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InfluenzaPhase 2NCT06508320

A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)

A Phase 2 study testing mRNA-1083 in people with Influenza and SARS-CoV-2, run by ModernaTX, Inc. at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to <65 years of age. Read more about this study

Who is it for?
Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, SARS-CoV-2
What is being tested?
mRNA-1083
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
931 participants
Where
17 sitesin 2 countries
Study dates
15 Jul 2024to 25 Sep 2025
Phase
Phase 2
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 50 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Investigator assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
  • Participants of nonchildbearing potential may be enrolled in the study.
  • Participants who could become pregnant: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
  • Have received an influenza vaccine in the previous season (since September 2023 for Part 1, since Sep 2024 for Part 2).

Who cannot join

  • Reported diagnosis or condition that is associated with increased risk of severe influenza disease or complications, including individuals with chronic medical conditions.
  • Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
  • History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
  • Received corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
  • Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (e.g., 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.
Show all 10Show fewer
  • Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
  • Received a licensed/authorized SARS-CoV-2 vaccine within 90 days prior to Day 1.
  • Received any investigational influenza vaccine, investigational coronavirus disease 2019 (COVID-19) vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1. Participants from mRNA-1083-P201 Part 1 will also be excluded from Part 2.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States12 sites
  • Cenexel IRA

    Decatur, Georgia, 30030

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • Cenexel RCA

    Hollywood, Florida, 33024

  • DM Clinical Research - Cyfair Clinical Research Center - PPDS

    Houston, Texas, 77065-5685

  • JCCT

    Lenexa, Kansas, 66219

  • Hassman Research Institute - Berlin - CenExel - PPDS

    Marlton, New Jersey, 80530

  • Suncoast Research Group, LLC DBA Flourish Research

    Miami, Florida, 33135

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • DM Clinical Research - River Forest

    River Forest, Illinois, 60305

  • Clinical Trials of Texas, LLC DBA Flourish Research

    San Antonio, Texas, 78229

  • DM Clinical Research - Sugarland

    Sugar Land, Texas, 77478

  • DM Clinical Research - Tomball MDC

    Tomball, Texas, 77375

Other trials in United States

Canada5 sites
  • Centricity Research

    Pointe-Claire, Quebec, H9R4S3

  • Diex Recherche Québec Inc.

    Québec, G1V 4T3

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Centricity Research

    Toronto, Ontario, M4G 3E8

  • Centricity Research

    Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity in Relation to the Product Attributes of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Adults ≥50 to <65 Years of Age

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to <65 years of age.

Read the detailed description

The study will be comprised of 2 parts, Parts 1 and 2. In Part 1, participants will be randomized into 4 study groups (Lots A, B, C, and D). Upon completion of Part 1, participants will be randomized into 2 study groups (Lots A and E) in Part 2.

Being tested
mRNA-1083
Keywords
Influenza, SARS-CoV-2, mRNA-1083
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1083Biological

    IM injection in a deltoid muscle.

Study groups in NCT06508320
Study groupRoleWhat they receive
Part 1 Group 1 - mRNA-1083 Lot AExperimentalParticipants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 1.
Receives: Biological: mRNA-1083
Part 1 Group 2 - mRNA-1083 Lot BExperimentalParticipants will receive mRNA-1083 Lot B as a single injection on Day 1 in Part 1.
Receives: Biological: mRNA-1083
Part 1 Group 3 - mRNA-1083 Lot CExperimentalParticipants will receive mRNA-1083 Lot C as a single injection on Day 1 in Part 1.
Receives: Biological: mRNA-1083
Part 1 Group 4 - mRNA-1083 Lot DExperimentalParticipants will receive mRNA-1083 Lot D as a single injection on Day 1 in Part 1.
Receives: Biological: mRNA-1083
Part 2 Group 5 - mRNA-1083 Lot AExperimentalParticipants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 2.
Receives: Biological: mRNA-1083
Part 2 Group 6 - mRNA-1083 Lot EExperimentalParticipants will receive mRNA-1083 Lot E as a single injection on Day 1 in Part 2.
Receives: Biological: mRNA-1083

What is being measured

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

  1. Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody for Seasonal Influenza A and B Strains

    The GMT has been measured by (Hemagglutination Inhibition) HAI assay based on ANCOVA Model. Antibody values reported as below the lower limit of quantification (LLOQ) are replaced by 0.5 x LLOQ. Values greater than the upper limit of quantification (ULOQ) are converted to the ULOQ.

    The log-transformed antibody levels are analyzed using an Analysis of Covariance model with intervention group as the fixed variable, log transformed baseline antibody values as a fixed covariate. The model based GMT, and its corresponding 95% CI are obtained by transforming the least square mean estimate and its CI back to the original scale for presentation.

    Measured: Day 29

  2. Geometric Mean Titer (GMT) of Neutralizing Antibody for SARS-CoV-2

    The GMT has been measured by Pseudovirus Neutralization (PsVNA) assay based on ANCOVA Model. Antibody values reported as below the lower limit of quantification (LLOQ) are replaced by 0.5 x LLOQ. Values greater than the upper limit of quantification (ULOQ) are converted to the ULOQ.

    The log-transformed antibody levels are analyzed using an Analysis of Covariance model with intervention group as the fixed variable, log transformed baseline antibody values as a fixed covariate. The model based GMT, and its corresponding 95% CI are obtained by transforming the least square mean estimate and its CI back to the original scale for presentation.

    Measured: Day 29

  3. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

    Solicited ARs 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.

    Measured: From the day of study injection through 6 subsequent days (Up to 7 days)

  4. Number of Participants With Unsolicited Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence, temporally associated with the use of study intervention, whether or not considered related to study intervention. Any solicited local or systemic adverse reaction that met SAE criteria was to be considered as AE.

    Measured: From the day of study injection through 27 subsequent days (Up to 28 days)

  5. Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation

    A 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 are 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: From Day 1 to End of Study (Up to 6 Months)

Secondary outcomes (4)
  1. Geometric Mean Fold Rise (GMFR) of Anti-Hemagglutinin (HA) Antibody for Seasonal Influenza A and B Strains

    The anti-HA antibody values have been measured by (Hemagglutination Inhibition) HAI assay. Antibody values reported as below the lower limit of quantification (LLOQ) are replaced by 0.5 x LLOQ. Values greater than the upper limit of quantification (ULOQ) are converted to the ULOQ. The GMFR 95% CI at Day 29 (relative to Day 1) was calculated based on the t-distribution of the log-transformed values and then back transformed to the original scale for presentation.

    Measured: Day 29

  2. Geometric Mean Fold Rise (GMT) of Neutralizing Antibody for SARS-CoV-2

    The neutralizing antibody values have been measured by Pseudovirus Neutralization (PsVNA) assay. Antibody values reported as below the lower limit of quantification (LLOQ) are replaced by 0.5 x LLOQ. Values greater than the upper limit of quantification (ULOQ) are converted to the ULOQ. The GMFR 95% CI at Day 29 (relative to Day 1) was calculated based on the t-distribution of the log-transformed values and then back transformed to the original scale for presentation.

    Measured: Day 29

  3. Percentage of Participants With Seroconversion in Anti-Hemagglutinin (HA) Antibody for Seasonal Influenza A and B Strains

    Seroconversion of antibodies for an influenza strain is defined as a post-vaccination anti-HA antibody value ≥1:40 if baseline is <1:10 or a ≥4-fold rise in post-vaccination value if baseline is ≥1:10. The anti-HA antibody values have been measured by (Hemagglutination Inhibition) HAI assay. Antibody values reported as below the lower limit of quantification (LLOQ) are replaced by 0.5 x LLOQ. Values greater than the upper limit of quantification (ULOQ) are converted to the ULOQ.

    Measured: Day 29

  4. Percentage of Participants With Seroresponse in Neutralizing Antibody for SARS-CoV-2

    Seroresponse of SARS-CoV-2 antibodies is defined as a post-vaccination neutralizing antibody value ≥4×LLOQ if baseline is <LLOQ, or a ≥4-fold rise in post-vaccination value if baseline is ≥LLOQ. The neutralizing antibody values have been measured by Pseudovirus Neutralization (PsVNA) assay. Antibody values reported as below the lower limit of quantification (LLOQ) are replaced by 0.5 x LLOQ. Values greater than the upper limit of quantification (ULOQ) are converted to the ULOQ.

    Measured: Day 29

Timeline

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

  1. First posted18 Jul 2024
  2. Study start15 Jul 2024
  3. Primary completion25 Sep 2025
  4. Study completion25 Sep 2025

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
931 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508320
Sponsor's protocol ID
mRNA-1083-P201
Status last verified
Sep 2026
First submitted
12 Jul 2024
Last updated
8 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mRNA-1083 in people with Influenza and SARS-CoV-2, run by ModernaTX, Inc. at 17 sites in 2 countries.

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 5 inclusion and 10 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Oct 2026). 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 for Seasonal Influenza A and B Strains (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?
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 8 Oct 2026.

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