Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

NCT05827978 | Completed Phase 3 Results FDA Drug

• 1 other identifier: mRNA-1010-P303
• Study Type: interventional
• Target: 8,411
• Locations: 1 country
• Sites: 103

Brief Summary

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.

Conditions

Seasonal Influenza

Keywords

mRNA-1010; Virus Diseases; Flu; Influenza vaccine; Moderna; mRNA vaccine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Percentage of Participants With HAI Titer ≥1:40

  Day 29

• Geometric Mean Fold-Rise (GMFR) of Postinjection Anti-HA Antibodies for Influenza, as Measured by HAI Assay

  Baseline (Day 1) to Day 29

Other Outcomes (1)

• Number of Deaths Related to Study Drug

  Day 1 through Day 181

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

Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

ACTIVE COMPARATOR

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

Interventions

mRNA-1010 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1010

Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine BIOLOGICAL

Sterile suspension for injection

Also known as: Fluarix Quadrivalent, Fluzone HD

Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

Eligibility Criteria

• Age: 18 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 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.

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 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (103)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

North Alabama Research Center LLC

Athens, Alabama, 35611, United States

Location

Cullman Research Center

Cullman, Alabama, 35055, United States

Location

Medical Affiliated Research Center Inc

Huntsville, Alabama, 35801-6002, United States

Location

Desert Clinical Research - CCT

Mesa, Arizona, 85213, United States

Location

Foothills Research Center - CCT

Phoenix, Arizona, 85044, United States

Location

Fiel Family &amp; Sports Medicine - PC - CCT

Tempe, Arizona, 85283, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, 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

Synexus Clinical Research US, Inc. - Cerritos

Cerritos, California, 90703, United States

Location

Marvel Clinical Research 002, LLC

Huntington Beach, California, 92647, United States

Location

Velocity Clinical Research

La Mesa, California, 91942, United States

Location

Pasadena Clinical Trials

Pasadena, California, 91105, United States

Location

Artemis Institute For Clinical Research LLC - Riverside - Headlands

Riverside, California, 92503, United States

Location

Peninsula Research Associates - CRN

Rolling Hills Estates, California, 90274, United States

Location

Optimal Research, LLC

San Diego, California, 92108, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Optimus Medical Group

San Francisco, California, 94102, United States

Location

Chase Medical Research LLC - Waterbury

Waterbury, Connecticut, 06708, United States

Location

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida, 33009, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

NeoClinical Reseaarch

Hialeah, Florida, 33016, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Health Awareness Inc

Jupiter, Florida, 33458, United States

Location

Wr-Msra, Llc.

Lake City, Florida, 32055, United States

Location

Sandhill Research, LLC d/b/a Accel Research Sites Network

Lake Mary, Florida, 32746, United States

Location

Sandhill Research, LLC d/b/a Accel Research Sites

Lake Mary, Florida, 32746, United States

Location

University Clinical Research-DeLand, LLC d/b/a Accel Research

Lake Mary, Florida, 32746, United States

Location

South Florida Research Center, Inc

Miami, Florida, 33135, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Suncoast Research Associates, LLC

Miami, Florida, 33173, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Miami, Florida, 33186, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Innovation Medical Group, LLC.

Palmetto Bay, Florida, 33157, United States

Location

Suncoast Research Associates, LLC

Pembroke Pines, Florida, 33024, United States

Location

St. Johns Center for Clinical Research - ERN

Saint Augustine, Florida, 32086, United States

Location

New Tampa Health, Inc.

Tampa, Florida, 33603, United States

Location

Synexus Clinical Research US, Inc. - The Villages

The Villages, Florida, 32162, United States

Location

Synexus Clinical Research US, Inc. - Atlanta

Atlanta, Georgia, 30328, United States

Location

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

Location

Javara, Inc.

Fayetteville, Georgia, 30214, United States

Location

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

Location

CRA, Headlands LLC

Stockbridge, Georgia, 30281, United States

Location

Synexus Clinical Research US, Inc. - Chicago

Chicago, Illinois, 60602, United States

Location

Great Lakes Clinical Trials- Ravenswood

Chicago, Illinois, 60640, United States

Location

DM Clinical Research

River Forest, Illinois, 60305, United States

Location

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, 46383, United States

Location

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, 66219, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Velocity Clinical Research, Inc.

Overland Park, Kansas, 66210, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67205, United States

Location

Velocity Clinic Research, Inc.

Baton Rouge, Louisiana, 70809, United States

Location

Velocity Clinical Research, Covington

Covington, Louisiana, 70433, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Javara Inc.

Annapolis, Maryland, 21401, United States

Location

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854, United States

Location

Oakland Medical Research

Troy, Michigan, 48085, United States

Location

Clinical Research Institute, Inc - CRN

Minneapolis, Minnesota, 55402, United States

Location

DelRicht Research

Gulfport, Mississippi, 39503, United States

Location

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, 39503, United States

Location

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri, 65802, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Methodist Physicians Clinic - CCT Research

Fremont, Nebraska, 68025, United States

Location

Velocity Clinical Research- Grand Island

Grand Island, Nebraska, 68803, United States

Location

Velocity Clinical Research (Norfolk - Nebraska) - PPDS

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research (Omaha - Nebraska) - PPDS

Omaha, Nebraska, 68134, United States

Location

Velocity Clinical Research, Inc.

Omaha, Nebraska, 68134, United States

Location

Midwest Regional Health Services - LLC - CCT

Omaha, Nebraska, 68144, United States

Location

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, 89119, United States

Location

Velocity Clinical Research (Binghamton - New York) - PPDS

Binghamton, New York, 13905, United States

Location

Velocity Clinical Research, Syracuse

East Syracuse, New York, 13057, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Velocity Clinical Research, Inc.

Vestal, New York, 13850, United States

Location

Javara Inc.

Charlotte, North Carolina, 28210, United States

Location

Lucas Research Inc.

Morehead City, North Carolina, 28557, United States

Location

M3 Wake Research, Inc

Raleigh, North Carolina, 27612, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Velocity Clinical Research, Mt. Auburn

Cincinnati, Ohio, 45219, United States

Location

Velocity Clinical Research, Inc.

Cincinnati, Ohio, 45246, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74133, United States

Location

Velocity Clinical Research - Grants Pass

Grants Pass, Oregon, 97527, United States

Location

DM Clinical Research - Philadelphia - ERN

Philadelphia, Pennsylvania, 19107, 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

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

DelRicht Research

Hendersonville, Tennessee, 37075, United States

Location

Tekton Research - Austin - PPDS

Austin, Texas, 78745, United States

Location

Tekton Research, LLC.

Beaumont, Texas, 77706, United States

Location

Javara Inc.

Conroe, Texas, 77384, United States

Location

Epic Medical Research - DeSoto

DeSoto, Texas, 75115, United States

Location

DM Clinical Research

Houston, Texas, 77065, United States

Location

DM Clinical Research

Humble, Texas, 77338, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, 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

Javara Inc.

Sugar Land, Texas, 77478, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Cope Family Medicine - CCT

Bountiful, Utah, 84010, United States

Location

J. Lewis Research, Inc., Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

Olympus Family Medicine - CCT Research

Salt Lake City, Utah, 84117, United States

Location

South Ogden Family Medicine Ogden Clinic/CCT Research

South Ogden, Utah, 84405, United States

Location

Clinical Research Partners LLC - Richmond - ERN

Richmond, Virginia, 23226, United States

Location

Related Publications (1)

• 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.

  PMID: 39919447 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Virus Diseases; Influenza, Human

Interventions

mRNA-1010 influenza vaccine; Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

+1-866-663-3762

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 25, 2023
• Study Start: April 17, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-06

Locations

US (103)