A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
Public ClinicalTrials.gov record NCT05330975. 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 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.
Study identification
- NCT ID
- NCT05330975
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,317 participants
Conditions and interventions
Conditions
Interventions
- Placebo Biological
- mRNA-1345 Biological
- Afluria® Quadrivalent Biological
- mRNA-1273.214 Biological
Biological
Eligibility (public fields only)
- Age range
- 50 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
- Apr 1, 2022 (Actual)
- Primary completion
- Nov 8, 2024 (Actual)
- Completion
- Nov 8, 2024 (Actual)
- Last update posted
- Dec 30, 2025
2022 – 2024
United States locations
- U.S. sites
- 62
- U.S. states
- 23
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates Inc | Birmingham | Alabama | 35205 | — |
| Del Sol Research Management - Clinedge - PPDS | Tucson | Arizona | 85715 | — |
| Paragon Rx Clinical, Inc | Garden Grove | California | 92703-1811 | — |
| Ark Clinical Research | Long Beach | California | 90806 | — |
| Long Beach Clinical Trials, LLC (Site 1) | Long Beach | California | 90806 | — |
| Long Beach Clinical Trials, LLC (Site 2) | Long Beach | California | 90806 | — |
| Central Valley Research, LLC | Modesto | California | 95350 | — |
| Velocity Clinical Research - Panorama City | Panorama City | California | 91402-3022 | — |
| Empire Clinical Research | Pomona | California | 91786 | — |
| Acclaim Clinical Research | San Diego | California | 92120 | — |
| Medical Center For Clinical Research - M3 WR - ERN - PPDS | San Diego | California | 92120 | — |
| Ark Clinical Research | Tustin | California | 92780 | — |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | — |
| Teradan Clinical Trials | Brandon | Florida | 33511-4925 | — |
| Revival Research Corporation - Clinedge - PPDS | Doral | Florida | 33122 | — |
| Dolphin Medical Research | Doral | Florida | 33172 | — |
| Indago Research and Health Center | Hialeah | Florida | 33012 | — |
| Westside Center for Clinical Research - ERN - PPDS | Jacksonville | Florida | 32205 | — |
| Suncoast Research Group LLC - ERN-PPDS | Miami | Florida | 33135 | — |
| Suncoast Research Associates LLC - ERN - PPDS | Miami | Florida | 33173 | — |
| Floridian Clinical Research - ClinEdge - PPDS | Miami Lakes | Florida | 33016 | — |
| Tekton Research - Georgia - Platinum - PPDS | Chamblee | Georgia | 30341 | — |
| Lifeline Primary Care / CCT Research | Lilburn | Georgia | 30047-2832 | — |
| Georgia Clinic / CCT Research | Norcross | Georgia | 30092-4544 | — |
| Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS | Savannah | Georgia | 31406 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Meridian Clinical Research (Sioux City - Iowa) | Sioux City | Iowa | 51106 | — |
| Meridian Clinical Research, LLC (Overland Park, Kansas) - Platinum - PPDS | Overland Park | Kansas | 66210-1863 | — |
| Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS | Baton Rouge | Louisiana | 70809 | — |
| Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | 70601 | — |
| Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS | Rockville | Maryland | 20854-2957 | — |
| Clinical Research Institute, Inc - CRN - PPDS | Minneapolis | Minnesota | 55402 | — |
| Meridian Clinical Research (Grand Island) - Platinum - PPDS | Grand Island | Nebraska | 68803 | — |
| Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS | Lincoln | Nebraska | 68510 | — |
| Be Well Clinical Studies, LLC | Lincoln | Nebraska | 68516 | — |
| Meridian Clinical Research | Norfolk | Nebraska | 68701 | — |
| Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS | Omaha | Nebraska | 68134 | — |
| Midwest Regional Health Services - CCT Research | Omaha | Nebraska | 68144 | — |
| Clinical Research Center of Nevada - ERN - PPDS | Las Vegas | Nevada | 89106 | — |
| Santa Rosa Medical Centers of Nevada - CCT Research | Las Vegas | Nevada | 89119-5483 | — |
| Meridian Clinical Research (Endwell-New York) - Platinum - PPDS | Endwell | New York | 13760 | — |
| IMA Medical Research, PC. | New York | New York | 10036-4103 | — |
| CHEAR Center LLC - ClinEdge - PPDS | The Bronx | New York | 10455-3908 | — |
| Javara Research Inc. - Charlotte - Javara - PPDS | Charlotte | North Carolina | 28210 | — |
| M3 Wake Research, Inc - M3 WR - ERN - PPDS | Raleigh | North Carolina | 27612 | — |
| Velocity Clinical Research - Cleveland - ERN - PPDS | Cleveland | Ohio | 44122 | — |
| Meridian Clinical Research - Cincinnati - Platinum - PPDS | Springdale | Ohio | 45246 | — |
| Tekton Research | Moore | Oklahoma | 73160-1386 | — |
| Velocity Clinical Research - Anderson - ERN - PPDS | Anderson | South Carolina | 29621 | — |
| Velocity Clinical Research - Greenville - ERN - PPDS | Greenville | South Carolina | 29615 | — |
| Trial Management Associates LLC - ERN - PPDS | Myrtle Beach | South Carolina | 29572-4612 | — |
| Velocity Clinical Research - Spartanburg - ERN - PPDS | Spartanburg | South Carolina | 29303-4225 | — |
| New Phase Research & Development | Knoxville | Tennessee | 37909 | — |
| Benchmark Research - Austin - HyperCore - PPDS | Austin | Texas | 78705 | — |
| Tekton Research - Beaumont - Platinum - PPDS | Beaumont | Texas | 77706 | — |
| Zenos Clinical Research | Dallas | Texas | 75230 | — |
| Milton Haber, M.D. | Laredo | Texas | 78041 | — |
| Sun Research Institute | San Antonio | Texas | 78215-1922 | — |
| Cope Family Medicine - Ogden Clinic | Bountiful | Utah | 84010-4862 | — |
| CCT Research at Springville Dermatology | Springville | Utah | 84663 | — |
| Javara Inc./Privia Medical Group INC | Forest | Virginia | 24551 | — |
| Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS | Portsmouth | Virginia | 23703 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05330975, 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 Dec 30, 2025 · Synced Oct 23, 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 public registry record, listed eligibility criteria, and available contact information for NCT05330975 live on ClinicalTrials.gov.