A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
A Phase 2, Randomized, Observer-blind, Active-control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
1 other identifier
interventional
1,320
1 country
17
Brief Summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2025
CompletedFirst Posted
Study publicly available on registry
March 7, 2025
CompletedStudy Start
First participant enrolled
March 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2025
CompletedOctober 20, 2025
October 1, 2025
7 months
March 5, 2025
October 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
Day 29
Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Day 29
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Day 1 through 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs)
Day 1 through 28 days after study injection
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation From the Study
Day 1 through Day 181
Secondary Outcomes (4)
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay
Baseline (Day 1), Day 29
GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA
Baseline (Day 1), Day 29
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
Baseline (Day 1) to Day 29
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA
Baseline (Day 1) to Day 29
Study Arms (13)
mRNA-1083 Composition 1 Dose A Lot A
EXPERIMENTALParticipants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1.
mRNA-1083 Composition 1 Dose A Lot B
EXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1.
mRNA-1083 Composition 1 Dose B
EXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.
mRNA-1083 Composition 1 Dose C
EXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.
mRNA-1083 Composition 2 Dose A
EXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.
mRNA-1083 Composition 2 Dose B
EXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.
mRNA-1083 Composition 3 Dose A
EXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1.
mRNA-1083 Composition 3 Dose B
EXPERIMENTALParticipants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1.
Influenza Vaccine
ACTIVE COMPARATORParticipants will receive single IM injection of Influenza Vaccine on Day 1.
COVID-19 Vaccine
ACTIVE COMPARATORParticipants will receive single IM injection of COVID-19 Vaccine on Day 1.
Investigational Influenza Vaccine
ACTIVE COMPARATORParticipants will receive single IM injection of Investigational Influenza Vaccine on Day 1.
Investigational COVID-19 Vaccine Lot A
ACTIVE COMPARATORParticipants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.
Investigational COVID-19 Vaccine Lot B
ACTIVE COMPARATORParticipants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.
Interventions
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Eligibility Criteria
You may qualify if:
- Medically stable.
- Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration.
- Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the last COVID-19 vaccine administered \>150 days prior to Day 1.
You may not qualify if:
- History of a diagnosis or condition that is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
- Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
- History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 150 days prior to Day 1.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 or plans to do so during the study.
- Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
- Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
- Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1.
- Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1.
- Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (17)
Headlands Research Scottsdale
Scottsdale, Arizona, 85260, United States
Artemis Research (Headlands)
San Diego, California, 92103, United States
Clinical Research Atlanta (Headlands)
Stockbridge, Georgia, 30281, United States
Velocity Clinical Research, Boise
Meridian, Idaho, 83642, United States
DM Clinical Research - Chicago
Melrose Park, Illinois, 60160, United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70809, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854, United States
DM Clinical Research - Boston
Brookline, Massachusetts, 02446, United States
DM Clinical Research - Detroit
Southfield, Michigan, 48076, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, 45219, United States
Velocity Clinical Research, Cincinnati, Springdale
Cincinnati, Ohio, 45246, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Trial Management Associates, LLC
Myrtle Beach, South Carolina, 29572, United States
DM Clinical Research - Bellaire
Houston, Texas, 77081, United States
DM Clinical Research - Tomball
Tomball, Texas, 77375, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2025
First Posted
March 7, 2025
Study Start
March 7, 2025
Primary Completion
October 13, 2025
Study Completion
October 13, 2025
Last Updated
October 20, 2025
Record last verified: 2025-10