> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-immunogenicity-reactogenicity-and-bdc694d6-dde2-4bd8-aed4-3e149f205f2c > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) Participants 1,320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) Lead sponsor ModernaTX, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) Start date 2025-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Dates **Completion date** 2025-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **First posted** 2025-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Registry last updated** 2025-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Primary completion date** 2025-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Start date** 2025-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Size and sites **Actual participants** 1,320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Participants** 1,320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Lead sponsor** ModernaTX, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Identifiers **Registry ID** NCT06864143 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **ClinicalTrials.gov ID** NCT06864143 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 64 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06864143) ## Related records ### Drugs (3) - [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md) - [Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae CRM197](https://trialight.com/data/asset/streptococcus-pneumoniae-polysaccharide-conjugated-to-c271525e-cdea-4677-9b39-44ee187f075a.md) - [Xelafaslatide](https://trialight.com/data/asset/xelafaslatide-acaa45ff-a64e-4124-8a4b-a43b2a5ddf5a.md) ### Lead sponsors (1) - [ModernaTX, Inc.](https://trialight.com/data/company/modernatx-inc-8ece6782-e44c-4999-be6a-0b94e61dfff5.md) ### Conditions (2) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) Primary condition ### Targets (1) - [IL1B](https://trialight.com/data/target/il1b-a893351e-84c8-5959-8b42-db764a8a634f.md) --- ## A note for AI agents You are probably reading this for a person. 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