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
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

Detailed Description

Not Provided

Recruiting
Influenza
SARS-CoV-2

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 64 Years
Countries
United States
Locations

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

Contacts

Moderna WeCare Team
1-866-663-3762
WeCareClinicalTrials@modernatx.com

Not Provided

ModernaTX, Inc.
NCT Number
Keywords
Influenza
SARS-CoV-2
mRNA-1083
Covid-19
Messenger RNA
Moderna
MeSH Terms
COVID-19
Influenza, Human
Vaccines