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OpenTrials
Completed

NCT Number: NCT06864143

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Headlands Research Scottsdale, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

mRNA-1083 Composition 1 Dose A Lot A

Biological

Sterile liquid for injection

mRNA-1083 Composition 1 Dose A Lot B

Biological

Sterile liquid for injection

mRNA-1083 Composition 1 Dose B

Biological

Sterile liquid for injection

mRNA-1083 Composition 1 Dose C

Biological

Sterile liquid for injection

mRNA-1083 Composition 2 Dose A

Biological

Sterile liquid for injection

mRNA-1083 Composition 2 Dose B

Biological

Sterile liquid for injection

mRNA-1083 Composition 3 Dose A

Biological

Sterile liquid for injection

mRNA-1083 Composition 3 Dose B

Biological

Sterile liquid for injection

influenza vaccine

Biological

Sterile liquid for injection

COVID-19 vaccine

Biological

Sterile liquid for injection

Investigational Influenza Vaccine

Biological

Sterile liquid for injection

Investigational COVID-19 Vaccine Lot A

Biological

Sterile liquid for injection

Investigational COVID-19 Vaccine Lot B

Biological

Sterile liquid for injection

Primary outcomes

  1. Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza

    Time frame: Day 29

  2. Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

    Time frame: Day 29

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

    Time frame: Day 1 through 7 days after study injection

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

    Time frame: Day 1 through 28 days after study injection

  5. 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

    Time frame: Day 1 through Day 181

Secondary outcomes

  1. Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay

    Time frame: Baseline (Day 1), Day 29

  2. GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA

    Time frame: Baseline (Day 1), Day 29

  3. Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay

    Time frame: Baseline (Day 1) to Day 29

    Seroconversion is defined as postinjection level ≥1:40 if baseline is <1:10 or at least a 4-fold rise if baseline is ≥1:10 in HAI antibody titer.

  4. SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA

    Time frame: Baseline (Day 1) to Day 29

    Seroresponse is defined as PsVNA concentration change from preinjection baseline below the lower limit of quantification (LLOQ) to postinjection ≥4×LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ.

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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