Seasonal InfluenzaPhase 3NCT06602024
A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age
A Phase 3 study testing mRNA-1010, Fluarix® and Influsplit® Tetra in people with Seasonal Influenza, run by ModernaTX, Inc. at 301 sites in 11 countries.
Trial summary
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- mRNA-1010, Fluarix® and Influsplit® Tetra
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,805 participants
- Where
- 301 sitesin 11 countries
- Study dates
- 16 Sep 2024to 21 Aug 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Participants who are assigned female at birth or can become pregnant are eligible to participate if:
- The participant is a person of nonchildbearing potential (PONCBP) or
- The participant is a person of childbearing potential (POCBP) who:
- Is not breast/chest feeding.
- Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline).
- Has a negative highly sensitive pregnancy test (urine or serum as required by local regulation or institutional review board [IRB]/independent ethics committee [IEC]) at the Screening Visit and before study intervention (if the Day 1 [Baseline] Visit is not on the same day as the Screening Visit).
Who cannot join
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4° Fahrenheit [F]]) within 72 hours prior to Day 1 (Baseline).
- Close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®/oseltamivir) within 5 days prior to Day 1 (Baseline).
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
- Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline).
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
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- Malignancy within 2 years prior to Day 1 (Baseline) (adequately treated basal cell carcinoma and squamous cell carcinoma are allowed).
- Received corticosteroids at ≥10 milligram (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
- Treated with antiviral therapies for influenza (for example, Tamiflu) within 180 days prior to Day 1 (Baseline).
- Received any vaccine authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
- Received a licensed seasonal influenza vaccine within 180 days prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
- Received an investigational seasonal influenza vaccine within 1 year prior to Day 1 (Baseline). Note: participants from mRNA-1010-P304 Season 1 are NOT eligible to re enroll into Season 2.
- Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline) based on the medical history interview or plans to do so while participating in this study.
- Is working or has worked as study personnel or is an immediate family member or house member of study personnel, study staff, or Sponsor personnel.
Trial locations and contacts
301 sites in 11 countries.
301 sites in 11 countries
United States188 sites
JAVARA
Albany, Georgia, 31707
DM Clinical Research-Albuquerque
Albuquerque, New Mexico, 87106
AXCES Research Group - Sante Fe
Albuquerque, New Mexico, 87109
Javara
Alexandria, Virginia, 22311
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
Privia Medical Group
Annapolis, Maryland, 21401
Pinnacle Research Group, Llc
Anniston, Alabama, 36207
Asheville Clinical Research
Asheville, North Carolina, 28803
North Alabama Research Center, LLC
Athens, Alabama, 35611
JEM Research Institue
Atlantis, Florida, 33462
Alliance for Multispecialty Research
Augusta, Kansas, 67010
Avant Reseach Associates
Austin, Texas, 78745
Tekton Research, Inc
Austin, Texas, 78745
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809
Tekton Research, LLC
Beaumont, Texas, 78705
Velocity Clinical Research - Binghamton
Binghamton, New York, 13905
Flourish Research
Birmingham, Alabama, 35209
EmVenio Research Brimingham, AL
Birmingham, Alabama, 35210
Bingham Memorial Hospital
Blackfoot, Idaho, 83221
DM Clinical Research - Brookline
Brookline, Massachusetts, 02446
DM Clinical
Brooklyn, New York, 11220
Headlands Research Brownsville
Brownsville, Texas, 78526
RCR Buffalo
Buffalo, New York, 14217
DelRicht Research
Charleston, South Carolina, 29407
Charleston Clinical Trials, LLC
Charleston, South Carolina, 29414
DelRicht Research, LLC
Charlotte, North Carolina, 28205
M3 Wake Research/ClinSearch, LLC
Chattanooga, Tennessee, 37421
Clinical Research Professionals
Chesterfield, Missouri, 63005
EmVenio Research
Chicago, Illinois, 60608
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Community Research
Cincinnati, Ohio, 45212
Velocity Clinical Research-Mt. Auburn
Cincinnati, Ohio, 45219
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242
Benchmark Research - Colton
Colton, California, 92324
Velocity Clinical Research, Spartanburg
Columbia, South Carolina, 29204
IACT Health
Columbus, Georgia, 31904
Centricity Research Columbus
Columbus, Ohio, 43213
The Corvallis Clinic
Corvallis, Oregon, 97330
Flourish Research
Covina, California, 91723
Nature Coast Clinical Research, LLC - Crystal River
Crystal River, Florida, 34429
Cullman Clinical Trials
Cullman, Alabama, 35055
Midwest Clinical Research Center
Dayton, Ohio, 45417
CenExel iResearch , LLC
Decatur, Georgia, 30030
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
Tekton Research, Inc - Edmond
Edmond, Oklahoma, 73013
3A Research, LLC
El Paso, Texas, 79225
Tekton Research - Fort Collins
Fort Collins, Colorado, 80525
Helios
Fort Worth, Texas, 76104
Benchmark Research
Fort Worth, Texas, 76135
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, 20877
Lenzmeier Family Medicine
Glendale, Arizona, 85308
Velocity Clinical Research-Grand Island
Grand Island, Nebraska, 68803
DELRICHT RESEARCH at GULFPORT MEMORIAL
Gulfport, Mississippi, 39503
Velocity Clinical Research-Hampton
Hampton, Virginia, 23666-5843
IMA Clinical Research
Hartsdale, New York, 10530
Henderson Clinical Trials
Henderson, Nevada, 89052
Homestead Associates in Research,Inc
Hialeah, Florida, 33016
CenExel RCA
Hollywood, Florida, 33024
East-West Medical Research Institute
Honolulu, Hawaii, 96814-4526
Helios Clinical Research
Houston, Texas, 77008-1374
DM Clinical Research - CyFair
Houston, Texas, 77065
DM Clinical Research- Bellaire
Houston, Texas, 77081
Velocity Clinical Research - Huntington Park
Huntington Park, California, 90255
Optimal Research
Huntsville, Alabama, 35802
Nature Coast Clinical Research, LLC - Inverness
Inverness, Florida, 34452
Helios Clinical Research
Jackson, Tennessee, 38305
Westside Center for Clinical Research
Jacksonville, Florida, 32205-4785
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
DM Clinical Research - New Jersey
Jersey City, New Jersey, 07306
MultiSpeciality Clinical Research
Johnson City, Tennessee, 37601
Health Awareness INC
Jupiter, Florida, 33458
Helios CR, Inc. Keller Tx
Keller, Texas, 76248
Velocity Clinical Research, San Diego
La Mesa, California, 91942
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508
M3 Wake Research/MSRA,LLC
Lake City, Florida, 32055
Accel Clinical Research
Lake Mary, Florida, 32746
M3 Wake Research/CRCN, LLC
Las Vegas, Nevada, 89106
Office of Michael B. Jacobs, MD
Las Vegas, Nevada, 89119
Clinical Site Partners - Leesburg
Leesburg, Florida, 34748
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219-1376
Platinum Research Network, LLC
Lincoln, Nebraska, 68510
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Long Beach Research Institute LLC
Long Beach, California, 90805
Tekton Research, Inc - Longmont Center
Longmont, Colorado, 80501
Velocity Clinical Research - Westlake
Los Angeles, California, 90057
ARS - Meridien Research
Maitland, Florida, 32751
K2 medical research
Maitland, Florida, 32751
DM Clinical Research- River Forest
Melrose Park, Illinois, 60160
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
South Florida Research Center, Inc.
Miami, Florida, 33135
Miami Clinical Research
Miami, Florida, 33155
Suncoast Research Associates, LLC
Miami, Florida, 33173
Floridian Clinical Research
Miami Lakes, Florida, 33016
Boeson Research MSO
Missoula, Montana, 59804
Elias Research Associates
Missoula, Montana, 59808
Velocity Clinical Research
Mobile, Alabama, 36608
IMA Clinical Research Monroe
Monroe, Louisiana, 71201
Lucas Research
Morehead City, North Carolina, 23730
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572
DelRicht Research
New Orleans, Louisiana, 70115
Velocity Clinical Research
New Orleans, Louisiana, 70119
IMA Research
New York, New York, 10036
M3 Wake Research/PRI, LLC
Newport Beach, California, 92660
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606-4537
Velocity Clinical Research-Norfolk
Norfolk, Nebraska, 68701
Carbon Health North Hollywood
North Hollywood, California, 91606
Valley Clinical Trials, Inc.
Northridge, California, 91325
Velocity Clinical Research-Omaha
Omaha, Nebraska, 68134
Headlands Research
Orlando, Florida, 32819
DelRicht Research - Overland Park
Overland Park, Kansas, 66209
Suncoast Research Associates
Pembroke Pines, Florida, 33024
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
DM Clinical Research
Phoenix, Arizona, 85012
Helios Clinical Research
Phoenix, Arizona, 85028
Research Your Health
Plano, Texas, 75093
Health Awareness INC
Port Saint Lucie, Florida, 34952
Summit Research
Portland, Oregon, 97210
Velocity Clinical Research-Portsmouth
Portsmouth, Virginia, 23702
DelRicht Research @ Neighborhood Health
Prairieville, Louisiana, 70769-4212
DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
Prosper, Texas, 75078
Velocity Clinical Research - Providence
Providence, Rhode Island, 02886
Eximia Clinical Research
Raleigh, North Carolina, 27607
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Black Hills Center for American Indian Health
Rapid City, South Dakota, 57701
Paradigm Research
Redding, California, 96001
Clinical Research Partners, LLC
Richmond, Virginia, 23226
Artemis Institute for Clinical Research
Riverside, California, 92503
Rochester Clinical Research, Inc
Rochester, New York, 14609
Matthew Mintz Clinic
Rockville, Maryland, 20852
Velocity Clinical Research - Covington
Rockville, Maryland, 20854
Woodland Research
Rogers, Arkansas, 72758
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, 90274
Accellacare US Inc.
Salisbury, North Carolina, 28144
Synexus Clinical Research US, Inc.
Salt Lake City, Utah, 84106
CenExel - JBR
Salt Lake City, Utah, 84107
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc.
Salt Lake City, Utah, 84121
DM Clinical Research
San Antonio, Texas, 78207
IMA Clinical Research
San Antonio, Texas, 78229
Tekton Research Inc - San Antonio
San Antonio, Texas, 78229
Velocity Clinical Research - Banning
San Bernardino, California, 92408
Artemis Institute for Clinical Research - Research Site
San Diego, California, 92103
WHCR- M3 Wake Research
San Diego, California, 92111
Wr-McCr, Llc
San Diego, California, 92120
San Marcos Family Medicine
San Marcos, Texas, 78666
Velocity Clinical Research
Santa Ana, California, 92704
CenExel iResearch Savannah
Savannah, Georgia, 31405
Velocity Clinical Research-Savannah
Savannah, Georgia, 31406-2675
Javara - Privia Medical Group Georgia, LLC
Savannah, Georgia, 31406
Velocity Clinical Research-Sioux City
Sioux City, Iowa, 51106
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan, Utah, 84095
Headlands Research - Detroit
Southfield, Michigan, 48034
Great Lakes Research Institute
Southfield, Michigan, 48075-5400
DM Clinical Research
Southfield, Michigan, 48076
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Velocity Clinical Research- Spokane
Spokane, Washington, 99218
Clinvest
Springfield, Missouri, 65807
Delricht Research
Springfield, Missouri, 65807
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
IMA Clinical Research Warren
St. Petersburg, Florida, 33704
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Stephenville Medical & Surgical Clinic, PA
Stephenville, Texas, 76401
Clinical Research Atlanta/Headlands
Stockbridge, Georgia, 30281
Breco Research - A Tarheel Clinical Research Site
Sugar Land, Texas, 77478
DM Clinical Research - Sugarland
Sugar Land, Texas, 77478
Forward Clinical Trials - Dermatology
Tampa, Florida, 33613
Fiel Family and Sports Medicine
Tempe, Arizona, 85283
DM Clinical Research - Tomball
Tomball, Texas, 77375
DM Clinical Research
Tomball, Texas, 77375
Delricht
Town and Country, Missouri, 63017
Arizona Liver Health
Tucson, Arizona, 85711
Delricht Tate
Tulsa, Oklahoma, 74133
Velocity Clinical Research- UNION
Union, South Carolina, 29379
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383
Velocity Clinical Research-Vestal
Vestal, New York, 13850
Diablo Clinical Research
Walnut Creek, California, 94598
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Confluence Health
Wenatchee, Washington, 98801
AMR
Wichita, Kansas, 67207
Accellacare Research Wilmington
Wilmington, North Carolina, 28401
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
Amherst Family Practice
Winchester, Virginia, 22601
Javara - Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Clinical Site Partners, LLC
Winter Park, Florida, 32789
Tekton Research, Inc - Yukon Location
Yukon, Oklahoma, 73099
United Kingdom28 sites
Panthera Biopartners site - York
Acomb, York
FutureMeds Birmingham
Birmingham
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Layton Medical Centre
Blackpool
Lakeside Healthcare
Corby
NHS Lothian - Western General Hospital
Edinburgh
Panthera Biopartners site - Enfield
Enfield
Royal Devon University Healthcare NHS Foundation Trust
Exeter
FutureMeds - Glasgow
Glasgow
Glasgow Panthera Biopartners Site
Glasgow
Barts Health NHS Trust - Mile End Hospital
London
Chelsea and Westminster Hospital NHS Foundation Trust
London
Guy's and St Thomas's NHS Foundation Trust
London
HMC Research Group
London
St George's University Hospitals (NHS Foundation Trust)
London
Velocity Clinical Research - North London
London
Manchester University NHS Foundation Trust
Manchester
FutureMeds Wirral
Metropolitan Borough of Wirral
Infectious Diseases Research - Clinical Research Facility
Newcastle upon Tyne
Norfolk nand Norwich University Hospital
Norwich
University of Nottingham Health Service
Nottingham
Wansford Research Limited
Peterborough
University Hospitals Plymouth NHS Trust
Plymouth
Portsmouth Hospitals University NHS Trust - Portsmouth Research Hub
Portsmouth
Panthera Biopartners - Manchester
Rochdale
Sheffield Panthera Biopartners Site
Sheffield
Southampton General Hospital
Southampton
Future Meds - Teesside
Stockton-on-Tees
Germany21 sites
Emovis GmbH
Berlin
Klinische Forschung Berlin-Mitte GmbH
Berlin
Velocity Clinical Research Berlin, GmbH
Berlin
Praxis Rinke
Bochum
Klinische Forschung Dresden GmbH
Dresden
Medizentrum Essen Borbeck
Essen
IKF Pneumologie
Frankfurt
Infektio Research GmbH & Co.KG
Frankfurt
Klinische Forschung Hamburg GmbH
Hamburg
Velocity Clincial Research Hamburg GmbH
Hamburg
Klinische Forschung Hannover Mitte GmbH
Hanover
Klinische Forschung Karlsruhe
Karlsruhe
SMO.MD
Magdeburg
Dermatologie Quist BAG Dres. Med. Quist Part G
Mainz
CDG Studienambulanz
München
Future meds Offenbach
Offenbach
Red-Institut
Oldenburg
Klinische Forschung Schwerin GmbH
Schwerin
Studienzentrum Brinkum
Stuhr
Hautarztpraxis Leitz & Kollegen
Stuttgart
Velocity Clinical Research Wiesbaden
Wiesbaden
Bulgaria16 sites
Medical center "Dr. Staykov" Ltd.
Burgas
MHAT "Sveti Ivan Rilski"
Kozloduy
Medical Center Medconsult Pleven, Lovech branch
Lovech
Medical Center Hera - Montana branch
Montana
MHAT "Dr. Stamen Iliev"
Montana
Medical Center Medconsult Pleven
Pleven
AIPPMP Dr. Levena Kireva
Plovdiv
MHAT "Sv. Panteleymon" Ltd.
Plovdiv
DCC-1 Sliven Lts.
Sliven
MHAT Sliven to MMA Sofia
Sliven
Diagnostic & Consultancy Center Ascendent, Sofia
Sofia
Medical Center "Hera" EOOD
Sofia
Medical Center Excelsior - Base 2
Sofia
Medical Center Excelsior OOD, Base1
Sofia
Medical Centre "Sirtuin" Ltd
Sofia
AIPPMP D-r Zhaneta Demireva Ltd.
Stamboliyski
Canada15 sites
Aviva Medical Diagnostics and Specialists Clinic and Heart & Vascular Centre
Burlington
CARe Clinic, Calgary, AB
Calgary
Centricity Research Quebec City
Lévis
Milestone Research Inc.
London
Red Maple Trials
Ottawa
Centricity Research Pointe-Claire
Pointe-Claire
Clinique de Lebourgneuf
Québec
CARe , Red Deer, AB.
Red Deer
Bluewater Clinical Research Group Inc.
Sarnia
Stouffville Medical Research Institute
Stouffville
Canadian Phase Onward Inc.
Toronto
Centricity Research Toronto LMC
Toronto
Diex Recherche
Trois-Rivières
Colchester Research Group
Truro
Diex Recherche Victoriaville
Victoriaville
South Korea9 sites
Korea University Ansan Hospital
Ansan-si
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Chungnam National University Hospital
Daejeon
Inha University Hospital
Incheon
Hallym University Kangnam Sacred Heart Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Ajou University Hospital
Suwon
Yonsei University, Wonju Severance Christian Hospital
Wŏnju
Georgia6 sites
Unimed Adjara Ltd - Batumi Referral Hospital
Batumi
LTD "Hospital service"
Kutaisi
LTD Clinic Rustavi
Rustavi
Emergency Cardiology Center named by acad. G. Chapidze
Tbilisi
Eristavi National Center of Experimental and Clinical Surgery
Tbilisi
LTD Israel-Georgian Medical Research Clinic Helsicore
Tbilisi
Estonia5 sites
Vee Family Doctors' Center
Paide, 6
Center of Clinical and Basic Research
Tallinn, 4
Merelahe Family Doctors Centre
Tallinn, 68A
Innomedica OU
Tallinn, 7
Clinical Research Center
Tartu, 54
Finland5 sites
FVR - Finnish Vaccine Research Ltd - Espoo
Espoo
FVR - Finnish Vaccine Research Ltd - Kokkola
Kokkola
FVR - Finnish Vaccine Research Ltd - Oulu
Oulu
FVR - Finnish Vaccine Research Ltd - Tampere
Tampere
FVR - Finnish Vaccine Research Ltd - Järvenpää
Turku
Belgium4 sites
Anima Research Center
Alken, 3570
Universitair Ziekenhuis Gent
Ghent, 10 - 9000
AZ Sint Maarten
Mechelen, 435 2800
University of Antwerpen - Vaccinopolis
Wilrijk, 663 2650
Taiwan4 sites
Kaohsiung Veterans General Hospital
Kaohsuing City
China Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan City
About this study
Official title: A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.
- Conditions
- Seasonal Influenza
- Being tested
- mRNA-1010, Fluarix®, Influsplit® Tetra, Fluarix Tetra, Alpharix® Tetra
- Keywords
- Seasonal Influenza, Flu, mRNA-1010, Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1010Biological
Intramuscular (IM) injection
Fluarix®Biological
IM injection
Influsplit® TetraBiological
IM injection
Fluarix TetraBiological
IM injection
Alpharix® TetraBiological
IM injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1010 | Experimental | Participants will receive a single injection of mRNA-1010 on Day 1. Receives: Biological: mRNA-1010 |
| Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra | Active comparator | Participants will receive a single injection of active comparator trivalent influenza vaccine (TIV) or quadrivalent influenza vaccine (QIV) (Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra) on Day 1. Receives: Biological: Fluarix®; Biological: Influsplit® Tetra; Biological: Fluarix Tetra; Biological: Alpharix® Tetra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
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.
Measured: Day 1 up to Day 7
Number of Participants With Unsolicited Adverse Events (AEs)
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.
Measured: 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)
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.
Measured: 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
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).
Measured: Day 14 up to end of influenza season (up to 7.5 months)
Secondary outcomes (6)
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
Modified CDC-defined ILI: Body temperature ≥37.2°C (≥99.0°F) accompanied by cough and/or sore throat.
Measured: 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
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.
Measured: Day 14 up to end of influenza season (up to 7.5 months)
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI)
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.
Measured: Day 29
Number of Participants Reaching Seroconversion as Measured by HAI
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.
Measured: Day 29
Number of Participants With an HAI Titer ≥1:40
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
Measured: Day 29
Geometric Mean Fold Rise (GMFR) of HAI Titers
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.
Measured: Baseline, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2024
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40,805 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602024
- Sponsor's protocol ID
- mRNA-1010-P304
- Other IDs
- 2024-516240-26-00
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2024
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Leroux-Roels I, Huang G, Ferguson M, Kohli A, Clark R, Bickel M, Soens M, Du E, Pucci A, Hicks B, Eschen C, Das R, Wilson E; Fluent Trial Investigators. Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults. N Engl J Med. 2026 May 7;394(18):1803-1813. doi: 10.1056/NEJMoa2516491.
PubMed 42090792