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
- Conditions
- InfluenzaSARS-CoV-2
- Interventions
- Biological: mRNA-1083 Composition 1 Dose A Lot ABiological: mRNA-1083 Composition 1 Dose A Lot BBiological: mRNA-1083 Composition 1 Dose BBiological: mRNA-1083 Composition 1 Dose CBiological: mRNA-1083 Composition 2 Dose ABiological: mRNA-1083 Composition 2 Dose BBiological: mRNA-1083 Composition 3 Dose ABiological: mRNA-1083 Composition 3 Dose BBiological: Investigational Influenza VaccineBiological: Investigational COVID-19 Vaccine Lot ABiological: Investigational COVID-19 Vaccine Lot B
- Registration Number
- NCT06864143
- Lead Sponsor
- ModernaTX, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1300
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mRNA-1083 Composition 1 Dose A Lot A mRNA-1083 Composition 1 Dose A Lot A Participants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1. mRNA-1083 Composition 1 Dose A Lot B mRNA-1083 Composition 1 Dose A Lot B Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1. mRNA-1083 Composition 1 Dose B mRNA-1083 Composition 1 Dose B Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1. mRNA-1083 Composition 1 Dose C mRNA-1083 Composition 1 Dose C Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1. mRNA-1083 Composition 2 Dose A mRNA-1083 Composition 2 Dose A Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1. mRNA-1083 Composition 2 Dose B mRNA-1083 Composition 2 Dose B Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1. mRNA-1083 Composition 3 Dose A mRNA-1083 Composition 3 Dose A Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1. mRNA-1083 Composition 3 Dose B mRNA-1083 Composition 3 Dose B Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1. Influenza Vaccine Influenza Vaccine Participants will receive single IM injection of Influenza Vaccine on Day 1. COVID-19 Vaccine COVID-19 Vaccine Participants will receive single IM injection of COVID-19 Vaccine on Day 1. Investigational Influenza Vaccine Investigational Influenza Vaccine Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1. Investigational COVID-19 Vaccine Lot A Investigational COVID-19 Vaccine Lot A Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1. Investigational COVID-19 Vaccine Lot B Investigational COVID-19 Vaccine Lot B Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.
- Primary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza Day 29 Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Day 29 Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Day 1 through 7 days after study injection Number of Participants With Unsolicited Adverse Events (AEs) Day 1 through 28 days after study injection 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 Day 1 through Day 181
- Secondary Outcome Measures
Name Time Method Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay Baseline (Day 1), Day 29 GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA Baseline (Day 1), Day 29 Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay 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.
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA 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.
Related Research Topics
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Trial Locations
- Locations (16)
Headlands Research Scottsdale
🇺🇸Scottsdale, Arizona, United States
Artemis Research (Headlands)
🇺🇸San Diego, California, United States
Clinical Research Atlanta (Headlands)
🇺🇸Stockbridge, Georgia, United States
Velocity Clinical Research, Boise
🇺🇸Meridian, Idaho, United States
DM Clinical Research - Chicago
🇺🇸Melrose Park, Illinois, United States
Velocity Clinical Research, Lafayette
🇺🇸Lafayette, Louisiana, United States
Velocity Clinical Research, Rockville
🇺🇸Rockville, Maryland, United States
DM Clinical Research - Boston
🇺🇸Brookline, Massachusetts, United States
DM Clinical Research - Detroit
🇺🇸Southfield, Michigan, United States
Velocity Clinical Research, Norfolk
🇺🇸Norfolk, Nebraska, United States
Trial Management Associates, LLC
🇺🇸Myrtle Beach, South Carolina, United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research, Cincinnati, Springdale
🇺🇸Cincinnati, Ohio, United States
DM Clinical Research - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
DM Clinical Research - Bellaire
🇺🇸Houston, Texas, United States
DM Clinical Research - Tomball
🇺🇸Tomball, Texas, United States