Seasonal InfluenzaPhase 3IGNITE P303NCT05827978

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

A Phase 3 study testing mRNA-1010 and Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine in people with Seasonal Influenza, run by ModernaTX, Inc. at 103 sites in United States.

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

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Seasonal Influenza
What is being tested?: mRNA-1010 and Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8,411 participants
Where: 103 sitesUnited States
Study dates: 17 Apr 2023to 24 Jun 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 18 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 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.

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 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.

Show all 13Show fewer

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.

Trial locations and contacts

103 sites in 1 country.

City, postcode or hospital

103 sites in 1 country

United States103 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Seasonal Influenza
Being tested: mRNA-1010, Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Keywords: mRNA-1010, Virus Diseases, Flu, Influenza vaccine, Moderna, mRNA vaccine
Medical subject headings: Virus Diseases, 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
Licensed Quadrivalent Inactivated Seasonal Influenza VaccineBiological
Also called Fluarix Quadrivalent, Fluzone HD
Sterile suspension for injection

Study groups in NCT05827978
Study group	Role	What they receive
mRNA-1010	Experimental	Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. Receives: 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. Receives: Biological: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

What is being measured

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

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 through Day 181

Secondary outcomes (2)

Percentage of Participants With HAI Titer ≥1:40
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria and Yamagata strains.
Measured: 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.
Measured: Baseline (Day 1) to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 202324 Jun 2024

First posted25 Apr 2023
Study start17 Apr 2023
Primary completion24 Jun 2024
Study completion24 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
More trials run by ModernaTX, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 8,411 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05827978
Sponsor's protocol ID: mRNA-1010-P303
Acronym: IGNITE P303
Status last verified: Jun 2025
First submitted: 13 Apr 2023
Last updated: 10 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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.
PubMed 39919447

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Influenza Prevention, Seasonal Influenza
Not yet recruitingPhase 1
Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)
Seasonal Influenza
Not yet recruitingPhase 4
A Study of Updated mRNA Seasonal Influenza Vaccines
Seasonal Influenza

All Seasonal Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05827978
Acronym / sponsor ID: IGNITE P303 / mRNA-1010-P303
Conditions: Seasonal Influenza
Keywords: mRNA-1010, Virus Diseases, Flu, Influenza vaccine, Moderna, mRNA vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 8,411 participants (actual)
Lead sponsor: ModernaTX, Inc.Industry (pharma, biotech, devices)
Study start: 17 Apr 2023 (actual)
Primary completion: 24 Jun 2024 (actual)
Study completion: 24 Jun 2024 (actual)
First posted: 25 Apr 2023 (actual)
Results: Posted 10 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
mRNA-1010	Experimental	Biological: mRNA-1010Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine	Active comparator	Biological: Licensed Quadrivalent Inactivated Seasonal Influenza VaccineParticipants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.
At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
At least 18 and <65 years of age, at the time of signing the ICF.
At least 65 years of age or older, at the time of signing the ICF.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mRNA-1010Also: Seasonal influenza vaccineSterile liquid for injection	Biological	mRNA-1010
Licensed Quadrivalent Inactivated Seasonal Influenza VaccineAlso: Fluarix Quadrivalent, Fluzone HDSterile suspension for injection	Biological	Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

Primary outcome

Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI)
Time frame: Day 29
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.
Percentage of Participants Reaching Seroconversion, as Measured by HAI
Time frame: Day 29
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.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to 7 days after study injection
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.
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Up to 28 days after study injection
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.
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Discontinuation
Time frame: Day 1 through Day 181
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.

2 secondary outcomes

Percentage of Participants With HAI Titer ≥1:40
Time frame: Day 29
Geometric Mean Fold-Rise (GMFR) of Postinjection Anti-HA Antibodies for Influenza, as Measured by HAI Assay
Time frame: Baseline (Day 1) to Day 29

Results and safety

Results posted to the registry on 10 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Fluarix Quadrivalent Influenza Vaccine (QIV)	1,189	1,106
Part A: mRNA-1010	1,225	1,113
Part B: Fluarix QIV	1,494	1,425
Part B: mRNA-1010	1,500	1,434
Part C: Fluzone High Dose (HD) QIV	1,496	1,456
Part C: mRNA-1010	1,507	1,484

Primary outcome: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI)

Time frame: Day 29. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Part A: Fluarix QIV n = 1135	Part A: mRNA-1010 n = 1185	Part B: Fluarix QIV n = 1426	Part B: mRNA-1010 n = 1441	Part C: Fluzone HD QIV n = 1409	Part C: mRNA-1010 n = 1425
Influenza A H1N1 Antibody	147.49 (138.07 to 157.55)	220.17 (207.30 to 233.84)	137.90 (129.89 to 146.40)	208.10 (196.43 to 220.47)	130.09 (122.86 to 137.74)	174.81 (165.15 to 185.04)
Influenza A H3N2 Antibody	107.21 (101.11 to 113.68)	152.56 (144.13 to 161.48)	97.18 (91.74 to 102.95)	157.88 (148.45 to 167.91)	116.24 (109.47 to 123.44)	141.62 (133.29 to 150.46)
Influenza B/Victoria Antibody	155.94 (147.78 to 164.55)	198.55 (188.44 to 209.22)	150.90 (144.37 to 157.73)	196.71 (187.68 to 206.17)	195.97 (187.44 to 204.89)	248.03 (237.34 to 259.21)
Influenza B/Yamagata Antibody	146.63 (138.91 to 154.78)	182.94 (173.61 to 192.76)	113.76 (109.21 to 118.51)	158.58 (151.55 to 165.93)	91.94 (88.33 to 95.71)	104.82 (100.70 to 109.11)

Population analysed: The Per-Protocol Immunogenicity Set (PPIS) included all randomized participants who received the planned dose of study intervention, complied with the immunogenicity testing schedule for Baseline and Day 29, and had no significant protocol deviations that impacted key or critical data. Participants were analyzed according to the group to which they were randomized.

Primary outcome: Percentage of Participants Reaching Seroconversion, as Measured by HAI

Time frame: Day 29. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Part A: Fluarix QIV n = 1135	Part A: mRNA-1010 n = 1185	Part B: Fluarix QIV n = 1426	Part B: mRNA-1010 n = 1441	Part C: Fluzone HD QIV n = 1409	Part C: mRNA-1010 n = 1425
Influenza A H1N1 Antibody	34.9 (32.12 to 37.74)	50.2 (47.32 to 53.10)	45.0 (42.42 to 47.65)	64.4 (61.87 to 66.88)	36.3 (33.75 to 38.84)	49.7 (47.06 to 52.31)
Influenza A H3N2 Antibody	32.2 (29.45 to 34.96)	51.1 (48.17 to 53.94)	44.0 (41.37 to 46.59)	66.4 (63.91 to 68.85)	47.8 (45.20 to 50.48)	56.4 (53.80 to 59.02)
Influenza B/Victoria Antibody	17.0 (14.86 to 19.32)	26.6 (24.09 to 29.20)	18.4 (16.39 to 20.48)	33.0 (30.54 to 35.46)	20.2 (18.09 to 22.35)	29.8 (27.46 to 32.27)
Influenza B/Yamagata Antibody	24.7 (22.19 to 27.29)	33.2 (30.57 to 36.01)	23.4 (21.25 to 25.71)	35.6 (33.12 to 38.13)	20.2 (18.09 to 22.35)	26.0 (23.77 to 28.40)

Population analysed: The PPIS included all randomized participants who received the planned dose of study intervention, complied with the immunogenicity testing schedule for Baseline and Day 29, and had no significant protocol deviations that impacted key or critical data. Participants were analyzed according to the group to which they were randomized.

Primary outcome: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

Time frame: Up to 7 days after study injection. Count of participants. Unit: Participants

Measure	Part A: Fluarix QIV n = 1180	Part A: mRNA-1010 n = 1220	Part B: Fluarix QIV n = 1488	Part B: mRNA-1010 n = 1492	Part C: Fluzone HD QIV n = 1490	Part C: mRNA-1010 n = 1502
Value	682	1060	796	1158	734	1131

Population analysed: Solicited Safety Set included all randomized participants who received any study intervention and contributed any solicited AR data. Participants were included in the group corresponding to the study intervention that they actually received.

Primary outcome: Number of Participants With Unsolicited Adverse Events (AEs)

Time frame: Up to 28 days after study injection. Count of participants. Unit: Participants

Measure	Part A: Fluarix QIV n = 1180	Part A: mRNA-1010 n = 1220	Part B: Fluarix QIV n = 1488	Part B: mRNA-1010 n = 1492	Part C: Fluzone HD QIV n = 1490	Part C: mRNA-1010 n = 1502
Value	134	145	134	147	137	155

Population analysed: Safety Set included all randomized participants who received any study intervention. Participants were included in the group corresponding to the study intervention that they actually received.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality and serious adverse events were collected from Day 1 through Day 181. Other (not including serious) unsolicited adverse events were collected up to 28 days after study injection (that is, Day 1 up to Day 29). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Fluarix QIV	21 of 1,180 (1.8%)	0 of 1,180 (0%)	1 of 1,189
Part A: mRNA-1010	27 of 1,220 (2.2%)	0 of 1,220 (0%)	5 of 1,225
Part B: Fluarix QIV	22 of 1,488 (1.5%)	0 of 1,488 (0%)	2 of 1,494
Part B: mRNA-1010	25 of 1,492 (1.7%)	0 of 1,492 (0%)	3 of 1,500
Part C: Fluzone HD QIV	38 of 1,490 (2.6%)	0 of 1,490 (0%)	1 of 1,496
Part C: mRNA-1010	41 of 1,502 (2.7%)	0 of 1,502 (0%)	3 of 1,507

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39919447Soens 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

103 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mRNA-1010 and Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine in people with Seasonal Influenza, run by ModernaTX, Inc. at 103 sites in United States.

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 8 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States. 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 10 Jul 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?

Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI) (time frame: Day 29). The study lists 5 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 NCT05827978, 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 10 Jul 2025.