A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older
NCT ID: NCT05566639
Last Updated: 2025-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
22502 participants
INTERVENTIONAL
2022-09-14
2024-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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mRNA-1010
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
mRNA-1010
Sterile liquid for injection
Fluarix Quadrivalent
Participants will receive a single dose of Fluarix Quadrivalent by IM injection on Day 1.
Fluarix Quadrivalent
Sterile suspension for injection.
Interventions
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mRNA-1010
Sterile liquid for injection
Fluarix Quadrivalent
Sterile suspension for injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose on Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.
Exclusion Criteria
* Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the US CDC or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening visit.
* Participant is acutely ill or febrile (temperature ≥38.0℃elcius \[100.4°Fahrenheit\]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window.
* Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Reported history of congenital or acquired immunodeficiency, immunocompromising/ immunosuppressive condition, asplenia, or recurrent severe infections.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.
* Participant has received systemic immunosuppressant drugs for \>14 days in total within 180 days prior to the Screening visit (for glucocorticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, and topical steroids are allowed.
* Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
* Participant is unaware whether they have received an influenza vaccine in the previous influenza season.
* Participant received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to Day 1
* Participant has tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening visit or plans to donate blood products during the study.
50 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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North Alabama Research Center, LLC
Athens, Alabama, United States
Lenzmeier Family Medicine
Glendale, Arizona, United States
CCT Research
Phoenix, Arizona, United States
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Velocity Clinical Research, Banning
Banning, California, United States
Hope Clinical Research, LLC
Canoga Park, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Velocity Clinical Research, Chula Vista
La Mesa, California, United States
Velocity Clinical Research, San Diego
La Mesa, California, United States
Velocity Clinical Research - Westlake
Los Angeles, California, United States
Empire Clinical Research
Pomona, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Benchmark Research-Texas
Riverside, California, United States
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Women's Health Care Research Corp.
San Diego, California, United States
Acclaim Clinical Research
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Shawn K Hassler MD
San Francisco, California, United States
West Coast Research LLC
San Ramon, California, United States
Velocity Clinical Research, Denver
Denver, Colorado, United States
Arthritis & Rheumatology - Clinic of Northern Colorado
Fort Collins, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
Nature Coast Clinical Research, LLC - Crystal River
Crystal River, Florida, United States
Floridian Clinical Research
Hialeah, Florida, United States
Homestead Associates in Research,Inc
Hialeah, Florida, United States
Broward Research Group
Hollywood, Florida, United States
Citrus Cardiology Consultants
Inverness, Florida, United States
Encore Research Group-Jacksonville Center for Clinical Resea
Jacksonville, Florida, United States
Health Awareness, Inc
Jupiter, Florida, United States
Multi-Therapeutic Research Associates, Inc.
Lake City, Florida, United States
Accel Research Sites - Lakeland
Lakeland, Florida, United States
ARS - Meridien Research
Maitland, Florida, United States
South Florida Research Center, Inc.
Miami, Florida, United States
Suncoast Research Associates Trials, LLC
Miami, Florida, United States
Miami centre of clinical research
Miami, Florida, United States
Clinical Trials of Florida, LLC
Miami, Florida, United States
Global Health Research Center
Miami Lakes, Florida, United States
Innovation Medical Research Center,inc
Palmetto Bay, Florida, United States
New Tampa Health, Inc
Tampa, Florida, United States
Tekton Research, Inc.
Chamblee, Georgia, United States
Southeast Regional Research Group
Columbus, Georgia, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
In-Quest Medical Research
Norcross, Georgia, United States
Mount Vernon Clinical Research
Sandy Springs, Georgia, United States
Meridian Clinical Research - Savannah
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Velocity Clinical Research - Boise
Meridian, Idaho, United States
Great Lakes Clinical Trials LLC
Chicago, Illinois, United States
Great Lakes Clinical Trials LLC
Chicago, Illinois, United States
Great Lakes Clinical Trials LLC
Gurnee, Illinois, United States
Chicago Health Medical Group
River Forest, Illinois, United States
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, United States
Meridian Clinical Research - Dakota Dunes
Sioux City, Iowa, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, United States
Heartland Research Associates LLC
Newton, Kansas, United States
Alliance for Multispecialty Research
Wichita, Kansas, United States
Meridian Clinical Research
Baton Rouge, Louisiana, United States
MedPharmics
Covington, Louisiana, United States
Medpharmics, LLC
Metairie, Louisiana, United States
Nathan H Fischman MD LLC
New Orleans, Louisiana, United States
Privia Medical Group
Annapolis, Maryland, United States
Rockville Internal Medicine Group
Rockville, Maryland, United States
Delricht Research
Springfield, Massachusetts, United States
DM Clinical Research - Detroit
Southfield, Michigan, United States
Paul G Matherne MD
Biloxi, Mississippi, United States
DELRICHT RESEARCH at GULFPORT MEMORIAL
Gulfport, Mississippi, United States
National Medical University and Embryonic Tissues Center EmC
Springfield, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Montana Medical Research, Inc
Missoula, Montana, United States
CCT Research at Skyline Medical Center, PC
Elkhorn, Nebraska, United States
CCT Research / Methodist Physicians Clinic, Prairie Fields Family Medicine, PC
Fremont, Nebraska, United States
Meridian Clinical Research
Grand Island, Nebraska, United States
Be Well Clinical Studies, LLC
Lincoln, Nebraska, United States
Medpace, Inc. - Clinical Pharmacology Unit (CPU)
Norfolk, Nebraska, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
Papillon Research Centre
Omaha, Nebraska, United States
Meridian Clinical Research - Omaha
Omaha, Nebraska, United States
Midwest Regional Health Services, LLC/CCT Research
Omaha, Nebraska, United States
CCT Research
Las Vegas, Nevada, United States
Clinical Research Center of Nevada LLC
Las Vegas, Nevada, United States
Santa Rosa Medical Centers of Nevada/ CCT Research
Las Vegas, Nevada, United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, United States
United Medical Associates
Binghamton, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Velocity Clinical Research - Syracuse
Syracuse, New York, United States
Tryon Medical Group
Charlotte, North Carolina, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Radiant Research
Akron, Ohio, United States
Sterling Research Group
Cincinnati, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Delricht Research Tulsa
Tulsa, Oklahoma, United States
Platinum Research Network, LLC
Yukon, Oklahoma, United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, United States
Velocity Clinical Resarch - Medford
Medford, Oregon, United States
Velocity Clinical Research - Providence
Warwick, Rhode Island, United States
Velocity Clinical Research, Greenville
Anderson, South Carolina, United States
Velocity Clinical Research - Columbia
Columbia, South Carolina, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, United States
Velocity Clinical Research - Greenville
Greenville, South Carolina, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, United States
Spartanburg Regional Health Services
Spartanburg, South Carolina, United States
Black Hills Center for American Indian Health
Rapid City, South Dakota, United States
Delricht Research
Hendersonville, Tennessee, United States
Tekton Research, Inc
Austin, Texas, United States
Platinum Research Network, LLC
Beaumont, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
DM Clinical Research
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
McKinney, Texas, United States
Research Your Health
Plano, Texas, United States
Epic Medical Research, LLC
Red Oak, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
DM Clinical Research
Sugar Land, Texas, United States
Breco Research - A Tarheel Clinical Research Site
Sugar Land, Texas, United States
Cope Family Medicine
Bountiful, Utah, United States
Olympus Family Medicine/CCT Research
Holladay, Utah, United States
CenExel - JBR
Salt Lake City, Utah, United States
South Ogden Family Medicine clinic/CCT
South Ogden, Utah, United States
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, United States
Meridian Clinical Research
Portsmouth, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Lakeview Medical Center
Suffolk, Virginia, United States
MHAT Sveti Ivan Rilski
Kozloduy, , Bulgaria
MC City Clinic Sveti Georgi - Montana
Montana, , Bulgaria
MHAT "Dr. Stamen Iliev
Montana, , Bulgaria
Medical Center Medconsult Pleven
Pleven, , Bulgaria
Military Medical Academy
Sofia, , Bulgaria
SHAT of Pneumo-phthisiatric diseases - Sofia District
Sofia, , Bulgaria
Aggarwal and Associates LTD
Brampton, , Canada
Aviva Clinical Trials Group Inc
Burlington, , Canada
Hamilton Medical Research Group
Hamilton, , Canada
Okanagan Clinical Trials
Kelowna, , Canada
Centricity Research Quebec City
Lévis, , Canada
Milestone Research Inc.
London, , Canada
Yang Medicine
Ottawa, , Canada
LMC Manna
Pointe-Claire, , Canada
DIEX Research Quebec Inc.
Québec, , Canada
DIEX Research Quebec Inc.
Québec, , Canada
Alpha Recherche Clinique Inc
Québec, , Canada
Clinique de Lebourgneuf
Québec, , Canada
Clinique spécialisée en allergie - Allergy/Immunology/Asthma/Mpoc
Québec, , Canada
Diex Research Sherbrooke Inc
Québec, , Canada
Central Alberta Research Clinic
Red Deer, , Canada
Diex Recherche - Joilette - HyperCore - PPDS
Saint-Charles-Borromée, , Canada
Glencar Medical Inc.
Sarnia, , Canada
Canadian Phase Onward Inc.
Toronto, , Canada
LMC
Toronto, , Canada
Manna Research
Toronto, , Canada
Medicine Professional Corporation
Toronto, , Canada
Toronto Western Hospital
Toronto, , Canada
Diex Recherche Trois-Rivières
Trois-Rivières, , Canada
Colchester East Hants Health Authority - Colchester Regional
Truro, , Canada
Diex Recherche Victoriaville
Victoriaville, , Canada
Aarhus Universitetshospital
Århus N, , Denmark
Odense University Hospital
Odense, , Denmark
Sjællands UniHosp, Roskilde - Medicine and Infectious Diseases
Roskilde, , Denmark
Center for Clinical and Basic Research
Tallinn, , Estonia
Innomedica OÜ
Tallinn, , Estonia
Merelahe Family Doctors Centre
Tallinn, , Estonia
Clinical Research Center
Tartu, , Estonia
Berliner Centrum für Reise- und Tropenmedizin
Berlin, , Germany
Emovis GmbH
Berlin, , Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
Klinische Forschung Berlin
Berlin, , Germany
University Hospital Cologne AöR
Cologne, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Medizentrum Essen Borbeck
Essen, , Germany
IKF Pneumologie
Frankfurt, , Germany
Infektiologikum Frankfurt-Sachsenhausen
Frankfurt, , Germany
Studienzentrum Dr. Keller
Frankfurt am Main, , Germany
Clinical Research Hamburg GmbH
Hamburg, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, , Germany
Siteworks GmbH
Hanover, , Germany
Siteworks GmbH
Heidelberg, , Germany
Synexus Clinical Research GmbH
Leipzig, , Germany
Praxis Illies
Magdeburg, , Germany
Dermatologie Quist
Mainz, , Germany
Praxis Schaum
Oldenburg, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Hautarztpraxis Leitz & Kollegen
Stuttgart, , Germany
Studienzentrum Brinkum
Wardenburg, , Germany
Leids Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
Utrecht, , Netherlands
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
Centrum Medyczne AMED Oddzial w Lodzi
Lodz, , Poland
ETG Lublin
Lublin, , Poland
KO-MED Centra Kliniczne Lublin II
Lublin, , Poland
ETG Skierniewice
Skierniewice, , Poland
Centrum Innowacyjnych Terapii Sp. z o.o.
Warsaw, , Poland
Provita Centrum Medyczne Sp. z o.o.
Warsaw, , Poland
RCMed
Warsaw, , Poland
ETG Zamosc
Zamość, , Poland
KO-MED Centra Kliniczne Sp. z o.o.
Zamość, , Poland
Hospital de Antequera
Antequera, , Spain
Hospital Clinic De Barcelona
Barcelona, , Spain
Hospital Santa Creu i Sant Pau - Research institut
Barcelona, , Spain
Universitat Autonoma de Barcelona (UAB) - Institut d'Investigacio en Atencio Primaria Jordi Gol (IDIAP Jordi Gol)
Barcelona, , Spain
Hospital Alvaro Cunqueiro
Vigo, , Spain
Hospital Povisa
Vigo, , Spain
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital - division of Rheumatology - Taichung
Taichung, , Taiwan
National Cheng Kung University hospital
Tainan City, , Taiwan
National Taiwan University Hospital - Family Medicine
Taipei, , Taiwan
Taipei Medical University - Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Medical University - WanFang Hospital
Taipei, , Taiwan
Tri-Service General Hospital - Neihu Branch - Infectious Diseases
Taipei, , Taiwan
Royal United Hospital
Bath, , United Kingdom
Layton Medical Centre
Blackpool, , United Kingdom
Hull University Teaching Hospitals NHS Foundation trust
Hull, , United Kingdom
University Hospitals of Leicester-Leicester Royal Hospital
Leicester, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust - Aintree University Hospital (Fazakerley Hospital)
Liverpool, , United Kingdom
GST NHS Found
London, , United Kingdom
Newcastle University - Institute of Cellular Medicine (ICM)
Newcastle, , United Kingdom
Panthera Biopartners - Manchester - multispeciality
Rochdale, , United Kingdom
Panthera Biopartners - Sheffield - multispeciality
Rochdale, , United Kingdom
Panthera Biopartners - Preston - multispeciality
Salford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Cornwall Hospitals Trust - Respiratory
Truro, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-001638-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
mRNA-1010-P302
Identifier Type: -
Identifier Source: org_study_id
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