> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-mrna-based-influenza-and-sars-cov-2-covid-19-937123f0-472c-44b7-bfe9-6c76e00404a7 > Record changed: 2026-10-13 # A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults NCT05827926 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) Participants 1,758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) Lead sponsor ModernaTX, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) Start date 2023-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) Number of sites 69 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Title and summary **Summary** The study is divided into 2 parts: Part 1 and Part 2\. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \\<50 years of age. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Short title** A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Official title** A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Dates **Completion date** 2024-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **First posted** 2023-04-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Registry last updated** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Primary completion date** 2024-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Start date** 2023-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Size and sites **Actual participants** 1,758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Participants** 1,758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Number of sites** 69 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Lead sponsor** ModernaTX, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Identifiers **Registry ID** NCT05827926 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **ClinicalTrials.gov ID** NCT05827926 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Outcomes ### Primary outcomes 1. Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Timeframe: Up to 7 days after study injection Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. 2. Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs Timeframe: Up to 28 days after study injection An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \\\[PT\\\]/partial thromboplastin time \\\[PTT\\\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Severity for all unsolicited AEs was determined by the Investigator based upon medical judgment and graded as Mild, Moderate or Severe. Number of participants with unsolicited AEs (SAEs and non-serious AEs) and severe AEs up to 28 days post-vaccination are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. 3. Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation Timeframe: Day 1 through Day 181 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/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were protocol-defined medical concepts. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site. Number of participants with SAEs, AESIs, MAAEs, and AEs leading to study discontinuation up to Day 181 are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. 4. Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay Timeframe: Day 29 Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \\\* LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for geometric mean (GM) titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. 5. Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) Timeframe: Day 29 SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \\\* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. 6. Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay Timeframe: Day 29 Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 \\\* LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. 7. Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA Timeframe: Day 29 SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \\\* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure. 8. Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay Timeframe: Baseline to Day 29 Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \\<1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. Arms based on the applicable vaccine for this Outcome Measure. 9. Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA Timeframe: Baseline to Day 29 SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 \\\* LLOQ if Baseline neutralizing antibody (nAb) level was \\< LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. Arms based on the applicable vaccine for this Outcome Measure. ### Secondary outcomes 1. Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay Timeframe: Baseline (Day 1), Day 29, and Day 181 Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 \\\* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/ Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 2. Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA Timeframe: Baseline (Day 1), Day 29, and Day 181 SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 \\\* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 3. Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay Timeframe: Day 29 and Day 181 Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 \\\* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 4. Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA Timeframe: Day 29 and Day 181 SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 \\\* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 5. Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay Timeframe: Baseline (Day 1) to Day 29, and Day 181 Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \\< 1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 6. Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA Timeframe: Baseline (Day 1) to Day 29, and Day 181 SARS-CoV-2 strain included BA.4/5 and D614G antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 x LLOQ if baseline nAb level was \\14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed. - Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. - Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1. - Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1. - Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1. - Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the clinical trial. - Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home. Part 2 (Phase 2 Extension) Only - Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study. Note: Other inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Sites - Chandler Clinical TrialsChandler, United States - Benchmark ResearchColton, United States - Marvel Clinical ResearchHuntington Beach, United States - Central Valley ResearchModesto, United States - Benchmark ResearchSacramento, United States - Tekton ResearchLongmont, United States - Accel Research SitesDeLand, United States - CenExelHollywood, United States - Nature Coast Clinical ResearchInverness, United States - Jacksonville Center For Clinical ResearchJacksonville, United States - Accel Research SitesMaitland, United States - Suncoast Research GroupMiami, United States - Centricity ResearchColumbus, United States - Accel Research SiteDecatur, United States - CenExel iResearchDecatur, United States - Lifeline Primary CareLilburn, United States - Koch Family MedicineMorton, United States - Optimal ResearchPeoria, United States - DM Clinical ResearchRiver Forest, United States - Johnson County Clin-TrialsLenexa, United States - Tekton ResearchWichita, United States - Versailles Family MedicineVersailles, United States - Velocity Clinical researchBaton Rouge, United States - Benchmark ResearchMetairie, United States - DelRicht ResearchNew Orleans, United States And 44 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## References - PubMed 40102593 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40102593/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05827926) ## Related records ### Drugs (1) - [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.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) Primary condition - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) ### 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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