A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

December 3, 2025 updated by: ModernaTX, Inc.

A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults

The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.

The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and <50 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Part 1: Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to <80 years of age or Cohort B for adults ≥18 to <65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to <50 years and ≥50 to <65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022).

Part 2: Approximately, 520 participants between ≥18 to <50 years of age will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since Sept 2023).

Study Type

Interventional

Enrollment (Actual)

1758

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224-6231
        • Chandler Clinical Trials
    • California
      • Colton, California, United States, 92324
        • Benchmark Research
      • Huntington Beach, California, United States, 92647-6835
        • Marvel Clinical Research
      • Modesto, California, United States, 95350-5365
        • Central Valley Research
      • Sacramento, California, United States, 95864-3102
        • Benchmark Research
    • Colorado
      • Longmont, Colorado, United States, 80501-6461
        • Tekton Research
    • Florida
      • DeLand, Florida, United States, 32720-0834
        • Accel Research Sites
      • Hollywood, Florida, United States, 33024
        • CenExel
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Maitland, Florida, United States, 32751
        • Accel Research Sites
      • Miami, Florida, United States, 33135-1687
        • Suncoast Research Group
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Centricity Research
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch
      • Decatur, Georgia, United States, 30030-2615
        • Accel Research Site
      • Lilburn, Georgia, United States, 30047-2832
        • Lifeline Primary Care
    • Illinois
      • Morton, Illinois, United States, 61550
        • Koch Family Medicine
      • Peoria, Illinois, United States, 61614-4885
        • Optimal Research
      • River Forest, Illinois, United States, 60305-1876
        • DM Clinical Research
    • Kansas
      • Lenexa, Kansas, United States, 66219-1389
        • Johnson County Clin-Trials
      • Wichita, Kansas, United States, 67218-2913
        • Tekton Research
    • Kentucky
      • Versailles, Kentucky, United States, 40383-1947
        • Versailles Family Medicine
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Velocity Clinical Research
      • Metairie, Louisiana, United States, 70006
        • Benchmark Research
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
      • Prairieville, Louisiana, United States, 70769
        • DelRicht Research
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Annapolis Internal Medicine
      • Rockville, Maryland, United States, 20854
        • Velocity Clinical Research
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445-7113
        • DM Clinical Research
    • Michigan
      • Dearborn Heights, Michigan, United States, 48127-2234
        • Vida Clinical Studies
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • DelRicht Research
    • Missouri
      • Kansas City, Missouri, United States, 64151-2411
        • Clay Platte Family Medicine
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Velocity Clinical Research
      • Norfolk, Nebraska, United States, 68701
        • Velocity Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89109-6209
        • Excel Clinical Research
      • Las Vegas, Nevada, United States, 89119
        • CCT Research
      • North Las Vegas, Nevada, United States, 89030-7193
        • Las Vegas Clinical Trials
    • New York
      • Rochester, New York, United States, 14609-3169
        • Rochester Clinical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Tryon Medical Partners
      • Wilmington, North Carolina, United States, 28403-6238
        • Trial Management Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45219
        • Velocity Clinical Research
      • Cincinnati, Ohio, United States, 45246
        • Velocity Clinical Research
      • Columbus, Ohio, United States, 43213
        • Centricity Research
      • Dayton, Ohio, United States, 45424-4019
        • WellNow Urgent Care & Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73111-3324
        • Lynn Institute of East Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • DelRicht Research
      • Yukon, Oklahoma, United States, 73099-9518
        • Tekton Research Inc
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-1530
        • DM Clinical Research
      • Philadelphia, Pennsylvania, United States, 19111-2432
        • Mercado Medical Practice
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • DelRicht Research
      • Myrtle Beach, South Carolina, United States, 29572-4612
        • Trial Management Associates
    • Tennessee
      • Elizabethton, Tennessee, United States, 37643
        • Medical Care
      • Hendersonville, Tennessee, United States, 37075
        • DelRicht Research
    • Texas
      • Austin, Texas, United States, 78705-3298
        • Benchmark Research
      • Austin, Texas, United States, 78745-1470
        • Tekton Research
      • Beaumont, Texas, United States, 77706-3061
        • Tekton Research
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development
      • Houston, Texas, United States, 77065
        • Cyfair Clinical Research
      • McKinney, Texas, United States, 75070
        • DelRicht Research
      • San Angelo, Texas, United States, 76904-7610
        • Benchmark Research
      • San Antonio, Texas, United States, 78229
        • Tekton Research
    • Utah
      • Pleasant View, Utah, United States, 84404
        • CCT Research
      • Roy, Utah, United States, 84067
        • Ogden Clinic
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Meridian Clinical Research
      • Portsmouth, Virginia, United States, 23703
        • Velocity Clinical Research
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital & Clinics Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

Part 1 (Phase 1/2)

  • Adults ≥18 to <80 years of age at the time of consent.
  • Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
  • Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests.
  • 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 Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
  • Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥120 days prior to Day 1.

Part 2 (Phase 2 Extension)

  • Adults ≥18 to <50 years of age at the time of consent.
  • BMI of 18 kg/m^2 to 35 kg/m^2 (inclusive) at the Screening Visit.
  • Healthy as determined by medical evaluation, including medical history, and physical examination.
  • 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 Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
  • Have received at least 2 doses of locally authorized or approved COVID-19 vaccines and last dose was ≥90 days prior to Day 1.

Key Exclusion Criteria:

Part 1 (Phase 1/2) and Part 2 (Phase 2 Extension)

  • Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
  • Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results.
  • Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
  • Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration.
  • Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1.
  • Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
  • Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 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 clinical trial.
  • Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home.

Part 2 (Phase 2 Extension) Only

  • Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study.

Note: Other inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Cohort A2: mRNA-1083.1 Dose B
Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.
Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Part 1 Cohort A3: mRNA-1083.1 Dose C
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Part 1 Cohort A4: mRNA-1083.2 Dose A
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Part 1 Cohort A5: mRNA-1083.2 Dose B
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Part 1 Cohort A6: mRNA-1083.2 Dose C
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Part 1 Cohort A7: mRNA-1083.3
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
Biological: mRNA-1083.3
Sterile liquid for injection
Active Comparator: Part 1 Cohort A8: Investigational Influenza Vaccine 1
Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.
Biological: Investigational Influenza Vaccine 1
Sterile liquid for injection
Active Comparator: Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
Biological: Investigational COVID-19 Vaccine 1
Sterile liquid for injection
Active Comparator: Part 1 Cohort A10: COVID-19 Vaccine 1
Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.
Biological: COVID-19 Vaccine 1
Sterile liquid for injection
Active Comparator: Part 1 Cohort A11: Investigational Influenza Vaccine 2
Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.
Biological: Investigational Influenza Vaccine 2
Sterile liquid for injection
Active Comparator: Part 1 Cohort A12: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
Biological: Influenza Vaccine 1
quadrivalent seasonal influenza vaccine
Active Comparator: Part 1 Cohort A13: Influenza Vaccine 2
Participants will receive single IM injection of Influenza Vaccine 2 on Day 1.
Biological: Influenza Vaccine 2
quadrivalent seasonal influenza vaccine
Experimental: Part 1 Cohort B1: mRNA-1083.1 Dose A
Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.
Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Part 1 Cohort B2: mRNA-1083.1 Dose B
Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.
Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Part 1 Cohort B3: mRNA-1083.1 Dose C
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
Biological: mRNA-1083.1
Sterile liquid for injection
Experimental: Part 1 Cohort B4: mRNA-1083.2 Dose A
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Part 1 Cohort B5: mRNA-1083.2 Dose B
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Part 1 Cohort B6: mRNA-1083.2 Dose C
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
Biological: mRNA-1083.2
Sterile liquid for injection
Experimental: Part 1 Cohort B7: mRNA-1083.3
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
Biological: mRNA-1083.3
Sterile liquid for injection
Active Comparator: Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.
Biological: Investigational Influenza Vaccine 1
Sterile liquid for injection
Active Comparator: Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
Biological: Investigational COVID-19 Vaccine 1
Sterile liquid for injection
Active Comparator: Part 1 Cohort B10: COVID-19 Vaccine 1
Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.
Biological: COVID-19 Vaccine 1
Sterile liquid for injection
Active Comparator: Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.
Biological: Investigational Influenza Vaccine 2
Sterile liquid for injection
Active Comparator: Part 1 Cohort B12: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
Biological: Influenza Vaccine 1
quadrivalent seasonal influenza vaccine
Experimental: Part 2: mRNA-1083 Composition 1 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A on Day 1.
Biological: mRNA-1083
Sterile liquid for injection
Experimental: Part 2: mRNA-1083 Composition 2 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.
Biological: mRNA-1083
Sterile liquid for injection
Experimental: Part 2: mRNA-1083 Composition 1 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.
Biological: mRNA-1083
Sterile liquid for injection
Experimental: Part 2: mRNA-1083 Composition 2 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.
Biological: mRNA-1083
Sterile liquid for injection
Experimental: Part 2: mRNA-1083 Composition 1 Dose C
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.
Biological: mRNA-1083
Sterile liquid for injection
Experimental: Part 2: mRNA-1083 Composition 2 Dose C
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level C on Day 1.
Biological: mRNA-1083
Sterile liquid for injection
Experimental: Part 2: mRNA-1083 Composition 1 Dose D
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level D on Day 1.
Biological: mRNA-1083
Sterile liquid for injection
Experimental: Part 2: mRNA-1083 Composition 2 Dose D
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level D on Day 1.
Biological: mRNA-1083
Sterile liquid for injection
Active Comparator: Part 2: Investigational Influenza Vaccine 1 Dose A
Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level A on Day 1.
Biological: Investigational Influenza Vaccine 1
Sterile liquid for injection
Active Comparator: Part 2: Investigational Influenza Vaccine 1 Dose B
Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level B on Day 1.
Biological: Investigational Influenza Vaccine 1
Sterile liquid for injection
Active Comparator: Part 2: Investigational COVID-19 Vaccine 2
Participants will receive single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
Biological: Investigational COVID-19 Vaccine 2
Sterile liquid for injection
Active Comparator: Part 2: COVID-19 Vaccine 2
Participants will receive single IM injection of COVID-19 Vaccine 2 on Day 1.
Biological: COVID-19 Vaccine 2
Sterile liquid for injection
Active Comparator: Part 2: Influenza Vaccine 1
Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.
Biological: Influenza Vaccine 1
quadrivalent seasonal influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to 7 days after study injection
Solicited ARs (local and systemic) were reported by participants 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.
Up to 7 days after study injection
Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe 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. 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. Severity for all unsolicited AEs was determined by the Investigator based upon medical judgment and graded as Mild, Moderate or Severe. Number of participants with unsolicited AEs (SAEs and non-serious AEs) and severe AEs up to 28 days post-vaccination are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 28 days after study injection
Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
Time Frame: Day 1 through Day 181
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 were protocol-defined medical concepts. 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 COVID-19 and visits to healthcare practitioners external to the study site. Number of participants with SAEs, AESIs, MAAEs, and AEs leading to study discontinuation up to Day 181 are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Day 181
Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Time Frame: Day 29
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the 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. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for geometric mean (GM) titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Day 29
Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA)
Time Frame: Day 29
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 * LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Day 29
Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay
Time Frame: Day 29
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Day 29
Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA
Time Frame: Day 29
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 * LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Day 29
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Time Frame: Baseline to Day 29
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. Arms based on the applicable vaccine for this Outcome Measure.
Baseline to Day 29
Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
Time Frame: Baseline to Day 29
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 * LLOQ if Baseline neutralizing antibody (nAb) level was < LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. Arms based on the applicable vaccine for this Outcome Measure.
Baseline to Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Time Frame: Baseline (Day 1), Day 29, and Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 * LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/ Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Baseline (Day 1), Day 29, and Day 181
Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
Time Frame: Baseline (Day 1), Day 29, and Day 181
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 * LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Baseline (Day 1), Day 29, and Day 181
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Time Frame: Day 29 and Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 * LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Day 29 and Day 181
Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
Time Frame: Day 29 and Day 181
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 * LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Day 29 and Day 181
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Time Frame: Baseline (Day 1) to Day 29, and Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer < 1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Baseline (Day 1) to Day 29, and Day 181
Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
Time Frame: Baseline (Day 1) to Day 29, and Day 181
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 x LLOQ if baseline nAb level was <LLOQ, or ≥4 fold rise if baseline nAb level was ≥LLOQ. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Baseline (Day 1) to Day 29, and Day 181
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Time Frame: Baseline (Day 1), Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Baseline (Day 1), Day 181
Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA
Time Frame: Baseline (Day 1), Day 181
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 * LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Baseline (Day 1), Day 181
Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Time Frame: Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ converted to ULOQ. LLOQ= 10, ULOQ= 3620 for Influenza A H1N1, LLOQ= 10, ULOQ= 5120 for Influenza A H3N2, LLOQ= 10, ULOQ= 1356 for Influenza B/Victoria-lineage, and LLOQ= 10, ULOQ= 1280 for Influenza B/Yamagata-lineage. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Day 181
Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
Time Frame: Day 181
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 * LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Day 181
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Time Frame: Baseline (Day 1) to Day 181
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Baseline (Day 1) to Day 181
Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
Time Frame: Baseline (Day 1) to Day 181
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 * LLOQ if Baseline nAb level was < LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Baseline (Day 1) to Day 181

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Actual)

December 3, 2024

Study Completion (Actual)

December 3, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

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Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1083-P101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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