A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
SARS-CoV-2, Influenza
About this trial
This is an interventional prevention trial for SARS-CoV-2 focused on measuring mRNA-1083, mRNA-1083 Vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, Influenza Vaccine, Moderna
Eligibility Criteria
Key Inclusion Criteria: Body mass index (BMI) of 18 kilograms (kg)/m2 to 35 kg/square meter (m^2) (inclusive) at the Screening Visit. Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests. For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding. Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥120 days prior to Day 1. Key Exclusion Criteria: Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1. Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed. Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1. Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1. Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1. Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the clinical trial. Note: Other inclusion/exclusion criteria may apply.
Sites / Locations
- Chandler Clinical Trials
- Benchmark Research
- Marvel Clinical Research
- Central Valley Research
- Benchmark Research
- Tekton Research
- Accel Research Sites
- CenExel
- Nature Coast Clinical Research
- Jacksonville Center For Clinical Research
- Accel Research Sites
- Suncoast Research Group
- Centricity Research
- Accel Research Site
- CenExel iResearch
- Lifeline Primary Care
- Koch Family Medicine
- Optimal Research
- DM Clinical Research
- Johnson County Clin-Trials
- Tekton Research
- Versailles Family Medicine
- Velocity Clinical research
- Benchmark Research
- DelRicht Research
- DelRicht Research
- Annapolis Internal Medicine
- Velocity Clinical Research
- DM Clinical Research
- Vida Clinical Studies
- DelRicht Research
- Clay Platte Family Medicine
- Velocity Clinical Research
- Velocity Clinical Research
- Excel Clinical Research
- CCT Research
- Las Vegas Clinical Trials
- Rochester Clinical Research
- Tryon Medical Partners
- Trial Management Associates
- CTI Clinical Research Center
- Velocity Clinical Research
- Velocity Clinical Research
- Centricity Research
- WellNow Urgent Care & Research
- Lynn Institute of East Oklahoma
- DelRicht Research
- Tekton Research Inc
- DM Clinical Research
- Mercado Medical Practice
- DelRicht Research
- Trial Management Associates
- Medical Care
- DelRicht Research
- Benchmark Research
- Tekton Research
- Tekton Research
- Benchmark Research
- Cyfair Clinical Research
- Texas Center for Drug Development
- DelRicht Research
- Benchmark Research
- Tekton Research
- CCT Research
- Ogden Clinic
- JBR Clinical Research
- Meridian Clinical Research
- Velocity Clinical Research
- Wenatchee Valley Hospital & Clinics Campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Arm 23
Arm 24
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Cohort A2: mRNA-1083.1 Dose B
Cohort A3: mRNA-1083.1 Dose C
Cohort A4: mRNA-1083.2 Dose A
Cohort A5: mRNA-1083.2 Dose B
Cohort A6: mRNA-1083.2 Dose C
Cohort A7: mRNA-1083.3
Cohort A8: mRNA-1010.4
Cohort A9: mRNA-1283.222
Cohort A10: mRNA-1273.222
Cohort A11: mRNA-1010
Cohort A12: Fluarix
Cohort A13: Fluzone HD
Cohort B1: mRNA-1083.1 Dose A
Cohort B2: mRNA-1083.1 Dose B
Cohort B3: mRNA-1083.1 Dose C
Cohort B4: mRNA-1083.2 Dose A
Cohort B5: mRNA-1083.2 Dose B
Cohort B6: mRNA-1083.2 Dose C
Cohort B7: mRNA-1083.3
Cohort B8: mRNA-1010.4
Cohort B9: mRNA-1283.222
Cohort B10: mRNA-1273.222
Cohort B11: mRNA-1010
Cohort B12: Fluarix
Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
Participants will receive single IM injection of mRNA-1010.4 on Day 1.
Participants will receive single IM injection of mRNA-1283.222 on Day 1.
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
Participants will receive single IM injection of mRNA-1010 on Day 1.
Participants will receive single IM injection of Fluarix on Day 1.
Participants will receive single IM injection of Fluzone HD on Day 1.
Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.
Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.
Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.
Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.
Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.
Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.
Participants will receive single IM injection of mRNA-1083.3 on Day 1.
Participants will receive single IM injection of mRNA-1010.4 on Day 1.
Participants will receive single IM injection of mRNA-1283.222 on Day 1.
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
Participants will receive single IM injection of mRNA-1010 on Day 1.
Participants will receive single IM injection of Fluarix on Day 1.