Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (IGNITE P303)

A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older

This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 8411
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center LLC
    • Cullman, Alabama, United States, 35055
      • Cullman Research Center
    • Huntsville, Alabama, United States, 35801-6002
      • Medical Affiliated Research Center Inc
  • Arizona
    • Mesa, Arizona, United States, 85213
      • Desert Clinical Research - CCT
    • Phoenix, Arizona, United States, 85044
      • Foothills Research Center - CCT
    • Tempe, Arizona, United States, 85283
      • Fiel Family & Sports Medicine - PC - CCT
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center For Clinical Research
  • California
    • Banning, California, United States, 92220
      • Velocity Clinical Research, Banning
    • Cerritos, California, United States, 90703
      • Synexus Clinical Research US, Inc. - Cerritos
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research 002, LLC
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research
    • Pasadena, California, United States, 91105
      • Pasadena Clinical Trials
    • Riverside, California, United States, 92503
      • Artemis Institute For Clinical Research LLC - Riverside - Headlands
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates - CRN
    • San Diego, California, United States, 92108
      • Optimal Research, LLC
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research LLC - Waterbury
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • Velocity Clinical Research - Hallandale Beach
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center
    • Hialeah, Florida, United States, 33016
      • NeoClinical Reseaarch
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jupiter, Florida, United States, 33458
      • Health Awareness Inc
    • Lake City, Florida, United States, 32055
      • Wr-Msra, Llc.
    • Lake Mary, Florida, United States, 32746
      • Sandhill Research, LLC d/b/a Accel Research Sites Network
    • Lake Mary, Florida, United States, 32746
      • Sandhill Research, LLC d/b/a Accel Research Sites
    • Lake Mary, Florida, United States, 32746
      • University Clinical Research-DeLand, LLC d/b/a Accel Research
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates, LLC
    • Miami, Florida, United States, 33186
      • Clinical Site Partners, LLC DBA Flourish Research
    • Miami, Florida, United States, 33135
      • South Florida Research Center, Inc
    • Miami Lakes, Florida, United States, 33016
      • Floridian Clinical Research
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Group, LLC.
    • Pembroke Pines, Florida, United States, 33024
      • Suncoast Research Associates, LLC
    • Saint Augustine, Florida, United States, 32086
      • St. Johns Center for Clinical Research - ERN
    • Tampa, Florida, United States, 33603
      • New Tampa Health, Inc.
    • The Villages, Florida, United States, 32162
      • Synexus Clinical Research US, Inc. - The Villages
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Synexus Clinical Research US, Inc. - Atlanta
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch, LLC
    • Fayetteville, Georgia, United States, 30214
      • Javara, Inc.
    • Savannah, Georgia, United States, 31406
      • Velocity Clinical Research, Savannah
    • Stockbridge, Georgia, United States, 30281
      • CRA, Headlands LLC
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Synexus Clinical Research US, Inc. - Chicago
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials- Ravenswood
    • River Forest, Illinois, United States, 60305
      • DM Clinical Research
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research - Valparaiso
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials (JCCT)
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC
    • Overland Park, Kansas, United States, 66210
      • Velocity Clinical Research, Inc.
    • Wichita, Kansas, United States, 67205
      • Alliance for Multispecialty Research, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Velocity Clinic Research, Inc.
    • Covington, Louisiana, United States, 70433
      • Velocity Clinical Research, Covington
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Javara Inc.
    • Rockville, Maryland, United States, 20854
      • Velocity Clinical Research, Rockville
  • Michigan
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc - CRN
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clinical Research, Gulfport
    • Gulfport, Mississippi, United States, 39503
      • DelRicht Research
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLC dba QPS-MO
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Methodist Physicians Clinic - CCT Research
    • Grand Island, Nebraska, United States, 68803
      • Velocity Clinical Research- Grand Island
    • Norfolk, Nebraska, United States, 68701
      • Velocity Clinical Research (Norfolk - Nebraska) - PPDS
    • Omaha, Nebraska, United States, 68144
      • Midwest Regional Health Services - LLC - CCT
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research (Omaha - Nebraska) - PPDS
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Alliance for Multispecialty Research, LLC
  • New York
    • Binghamton, New York, United States, 13905
      • Velocity Clinical Research (Binghamton - New York) - PPDS
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research, Syracuse
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc
    • Vestal, New York, United States, 13850
      • Velocity Clinical Research, Inc.
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Javara Inc.
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research Inc.
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45219
      • Velocity Clinical Research, Mt. Auburn
    • Cincinnati, Ohio, United States, 45246
      • Velocity Clinical Research, Inc.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • DelRicht Research
  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • Velocity Clinical Research - Grants Pass
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • DM Clinical Research - Philadelphia - ERN
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Velocity Clinical Research - Columbia
    • Gaffney, South Carolina, United States, 29340
      • Velocity Clinical Research - Gaffney
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Tennessee
    • Hendersonville, Tennessee, United States, 37075
      • DelRicht Research
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research - Austin - PPDS
    • Beaumont, Texas, United States, 77706
      • Tekton Research, LLC.
    • Conroe, Texas, United States, 77384
      • Javara Inc.
    • DeSoto, Texas, United States, 75115
      • Epic Medical Research - DeSoto
    • Houston, Texas, United States, 77065
      • DM Clinical Research
    • Humble, Texas, United States, 77338
      • DM Clinical Research
    • Lewisville, Texas, United States, 75057
      • Epic Clinical Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • Sugar Land, Texas, United States, 77478
      • Javara Inc.
    • Sugar Land, Texas, United States, 77478
      • DM Clinical Research
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Utah
    • Bountiful, Utah, United States, 84010
      • Cope Family Medicine - CCT
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc., Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84117
      • Olympus Family Medicine - CCT Research
    • South Ogden, Utah, United States, 84405
      • South Ogden Family Medicine Ogden Clinic/CCT Research
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners LLC - Richmond - ERN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures.
• For assigned females at birth and 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 Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.

Part A:

• At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).

Part B:

• At least 18 and <65 years of age, at the time of signing the ICF.

Part C:

• At least 65 years of age or older, at the time of signing the ICF.

Exclusion Criteria:

• Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
• 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, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
• Participant has tested positive for influenza by local health authority-approved testing methods within 150 days (for Part A) or 180 days (for Parts B and C) prior to Day 1.
• Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.
• Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 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. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.
• Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.
• Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) (for part A) or within 6 months (180 days) (for Parts B and C) prior to Day 1.
• Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.
• Participant is not aware whether they have received an influenza vaccine in the most recent influenza season (in the prior 12 months) (for Part A) or since September 2022 (for Parts B and C).
• Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI)	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ.	Day 29
Percentage of Participants Reaching Seroconversion, as Measured by HAI	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. Seroconversion rate was defined as the percentage of participants with either a Baseline HAI titer <1:10 and a postbaseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in postbaseline HAI antibody titer. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were converted to the ULOQ.	Day 29
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)	Solicited ARs, representative of vaccine reactogenicity, were collected in an electronic diary (eDiary). 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. Per prespecified analysis, only solicited ARs that were assessed and confirmed by the Investigator as both serious and related to IP were recorded as an adverse event. These adverse events were recorded as a serious AE (SAE) and are included in the summary of SAEs in the "Reported Adverse Events" section.	Up to 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs)	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Unsolicited AEs included any AE not collected as a solicited AR, and also included solicited ARs assessed and confirmed as both serious and related by the Investigator. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.	Up to 28 days after study injection
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Discontinuation	An MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. An AESI was an AE (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. 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, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.	Day 1 through Day 181

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With HAI Titer ≥1:40	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains.	Day 29
Geometric Mean Fold-Rise (GMFR) of Postinjection Anti-HA Antibodies for Influenza, as Measured by HAI Assay	Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains. The GMFR measured 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% confidence interval (CI) for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.	Baseline (Day 1) to Day 29

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Deaths Related to Study Drug	A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.	Day 1 through Day 181

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Publications and helpful links

General Publications

• Soens M, Ananworanich J, Hicks B, Lucas KJ, Cardona J, Sher L, Livermore G, Schaefers K, Henry C, Choi A, Avanesov A, Chen R, Du E, Pucci A, Das R, Miller J, Nachbagauer R. A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults. Vaccine. 2025 Mar 19;50:126847. doi: 10.1016/j.vaccine.2025.126847. Epub 2025 Feb 7.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): June 24, 2024
• Study Completion (Actual): June 24, 2024

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Influenza vaccine; Virus Diseases; Moderna; Flu; mRNA vaccine; mRNA-1010
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: mRNA-1010-P303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No