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

Purpose

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.

Conditions

  • Influenza
  • SARS-CoV-2

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Biological: mRNA-1083 Composition 1 Dose A Lot A
    Sterile liquid for injection
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.
  • Biological: mRNA-1083 Composition 1 Dose A Lot B
    Sterile liquid for injection
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.
  • Biological: mRNA-1083 Composition 1 Dose B
    Sterile liquid for injection
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.
  • Biological: mRNA-1083 Composition 1 Dose C
    Sterile liquid for injection
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.
  • Biological: mRNA-1083 Composition 2 Dose A
    Sterile liquid for injection
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.
  • Biological: mRNA-1083 Composition 2 Dose B
    Sterile liquid for injection
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.
  • Biological: mRNA-1083 Composition 3 Dose A
    Sterile liquid for injection
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.
  • Biological: mRNA-1083 Composition 3 Dose B
    Sterile liquid for injection
Active Comparator
Influenza Vaccine 		Participants will receive single IM injection of Influenza Vaccine on Day 1.
  • Biological: Influenza Vaccine
    Sterile liquid for injection
  • Biological: Investigational Influenza Vaccine
    Sterile liquid for injection
Active Comparator
COVID-19 Vaccine 		Participants will receive single IM injection of COVID-19 Vaccine on Day 1.
  • Biological: COVID-19 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
Active Comparator
Investigational Influenza Vaccine 		Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1.
  • Biological: Investigational Influenza Vaccine
    Sterile liquid for injection
Active Comparator
Investigational COVID-19 Vaccine Lot A 		Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1.
  • Biological: Investigational COVID-19 Vaccine Lot A
    Sterile liquid for injection
Active Comparator
Investigational COVID-19 Vaccine Lot B 		Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1.
  • Biological: Investigational COVID-19 Vaccine Lot B
    Sterile liquid for injection

Recruiting Locations

DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania 19107

More Details

NCT ID
NCT06864143
Status
Recruiting
Sponsor
ModernaTX, Inc.

Study Contact

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