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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1273 (Variant Formulation) | Experimental | Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1. |
|
| mRNA-1283 (Variant Formulation) | Experimental | Participants will receive a single IM injection of mRNA-1283 on Day 1. |
|
| Placebo | Placebo Comparator | Participants will receive a single IM injection of placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1273 | Biological | Sterile liquid for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection | The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR). | Day 1 through Day 181 |
| Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of Symptomatic COVID-19 after Study Injection | The VE is defined as the percent reduction in the hazard of the first event of symptomatic COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR). | Day 1 through Day 181 |
| Number of Participants with Unsolicited Adverse Events (AEs) | Day 1 through Day 28 | |
| Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation | Day 1 through Day 181 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with a First Event of Severe COVID-19 after Study Injection | Day 1 through Day 181 |
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Key Inclusion Criteria:
Key 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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Clinical Research | Birmingham | Alabama | 35216 | United States | ||
| Cullman Clinical Trials |
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| mRNA-1283 |
| Biological |
Sterile liquid for injection |
|
| Placebo | Biological | 0.9% sodium chloride (normal saline) injection |
|
| Cullman |
| Alabama |
| 35055 |
| United States |
| AMR Clinical Mobile | Mobile | Alabama | 36608 | United States |
| Velocity Clinical Research, Mobile | Mobile | Alabama | 36608 | United States |
| Lenzmeier Family Medicine - Avacare | Glendale | Arizona | 85308 | United States |
| Desert Clinical Research | Mesa | Arizona | 85213 | United States |
| Velocity Clinical Research - Phoenix | Phoenix | Arizona | 85006 | United States |
| Foothills Research Center/Avacare | Phoenix | Arizona | 85044 | United States |
| Headlands Research Scottsdale | Scottsdale | Arizona | 85260 | United States |
| Fiel Family and Sports Medicine / Avacare | Tempe | Arizona | 85283 | United States |
| Avacare | Colton | California | 92324 | United States |
| CenExel CNR | Garden Grove | California | 92845 | United States |
| Velocity Clinical Research, Huntington Park | Huntington Park | California | 90255 | United States |
| Velocity Clinical Research - San Diego - ERN - PPDS-Site Number:8400010 | La Mesa | California | 91942 | United States |
| Velocity Clinical Research - Los Angeles | Los Angeles | California | 90017 | United States |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Velocity Clinical Research -- Banning | San Bernardino | California | 92408 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Tekton Research, LLC | Denver | Colorado | 80238 | United States |
| Tekton Research, LLC | Fort Collins | Colorado | 80525 | United States |
| Critical Care, Pulmonary and Sleep Associates, P.LLP/Avacare | Lakewood | Colorado | 80228 | United States |
| Tekton Research, LLC | Longmont | Colorado | 80501 | United States |
| New England Research Associates | Bridgeport | Connecticut | 06606 | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
| Velocity Clinical Research-Washington, DC | Washington D.C. | District of Columbia | 20016 | United States |
| Hillcrest Medical Research, LLC | DeLand | Florida | 32720 | United States |
| University Clinical Research-Deland, LLC d/b/a Accel Research Sites - Deland Clinical Research Unit | DeLand | Florida | 32720 | United States |
| Suncoast Research Associates, LLC | Doral | Florida | 33172 | United States |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | United States |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States |
| CenExel Research Centers of America | Hollywood | Florida | 33024 | United States |
| NextPhase Research Florida | Hollywood | Florida | 33024 | United States |
| Health Awareness Inc. | Jupiter | Florida | 33458 | United States |
| Sandhill Research, LLC d/b/a Accel Research Sites - Lakeland Clinical Research Unit | Lakeland | Florida | 33803 | United States |
| Sandhill Research, LLC d/b/a Accel Research Sites- St. Pete-Largo Clinical Research Unit | Largo | Florida | 33777 | United States |
| Accel Research Sites | Maitland | Florida | 32751 | United States |
| Global Health Research Center, Inc. | Miami Lakes | Florida | 33016 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| Headlands Research Orlando | Orlando | Florida | 32819 | United States |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Global Health Research Center, Inc. | Tampa | Florida | 33615 | United States |
| Javara Inc. and PRIVIA Medical Group of Georgia, LLC | Albany | Georgia | 31707 | United States |
| DelRicht Research | Atlanta | Georgia | 30329 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Accel Research Sites - Neurostudies | Decatur | Georgia | 30030 | United States |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | United States |
| Javara Inc. and Privia Medical Group of Georgia, LLC | Fayetteville | Georgia | 30214 | United States |
| Velocity Clinical Research Savannah | Savannah | Georgia | 31406 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Velocity Clinical Research - Boise - ERN - PPDS | Meridian | Idaho | 83642 | United States |
| DM Clinical Research - Melrose Park | Melrose Park | Illinois | 60160 | United States |
| Velocity Clinical Research Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Velocity Clinical Research - Sioux City | Sioux City | Iowa | 51106 | United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66212 | United States |
| Tekton Research, LLC | Wichita | Kansas | 67218 | United States |
| DelRicht Research | Louisville | Kentucky | 40205 | United States |
| Versailles Family Medicine - CCT Research | Versailles | Kentucky | 40383 | United States |
| Velocity Clinical Research-Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Velocity Clinical Research - Covington | Covington | Louisiana | 70433 | United States |
| Avacare | Kenner | Louisiana | 70065 | United States |
| Velocity Clinical Research, Lafayette | Lafayette | Louisiana | 70508 | United States |
| DelRicht Research | Mandeville | Louisiana | 70471 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Velocity Clinical Research, New Orleans | New Orleans | Louisiana | 70119 | United States |
| DelRicht Research | Prairieville | Louisiana | 70769 | United States |
| Annapolis Internal Medicine | Annapolis | Maryland | 21401 | United States |
| Centennial Medical Group | Columbia | Maryland | 21045 | United States |
| Velocity Clinical Research, Rockville | Rockville | Maryland | 20854 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| DM Clinical Research - Brookline | Brookline | Massachusetts | 02446 | United States |
| ActivMed Practices & Research, LLC | Methuen | Massachusetts | 01844 | United States |
| Headlands Research Detroit | Southfield | Michigan | 48034 | United States |
| DM Clinical Research - Southfield | Southfield | Michigan | 48076 | United States |
| Javara Inc. and Mankato Clinic, Ltd. | Mankato | Minnesota | 56001 | United States |
| Velocity Clinical Research Gulfport | Gulfport | Mississippi | 39503 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| AMR Clinical | Kansas City | Missouri | 64116 | United States |
| Clay-Platte Family Medicine Clinic | Kansas City | Missouri | 64151 | United States |
| DelRicht Research | Springfield | Missouri | 65807 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| DelRicht Research | Town and Country | Missouri | 63017 | United States |
| Avacare Research/Methodist Physicians Clinic | Fremont | Nebraska | 68025 | United States |
| Velocity Clinical Research, Grand Island | Grand Island | Nebraska | 68803 | United States |
| Velocity Clinical Research | Lincoln | Nebraska | 68510 | United States |
| Velocity Clinical Research Norfolk | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research Omaha | Omaha | Nebraska | 68134 | United States |
| Avacare/Midwest Regional Health Services | Omaha | Nebraska | 68144 | United States |
| Papillion Research/Avacare | Papillion | Nebraska | 68046 | United States |
| Santa Rosa Medical Centers of Nevada | Las Vegas | Nevada | 89119 | United States |
| DM Clinical Research - Jersey City | Jersey City | New Jersey | 07306 | United States |
| DM Clinical Research - Albuquerque | Albuquerque | New Mexico | 87106 | United States |
| Velocity Clinical Research - Albuquerque | Albuquerque | New Mexico | 87107 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Velocity Clinical Research, Durham | Durham | North Carolina | 27701 | United States |
| Eximia Research - NC, LLC | Raleigh | North Carolina | 27607 | United States |
| TMA Headlands LLC d/b/a Trial Management Associates | Wilmington | North Carolina | 28403 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Velocity Clinical Research - Cleveland | Beachwood | Ohio | 44122 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Velocity Clinical Research-Mt. Auburn | Cincinnati | Ohio | 45242 | United States |
| Velocity Clinical Research Springdale | Cincinnati | Ohio | 45246 | United States |
| Tekton Research, LLC | Edmond | Oklahoma | 73013 | United States |
| Tekton Research, LLC | Moore | Oklahoma | 73160 | United States |
| DelRicht Research | Tulsa | Oklahoma | 74133 | United States |
| Tekton Research, LLC | Yukon | Oklahoma | 73099 | United States |
| Velocity Clinical Research - Medford | Medford | Oregon | 97504 | United States |
| Summit Headlands LLC | Portland | Oregon | 97210 | United States |
| Hatboro Medical Associates/Avacare | Horsham | Pennsylvania | 19044 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Velocity Clinical Research - East Greenwich | East Greenwich | Rhode Island | 02818 | United States |
| Velocity Clinical Research, Anderson | Anderson | South Carolina | 29621 | United States |
| DelRicht Research | Charleston | South Carolina | 29407 | United States |
| Velocity Clinical Research - Columbia | Columbia | South Carolina | 29204 | United States |
| Coastal Carolina Research Center, LLC | North Charleston | South Carolina | 29405 | United States |
| Velocity Clinical Research Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| Velocity Clinical Research Union | Union | South Carolina | 29379 | United States |
| DelRicht Research | Hendersonville | Tennessee | 37075 | United States |
| Velocity Clinical Research, Abilene | Abilene | Texas | 79606 | United States |
| Tekton Research, LLC | Austin | Texas | 78745 | United States |
| Velocity Clinical Research - Austin | Austin | Texas | 78759 | United States |
| Tekton Research, LLC | Beaumont | Texas | 77706 | United States |
| Javara Inc. and Privia Medical Group Gulf Coast, PLLC | Conroe | Texas | 77384 | United States |
| Velocity Clinical Research - Dallas | Dallas | Texas | 75230 | United States |
| Avacare | Fort Worth | Texas | 76135 | United States |
| DM Clinical Research - Houston | Houston | Texas | 77065 | United States |
| DM Clinical Research - Houston | Houston | Texas | 77081 | United States |
| DelRicht Research | Prosper | Texas | 75078 | United States |
| Be Well Clinical Studies | Round Rock | Texas | 78681 | United States |
| DM Clinical Research - San Antonio | San Antonio | Texas | 78207 | United States |
| Tekton Research, LLC | San Antonio | Texas | 78229 | United States |
| Javara Inc. and Privia Medical Group Gulf Coast, PLLC | San Marcos | Texas | 78666 | United States |
| Javara Inc. and Privia Medical Group - North Texas | Stephenville | Texas | 76401 | United States |
| DM Clinical Research - Sugar Land | Sugar Land | Texas | 77478 | United States |
| Javara Inc. and Privia Medical Group Gulf Coast, PLLC | Sugar Land | Texas | 77478 | United States |
| Olympus Clinical Research | Sugar Land | Texas | 77479 | United States |
| DM Clinical Research - Tomball | Tomball | Texas | 77375 | United States |
| Cope Family Medicine / Avacare | Bountiful | Utah | 84010 | United States |
| Mountain View/Avacare | Pleasant View | Utah | 84404 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Olympus Family Medicine/Avacare | Salt Lake City | Utah | 84117 | United States |
| J. Lewis Research, Inc/Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| South Ogden Family Medicine/ Avacare | South Ogden | Utah | 84405 | United States |
| Velocity Clinical Research - Salt Lake City (West Jordan) | West Jordan | Utah | 84088 | United States |
| Charlottesville Medical Research, LLC | Charlottesville | Virginia | 22911 | United States |
| Velocity Clinical Research-Hampton | Hampton | Virginia | 23666 | United States |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | United States |
| Velocity Clinical Research - Suffolk | Suffolk | Virginia | 23435 | United States |
| Velocity Clinical Research, Spokane | Spokane | Washington | 99218 | United States |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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