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
Not Provided
Biological: mRNA-1083 Composition 1 Dose A Lot A
Sterile liquid for injection
Biological: mRNA-1083 Composition 1 Dose A Lot B
Sterile liquid for injection
Biological: mRNA-1083 Composition 1 Dose B
Sterile liquid for injection
Biological: mRNA-1083 Composition 1 Dose C
Sterile liquid for injection
Biological: mRNA-1083 Composition 2 Dose A
Sterile liquid for injection
Biological: mRNA-1083 Composition 2 Dose B
Sterile liquid for injection
Biological: mRNA-1083 Composition 3 Dose A
Sterile liquid for injection
Biological: mRNA-1083 Composition 3 Dose B
Sterile liquid for injection
Biological: Influenza Vaccine
Sterile liquid for injection
Biological: COVID-19 Vaccine
Sterile liquid for injection
Biological: Investigational Influenza Vaccine
Sterile liquid for injection
Biological: Investigational COVID-19 Vaccine Lot A
Sterile liquid for injection
Biological: Investigational COVID-19 Vaccine Lot B
Sterile liquid for injection
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.
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
Wilmington, North 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
Trial Management Associates, LLC
Myrtle Beach, South Carolina, United States
DM Clinical Research - Bellaire
Houston, Texas, United States
DM Clinical Research - Tomball
Tomball, Texas, United States
Moderna WeCare Team
1-866-663-3762
WeCareClinicalTrials@modernatx.com
Not Provided