A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older

A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older

The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older.

Study Overview

• Status: Completed
• Conditions: Seasonal Influenza
• Intervention / Treatment: Biological: mRNA-1010; Biological: Fluarix Quadrivalent

• Study Type: Interventional
• Enrollment (Actual): 22502
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Kozloduy, Bulgaria
    • MHAT Sveti Ivan Rilski
  • Montana, Bulgaria
    • MC City Clinic Sveti Georgi - Montana
  • Montana, Bulgaria
    • MHAT "Dr. Stamen Iliev
  • Pleven, Bulgaria
    • Medical Center Medconsult Pleven
  • Sofia, Bulgaria
    • Military Medical Academy
  • Sofia, Bulgaria
    • SHAT of Pneumo-phthisiatric diseases - Sofia District
• Canada
  • Brampton, Canada
    • Aggarwal and Associates Ltd
  • Burlington, Canada
    • Aviva Clinical Trials Group Inc
  • Hamilton, Canada
    • Hamilton Medical Research Group
  • Kelowna, Canada
    • Okanagan Clinical Trials
  • Levis, Canada
    • Centricity Research Quebec City
  • London, Canada
    • Milestone Research Inc.
  • Ottawa, Canada
    • Yang Medicine
  • Pointe-Claire, Canada
    • LMC Manna
  • Quebec, Canada, G1G 3Y8
    • DIEX Research Quebec Inc.
  • Quebec, Canada, G1N 4V3
    • DIEX Research Quebec Inc.
  • Quebec, Canada
    • Alpha Recherche Clinique Inc
  • Quebec, Canada
    • Clinique de Lebourgneuf
  • Quebec, Canada
    • Clinique spécialisée en allergie - Allergy/Immunology/Asthma/Mpoc
  • Quebec, Canada
    • Diex Research Sherbrooke Inc
  • Red Deer, Canada
    • Central Alberta Research Clinic
  • Saint-Charles-Borromée, Canada
    • Diex Recherche - Joilette - HyperCore - PPDS
  • Sarnia, Canada
    • Glencar Medical Inc.
  • Toronto, Canada
    • Toronto Western Hospital
  • Toronto, Canada
    • Manna Research
  • Toronto, Canada
    • Canadian Phase Onward Inc.
  • Toronto, Canada
    • LMC
  • Toronto, Canada
    • Medicine Professional Corporation
  • Trois-Rivieres, Canada
    • Diex Recherche Trois-Rivieres
  • Truro, Canada
    • Colchester East Hants Health Authority - Colchester Regional
  • Victoriaville, Canada
    • Diex Recherche Victoriaville
• Denmark
  • Odense, Denmark
    • Odense University Hospital
  • Roskilde, Denmark
    • Sjællands UniHosp, Roskilde - Medicine and Infectious Diseases
  • Århus N, Denmark
    • Aarhus Universitetshospital
• Estonia
  • Tallinn, Estonia
    • Merelahe Family Doctors Centre
  • Tallinn, Estonia
    • Center for Clinical and Basic Research
  • Tallinn, Estonia
    • Innomedica OÜ
  • Tartu, Estonia
    • Clinical Research Center
• Germany
  • Berlin, Germany
    • emovis GmbH
  • Berlin, Germany
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany
    • Klinische Forschung Berlin
  • Berlin, Germany
    • Berliner Centrum für Reise- und Tropenmedizin
  • Dresden, Germany
    • Klinische Forschung Dresden Gmbh
  • Essen, Germany
    • Medizentrum Essen Borbeck
  • Frankfurt, Germany
    • IKF Pneumologie
  • Frankfurt, Germany
    • Infektiologikum Frankfurt-Sachsenhausen
  • Frankfurt/Main, Germany
    • Studienzentrum Dr. Keller
  • Hamburg, Germany
    • Klinische Forschung Hamburg GmbH
  • Hamburg, Germany
    • Clinical Research Hamburg GmbH
  • Hannover, Germany
    • Klinische Forschung Hannover-Mitte GmbH
  • Hannover, Germany
    • Siteworks GmbH
  • Heidelberg, Germany
    • Siteworks GmbH
  • Köln, Germany
    • University Hospital Cologne AöR
  • Leipzig, Germany
    • Synexus Clinical Research GmbH
  • Magdeburg, Germany
    • Praxis Illies
  • Mainz, Germany
    • Dermatologie Quist
  • Oldenburg, Germany
    • Praxis Schaum
  • Schwerin, Germany
    • Klinische forschung Schwerin GmbH
  • Stuttgart, Germany
    • Hautarztpraxis Leitz & Kollegen
  • Wardenburg, Germany
    • Studienzentrum Brinkum
• Netherlands
  • Leiden, Netherlands
    • Leids Universitair Medisch Centrum (LUMC)
  • Utrecht, Netherlands
    • Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
• Poland
  • Bydgoszcz, Poland
    • Centrum Medyczne PRATIA Bydgoszcz
  • Krakow, Poland
    • Centrum Medyczne Plejady
  • Kraków, Poland
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Lodz, Poland
    • Centrum Medyczne AMED oddzial w Lodzi
  • Lublin, Poland
    • ETG Lublin
  • Lublin, Poland
    • KO-MED Centra Kliniczne Lublin II
  • Skierniewice, Poland
    • ETG Skierniewice
  • Warszawa, Poland
    • Centrum Innowacyjnych Terapii Sp. z o.o.
  • Warszawa, Poland
    • Provita Centrum Medyczne Sp. z o.o.
  • Warszawa, Poland
    • RCMed
  • Zamosc, Poland
    • ETG Zamosc
  • Zamosc, Poland
    • KO-MED Centra Kliniczne Sp. z o.o.
• Spain
  • Antequera, Spain
    • Hospital de Antequera
  • Barcelona, 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)
  • Vigo, Spain
    • Hospital Alvaro Cunqueiro
  • Vigo, Spain
    • Hospital Povisa
• Taiwan
  • Kaohsiung City, Taiwan
    • Kaohsiung Veterans General Hospital
  • Taichung, Taiwan
    • China Medical University Hospital - division of Rheumatology - Taichung
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Taipei Medical University - WanFang Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital - Family Medicine
  • Taipei, Taiwan
    • Taipei Medical University - Taipei Medical University Hospital
  • Taipei, Taiwan
    • Tri-Service General Hospital - Neihu Branch - Infectious Diseases
• United Kingdom
  • Bath, United Kingdom
    • Royal United Hospital
  • Blackpool, United Kingdom
    • Layton Medical Centre
  • Hull, United Kingdom
    • Hull University Teaching Hospitals NHS Foundation trust
  • Leicester, United Kingdom
    • University Hospitals of Leicester-Leicester Royal Hospital
  • Liverpool, United Kingdom
    • Liverpool University Hospitals NHS Foundation Trust - Aintree University Hospital (Fazakerley Hospital)
  • London, United Kingdom
    • GST NHS Found
  • Newcastle, United Kingdom
    • Newcastle University - Institute of Cellular Medicine (ICM)
  • Rochdale, United Kingdom
    • Panthera Biopartners - Manchester - multispeciality
  • Rochdale, United Kingdom
    • Panthera Biopartners - Sheffield - multispeciality
  • Salford, United Kingdom
    • Panthera Biopartners - Preston - multispeciality
  • Southampton, United Kingdom
    • Southampton General Hospital
  • Truro, United Kingdom
    • Royal Cornwall Hospitals Trust - Respiratory
• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center, LLC
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Lenzmeier Family Medicine
    • Phoenix, Arizona, United States, 85044
      • CCT Research
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine/CCT Research
    • Tucson, Arizona, United States, 85712
      • Noble Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center For Clinical Research
    • Little Rock, Arkansas, United States, 72204
      • Lynn Institute of the Ozarks
  • California
    • Banning, California, United States, 92220
      • Velocity Clinical Research, Banning
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, LLC
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research, San Diego
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research, Chula Vista
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research - Westlake
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • Riverside, California, United States, 92503
      • Artemis Institute for Clinical Research
    • Riverside, California, United States, 92504-3206
      • Benchmark Research-Texas
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates (PRA)
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
    • San Diego, California, United States, 92120
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92111
      • Women's Health Care Research Corp.
    • San Francisco, California, United States, 94102-3014
      • Shawn K Hassler MD
    • San Ramon, California, United States, 94582
      • West Coast Research LLC
  • Colorado
    • Denver, Colorado, United States, 80209
      • Velocity Clinical Research, Denver
    • Fort Collins, Colorado, United States, 80528
      • Arthritis & Rheumatology - Clinic of Northern Colorado
    • Longmont, Colorado, United States, 80501
      • Longmont Medical Research Network
  • Florida
    • Crystal River, Florida, United States, 34429
      • Nature Coast Clinical Research, LLC - Crystal River
    • Hialeah, Florida, United States, 33016
      • Floridian Clinical Research
    • Hialeah, Florida, United States, 33016
      • Homestead Associates in Research,Inc
    • Hollywood, Florida, United States, 33024
      • Broward Research Group
    • Inverness, Florida, United States, 34452
      • Citrus Cardiology Consultants
    • Jacksonville, Florida, United States, 32216
      • Encore Research Group-Jacksonville Center for Clinical Resea
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc
    • Lake City, Florida, United States, 32055
      • Multi-Therapeutic Research Associates, Inc.
    • Lakeland, Florida, United States, 33805
      • Accel Research Sites - Lakeland
    • Maitland, Florida, United States, 32751
      • ARS - Meridien Research
    • Miami, Florida, United States, 33186
      • Clinical Trials of Florida, LLC
    • Miami, Florida, United States, 33135
      • South Florida Research Center, Inc.
    • Miami, Florida, United States, 33135
      • Suncoast Research Associates Trials, LLC
    • Miami, Florida, United States, 33155
      • Miami centre of clinical research
    • Miami Lakes, Florida, United States, 33016
      • Global Health Research center
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center,inc
    • Tampa, Florida, United States, 33603
      • New Tampa Health, Inc
  • Georgia
    • Chamblee, Georgia, United States, 30341
      • Tekton Research, Inc.
    • Columbus, Georgia, United States, 31904
      • Southeast Regional Research Group
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
    • Norcross, Georgia, United States, 30092-4544
      • In-Quest Medical Research
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research
    • Savannah, Georgia, United States, 31406-2675
      • Meridian Clinical Research - Savannah
    • Stockbridge, Georgia, United States, 30281-9054
      • Clinical Research Atlanta
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research - Boise
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials LLC
    • Chicago, Illinois, United States, 60625
      • Great Lakes Clinical Trials LLC
    • Gurnee, Illinois, United States, 60031
      • Great Lakes Clinical Trials LLC
    • River Forest, Illinois, United States, 60305
      • Chicago Health Medical Group
  • Indiana
    • Valparaiso, Indiana, United States, 46385
      • Velocity Clinical Research - Valparaiso
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Meridian Clinical Research - Dakota Dunes
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials (JCCT)
    • Newton, Kansas, United States, 67114-9017
      • Heartland Research Associates LLC
    • Wichita, Kansas, United States, 67207
      • Alliance for Multispecialty Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Meridian Clinical Research
    • Covington, Louisiana, United States, 70433
      • MedPharmics
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
    • New Orleans, Louisiana, United States, 70124
      • Nathan H Fischman MD LLC
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Privia Medical Group
    • Rockville, Maryland, United States, 20854-2957
      • Rockville Internal Medicine Group
  • Massachusetts
    • Springfield, Massachusetts, United States, 65807-7303
      • DelRicht Research
  • Michigan
    • Southfield, Michigan, United States, 48076
      • DM Clinical Research - Detroit
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • Paul G Matherne MD
    • Gulfport, Mississippi, United States, 39503
      • DelRicht Research at Gulfport Memorial
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
    • Springfield, Missouri, United States, 65802
      • National Medical University and Embryonic Tissues Center EmC
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research, Inc
  • Nebraska
    • Elkhorn, Nebraska, United States, 68022
      • CCT Research at Skyline Medical Center, PC
    • Fremont, Nebraska, United States, 68025-2592
      • CCT Research / Methodist Physicians Clinic, Prairie Fields Family Medicine, PC
    • Grand Island, Nebraska, United States, 68803
      • Meridian Clinical Research
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies, LLC
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research
    • Norfolk, Nebraska, United States, 68701
      • Medpace, Inc. - Clinical Pharmacology Unit (CPU)
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research - Omaha
    • Omaha, Nebraska, United States, 68130
      • Papillon Research Centre
    • Omaha, Nebraska, United States, 68144-5225
      • Midwest Regional Health Services, LLC/CCT Research
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research Center of Nevada LLC
    • Las Vegas, Nevada, United States, 89119
      • Santa Rosa Medical Centers of Nevada/ CCT Research
    • Las Vegas, Nevada, United States, 89102-1682
      • CCT Research
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials, LLC
  • New York
    • Binghamton, New York, United States, 13901-1043
      • United Medical Associates
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc
    • Syracuse, New York, United States, 13057
      • Velocity Clinical Research - Syracuse
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Tryon Medical Group
    • Fayetteville, North Carolina, United States, 28303
      • Carolina Institute for Clinical Research
    • Morehead City, North Carolina, United States, 28557
      • Diabetes & Endocrinology Consultants
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research
    • Cincinnati, Ohio, United States, 45227
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research - Cincinnati
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Tulsa, Oklahoma, United States, 74133
      • Delricht Research Tulsa
    • Yukon, Oklahoma, United States, 73099
      • Platinum Research Network, LLC
  • Oregon
    • Grants Pass, Oregon, United States, 97520
      • Velocity Clinical Research - Grants Pass
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Resarch - Medford
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Velocity Clinical Research - Providence
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Velocity Clinical Research, Greenville
    • Columbia, South Carolina, United States, 29204
      • Velocity Clinical Research - Columbia
    • Gaffney, South Carolina, United States, 29340
      • Velocity Clinical Research, Gaffney
    • Greenville, South Carolina, United States, 29615
      • Velocity Clinical Research - Greenville
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Health Specialists
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Health Services
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Center for American Indian Health
  • Tennessee
    • Hendersonville, Tennessee, United States, 37075
      • DelRicht Research
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc
    • Beaumont, Texas, United States, 77706
      • Platinum Research Network, LLC
    • Dallas, Texas, United States, 75230-2505
      • Zenos Clinical Research
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
    • Houston, Texas, United States, 77065
      • DM Clinical Research
    • McKinney, Texas, United States, 75070
      • Delricht Research At Zomnir Family Medicine
    • Plano, Texas, United States, 75093
      • Research Your Health
    • Red Oak, Texas, United States, 75154
      • Epic Medical Research, LLC
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc
    • Sugar Land, Texas, United States, 77478
      • DM Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Breco Research - A Tarheel Clinical Research Site
  • Utah
    • Bountiful, Utah, United States, 84010
      • Cope Family Medicine
    • Holladay, Utah, United States, 84117
      • Olympus Family Medicine/CCT Research
    • Salt Lake City, Utah, United States, 84107
      • CenExel - JBR
    • South Ogden, Utah, United States, 84405-4869
      • South Ogden Family Medicine clinic/CCT
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research - Salt Lake City
  • Virginia
    • Portsmouth, Virginia, United States, 23703-3200
      • Meridian Clinical Research
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC
    • Suffolk, Virginia, United States, 23435
      • Lakeview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow-up, including all procedures.

  • 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 with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to the Screening visit.
• 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.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1010; Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.	Biological: mRNA-1010; Sterile liquid for injection; Other Names: Seasonal influenza vaccine
Active Comparator: Fluarix Quadrivalent; Participants will receive a single dose of Fluarix Quadrivalent by IM injection on Day 1.	Biological: Fluarix Quadrivalent; Sterile suspension for injection.; Other Names: Licensed quadrivalent inactivated seasonal influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)	Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.	7 days post-vaccination
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation	An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 361) are reported in this outcome measure.	Day 1 through Day 361 (Month 12)
Number of Participants With Unsolicited Adverse Events (AEs)	An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.	Up to 28 days post-vaccination
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine	Protocol-defined ILI: The presence of body temperature ≥37.5 degrees celsius (°C) (≥99.5 degrees fahrenheit [°F]), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive Reverse Transcription Polymerase Chain Reaction (RT-PCR) for influenza.	14 days post-vaccination through Day 181 (Month 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29		Day 29
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains With Similarity to Those Selected for the Seasonal Vaccine	Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza.	14 days post-vaccination through Day 181 (Month 6)
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains Antigenically Matched to the Vaccine Strains Selected for the Seasonal Vaccine	Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza.	14 days post-vaccination through Day 181 (Month 6)
Number of Participants With First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains	CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.	14 days post-vaccination through Day 181 (Month 6)
Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains With Similarity to Vaccine Strains	CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.	14 days post-vaccination through Day 181 (Month 6)
Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains That Were Antigenically Matched to Vaccine Strains	CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.	14 days post-vaccination through Day 181 (Month 6)
Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine	Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza.	14 days post-vaccination through Day 181 (Month 6)
Number of Participants With First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine	CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.	14 days post-vaccination through Day 181 (Month 6)
Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine	Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza.	14 days post-vaccination through Day 181 (Month 6)
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains	Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% confidence interval (CI) was calculated based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.	Day 29
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains	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.	Day 29
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains	The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.	Baseline, Day 29

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Moderna; Flu; mRNA vaccine; mRNA-1010
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: mRNA-1010-P302; 2022-001638-12 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No