, Taiwan
- Kaohsiung Veterans General Hospital
-
Taichung, Taiwan
- China Medical University Hospital
-
Taipei, Taiwan
- National Taiwan University Hospital
-
Taoyuan City, Taiwan
- Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
-
-
-
-
-
Berlin, Tyskland
- Emovis GmbH
-
Berlin, Tyskland
- Klinische Forschung Berlin-Mitte GmbH
-
Berlin, Tyskland
- Velocity Clinical Research Berlin, GmbH
-
Bochum, Tyskland
- Praxis Rinke
-
Dresden, Tyskland
- Klinische Forschung Dresden GmbH
-
Essen, Tyskland
- Medizentrum Essen Borbeck
-
Frankfurt, Tyskland
- IKF Pneumologie
-
Frankfurt, Tyskland
- Infektio Research GmbH & Co.KG
-
Hamburg, Tyskland
- Klinische Forschung Hamburg GmbH
-
Hamburg, Tyskland
- Velocity Clincial Research Hamburg GmbH
-
Hanover, Tyskland
- Klinische Forschung Hannover Mitte GmbH
-
Karlsruhe, Tyskland
- Klinische Forschung Karlsruhe
-
Magdeburg, Tyskland
- SMO.MD
-
Mainz, Tyskland
- Dermatologie Quist BAG Dres. Med. Quist Part G
-
München, Tyskland
- CDG Studienambulanz
-
Offenbach, Tyskland
- Future meds Offenbach
-
Oldenburg, Tyskland
- Red-Institut
-
Schwerin, Tyskland
- Klinische Forschung Schwerin GmbH
-
Stuhr, Tyskland
- Studienzentrum Brinkum
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Stuttgart, Tyskland
- Hautarztpraxis Leitz & Kollegen
-
Wiesbaden, Tyskland
- Velocity Clinical Research Wiesbaden
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- I stand til at give underskrevet informeret samtykke, hvilket omfatter overholdelse af de krav og begrænsninger, der er anført i den informerede samtykkeformular (ICF) og i protokollen.
Deltagere, der tildeles kvindelige ved fødslen eller kan blive gravide, er berettiget til at deltage, hvis:
- Deltageren er en person med ikke-fertilitet (PONCBP) eller
- Deltageren er en person i den fødedygtige alder (POCBP), som:
- Er ikke amning/brystmad.
- Bruger en acceptabel præventionsmetode mindst 28 dage før dag 1 (basislinje) til mindst 90 dage efter dag 1 (basislinje).
- Har en negativ meget følsom graviditetstest (urin eller serum som krævet af lokale reguleringer eller institutionelle revisionsnævn [IRB]/uafhængig etisk komité [IEC]) ved screeningsbesøget og før undersøgelsesintervention (hvis dag 1 [Baseline] besøg ikke er samme dag som screeningsbesøget).
Ekskluderingskriterier:
- Akut syg eller feber (temperatur ≥38,0 grader Celsius (℃) [100,4° Fahrenheit [F]]) inden for 72 timer før dag 1 (basislinje).
- Tæt kontakt med en person med laboratoriebekræftet influenzainfektion eller med en person, der er blevet behandlet med antivirale terapier mod influenza (f.eks. Tamiflu®/oseltamivir) inden for 5 dage før dag 1 (basislinje).
- Anamnese med en diagnose eller tilstand, der efter investigatorens vurdering er klinisk ustabil eller kan påvirke deltagernes sikkerhed, vurdering af undersøgelsens endepunkter, vurdering af immunrespons eller overholdelse af undersøgelsesprocedurer.
- Rapporteret historie med medfødt eller erhvervet immundefekt, immunsuppressiv tilstand, aspleni eller tilbagevendende alvorlig infektionssygdom.
- Testet positivt for influenza af lokale sundhedsmyndigheder-godkendte testmetoder inden for 180 dage før dag 1 (baseline).
- Anamnese med anafylaksi eller alvorlig overfølsomhedsreaktion, der kræver medicinsk indgriben efter modtagelse af et af følgende: mRNA-vaccine eller terapeutisk; komponenter af en mRNA-vaccine eller terapeutisk middel; influenzavaccine; eller komponenter af en influenzavaccine, herunder æggeprotein.
- Malignitet inden for 2 år før dag 1 (baseline) (tilstrækkeligt behandlet basalcellekarcinom og pladecellecarcinom er tilladt).
- Modtog kortikosteroider med ≥10 milligram (mg)/dag af prednison eller tilsvarende i >14 dage i alt inden for 90 dage før dag 1 (baseline) eller forventer behovet for kortikosteroider på et hvilket som helst tidspunkt under undersøgelsen.
- Modtog systemisk immunsuppressiv behandling, inklusive langtidsvirkende biologiske terapier, der påvirker immunresponser (f.eks. infliximab), inden for 180 dage før dag 1 (basislinje) eller planlægger at gøre det under undersøgelsen.
- Behandlet med antivirale behandlinger mod influenza (f.eks. Tamiflu) inden for 180 dage før dag 1 (basislinje).
- Modtaget enhver vaccine godkendt eller godkendt af det lokale sundhedsagentur inden for 28 dage før dag 1 (basislinje) eller planlægger at gøre det inden for 14 dage efter dag 1 (basislinje).
- Modtog en licenseret sæsonbestemt influenzavaccine inden for 180 dage før dag 1 (basislinje) eller planlægger at gøre det (uden for denne undersøgelse) på et hvilket som helst tidspunkt under undersøgelsen.
- Modtog en sæsonbestemt influenzavaccine inden for 1 år før dag 1 (baseline).
- Deltog i et klinisk studie med forsøgsbehandling inden for 90 dage før dag 1 (baseline) baseret på sygehistorieinterviewet eller planlægger at gøre det, mens han deltog i denne undersøgelse.
- Arbejder eller har arbejdet som studiepersonale eller er et nært familiemedlem eller husmedlem af studiepersonale, studiepersonale eller sponsorpersonale.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: mRNA-1010
Deltagerne vil modtage en enkelt injektion af mRNA-1010 på dag 1.
|
Intramuskulær (IM) injektion
|
|
Aktiv komparator: Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra
Deltagerne vil modtage en enkelt injektion af Active Comparator Trivalent Influenza Vaccine (TIV) eller quadrivalent influenza -vaccine (QIV) (Fluarix®, Fluarix Tetra, InflusPlit® Tetra, Alpharix® Tetra) på dag 1.
|
IM injektion
Jeg er injektion
Jeg er injektion
Jeg er injektion
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Tidsramme: Day 1 up to Day 7
|
Solicited ARs were recorded daily using electronic diaries (eDiaries).
Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.
Note, not all solicited ARs were considered adverse events (AEs).
Investigator reviewed whether the solicited AR was also to be recorded as an AE.
A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
|
Day 1 up to Day 7
|
|
Number of Participants With Unsolicited Adverse Events (AEs)
Tidsramme: Day 1 up to Day 28
|
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
|
Day 1 up to Day 28
|
|
Number of Participants With Medically Attended AEs (MAAEs), AEs Leading to Study Discontinuation, SAEs, or Adverse Events of Special Interests (AESIs)
Tidsramme: Day 1 up to Day 181
|
MAAEs were AEs that led to an unscheduled visit to a healthcare provider.
SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event.
AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required.
A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
|
Day 1 up to Day 181
|
|
Number of Participants With First Episode of Reverse Tanscription Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined Influenza-like Illness (ILI) Caused by Any Influenza A or B Strains
Tidsramme: Day 14 up to end of influenza season (up to 7.5 months)
|
Protocol-defined ILI: At least 1 systemic symptom (temperature >37.2 degrees celsius [°C] [>99.0 degrees Fahrenheit {°F}], chills, feverish, tiredness, headaches, or myalgia) and at least 1 respiratory symptom (sore throat, cough, sputum production, wheezing, or difficulty breathing).
|
Day 14 up to end of influenza season (up to 7.5 months)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With First Episode of RT-PCR Confirmed Modified United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains
Tidsramme: Day 14 up to end of influenza season (up to 7.5 months)
|
Modified CDC-defined ILI: Body temperature ≥37.2°C (≥99.0°F)
accompanied by cough and/or sore throat.
|
Day 14 up to end of influenza season (up to 7.5 months)
|
|
Number of Participants With First Episode of RT-PCR-confirmed Protocol-defined ILI or Modified CDC-defined ILI Caused by Any Influenza A or B Strains With Antigenic Match to the Vaccine Strains
Tidsramme: Day 14 up to end of influenza season (up to 7.5 months)
|
Protocol-defined ILI: At least 1 systemic symptom (temperature >37.2°C [>99.0°F],
chills, feverish, tiredness, headaches, or myalgia) and at least 1 respiratory symptom (sore throat, cough, sputum production, wheezing, or difficulty breathing).
Modified CDC-defined ILI: Body temperature >37.2°C (>99.0°F)
accompanied by cough and/or sore throat.
The confirmed RT-PCR test of influenza A or B strains with antigentic match to the vaccine strains.
|
Day 14 up to end of influenza season (up to 7.5 months)
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI)
Tidsramme: Day 29
|
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5 * LLOQ.
Values greater than upper limit of quantification (ULOQ) were converted to ULOQ.
LLOQ = 10, ULOQ = 3620 for H1N1.
LLOQ = 10, ULOQ = 2560 for H3N2.
LLOQ = 10, ULOQ = 1356.
95% confidence interval (CI) was calculated based on the t-distribution of log-transformed values for geometric mean (GM) titer, then back transformed to original scale for presentation.
|
Day 29
|
|
Number of Participants Reaching Seroconversion as Measured by HAI
Tidsramme: Day 29
|
Seroconversion was defined as either a Baseline HAI titer <1:10 and a post-baseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in post-baseline HAI antibody titer.
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
|
Day 29
|
|
Number of Participants With an HAI Titer ≥1:40
Tidsramme: Day 29
|
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
|
Day 29
|
|
Geometric Mean Fold Rise (GMFR) of HAI Titers
Tidsramme: Baseline, Day 29
|
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
95% CI was calculated based on the t-distribution of the difference in the log-transformed values for GM fold rise, then back transformed to the original scale for presentation.
|
Baseline, Day 29
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. september 2024
Primær færdiggørelse (Faktiske)
21. august 2025
Studieafslutning (Faktiske)
21. august 2025
Datoer for studieregistrering
Først indsendt
15. september 2024
Først indsendt, der opfyldte QC-kriterier
15. september 2024
Først opslået (Faktiske)
19. september 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- mRNA-1010-P304
- 2024-516240-26-00 (Anden identifikator: EU CT)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .