A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)
Purpose
The purpose of this study is to evaluate the efficacy and safety of mRNA-1283 and mRNA-1273 (variant formulations) in adults 50 to 64 years of age without high risk factors for severe COVID-19.
Condition
- SARS-CoV-2
Eligibility
- Eligible Ages
- Between 50 Years and 64 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Healthy and without underlying medical conditions that may put them at higher risk of experiencing severe outcomes of COVID-19, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Exclusion Criteria
- History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment. - Acutely ill or febrile within 72 hours prior to or at the Screening Visit or Day 1. - Receipt of any of the following: - COVID-19 vaccine within 3 months prior to enrollment, - Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention, - Corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study or, - Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. - Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study injection. - Has participated in an investigational clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study. Note: Additional inclusion/exclusion criteria may apply, per protocol.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental mRNA-1273 (Variant Formulation) |
Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1. |
|
|
Experimental mRNA-1283 (Variant Formulation) |
Participants will receive a single IM injection of mRNA-1283 on Day 1. |
|
|
Placebo Comparator Placebo |
Participants will receive a single IM injection of placebo on Day 1. |
|
Recruiting Locations
DelRicht Research
Louisville 4299276, Kentucky 6254925 40205
Louisville 4299276, Kentucky 6254925 40205
Velocity Clinical Research - Covington
Covington 4321005, Louisiana 4331987 70433
Covington 4321005, Louisiana 4331987 70433
DelRicht Research
New Orleans 4335045, Louisiana 4331987 70115
New Orleans 4335045, Louisiana 4331987 70115
DelRicht Research
Prairieville 4338012, Louisiana 4331987 70769
Prairieville 4338012, Louisiana 4331987 70769
Velocity Clinical Research, Rockville
Rockville 4367175, Maryland 4361885 20854
Rockville 4367175, Maryland 4361885 20854
Velocity Clinical Research, Grand Island
Grand Island 5069297, Nebraska 5073708 68803
Grand Island 5069297, Nebraska 5073708 68803
Velocity Clinical Research
Lincoln 5072006, Nebraska 5073708 68510
Lincoln 5072006, Nebraska 5073708 68510
Velocity Clinical Research Omaha
Omaha 5074472, Nebraska 5073708 68134
Omaha 5074472, Nebraska 5073708 68134
Velocity Clinical Research Springdale
Cincinnati 4508722, Ohio 5165418 45246
Cincinnati 4508722, Ohio 5165418 45246
DelRicht Research
Hendersonville 4628735, Tennessee 4662168 37075
Hendersonville 4628735, Tennessee 4662168 37075
More Details
- Status
- Recruiting
- Sponsor
- ModernaTX, Inc.