A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06097273
Collaborator
(none)
8,000
173
4
7.3
46.2
6.3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to <65 years of age (Cohort B).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
8000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Anticipated Study Start Date
:
Oct 19, 2023
Anticipated Primary Completion Date
:
Dec 29, 2023
Anticipated Study Completion Date
:
May 29, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A1: mRNA-1083 and Placebo Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1. |
Biological: mRNA-1083
Suspension for injection
Biological: Placebo
0.9% sodium chloride suspension for injection
|
| Active Comparator: Cohort A2: Influenza Vaccine and COVID-19 Vaccine Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1. |
Biological: Influenza Vaccine
Commercially available formulation (Suspension for injection [pre-filled syringe])
Biological: COVID-19 Vaccine
Commercially available formulation (Suspension for injection)
|
| Experimental: Cohort B1: mRNA-1083 and Placebo Participants of age 50 to <65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1. |
Biological: mRNA-1083
Suspension for injection
Biological: Placebo
0.9% sodium chloride suspension for injection
|
| Active Comparator: Cohort B2: Influenza Vaccine and COVID-19 Vaccine Participants of age 50 to <65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1. |
Biological: Influenza Vaccine
Commercially available formulation (Suspension for injection [pre-filled syringe])
Biological: COVID-19 Vaccine
Commercially available formulation (Suspension for injection)
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay [Day 29]
- GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) [Day 29]
- Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay [Baseline to Day 29]
Seroconversion is defined as a Day 29 post-injection level ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
- SARS-CoV-2: Number of Participants with Seroresponse, as Measured by PsVNA [Baseline to Day 29]
Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in neutralizing antibody (nAb) values measured by PsVNA.
- Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [Up to 7 days after study injection]
- Number of Participants With Unsolicited Adverse Events (AEs) [Up to 28 days after study injection]
- Number of Participants With Medically Attended Adverse Events (MAAEs) [Day 1 through Day 181]
- Number of Participants With Adverse Events of Special Interest (AESIs) [Day 1 through Day 181]
- Number of Participants With Serious Adverse Events (SAEs) [Day 1 through Day 181]
- Number of Participants With AEs Leading to Discontinuation [Day 1 through Day 181]
Secondary Outcome Measures
- Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay [Day 1, Day 29]
- GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA [Day 1, Day 29]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria:
-
Healthy adults either ≥65 years of age (Cohort A) or 50 to <65 years of age (Cohort B) at the time of consent (Screening Visit).
-
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, and agreement to continue adequate contraception through 3 months following vaccine administration.
-
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 ≥90 days prior to Day 1.
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 study or could interfere with the interpretation of study results.
-
Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
-
Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
-
Received a seasonal influenza vaccine ≤150 days prior to Day 1.
-
Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
-
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.
-
Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Research Group-409 E 10th St | Anniston | Alabama | United States | 36207-4780 |
| 2 | Accel Research Site - Achieve - Birmingham | Birmingham | Alabama | United States | 35216 |
| 3 | Cullman Clinical Trials | Cullman | Alabama | United States | 35055-1902 |
| 4 | Lenzmeier Family Medicine - CCT - PPDS | Glendale | Arizona | United States | 85308-5093 |
| 5 | Centricity Research - Mesa - HyperCore - PPDS | Mesa | Arizona | United States | 85206-5238 |
| 6 | Desert Clinical Research - CCT - PPDS | Mesa | Arizona | United States | 85213-5226 |
| 7 | Foothills Research Center - CCT - PPDS | Phoenix | Arizona | United States | 85044-6097 |
| 8 | Headlands Research - Scottsdale - PPDS | Scottsdale | Arizona | United States | 85260-6411 |
| 9 | Fiel Family & Sports Medicine - PC - CCT - PPDS | Tempe | Arizona | United States | 85283-1528 |
| 10 | Noble Clinical Research | Tucson | Arizona | United States | 85704-7892 |
| 11 | AES - DRS - Synexus Clinical Research US, Inc. - Tucson | Tucson | Arizona | United States | 85741-3118 |
| 12 | AES - DRS - Synexus Clinical Research US, Inc. - Cerritos | Cerritos | California | United States | 90703-2544 |
| 13 | Velocity Clinical Research, San Diego | La Mesa | California | United States | 91942-3020 |
| 14 | Long Beach Research Institute, LLC | Long Beach | California | United States | 90805-4587 |
| 15 | CenExel Apex (CNS) - Los Alamitos - PPDS | Los Alamitos | California | United States | 90720-3118 |
| 16 | Central Valley Research, LLC | Modesto | California | United States | 95350-5365 |
| 17 | Carbon Health- NoHo West Urgent Care and Primary Care | North Hollywood | California | United States | 91606-3287 |
| 18 | Carbon Health - Oakland | Oakland | California | United States | 94610-5022 |
| 19 | Empire Clinical Research | Pomona | California | United States | 91767-1800 |
| 20 | Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS | Riverside | California | United States | 92503-4955 |
| 21 | Clinical Innovations Trials - Riverside - CenExel - PPDS | Riverside | California | United States | 92506-3257 |
| 22 | Peninsula Research Associates - Headlands - PPDS | Rolling Hills Estates | California | United States | 90274-7604 |
| 23 | Benchmark Research - Sacramento - HyperCore - PPDS | Sacramento | California | United States | 95864-3102 |
| 24 | Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS | San Diego | California | United States | 92103-2204 |
| 25 | AME Medical Group, Inc | Santa Ana | California | United States | 92704-5718 |
| 26 | AES - DRS - Synexus Clinical Research US, Inc. - Vista | Vista | California | United States | 92083-6051 |
| 27 | Tekton Research - Fort Collins - PPDS | Fort Collins | Colorado | United States | 80525-5752 |
| 28 | Tekton Research - Longmont - PPDS | Longmont | Colorado | United States | 80501-6461 |
| 29 | Stamford Therapeutics Consortium - ERN - PPDS | Stamford | Connecticut | United States | 06905-5316 |
| 30 | Chase Medical Research LLC - Waterbury | Waterbury | Connecticut | United States | 06708-3346 |
| 31 | Revival Research Corporation | Doral | Florida | United States | 33122-1902 |
| 32 | Indago Research and Health Center | Hialeah | Florida | United States | 33012 |
| 33 | CenExel RCA - Hollywood | Hollywood | Florida | United States | 33024-2709 |
| 34 | Nature Coast Clinical Research | Inverness | Florida | United States | 34452 |
| 35 | Jacksonville Center For Clinical Research | Jacksonville | Florida | United States | 32216 |
| 36 | Health Awareness - Jupiter - ERN - ERN | Jupiter | Florida | United States | 33458-2775 |
| 37 | Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS | Largo | Florida | United States | 33777-1359 |
| 38 | Flourish Research - Leesburg - PPDS | Leesburg | Florida | United States | 34748-5077 |
| 39 | Accel Research Sites - Maitland | Maitland | Florida | United States | 32751-7258 |
| 40 | AES - DRS - Optimal Research Florida - Melbourne | Melbourne | Florida | United States | 32934-8172 |
| 41 | Suncoast Research Group LLC - Flourish - PPDS | Miami | Florida | United States | 33135-1687 |
| 42 | Flourish Research - Miami - PPDS | Miami | Florida | United States | 33186-9066 |
| 43 | Suncoast Research Associates, LLC | Pembroke Pines | Florida | United States | 33024-3611 |
| 44 | St. Johns Center for Clinical Research - ERN - PPDS | Saint Augustine | Florida | United States | 32086-5775 |
| 45 | ForCare Clinical Research - CenExel FCR - PPDS | Tampa | Florida | United States | 33613-1244 |
| 46 | AES - DRS - Synexus Clinical Research US, Inc. - Atlanta | Atlanta | Georgia | United States | 30328-4018 |
| 47 | DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS | Atlanta | Georgia | United States | 30329-2201 |
| 48 | Atlanta Center for Medical Research - CenExel ACMR - PPDS | Atlanta | Georgia | United States | 30331 |
| 49 | iResearch Atlanta - CenExel - PPDS | Decatur | Georgia | United States | 30030-3438 |
| 50 | Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS | Fayetteville | Georgia | United States | 30214 |
| 51 | Georgia Clinic - CCT - PPDS | Norcross | Georgia | United States | 30092-4544 |
| 52 | Centricity Research Southeast Lung Associates Research - Hypercore - PPDS | Rincon | Georgia | United States | 31326-5131 |
| 53 | iResearch Savannah - CenExel - PPDS | Savannah | Georgia | United States | 31405 |
| 54 | Clinical Research Atlanta - ERN - PPDS | Stockbridge | Georgia | United States | 30281-9054 |
| 55 | AES - DRS - Synexus Clinical Research US, Inc. - Chicago | Chicago | Illinois | United States | 60602-3960 |
| 56 | Cedar Crosse Research Center | Chicago | Illinois | United States | 60607-4559 |
| 57 | Flourish Research - Andersonville - PPDS | Chicago | Illinois | United States | 60640-2781 |
| 58 | Koch Family Medicine | Morton | Illinois | United States | 61550-2495 |
| 59 | AES - DRS - Optimal Research Illinois - Peoria | Peoria | Illinois | United States | 61614 |
| 60 | DM Clinical Research - Chicago - ERN - PPDS | River Forest | Illinois | United States | 60305-1876 |
| 61 | AES - DRS - Synexus Clinical Research US, Inc. - Evansville | Evansville | Indiana | United States | 47714-7513 |
| 62 | Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS | Valparaiso | Indiana | United States | 46383-2195 |
| 63 | The Iowa Clinic, P.C. - West Des Moines Campus | West Des Moines | Iowa | United States | 50266-8216 |
| 64 | Johnson County Clin-Trials | Lenexa | Kansas | United States | 66219-1389 |
| 65 | Tekton Research - Wichita - PPDS | Wichita | Kansas | United States | 67218-2913 |
| 66 | DelRicht Research, LLC - Louisville - PPDS | Louisville | Kentucky | United States | 40205-3162 |
| 67 | Versailles Family Medicine - CCT - PPDS | Versailles | Kentucky | United States | 40383-1947 |
| 68 | Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS | Baton Rouge | Louisiana | United States | 70809-3416 |
| 69 | Velocity Clinical Research - Covington - PPDS | Covington | Louisiana | United States | 70433-7237 |
| 70 | IMA Clinical Research - Monroe, LA - PPDS | Monroe | Louisiana | United States | 71201-3915 |
| 71 | DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS | New Orleans | Louisiana | United States | 70115-3584 |
| 72 | DelRicht Research, LLC - Internal - Baton Rouge - PPDS | Prairieville | Louisiana | United States | 70769-4222 |
| 73 | Annapolis Internal Medicine - CCT - PPDS | Annapolis | Maryland | United States | 21401-7050 |
| 74 | Advanced Primary Care & Geriatric Care - CCT - PPDS | Rockville | Maryland | United States | 20850-6246 |
| 75 | DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS | Rockville | Maryland | United States | 20852-3803 |
| 76 | Velocity Clinical Research (Rockville - Maryland) - PPDS | Rockville | Maryland | United States | 20854-2960 |
| 77 | Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS | Silver Spring | Maryland | United States | 20901-4402 |
| 78 | DM Clinical Research - The Brook House - ERN - PPDS | Brookline | Massachusetts | United States | 02445-7113 |
| 79 | Headlands Research - Detroit - Headlands - PPDS | Southfield | Michigan | United States | 48034-1088 |
| 80 | Great Lakes Research Institute | Southfield | Michigan | United States | 48075-5400 |
| 81 | DM Clinical Research - Southfield - ERN - PPDS | Southfield | Michigan | United States | 48076-5412 |
| 82 | AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis | Richfield | Minnesota | United States | 55423-2590 |
| 83 | DelRicht Research, LLC - Gulfport - PPDS | Gulfport | Mississippi | United States | 39503-4176 |
| 84 | Clay Platte Family Medicine - CCT Research | Kansas City | Missouri | United States | 64151-2411 |
| 85 | Sundance Clinical Research - ERN - PPDS | Saint Louis | Missouri | United States | 63141-7068 |
| 86 | Clinvest - National Ave - Headlands - PPDS | Springfield | Missouri | United States | 65807-6012 |
| 87 | DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS | Springfield | Missouri | United States | 65807-7303 |
| 88 | DelRicht Clinical Research, LLC - MS. Medicine - PPDS | Town And Country | Missouri | United States | 63017-8209 |
| 89 | Skyline Medical Center - PC - CCT - PPDS | Elkhorn | Nebraska | United States | 68022-2889 |
| 90 | Methodist Physicians Clinic - CCT Research - PPDS | Fremont | Nebraska | United States | 68025-2592 |
| 91 | Velocity Clinical Research (Lincoln - Nebraska) - PPDS | Lincoln | Nebraska | United States | 68510-4855 |
| 92 | Be Well Clinical Studies, LLC | Lincoln | Nebraska | United States | 68516 |
| 93 | Velocity Clinical Research | Omaha | Nebraska | United States | 68134 |
| 94 | Midwest Regional Health Services - LLC - CCT - PPDS | Omaha | Nebraska | United States | 68144 |
| 95 | Papillion Research Center | Papillion | Nebraska | United States | 68046-4194 |
| 96 | AES - DRS - Synexus Clinical Research US, Inc. - Henderson | Henderson | Nevada | United States | 89052-3992 |
| 97 | Henderson Clinical Trials | Henderson | Nevada | United States | 89052-5016 |
| 98 | Santa Rosa Urgent Care - Primary Care - CCT - PPDS | Las Vegas | Nevada | United States | 89119-5483 |
| 99 | Las Vegas Clinical Trials | North Las Vegas | Nevada | United States | 89030-7187 |
| 100 | Hassman Research Institute - HRI - Berlin - CenExel - PPDS | Berlin | New Jersey | United States | 08009 |
| 101 | Velocity Clinical Research - Albuquerque - PPDS | Albuquerque | New Mexico | United States | 87107-4503 |
| 102 | AXCES Research Group - Sante Fe - ERN - PPDS | Santa Fe | New Mexico | United States | 87505-4753 |
| 103 | Prime Global Research, Inc. | Bronx | New York | United States | 10456-2102 |
| 104 | DM Clinical Research - Brooklyn | Brooklyn | New York | United States | 11220-5906 |
| 105 | AES - DRS - Synexus Clinical Research US, Inc. - New York | New York | New York | United States | 10017-4008 |
| 106 | Rochester Clinical Research, Inc | Rochester | New York | United States | 14609-3173 |
| 107 | WellNow Urgent Care and Clinical Research - Niskayuna | Schenectady | New York | United States | 12304-2268 |
| 108 | DelRicht Research, LLC - Charlotte - PPDS | Charlotte | North Carolina | United States | 28205-5078 |
| 109 | Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS | Charlotte | North Carolina | United States | 28287-3884 |
| 110 | Monroe Biomedical Research -343 Venus St | Monroe | North Carolina | United States | 28112-4025 |
| 111 | Trial Management Associates LLC - ERN - PPDS | Wilmington | North Carolina | United States | 28403-6235 |
| 112 | CTI Clinical Research Center - PPDS | Cincinnati | Ohio | United States | 45212 |
| 113 | Velocity Clinical Research (Cincinnati - Ohio) - PPDS | Cincinnati | Ohio | United States | 45219-2975 |
| 114 | AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati | Cincinnati | Ohio | United States | 45236-3669 |
| 115 | Velocity Clinical Research (Cincinnati - Ohio) - PPDS | Cincinnati | Ohio | United States | 45246-2316 |
| 116 | AES - DRS - Synexus Clinical Research US, Inc. - Columbus | Columbus | Ohio | United States | 43212-3119 |
| 117 | Centricity Research - Columbus - (Ohio) - HyperCore - PPDS | Columbus | Ohio | United States | 43213-6523 |
| 118 | WellNow Urgent Care & Research - Huber Heights | Huber Heights | Ohio | United States | 45424-4019 |
| 119 | Tekton Research - Edmond - PPDS | Edmond | Oklahoma | United States | 73013-5478 |
| 120 | Lynn Institute of East Oklahoma - ERN - PPDS | Oklahoma City | Oklahoma | United States | 73111-3324 |
| 121 | DelRicht Research, LLC - Internal - Tulsa - PPDS | Tulsa | Oklahoma | United States | 74133-8902 |
| 122 | Tekton Research - Yukon - PPDS | Yukon | Oklahoma | United States | 73099-9518 |
| 123 | The Corvallis Clinic, PC - 3680 NW Samaritan Drive | Corvallis | Oregon | United States | 97330-3737 |
| 124 | Hatboro Medical Associates - CCT - PPDS | Hatboro | Pennsylvania | United States | 19040-2045 |
| 125 | DM Clinical Research - Philadelphia - ERN - PPDS | Philadelphia | Pennsylvania | United States | 19107-1530 |
| 126 | AES - DRS - Synexus Clinical Research US, Inc. - Anderson | Anderson | South Carolina | United States | 29621-2062 |
| 127 | TMA - Myrtle Beach - ERN - PPDS | Myrtle Beach | South Carolina | United States | 29572-4610 |
| 128 | Velocity Clinical Research - Spartanburg - PPDS | Spartanburg | South Carolina | United States | 29303-4225 |
| 129 | DelRicht Research, LLC - Hendersonville - PPDS | Hendersonville | Tennessee | United States | 37075-8947 |
| 130 | AES - DRS - Optimal Research Texas - Austin | Austin | Texas | United States | 78705-2655 |
| 131 | Benchmark Research - Austin - HyperCore - PPDS | Austin | Texas | United States | 78705-3298 |
| 132 | Tekton Research - Austin - PPDS | Austin | Texas | United States | 78745 |
| 133 | Tekton Research Inc | Beaumont | Texas | United States | 77706-3061 |
| 134 | Headlands Research - Brownsville - Headlands - PPDS | Brownsville | Texas | United States | 78526-4332 |
| 135 | 3A Research, LLC | El Paso | Texas | United States | 79925 |
| 136 | Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS | Fort Worth | Texas | United States | 76133-4953 |
| 137 | Mount Olympus Medical Research Group - ClinEdge - PPDS | Friendswood | Texas | United States | 77546 |
| 138 | DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS | Houston | Texas | United States | 77065-5685 |
| 139 | DM Clinical Research - Bellaire - ERN - PPDS | Houston | Texas | United States | 77081-4648 |
| 140 | DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS | Humble | Texas | United States | 77338-4205 |
| 141 | Activian Clinical Research | Kingwood | Texas | United States | 77339 |
| 142 | DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS | McKinney | Texas | United States | 75070-8481 |
| 143 | Advances in Health-9430 Broadway St | Pearland | Texas | United States | 77584-8075 |
| 144 | Epic Medical Research LLC - Red Oak | Red Oak | Texas | United States | 75154 |
| 145 | Benchmark Research - San Angelo - HyperCore - PPDS | San Angelo | Texas | United States | 76904-7610 |
| 146 | Sun Research Institute -427 9th St | San Antonio | Texas | United States | 78215-1528 |
| 147 | AES - DRS - Synexus Clinical Research US, Inc. - San Antonio | San Antonio | Texas | United States | 78229-3272 |
| 148 | Clinical Trials of Texas, Inc. - PPDS | San Antonio | Texas | United States | 78229-3539 |
| 149 | IMA Clinical Research - San Antonio - PPDS | San Antonio | Texas | United States | 78229 |
| 150 | Tekton Research - San Antonio - PPDS | San Antonio | Texas | United States | 78229 |
| 151 | Privia Medical Group- North Texas - Stephenville - Javara - PPDS | Stephenville | Texas | United States | 76401-1860 |
| 152 | DM Clinical Research - Sugarland - ERN - PPDS | Sugar Land | Texas | United States | 77478-4913 |
| 153 | Mt. Olympus Medical Research Group, LLC | Sugar Land | Texas | United States | 77479-3481 |
| 154 | DM Clinical Research - ERN - PPDS | Tomball | Texas | United States | 77375-3330 |
| 155 | Cope Family Medicine - CCT - PPDS | Bountiful | Utah | United States | 84010-4862 |
| 156 | Ogden Clinic - Mountain View - CCT - PPDS | Pleasant View | Utah | United States | 84404-4791 |
| 157 | Ogden Clinic - Grandview - CCT - PPDS | Roy | Utah | United States | 84067-9438 |
| 158 | AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City | S. Salt Lake | Utah | United States | 84106-1466 |
| 159 | JBR Clinical Research - CenExel JBR - PPDS | Salt Lake City | Utah | United States | 84107-4536 |
| 160 | Velocity Clinical Research | West Jordan | Utah | United States | 84088-8865 |
| 161 | Velocity Clinical Research - Family Practice - Portsmouth - PPDS | Portsmouth | Virginia | United States | 23703-3200 |
| 162 | Wenatchee Valley Hospital & Clinics Campus | Wenatchee | Washington | United States | 98801-2028 |
| 163 | Centricity Research - New Minas - HyperCore - PPDS | New Minas | Nova Scotia | Canada | B4N 3R7 |
| 164 | Colchester Research Group | Truro | Nova Scotia | Canada | B2N 1L2 |
| 165 | Mirtorabi Medicine Professional Corp | Stouffville | Ontario | Canada | L4A 1H2 |
| 166 | Centricity Research - Bayview - HyperCore - PPDS | Toronto | Ontario | Canada | M4G 3E8 |
| 167 | Centricity Research - Toronto - HyperCore - PPDS | Toronto | Ontario | Canada | M9W 4L6 |
| 168 | Centricity Research - Quebec - HyperCore - PPDS | Levis | Quebec | Canada | G6W 0M5 |
| 169 | Centricity Research - Mirabel - HyperCore - PPDS | Mirabel | Quebec | Canada | J7J 2K8 |
| 170 | Centricity Research - Montreal - HyperCore - PPDS | Pointe-Claire | Quebec | Canada | H9R 4S3 |
| 171 | Diex Recherche - Joliette - PPDS | Saint-Charles-Borromée | Quebec | Canada | J6E 2B4 |
| 172 | Diex Recherche - Trois Rivieres - PPDS | Trois-Rivieres | Quebec | Canada | G9A 4P3 |
| 173 | Diex Recherche - Victoriaville - PPDS | Victoriaville | Quebec | Canada | G6P 6P6 |
Sponsors and Collaborators
- ModernaTX, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ModernaTX, Inc.
ClinicalTrials.gov Identifier:
NCT06097273
Other Study ID Numbers:
- mRNA-1083-P301
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ModernaTX, Inc.
Additional relevant MeSH terms: