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

NCT05566639 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: mRNA-1010-P3022022-001638-12
• Study Type: interventional
• Target: 22,502
• Locations: 10 countries
• Sites: 227

Brief 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.

Conditions

Seasonal Influenza

Keywords

Flu; Influenza; Vaccine; mRNA vaccine; mRNA-1010; Moderna

Outcome Measures

Primary Outcomes (4)

• 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 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 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 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 Outcomes (12)

• 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

  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

  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

  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

  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

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

Study Arms (2)

mRNA-1010

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Biological: mRNA-1010

Fluarix Quadrivalent

ACTIVE COMPARATOR

Participants will receive a single dose of Fluarix Quadrivalent by IM injection on Day 1.

Biological: Fluarix Quadrivalent

Interventions

mRNA-1010 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1010

Fluarix Quadrivalent BIOLOGICAL

Sterile suspension for injection.

Also known as: Licensed quadrivalent inactivated seasonal influenza vaccine

Fluarix Quadrivalent

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (233)

North Alabama Research Center, LLC

Athens, Alabama, 35611, United States

Location

Lenzmeier Family Medicine

Glendale, Arizona, 85308, United States

Location

CCT Research

Phoenix, Arizona, 85044, United States

Location

Fiel Family and Sports Medicine/CCT Research

Tempe, Arizona, 85283, United States

Location

Noble Clinical Research

Tucson, Arizona, 85712, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72204, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Velocity Clinical Research, Banning

Banning, California, 92220, United States

Location

Hope Clinical Research, LLC

Canoga Park, California, 91303, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Velocity Clinical Research, Chula Vista

La Mesa, California, 91942, United States

Location

Velocity Clinical Research, San Diego

La Mesa, California, 91942, United States

Location

Velocity Clinical Research - Westlake

Los Angeles, California, 90057, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Benchmark Research-Texas

Riverside, California, 92504-3206, United States

Location

Peninsula Research Associates (PRA)

Rolling Hills Estates, California, 90274, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Women's Health Care Research Corp.

San Diego, California, 92111, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Medical Center for Clinical Research

San Diego, California, 92120, United States

Location

Shawn K Hassler MD

San Francisco, California, 94102-3014, United States

Location

West Coast Research LLC

San Ramon, California, 94582, United States

Location

Velocity Clinical Research, Denver

Denver, Colorado, 80209, United States

Location

Arthritis & Rheumatology - Clinic of Northern Colorado

Fort Collins, Colorado, 80528, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

Nature Coast Clinical Research, LLC - Crystal River

Crystal River, Florida, 34429, United States

Location

Floridian Clinical Research

Hialeah, Florida, 33016, United States

Location

Homestead Associates in Research,Inc

Hialeah, Florida, 33016, United States

Location

Broward Research Group

Hollywood, Florida, 33024, United States

Location

Citrus Cardiology Consultants

Inverness, Florida, 34452, United States

Location

Encore Research Group-Jacksonville Center for Clinical Resea

Jacksonville, Florida, 32216, United States

Location

Health Awareness, Inc

Jupiter, Florida, 33458, United States

Location

Multi-Therapeutic Research Associates, Inc.

Lake City, Florida, 32055, United States

Location

Accel Research Sites - Lakeland

Lakeland, Florida, 33805, United States

Location

ARS - Meridien Research

Maitland, Florida, 32751, United States

Location

South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

Suncoast Research Associates Trials, LLC

Miami, Florida, 33135, United States

Location

Miami centre of clinical research

Miami, Florida, 33155, United States

Location

Clinical Trials of Florida, LLC

Miami, Florida, 33186, United States

Location

Global Health Research Center

Miami Lakes, Florida, 33016, United States

Location

Innovation Medical Research Center,inc

Palmetto Bay, Florida, 33157, United States

Location

New Tampa Health, Inc

Tampa, Florida, 33603, United States

Location

Tekton Research, Inc.

Chamblee, Georgia, 30341, United States

Location

Southeast Regional Research Group

Columbus, Georgia, 31904, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

In-Quest Medical Research

Norcross, Georgia, 30092-4544, United States

Location

Mount Vernon Clinical Research

Sandy Springs, Georgia, 30328, United States

Location

Meridian Clinical Research - Savannah

Savannah, Georgia, 31406-2675, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281-9054, United States

Location

Velocity Clinical Research - Boise

Meridian, Idaho, 83642, United States

Location

Great Lakes Clinical Trials LLC

Chicago, Illinois, 60625, United States

Location

Great Lakes Clinical Trials LLC

Chicago, Illinois, 60640, United States

Location

Great Lakes Clinical Trials LLC

Gurnee, Illinois, 60031, United States

Location

Chicago Health Medical Group

River Forest, Illinois, 60305, United States

Location

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, 46385, United States

Location

Meridian Clinical Research - Dakota Dunes

Sioux City, Iowa, 51106, United States

Location

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, 66219, United States

Location

Heartland Research Associates LLC

Newton, Kansas, 67114-9017, United States

Location

Alliance for Multispecialty Research

Wichita, Kansas, 67207, United States

Location

Meridian Clinical Research

Baton Rouge, Louisiana, 70809, United States

Location

MedPharmics

Covington, Louisiana, 70433, United States

Location

Medpharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Nathan H Fischman MD LLC

New Orleans, Louisiana, 70124, United States

Location

Privia Medical Group

Annapolis, Maryland, 21401, United States

Location

Rockville Internal Medicine Group

Rockville, Maryland, 20854-2957, United States

Location

Delricht Research

Springfield, Massachusetts, 65807-7303, United States

Location

DM Clinical Research - Detroit

Southfield, Michigan, 48076, United States

Location

Paul G Matherne MD

Biloxi, Mississippi, 39531, United States

Location

DELRICHT RESEARCH at GULFPORT MEMORIAL

Gulfport, Mississippi, 39503, United States

Location

National Medical University and Embryonic Tissues Center EmC

Springfield, Missouri, 65802, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Montana Medical Research, Inc

Missoula, Montana, 59808, United States

Location

CCT Research at Skyline Medical Center, PC

Elkhorn, Nebraska, 68022, United States

Location

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

Fremont, Nebraska, 68025-2592, United States

Location

Meridian Clinical Research

Grand Island, Nebraska, 68803, United States

Location

Be Well Clinical Studies, LLC

Lincoln, Nebraska, 68516, United States

Location

Medpace, Inc. - Clinical Pharmacology Unit (CPU)

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Papillon Research Centre

Omaha, Nebraska, 68130, United States

Location

Meridian Clinical Research - Omaha

Omaha, Nebraska, 68134, United States

Location

Midwest Regional Health Services, LLC/CCT Research

Omaha, Nebraska, 68144-5225, United States

Location

CCT Research

Las Vegas, Nevada, 89102-1682, United States

Location

Clinical Research Center of Nevada LLC

Las Vegas, Nevada, 89104, United States

Location

Santa Rosa Medical Centers of Nevada/ CCT Research

Las Vegas, Nevada, 89119, United States

Location

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, 89030, United States

Location

United Medical Associates

Binghamton, New York, 13901-1043, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Velocity Clinical Research - Syracuse

Syracuse, New York, 13057, United States

Location

Tryon Medical Group

Charlotte, North Carolina, 28210, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

Diabetes & Endocrinology Consultants

Morehead City, North Carolina, 28557, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Trial Management Associates

Wilmington, North Carolina, 28403, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Radiant Research

Akron, Ohio, 44311, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45219, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45227, United States

Location

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, 45242, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Delricht Research Tulsa

Tulsa, Oklahoma, 74133, United States

Location

Platinum Research Network, LLC

Yukon, Oklahoma, 73099, United States

Location

Velocity Clinical Research - Grants Pass

Grants Pass, Oregon, 97520, United States

Location

Velocity Clinical Resarch - Medford

Medford, Oregon, 97504, United States

Location

Velocity Clinical Research - Providence

Warwick, Rhode Island, 02886, United States

Location

Velocity Clinical Research, Greenville

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research - Columbia

Columbia, South Carolina, 29204, United States

Location

Velocity Clinical Research, Gaffney

Gaffney, South Carolina, 29340, United States

Location

Velocity Clinical Research - Greenville

Greenville, South Carolina, 29615, United States

Location

Carolina Health Specialists

Myrtle Beach, South Carolina, 29572, United States

Location

Spartanburg Regional Health Services

Spartanburg, South Carolina, 29303, United States

Location

Black Hills Center for American Indian Health

Rapid City, South Dakota, 57701, United States

Location

Delricht Research

Hendersonville, Tennessee, 37075, United States

Location

Tekton Research, Inc

Austin, Texas, 78745, United States

Location

Platinum Research Network, LLC

Beaumont, Texas, 77706, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230-2505, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

DM Clinical Research

Houston, Texas, 77065, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE

McKinney, Texas, 75070, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Epic Medical Research, LLC

Red Oak, Texas, 75154, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

DM Clinical Research

Sugar Land, Texas, 77478, United States

Location

Breco Research - A Tarheel Clinical Research Site

Sugar Land, Texas, 77479, United States

Location

Cope Family Medicine

Bountiful, Utah, 84010, United States

Location

Olympus Family Medicine/CCT Research

Holladay, Utah, 84117, United States

Location

CenExel - JBR

Salt Lake City, Utah, 84107, United States

Location

South Ogden Family Medicine clinic/CCT

South Ogden, Utah, 84405-4869, United States

Location

Velocity Clinical Research - Salt Lake City

West Jordan, Utah, 84088, United States

Location

Meridian Clinical Research

Portsmouth, Virginia, 23703-3200, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

Lakeview Medical Center

Suffolk, Virginia, 23435, United States

Location

MHAT Sveti Ivan Rilski

Kozloduy, Bulgaria

Location

MC City Clinic Sveti Georgi - Montana

Montana, Bulgaria

Location

MHAT "Dr. Stamen Iliev

Montana, Bulgaria

Location

Medical Center Medconsult Pleven

Pleven, Bulgaria

Location

Military Medical Academy

Sofia, Bulgaria

Location

SHAT of Pneumo-phthisiatric diseases - Sofia District

Sofia, Bulgaria

Location

Aggarwal and Associates LTD

Brampton, Canada

Location

Aviva Clinical Trials Group Inc

Burlington, Canada

Location

Hamilton Medical Research Group

Hamilton, Canada

Location

Okanagan Clinical Trials

Kelowna, Canada

Location

Centricity Research Quebec City

Lévis, Canada

Location

Milestone Research Inc.

London, Canada

Location

Yang Medicine

Ottawa, Canada

Location

LMC Manna

Pointe-Claire, Canada

Location

DIEX Research Quebec Inc.

Québec, G1G 3Y8, Canada

Location

DIEX Research Quebec Inc.

Québec, G1N 4V3, Canada

Location

Alpha Recherche Clinique Inc

Québec, Canada

Location

Clinique de Lebourgneuf

Québec, Canada

Location

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

Québec, Canada

Location

Diex Research Sherbrooke Inc

Québec, Canada

Location

Central Alberta Research Clinic

Red Deer, Canada

Location

Diex Recherche - Joilette - HyperCore - PPDS

Saint-Charles-Borromée, Canada

Location

Glencar Medical Inc.

Sarnia, Canada

Location

Canadian Phase Onward Inc.

Toronto, Canada

Location

LMC

Toronto, Canada

Location

Manna Research

Toronto, Canada

Location

Medicine Professional Corporation

Toronto, Canada

Location

Toronto Western Hospital

Toronto, Canada

Location

Diex Recherche Trois-Rivières

Trois-Rivières, Canada

Location

Colchester East Hants Health Authority - Colchester Regional

Truro, Canada

Location

Diex Recherche Victoriaville

Victoriaville, Canada

Location

Aarhus Universitetshospital

Århus N, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Sjællands UniHosp, Roskilde - Medicine and Infectious Diseases

Roskilde, Denmark

Location

Center for Clinical and Basic Research

Tallinn, Estonia

Location

Innomedica OÜ

Tallinn, Estonia

Location

Merelahe Family Doctors Centre

Tallinn, Estonia

Location

Clinical Research Center

Tartu, Estonia

Location

Berliner Centrum für Reise- und Tropenmedizin

Berlin, Germany

Location

Emovis GmbH

Berlin, Germany

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, Germany

Location

Klinische Forschung Berlin

Berlin, Germany

Location

University Hospital Cologne AöR

Cologne, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Germany

Location

Medizentrum Essen Borbeck

Essen, Germany

Location

IKF Pneumologie

Frankfurt, Germany

Location

Infektiologikum Frankfurt-Sachsenhausen

Frankfurt, Germany

Location

Studienzentrum Dr. Keller

Frankfurt am Main, Germany

Location

Clinical Research Hamburg GmbH

Hamburg, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, Germany

Location

Klinische Forschung Hannover-Mitte GmbH

Hanover, Germany

Location

Siteworks GmbH

Hanover, Germany

Location

Siteworks GmbH

Heidelberg, Germany

Location

Synexus Clinical Research GmbH

Leipzig, Germany

Location

Praxis Illies

Magdeburg, Germany

Location

Dermatologie Quist

Mainz, Germany

Location

Praxis Schaum

Oldenburg, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, Germany

Location

Hautarztpraxis Leitz & Kollegen

Stuttgart, Germany

Location

Studienzentrum Brinkum

Wardenburg, Germany

Location

Leids Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Location

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

Utrecht, Netherlands

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Poland

Location

Centrum Medyczne Plejady

Krakow, Poland

Location

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, Poland

Location

Centrum Medyczne AMED Oddzial w Lodzi

Lodz, Poland

Location

ETG Lublin

Lublin, Poland

Location

KO-MED Centra Kliniczne Lublin II

Lublin, Poland

Location

ETG Skierniewice

Skierniewice, Poland

Location

Centrum Innowacyjnych Terapii Sp. z o.o.

Warsaw, Poland

Location

Provita Centrum Medyczne Sp. z o.o.

Warsaw, Poland

Location

RCMed

Warsaw, Poland

Location

ETG Zamosc

Zamość, Poland

Location

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

Zamość, Poland

Location

Hospital de Antequera

Antequera, Spain

Location

Hospital Clinic De Barcelona

Barcelona, Spain

Location

Hospital Santa Creu i Sant Pau - Research institut

Barcelona, Spain

Location

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

Barcelona, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Spain

Location

Hospital Povisa

Vigo, Spain

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital - division of Rheumatology - Taichung

Taichung, Taiwan

Location

National Cheng Kung University hospital

Tainan, Taiwan

Location

National Taiwan University Hospital - Family Medicine

Taipei, Taiwan

Location

Taipei Medical University - Taipei Medical University Hospital

Taipei, Taiwan

Location

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital - Neihu Branch - Infectious Diseases

Taipei, Taiwan

Location

Royal United Hospital

Bath, United Kingdom

Location

Layton Medical Centre

Blackpool, United Kingdom

Location

Hull University Teaching Hospitals NHS Foundation trust

Hull, United Kingdom

Location

University Hospitals of Leicester-Leicester Royal Hospital

Leicester, United Kingdom

Location

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

Liverpool, United Kingdom

Location

GST NHS Found

London, United Kingdom

Location

Newcastle University - Institute of Cellular Medicine (ICM)

Newcastle, United Kingdom

Location

Panthera Biopartners - Manchester - multispeciality

Rochdale, United Kingdom

Location

Panthera Biopartners - Sheffield - multispeciality

Rochdale, United Kingdom

Location

Panthera Biopartners - Preston - multispeciality

Salford, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Royal Cornwall Hospitals Trust - Respiratory

Truro, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

mRNA-1010 influenza vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Moderna Clinical Trials Support Center
• Organization: ModernaTX, Inc.

clinicaltrials@modernatx.com

1-877-777-7187

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: September 14, 2022
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2024-12

Locations

BU (6); ES (4); GB (12); DE (22); US (134); DK (3); NL (2); CA (25); PL (12); TW (7)