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
| Arm | Description | Assigned 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. |
|
|
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. |
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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. |
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|
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. |
|
Recruiting Locations
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
More Details
- NCT ID
- NCT06864143
- Status
- Recruiting
- Sponsor
- ModernaTX, Inc.