AzTrials
AzTrials

Seasonal InfluenzaPhase 3NCT05566639

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

A Phase 3 study testing mRNA-1010 and Fluarix Quadrivalent in people with Seasonal Influenza, run by ModernaTX, Inc. at 233 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. 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 and Fluarix Quadrivalent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22,502 participants
Where
233 sitesin 11 countries
Study dates
14 Sep 2022to 5 Jan 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

233 sites in 11 countries.

233 sites in 11 countries

United States134 sites

  • Radiant Research

    Akron, Ohio, 44311

  • Velocity Clinical Research, Greenville

    Anderson, South Carolina, 29621

  • Privia Medical Group

    Annapolis, Maryland, 21401

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Tekton Research, Inc

    Austin, Texas, 78745

  • Velocity Clinical Research, Banning

    Banning, California, 92220

  • Meridian Clinical Research

    Baton Rouge, Louisiana, 70809

  • Platinum Research Network, LLC

    Beaumont, Texas, 77706

  • Paul G Matherne MD

    Biloxi, Mississippi, 39531

  • United Medical Associates

    Binghamton, New York, 13901-1043

  • Cope Family Medicine

    Bountiful, Utah, 84010

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303

  • Tekton Research, Inc.

    Chamblee, Georgia, 30341

  • Tryon Medical Group

    Charlotte, North Carolina, 28210

  • Great Lakes Clinical Trials LLC

    Chicago, Illinois, 60625

  • Great Lakes Clinical Trials LLC

    Chicago, Illinois, 60640

  • Sterling Research Group

    Cincinnati, Ohio, 45219

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45227

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45242

  • Velocity Clinical Research - Columbia

    Columbia, South Carolina, 29204

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • MedPharmics

    Covington, Louisiana, 70433

  • Nature Coast Clinical Research, LLC - Crystal River

    Crystal River, Florida, 34429

  • Zenos Clinical Research

    Dallas, Texas, 75230-2505

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Velocity Clinical Research, Denver

    Denver, Colorado, 80209

  • CCT Research at Skyline Medical Center, PC

    Elkhorn, Nebraska, 68022

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28303

  • Arthritis & Rheumatology - Clinic of Northern Colorado

    Fort Collins, Colorado, 80528

  • Benchmark Research

    Fort Worth, Texas, 76135

  • CCT Research / Methodist Physicians Clinic, Prairie Fields Family Medicine, PC

    Fremont, Nebraska, 68025-2592

  • Velocity Clinical Research, Gaffney

    Gaffney, South Carolina, 29340

  • Lenzmeier Family Medicine

    Glendale, Arizona, 85308

  • Meridian Clinical Research

    Grand Island, Nebraska, 68803

  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon, 97520

  • Velocity Clinical Research - Greenville

    Greenville, South Carolina, 29615

  • DELRICHT RESEARCH at GULFPORT MEMORIAL

    Gulfport, Mississippi, 39503

  • Great Lakes Clinical Trials LLC

    Gurnee, Illinois, 60031

  • Delricht Research

    Hendersonville, Tennessee, 37075

  • Floridian Clinical Research

    Hialeah, Florida, 33016

  • Homestead Associates in Research,Inc

    Hialeah, Florida, 33016

  • Olympus Family Medicine/CCT Research

    Holladay, Utah, 84117

  • Broward Research Group

    Hollywood, Florida, 33024

  • DM Clinical Research

    Houston, Texas, 77065

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Citrus Cardiology Consultants

    Inverness, Florida, 34452

  • Encore Research Group-Jacksonville Center for Clinical Resea

    Jacksonville, Florida, 32216

  • Health Awareness, Inc

    Jupiter, Florida, 33458

  • Velocity Clinical Research, Chula Vista

    La Mesa, California, 91942

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942

  • Multi-Therapeutic Research Associates, Inc.

    Lake City, Florida, 32055

  • Accel Research Sites - Lakeland

    Lakeland, Florida, 33805

  • CCT Research

    Las Vegas, Nevada, 89102-1682

  • Clinical Research Center of Nevada LLC

    Las Vegas, Nevada, 89104

  • Santa Rosa Medical Centers of Nevada/ CCT Research

    Las Vegas, Nevada, 89119

  • Johnson County Clin-Trials (JCCT)

    Lenexa, Kansas, 66219

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska, 68516

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Longmont Medical Research Network

    Longmont, Colorado, 80501

  • Velocity Clinical Research - Westlake

    Los Angeles, California, 90057

  • ARS - Meridien Research

    Maitland, Florida, 32751

  • DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE

    McKinney, Texas, 75070

  • Velocity Clinical Resarch - Medford

    Medford, Oregon, 97504

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642

  • Medpharmics, LLC

    Metairie, Louisiana, 70006

  • South Florida Research Center, Inc.

    Miami, Florida, 33135

  • Suncoast Research Associates Trials, LLC

    Miami, Florida, 33135

  • Miami centre of clinical research

    Miami, Florida, 33155

  • Clinical Trials of Florida, LLC

    Miami, Florida, 33186

  • Global Health Research Center

    Miami Lakes, Florida, 33016

  • Montana Medical Research, Inc

    Missoula, Montana, 59808

  • Diabetes & Endocrinology Consultants

    Morehead City, North Carolina, 28557

  • Carolina Health Specialists

    Myrtle Beach, South Carolina, 29572

  • Nathan H Fischman MD LLC

    New Orleans, Louisiana, 70124

  • Heartland Research Associates LLC

    Newton, Kansas, 67114-9017

  • In-Quest Medical Research

    Norcross, Georgia, 30092-4544

  • Medpace, Inc. - Clinical Pharmacology Unit (CPU)

    Norfolk, Nebraska, 68701

  • Meridian Clinical Research

    Norfolk, Nebraska, 68701

  • Las Vegas Clinical Trials, LLC

    North Las Vegas, Nevada, 89030

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Papillon Research Centre

    Omaha, Nebraska, 68130

  • Meridian Clinical Research - Omaha

    Omaha, Nebraska, 68134

  • Midwest Regional Health Services, LLC/CCT Research

    Omaha, Nebraska, 68144-5225

  • Innovation Medical Research Center,inc

    Palmetto Bay, Florida, 33157

  • CCT Research

    Phoenix, Arizona, 85044

  • Research Your Health

    Plano, Texas, 75093

  • Empire Clinical Research

    Pomona, California, 91767

  • Meridian Clinical Research

    Portsmouth, Virginia, 23703-3200

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612

  • Black Hills Center for American Indian Health

    Rapid City, South Dakota, 57701

  • Epic Medical Research, LLC

    Red Oak, Texas, 75154

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • Chicago Health Medical Group

    River Forest, Illinois, 60305

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Benchmark Research-Texas

    Riverside, California, 92504-3206

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609

  • Rockville Internal Medicine Group

    Rockville, Maryland, 20854-2957

  • Peninsula Research Associates (PRA)

    Rolling Hills Estates, California, 90274

  • CenExel - JBR

    Salt Lake City, Utah, 84107

  • Clinical Trials of Texas, Inc

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Women's Health Care Research Corp.

    San Diego, California, 92111

  • Acclaim Clinical Research

    San Diego, California, 92120

  • Medical Center for Clinical Research

    San Diego, California, 92120

  • Shawn K Hassler MD

    San Francisco, California, 94102-3014

  • West Coast Research LLC

    San Ramon, California, 94582

  • Mount Vernon Clinical Research

    Sandy Springs, Georgia, 30328

  • Meridian Clinical Research - Savannah

    Savannah, Georgia, 31406-2675

  • Meridian Clinical Research - Dakota Dunes

    Sioux City, Iowa, 51106

  • South Ogden Family Medicine clinic/CCT

    South Ogden, Utah, 84405-4869

  • DM Clinical Research - Detroit

    Southfield, Michigan, 48076

  • Spartanburg Regional Health Services

    Spartanburg, South Carolina, 29303

  • Delricht Research

    Springfield, Massachusetts, 65807-7303

  • National Medical University and Embryonic Tissues Center EmC

    Springfield, Missouri, 65802

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281-9054

  • Lakeview Medical Center

    Suffolk, Virginia, 23435

  • DM Clinical Research

    Sugar Land, Texas, 77478

  • Breco Research - A Tarheel Clinical Research Site

    Sugar Land, Texas, 77479

  • Velocity Clinical Research - Syracuse

    Syracuse, New York, 13057

  • New Tampa Health, Inc

    Tampa, Florida, 33603

  • Fiel Family and Sports Medicine/CCT Research

    Tempe, Arizona, 85283

  • Noble Clinical Research

    Tucson, Arizona, 85712

  • Delricht Research Tulsa

    Tulsa, Oklahoma, 74133

  • Velocity Clinical Research - Valparaiso

    Valparaiso, Indiana, 46385

  • Velocity Clinical Research - Providence

    Warwick, Rhode Island, 02886

  • Velocity Clinical Research - Salt Lake City

    West Jordan, Utah, 84088

  • Alliance for Multispecialty Research

    Wichita, Kansas, 67207

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Trial Management Associates

    Wilmington, North Carolina, 28403

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • Platinum Research Network, LLC

    Yukon, Oklahoma, 73099

Other trials in United States

Canada25 sites

  • Aggarwal and Associates LTD

    Brampton

  • Aviva Clinical Trials Group Inc

    Burlington

  • Hamilton Medical Research Group

    Hamilton

  • Okanagan Clinical Trials

    Kelowna

  • Centricity Research Quebec City

    Lévis

  • Milestone Research Inc.

    London

  • Yang Medicine

    Ottawa

  • LMC Manna

    Pointe-Claire

  • DIEX Research Quebec Inc.

    Québec, G1G 3Y8

  • DIEX Research Quebec Inc.

    Québec, G1N 4V3

  • Alpha Recherche Clinique Inc

    Québec

  • Clinique de Lebourgneuf

    Québec

  • Clinique spécialisée en allergie - Allergy/Immunology/Asthma/Mpoc

    Québec

  • Diex Research Sherbrooke Inc

    Québec

  • Central Alberta Research Clinic

    Red Deer

  • Diex Recherche - Joilette - HyperCore - PPDS

    Saint-Charles-Borromée

  • Glencar Medical Inc.

    Sarnia

  • Canadian Phase Onward Inc.

    Toronto

  • LMC

    Toronto

  • Manna Research

    Toronto

  • Medicine Professional Corporation

    Toronto

  • Toronto Western Hospital

    Toronto

  • Diex Recherche Trois-Rivières

    Trois-Rivières

  • Colchester East Hants Health Authority - Colchester Regional

    Truro

  • Diex Recherche Victoriaville

    Victoriaville

Other trials in Canada

Germany22 sites

  • Berliner Centrum für Reise- und Tropenmedizin

    Berlin

  • Emovis GmbH

    Berlin

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin

  • Klinische Forschung Berlin

    Berlin

  • University Hospital Cologne AöR

    Cologne

  • Klinische Forschung Dresden GmbH

    Dresden

  • Medizentrum Essen Borbeck

    Essen

  • IKF Pneumologie

    Frankfurt

  • Infektiologikum Frankfurt-Sachsenhausen

    Frankfurt

  • Studienzentrum Dr. Keller

    Frankfurt am Main

  • Clinical Research Hamburg GmbH

    Hamburg

  • Klinische Forschung Hamburg GmbH

    Hamburg

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover

  • Siteworks GmbH

    Hanover

  • Siteworks GmbH

    Heidelberg

  • Synexus Clinical Research GmbH

    Leipzig

  • Praxis Illies

    Magdeburg

  • Dermatologie Quist

    Mainz

  • Praxis Schaum

    Oldenburg

  • Klinische Forschung Schwerin GmbH

    Schwerin

  • Hautarztpraxis Leitz & Kollegen

    Stuttgart

  • Studienzentrum Brinkum

    Wardenburg

Other trials in Germany

Poland12 sites

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz

  • Centrum Medyczne Plejady

    Krakow

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow

  • Centrum Medyczne AMED Oddzial w Lodzi

    Lodz

  • ETG Lublin

    Lublin

  • KO-MED Centra Kliniczne Lublin II

    Lublin

  • ETG Skierniewice

    Skierniewice

  • Centrum Innowacyjnych Terapii Sp. z o.o.

    Warsaw

  • Provita Centrum Medyczne Sp. z o.o.

    Warsaw

  • RCMed

    Warsaw

  • ETG Zamosc

    Zamość

  • KO-MED Centra Kliniczne Sp. z o.o.

    Zamość

Other trials in Poland

United Kingdom12 sites

  • Royal United Hospital

    Bath

  • Layton Medical Centre

    Blackpool

  • Hull University Teaching Hospitals NHS Foundation trust

    Hull

  • University Hospitals of Leicester-Leicester Royal Hospital

    Leicester

  • Liverpool University Hospitals NHS Foundation Trust - Aintree University Hospital (Fazakerley Hospital)

    Liverpool

  • GST NHS Found

    London

  • Newcastle University - Institute of Cellular Medicine (ICM)

    Newcastle

  • Panthera Biopartners - Manchester - multispeciality

    Rochdale

  • Panthera Biopartners - Sheffield - multispeciality

    Rochdale

  • Panthera Biopartners - Preston - multispeciality

    Salford

  • Southampton General Hospital

    Southampton

  • Royal Cornwall Hospitals Trust - Respiratory

    Truro

Other trials in United Kingdom

Taiwan7 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • China Medical University Hospital - division of Rheumatology - Taichung

    Taichung

  • National Cheng Kung University hospital

    Tainan

  • National Taiwan University Hospital - Family Medicine

    Taipei

  • Taipei Medical University - Taipei Medical University Hospital

    Taipei

  • Taipei Medical University - WanFang Hospital

    Taipei

  • Tri-Service General Hospital - Neihu Branch - Infectious Diseases

    Taipei

Other trials in Taiwan

Bulgaria6 sites

  • MHAT Sveti Ivan Rilski

    Kozloduy

  • MC City Clinic Sveti Georgi - Montana

    Montana

  • MHAT "Dr. Stamen Iliev

    Montana

  • Medical Center Medconsult Pleven

    Pleven

  • Military Medical Academy

    Sofia

  • SHAT of Pneumo-phthisiatric diseases - Sofia District

    Sofia

Other trials in Bulgaria

Spain6 sites

  • Hospital de Antequera

    Antequera

  • Hospital Clinic De Barcelona

    Barcelona

  • Hospital Santa Creu i Sant Pau - Research institut

    Barcelona

  • Universitat Autonoma de Barcelona (UAB) - Institut d'Investigacio en Atencio Primaria Jordi Gol (IDIAP Jordi Gol)

    Barcelona

  • Hospital Alvaro Cunqueiro

    Vigo

  • Hospital Povisa

    Vigo

Other trials in Spain

Estonia4 sites

  • Center for Clinical and Basic Research

    Tallinn

  • Innomedica OÜ

    Tallinn

  • Merelahe Family Doctors Centre

    Tallinn

  • Clinical Research Center

    Tartu

Other trials in Estonia

Denmark3 sites

  • Aarhus Universitetshospital

    Århus N

  • Odense University Hospital

    Odense

  • Sjællands UniHosp, Roskilde - Medicine and Infectious Diseases

    Roskilde

Other trials in Denmark

Netherlands2 sites

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden

  • Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care

    Utrecht

Other trials in Netherlands

About this study

Official title: 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.

Being tested
mRNA-1010, Fluarix Quadrivalent
Keywords
Flu, Influenza, Vaccine, mRNA vaccine, mRNA-1010, Moderna
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

    Also called Seasonal influenza vaccine

    Sterile liquid for injection

  • Fluarix QuadrivalentBiological

    Also called Licensed quadrivalent inactivated seasonal influenza vaccine

    Sterile suspension for injection.

Study groups in NCT05566639
Study groupRoleWhat they receive
mRNA-1010ExperimentalParticipants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Receives: Biological: mRNA-1010
Fluarix QuadrivalentActive comparatorParticipants will receive a single dose of Fluarix Quadrivalent by IM injection on Day 1.
Receives: Biological: Fluarix Quadrivalent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 days post-vaccination

  2. 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.

    Measured: Up to 28 days post-vaccination

  3. 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.

    Measured: Day 1 through Day 361 (Month 12)

  4. 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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

Secondary outcomes (12)

  1. 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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

  2. 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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

  3. 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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

  4. 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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

  5. 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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

  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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

  7. 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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

  8. 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.

    Measured: 14 days post-vaccination through Day 181 (Month 6)

  9. 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.

    Measured: Day 29

  10. 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.

    Measured: Day 29

  11. Percentage of Participants With HAI Titer ≥ 1:40 at Day 29

    Measured: Day 29

  12. 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.

    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.

  1. First posted4 Oct 2022
  2. Study start14 Sep 2022
  3. Primary completion5 Jan 2024
  4. Study completion5 Jan 2024

Resources

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
22,502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566639
Sponsor's protocol ID
mRNA-1010-P302
Other IDs
2022-001638-12
Status last verified
Dec 2024
First submitted
30 Sep 2022
Last updated
16 Jan 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kandinov B, Soens M, Huang W, Llapur C, Ensz D, Essink B, Fierro C, Vakil J, Pucci A, Guo J, Rudden S, Hall K, Hicks B, Schaefers K, Zhou H, Ma C, Zheng L, Avanesov A, Park Y, Du E, Miller J, Ananworanich J, Nachbagauer R. An mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers. Hum Vaccin Immunother. 2025 Dec;21(1):2484088. doi: 10.1080/21645515.2025.2484088. Epub 2025 Apr 2.

    PubMed 40174609

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mRNA-1010 and Fluarix Quadrivalent in people with Seasonal Influenza, run by ModernaTX, Inc. at 233 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 233 sites in United States, Canada, Germany, Poland, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) (time frame: 7 days post-vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05566639, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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