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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:
• 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.
Locations
United States
Arizona
Headlands Research Scottsdale
NOT_YET_RECRUITING
Scottsdale
California
Artemis Research (Headlands)
NOT_YET_RECRUITING
San Diego
Georgia
Clinical Research Atlanta (Headlands)
NOT_YET_RECRUITING
Stockbridge
Idaho
Velocity Clinical Research, Boise
NOT_YET_RECRUITING
Meridian
Illinois
DM Clinical Research - Chicago
NOT_YET_RECRUITING
Melrose Park
Louisiana
Velocity Clinical Research, Lafayette
NOT_YET_RECRUITING
Lafayette
Massachusetts
DM Clinical Research - Boston
NOT_YET_RECRUITING
Brookline
Maryland
Velocity Clinical Research, Rockville
NOT_YET_RECRUITING
Rockville
Michigan
DM Clinical Research - Detroit
NOT_YET_RECRUITING
Southfield
North Carolina
Trial Management Associates, LLC
NOT_YET_RECRUITING
Wilmington
Nebraska
Velocity Clinical Research, Norfolk
NOT_YET_RECRUITING
Norfolk
Ohio
Velocity Clinical Research, Cincinnati, Mt. Auburn
NOT_YET_RECRUITING
Cincinnati
Velocity Clinical Research, Cincinnati, Springdale
NOT_YET_RECRUITING
Cincinnati
Pennsylvania
DM Clinical Research - Philadelphia
RECRUITING
Philadelphia
South Carolina
Trial Management Associates, LLC
NOT_YET_RECRUITING
Myrtle Beach
Texas
DM Clinical Research - Bellaire
NOT_YET_RECRUITING
Houston
DM Clinical Research - Tomball
NOT_YET_RECRUITING
Tomball
Contact Information
Primary
Moderna WeCare Team
WeCareClinicalTrials@modernatx.com
1-866-663-3762
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2025-10-06
Participants
Target number of participants: 1300
Treatments
Experimental: 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.
Experimental: 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.
Experimental: mRNA-1083 Composition 1 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.
Experimental: mRNA-1083 Composition 1 Dose C
Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.
Experimental: mRNA-1083 Composition 2 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.
Experimental: mRNA-1083 Composition 2 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.
Experimental: mRNA-1083 Composition 3 Dose A
Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1.
Experimental: mRNA-1083 Composition 3 Dose B
Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1.
Active_comparator: Influenza Vaccine
Participants will receive single IM injection of Influenza Vaccine on Day 1.
Active_comparator: COVID-19 Vaccine
Participants will receive single IM injection of COVID-19 Vaccine on Day 1.
Active_comparator: Investigational Influenza Vaccine
Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1.
Active_comparator: Investigational COVID-19 Vaccine Lot A
Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.
Active_comparator: Investigational COVID-19 Vaccine Lot B
Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.
Sponsors
Leads: ModernaTX, Inc.