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NCT06602024

PHASE3

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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 any influenza A or B strains.

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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40805

Start Date

2024-09-16

Completion Date

2025-08-21

Last Updated

2026-09-16

Healthy Volunteers

Yes

Conditions

Seasonal Influenza

Interventions

BIOLOGICAL

mRNA-1010

Intramuscular (IM) injection

BIOLOGICAL

Fluarix®

IM injection

BIOLOGICAL

Influsplit® Tetra

IM injection

BIOLOGICAL

Fluarix Tetra

IM injection

BIOLOGICAL

Alpharix® Tetra

IM injection

Inclusion Criteria: * 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). Exclusion Criteria: * 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. * 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.

Locations (301)

Pinnacle Research Group, Llc

Anniston, Alabama, United States

North Alabama Research Center, LLC

Athens, Alabama, United States

Flourish Research

Birmingham, Alabama, United States

EmVenio Research Brimingham, AL

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Optimal Research

Huntsville, Alabama, United States

Velocity Clinical Research

Mobile, Alabama, United States

Lenzmeier Family Medicine

Glendale, Arizona, United States

DM Clinical Research

Phoenix, Arizona, United States

Helios Clinical Research

Phoenix, Arizona, United States

Fiel Family and Sports Medicine

Tempe, Arizona, United States

Arizona Liver Health

Tucson, Arizona, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Woodland Research

Rogers, Arkansas, United States

Benchmark Research - Colton

Colton, California, United States

Flourish Research

Covina, California, United States

Velocity Clinical Research - Huntington Park

Huntington Park, California, United States

Velocity Clinical Research, San Diego

La Mesa, California, United States

Long Beach Research Institute LLC

Long Beach, California, United States

Velocity Clinical Research - Westlake

Los Angeles, California, United States

M3 Wake Research/PRI, LLC

Newport Beach, California, United States

Carbon Health North Hollywood

North Hollywood, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Paradigm Research

Redding, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Peninsula Research Associates (PRA)

Rolling Hills Estates, California, United States

Velocity Clinical Research - Banning

San Bernardino, California, United States

Artemis Institute for Clinical Research - Research Site

San Diego, California, United States

WHCR- M3 Wake Research

San Diego, California, United States

Wr-McCr, Llc

San Diego, California, United States

Velocity Clinical Research

Santa Ana, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Tekton Research - Fort Collins

Fort Collins, Colorado, United States

Tekton Research, Inc - Longmont Center

Longmont, Colorado, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

JEM Research Institue

Atlantis, Florida, United States

Nature Coast Clinical Research, LLC - Crystal River

Crystal River, Florida, United States

Homestead Associates in Research,Inc

Hialeah, Florida, United States

CenExel RCA

Hollywood, Florida, United States

Nature Coast Clinical Research, LLC - Inverness

Inverness, Florida, United States

Westside Center for Clinical Research

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Health Awareness INC

Jupiter, Florida, United States

M3 Wake Research/MSRA,LLC

Lake City, Florida, United States

Accel Clinical Research

Lake Mary, Florida, United States

Clinical Site Partners - Leesburg

Leesburg, Florida, United States

ARS - Meridien Research

Maitland, Florida, United States

K2 medical research

Maitland, Florida, United States

South Florida Research Center, Inc.

Miami, Florida, United States

Miami Clinical Research

Miami, Florida, United States

Suncoast Research Associates, LLC

Miami, Florida, United States

Floridian Clinical Research

Miami Lakes, Florida, United States

Headlands Research

Orlando, Florida, United States

Suncoast Research Associates

Pembroke Pines, Florida, United States

Health Awareness INC

Port Saint Lucie, Florida, United States

IMA Clinical Research Warren

St. Petersburg, Florida, United States

Forward Clinical Trials - Dermatology

Tampa, Florida, United States

Clinical Site Partners, LLC

Winter Park, Florida, United States

JAVARA

Albany, Georgia, United States

IACT Health

Columbus, Georgia, United States

CenExel iResearch , LLC

Decatur, Georgia, United States

CenExel iResearch Savannah

Savannah, Georgia, United States

Velocity Clinical Research-Savannah

Savannah, Georgia, United States

Javara - Privia Medical Group Georgia, LLC

Savannah, Georgia, United States

Clinical Research Atlanta/Headlands

Stockbridge, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Bingham Memorial Hospital

Blackfoot, Idaho, United States

Velocity Clinical Research - Boise

Meridian, Idaho, United States

EmVenio Research

Chicago, Illinois, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

DM Clinical Research- River Forest

Melrose Park, Illinois, United States

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, United States

Velocity Clinical Research-Sioux City

Sioux City, Iowa, United States

Alliance for Multispecialty Research

Augusta, Kansas, United States

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, United States

DelRicht Research - Overland Park

Overland Park, Kansas, United States

AMR

Wichita, Kansas, United States

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana, United States

Velocity Clinical Research - Lafayette

Lafayette, Louisiana, United States

IMA Clinical Research Monroe

Monroe, Louisiana, United States

DelRicht Research

New Orleans, Louisiana, United States

Velocity Clinical Research

New Orleans, Louisiana, United States

DelRicht Research @ Neighborhood Health

Prairieville, Louisiana, United States

Privia Medical Group

Annapolis, Maryland, United States

Cenexel CBH (CBH Health)

Gaithersburg, Maryland, United States

Matthew Mintz Clinic

Rockville, Maryland, United States

Velocity Clinical Research - Covington

Rockville, Maryland, United States

DM Clinical Research - Brookline

Brookline, Massachusetts, United States

Headlands Research - Detroit

Southfield, Michigan, United States

Great Lakes Research Institute

Southfield, Michigan, United States

DM Clinical Research

Southfield, Michigan, United States

DELRICHT RESEARCH at GULFPORT MEMORIAL

Gulfport, Mississippi, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

Clinvest

Springfield, Missouri, United States

Delricht Research

Springfield, Missouri, United States

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Delricht

Town and Country, Missouri, United States

Boeson Research MSO

Missoula, Montana, United States

Elias Research Associates

Missoula, Montana, United States

And 201 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (301)