ClinicalTrials.gov record
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
ClinicalTrials.gov ID: NCT05127434
Public ClinicalTrials.gov record NCT05127434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
Study identification
- NCT ID
- NCT05127434
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 36,814 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 16, 2021
- Primary completion
- Jul 27, 2025
- Completion
- Jul 27, 2025
- Last update posted
- Aug 18, 2025
2021 – 2025
United States locations
- U.S. sites
- 133
- U.S. states
- 36
- U.S. cities
- 117
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AES - DRS - Synexus Clinical Research US, Inc. - Birmingham | Birmingham | Alabama | 35211 | — |
| Accel Research Site - Achieve - Birmingham | Birmingham | Alabama | 35216 | — |
| Lakeview Clinical Research | Guntersville | Alabama | 35976 | — |
| AES - DRS - Optimal Research Alabama - Huntsville | Huntsville | Alabama | 35802 | — |
| Hope Research Institute LLC - Hunt - PPDS | Hunt | Arizona | 85023 | — |
| Hope Research Institute LLC - Hunt - PPDS | Hunt | Arizona | 85284 | — |
| Desert Clinical Research, LLC - CCT | Mesa | Arizona | 85213 | — |
| Hope Research Institute LLC - Phoenix - Hunt - PPDS | Phoenix | Arizona | 85018 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central | Phoenix | Arizona | 85020 | — |
| Synexus Clinical Research US, Inc. - Phoenix Southeast | Phoenix | Arizona | 85224 | — |
| Tucson Neuroscience Research - M3 WR | Tucson | Arizona | 85710 | — |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | — |
| Velocity Clinical Research, Banning | Banning | California | 92220 | — |
| Hope Clinical Research, LLC | Canoga Park | California | 91303 | — |
| Velocity Clinical Research - Chula Vista - PPDS | Chula Vista | California | 91911 | — |
| PPD Virtual - Science 37, Inc | Culver City | California | 90230 | — |
| Velocity Clinical Research, San Diego | La Mesa | California | 91942 | — |
| PRI, LLC - Los Alamitos - M3 WR | Los Alamitos | California | 90720 | — |
| PRI, LLC - Newport Beach - M3 WR | Newport Beach | California | 92660 | — |
| FOMAT Medical Research - FOMAT - HyperCore - PPDS | Oxnard | California | 93030 | — |
| Reddy Care Medical | Pomona | California | 91768 | — |
| Paradigm Clinical Research Institute Inc - ClinEdge - PPDS | Redding | California | 96001 | — |
| Medical Center For Clinical Research - M3 WR | San Diego | California | 92660 | — |
| Lynn Institute of Denver | Aurora | Colorado | 80012 | — |
| Tekton Research - Fort Collins - PPDS | Fort Collins | Colorado | 80525 | — |
| Tekton Research - Longmont - PPDS | Longmont | Colorado | 80501 | — |
| Paradigm Clinical Research Institute Inc - ClinEdge - PPDS | Wheat Ridge | Colorado | 80033 | — |
| Clinical Research Consultants LLC - ClinEdge - PPDS | Milford | Connecticut | 06460 | — |
| Washington Health Institute | Washington D.C. | District of Columbia | 20017 | — |
| Velocity Clinical Research, New Smyrna Beach | Edgewater | Florida | 32132 | — |
| Fleming Island Clinical Research Center | Fleming Island | Florida | 32003 | — |
| Velocity Clinical Research - Hallandale Beach - PPDS | Hallandale | Florida | 33009 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Multi-Specialty Research Associates, Inc. M3 WR | Lake City | Florida | 32055 | — |
| Accel Research Sites - Maitland - ERN - PPDS | Maitland | Florida | 32751 | — |
| Spotlight Research Center, LLC | Miami | Florida | 33176 | — |
| IMA Clinical Research - Manhattan - PPDS | Miami Beach | Florida | 33140 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - The Villages | Orlando | Florida | 32162 | — |
| Health Awareness Inc | Port Saint Lucie | Florida | 33458 | — |
| IMA Clinical Research - Saint Petersburg - PPDS | St. Petersburg | Florida | 33709 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg | St. Petersburg | Florida | 33781 | — |
| Clinical Trials of Tampa | Tampa | Florida | 33614 | — |
| Palm Beach Research - ClinEdge - PPDS | West Palm Beach | Florida | 33409 | — |
| Clinical Site Partners - Winter Park - HyperCore -PPDS | Winter Park | Florida | 32789 | — |
| Mount Vernon Clinical Research, LLC - M3 WR | Atlanta | Georgia | 30328 | — |
| Masters of Clinical Research Inc | Augusta | Georgia | 30909 | — |
| Centricity Research - Roswell - HyperCore - PPDS | Columbus | Georgia | 31904 | — |
| iResearch Atlanta | Decatur | Georgia | 30030 | — |
| Javara, Inc./Privia Medical Group Georgia, LLC | Fayetteville | Georgia | 30214 | — |
| Drug Studies America - ClinEdge - PPDS | Marietta | Georgia | 30060 | — |
| Randomize Now -Commerce Dr | Peachtree City | Georgia | 30269 | — |
| Velocity Clinical Research (Savannah - Georgia) - PPDS | Savannah | Georgia | 31406 | — |
| Clinical Research Atlanta - ERN-PPDS | Stockbridge | Georgia | 30281 | — |
| East West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Velocity Clinical Research - Boise - PPDS | Meridian | Idaho | 83642 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - Chicago | Chicago | Illinois | 60602 | — |
| Affinity Health (Oak Brook) | Oak Brook | Illinois | 60523 | — |
| DM Clinical - Chicago | River Forest | Illinois | 60305 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - Evansville | Evansville | Indiana | 47714 | — |
| Velocity Clinical Research - Valparaiso - PPDS | Valparaiso | Indiana | 46383 | — |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | — |
| Versailles Family Medicine - CCT - PPDS | Versailles | Kentucky | 40383 | — |
| Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS | Baton Rouge | Louisiana | 70809 | — |
| Benchmark Research - Covington - HyperCore - PPDS | Covington | Louisiana | 70433 | — |
| Benchmark Research - Metairie - HyperCore - PPDS | Metairie | Louisiana | 70006 | — |
| IMA Clinical Research - Monroe, LA - PPDS | Monroe | Louisiana | 71259 | — |
| DelRicht Clinical Research, LLC - Internal - Covington - PPDS | New Orleans | Louisiana | 70115 | — |
| Privia Medical Group, LLC - Annapolis - Javara - PPDS | Annapolis | Maryland | 21401 | — |
| CBH Health - CenExel CBH - PPDS | Gaithersburg | Maryland | 20877 | — |
| Velocity Clinical Research (Rockville - Maryland) - PPDS | Rockville | Maryland | 20854 | — |
| Great Lakes Research Institute | Southfield | Michigan | 48075 | — |
| DM Clinical Research - Southfield - ERN - PPDS | Southfield | Michigan | 48076 | — |
| Clinical Research Institute, Inc - CRN - PPDS | Minneapolis | Minnesota | 55402 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis | Richfield | Minnesota | 55423 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - St. Louis | Creve Coeur | Missouri | 63141 | — |
| Montana Medical Research | Missoula | Montana | 59804 | — |
| Boeson Research MSO - Missoula - ERN - PPDS | Missoula | Montana | 59808 | — |
| Skyline Medical Center, PC - CCT Research | Elkhorn | Nebraska | 68022 | — |
| Methodist Physicians Clinic - CCT Research - PPDS | Fremont | Nebraska | 68025 | — |
| Velocity Clinical Research (Grand Island - Nebraska) - PPDS | Grand Island | Nebraska | 68803 | — |
| Velocity Clinical Research (Lincoln - Nebraska) - PPDS | Lincoln | Nebraska | 68510 | — |
| Velocity Clinical Research (Omaha - Nebraska) - PPDS | Omaha | Nebraska | 68134 | — |
| CCT Research | Papillion | Nebraska | 68046 | — |
| HEALOR Primary Care - Physicians Las Vegas - CCT | Las Vegas | Nevada | 89102 | — |
| Excel Clinical Research - Las Vegas | Las Vegas | Nevada | 89109 | — |
| IMA Clinical Research - Raritan - PPDS | Raritan | New Jersey | 08869 | — |
| Riverside Medical Group - Circuit - PPDS | Secaucus | New Jersey | 07094 | — |
| Velocity Clinical Research - East Syracuse - PPDS | East Syracuse | New York | 13057 | — |
| Velocity Clinical Research (Endwell - New York) - PPDS | Endwell | New York | 13760 | — |
| Drug Trials America | Hartsdale | New York | 10530 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - New York | New York | New York | 10017 | — |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | — |
| Carolina Institute for Clinical Research - M3 WR | Fayetteville | North Carolina | 28303 | — |
| Triad Clinical Trials | Greensboro | North Carolina | 27410 | — |
| Trial Management Associates, LLC | Wilmington | North Carolina | 28403 | — |
| CTI Clinical Research | Cincinnati | Ohio | 45212 | — |
| Velocity Clinical Research (Cincinnati - Ohio) - PPDS | Cincinnati | Ohio | 45219 | — |
| Velocity Clinical Research - Cincinnati - PPDS | Cincinnati | Ohio | 45219 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati | Cincinnati | Ohio | 45236 | — |
| Tekton Research - Oklahoma - PPDS | Edmond | Oklahoma | 73013 | — |
| Tekton Research | Yukon | Oklahoma | 73099 | — |
| Summit Research Network, Inc. - Portland - Headlands - PPDS | Portland | Oregon | 97210 | — |
| Hatboro Medical Associates - CCT - PPDS | Hatboro | Pennsylvania | 19040 | — |
| DM Clinical Research - Philadelphia - ERN - PPDS | Philadelphia | Pennsylvania | 19107 | — |
| Velocity Clinical Research (Dakota Dunes - South Dakota) - PPDS | Dakota Dunes | South Dakota | 57049 | — |
| American Indian Clinical Trials Research Network | Rapid City | South Dakota | 57701 | — |
| Affinity Health - Nashville | Nashville | Tennessee | 37203 | — |
| Premier Family Physicians - Austin - Hunt - PPDS | Austin | Texas | 78735 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| PanAmerican Clinical Research LLC | Brownsville | Texas | 78520 | — |
| ACRC Trials - Carrollton - Hunt - PPDS | Carrollton | Texas | 75010 | — |
| Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS | Fort Worth | Texas | 76132 | — |
| Allure Health LLC | Friendswood | Texas | 77546 | — |
| Olympus Family Medicine- CCT | Friendswood | Texas | 77546 | — |
| Village Health Partners Frisco Medical Village | Frisco | Texas | 75033 | — |
| West Houston Clinical Research - Hunt - PPDS | Houston | Texas | 77055 | — |
| DM Clinical Research - Bellaire - ERN - PPDS | Houston | Texas | 77081 | — |
| DM Clinical-TCDD | Humble | Texas | 77338 | — |
| Helios CR, Inc. - Houston - PPDS | Keller | Texas | 76248 | — |
| AIM Trials | Plano | Texas | 75093 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - San Antonio | San Antonio | Texas | 78229 | — |
| Clinical Trials of Texas, LLC - HyperCore - PPDS | San Antonio | Texas | 78229 | — |
| Privia Medical Group- North Texas - Stephenville - Javara - PPDS | Stephenville | Texas | 76401 | — |
| DM Clinical Research - Sugarland - ERN - PPDS | Sugar Land | Texas | 77338 | — |
| DM Clinical Research - ERN - PPDS | Tomball | Texas | 77375 | — |
| DM Clinical Research - ERN | Tomball | Texas | 77375 | — |
| Cope Family Medicine - CCT - PPDS | Bountiful | Utah | 84010 | — |
| Alpine Research Organization, Inc | Clinton | Utah | 84015 | — |
| South Ogden Family Medicine - CCT | South Ogden | Utah | 84405 | — |
| Health Research of Hampton Roads Inc. | Newport News | Virginia | 23606 | — |
| Velocity Clinical Research - Family Practice - Portsmouth - PPDS | Portsmouth | Virginia | 23703 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
| Seattle Clinical Research Center | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 136 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05127434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2025 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05127434 live on ClinicalTrials.gov.