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

NCT06864143
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Phase
Phase 2
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Recruitment status
Completed
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Participants
1,320
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Lead sponsor
ModernaTX, Inc.
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Start date
2025-03-07
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Number of sites
17
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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.
clinicaltrials.gov
Short title
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
clinicaltrials.gov
Official 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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-10-13
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First posted
2025-03-07
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Registry last updated
2025-10-20
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Primary completion date
2025-10-13
clinicaltrials.gov
Start date
2025-03-07
clinicaltrials.gov

Actual participants
1,320
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Participants
1,320
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
17
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Registry sponsor category
Industry
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Lead sponsor
ModernaTX, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06864143
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ClinicalTrials.gov ID
NCT06864143
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Day 29

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

    Timeframe: Day 29

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

    Timeframe: Day 1 through 7 days after study injection

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

    Timeframe: 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

    Timeframe: Day 1 through Day 181

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

    Timeframe: Baseline (Day 1), Day 29

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

    Timeframe: Baseline (Day 1), Day 29

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

    Timeframe: 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

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
Yes

  • 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.

  • 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.

Sources for eligibility
clinicaltrials.gov

  • Headlands Research ScottsdaleScottsdale, United States
  • Artemis Research (Headlands)San Diego, United States
  • Clinical Research Atlanta (Headlands)Stockbridge, United States
  • Velocity Clinical Research, BoiseMeridian, United States
  • DM Clinical Research - ChicagoMelrose Park, United States
  • Velocity Clinical Research, LafayetteLafayette, United States
  • Velocity Clinical Research, RockvilleRockville, United States
  • DM Clinical Research - BostonBrookline, United States
  • DM Clinical Research - DetroitSouthfield, United States
  • Velocity Clinical Research, NorfolkNorfolk, United States
  • Trial Management Associates, LLCWilmington, United States
  • Velocity Clinical Research, Cincinnati, Mt. AuburnCincinnati, United States
  • Velocity Clinical Research, Cincinnati, SpringdaleCincinnati, United States
  • DM Clinical Research - PhiladelphiaPhiladelphia, United States
  • Trial Management Associates, LLCMyrtle Beach, United States
  • DM Clinical Research - BellaireHouston, United States
  • DM Clinical Research - TomballTomball, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (2)

Targets (1)