Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years.
Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: mRNA-1345 Dose 1 | Experimental | Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1. |
|
| Part A: mRNA-1345 Dose 2 | Experimental | Single injection of mRNA-1345 administered IM on Day 1. |
|
| Part B: mRNA-1345 Dose 2 | Experimental | Two injections of mRNA-1345 administered IM on Day 1 and Day 57. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1345 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Day 1 through Day 7 (7 days post injection) for Part A and Day 1 through Day 64 (7 days post second injection) for Part B | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Day 1 through Day 28 (28 days post injection) for Part A and Day 1 through Day 84 (28 days post second injection) for Part B | |
| Number of Participants With Medically Attended AEs (MAAEs) | Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B) | |
| Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation | Day 1 through End of Study (Day 730) | |
| Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (Abs) at Day 29 | Day 29 | |
| Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85 | Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29 | Day 29 | |
| Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs | Up to End of Study (Day 730) |
Not provided
Key Inclusion Criteria:
Part A:
Adults ≥18 to <60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
Part B:
Parts A and B:
- Able to comply with study requirements.
Key Exclusion Criteria:
Part A:
Part B:
Note: Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenzmeier Family Medicine - CCT - PPDS | Glendale | Arizona | 85308-5093 | United States | ||
| Foothills Research Center - CCT - PPDS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41711453 | Derived | Mayer EF, Falsey AR, Wolfe CR, Herc E, Burns F, Kabbani D, Kumar D, Mannan A, She F, Lan L, McGrath S, Kapoor A, Priddy F. Respiratory Syncytial Virus Vaccination in Solid Organ Transplant Recipients: Interim Findings From a Phase 3 Trial of mRNA-1345. Clin Infect Dis. 2026 May 20;82(5):e1112-e1121. doi: 10.1093/cid/ciag108. | |
| 40464662 |
Not provided
Not provided
Not provided
Part A participants will be randomized into 2 treatment dose groups at a 1:1 ratio.
Part B is non-randomized.
Not provided
Not provided
Part A: double-blind Part B: open-label (no masking)
| Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs | Up to End of Study (Day 730) |
| Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels | Baseline up to Day 730 |
| Part A: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs | Up to End of Study (Day 730) |
| Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29 | Day 29 |
| Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs | Baseline up to Day 730 |
| Part A: GMFR of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs | Baseline up to Day 730 |
| Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs | Up to End of Study (Day 730) |
| Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers | Up to End of Study (Day 730) |
| Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29 | Day 29 |
| Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29 | Day 29 |
| Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85 | Day 85 |
| Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs | Up to End of Study (Day 730) |
| Part B: GMFR of Serum RSV-A and RSV-B Neutralizing Abs | Up to End of Study (Day 730) |
| Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs at Postbaseline/Baseline Levels | Baseline up to Day 730 |
| Part B: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs | Up to End of Study (Day 730) |
| Part B: GMC of Serum RSV Pre-F Binding Abs | Up to End of Study (Day 730) |
| Part B: GMFR of Serum RSV Pre-F Binding Abs | Up to End of Study (Day 730) |
| Part B: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels | Baseline up to End of Study (Day 730) |
| Part B: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs | Up to End of Study (Day 730) |
| Phoenix |
| Arizona |
| 85044-6097 |
| United States |
| Fiel Family & Sports Medicine - PC - CCT - PPDS | Tempe | Arizona | 85283-1528 | United States |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | United States |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095-3075 | United States |
| Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS | San Diego | California | 92103-2209 | United States |
| Critical Care, Pulmonary and Sleep Associates / CCT Research | Lakewood | Colorado | 80228 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510-2483 | United States |
| Excel Medical Clinical Trials DBA Flourish | Boca Raton | Florida | 33434 | United States |
| Indago Research and Health Center | Hialeah | Florida | 33012-4170 | United States |
| CenExel RCA - Hollywood | Hollywood | Florida | 33024-2709 | United States |
| Clinical Research Atlanta - Headlands - PPDS | Stockbridge | Georgia | 30281-9054 | United States |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404-7573 | United States |
| University of Chicago | Chicago | Illinois | 60637-1443 | United States |
| AES - DRS - Optimal Research Illinois - Peoria | Peoria | Illinois | 61614-4885 | United States |
| Benchmark Research - Covington - HyperCore - PPDS | Covington | Louisiana | 70433 | United States |
| Velocity Clinical Research (Rockville - Maryland) - PPDS | Rockville | Maryland | 20854-2960 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202-2608 | United States |
| DM Clinical Research - Southfield - ERN - PPDS | Southfield | Michigan | 48076-5412 | United States |
| Velocity Clinical Research (Lincoln - Nebraska) - PPDS | Lincoln | Nebraska | 68510 | United States |
| University of Rochester - Rochester General Hospital - PPDS | Rochester | New York | 14621-3011 | United States |
| Montefiore Medical Center - BRANY - PPDS | The Bronx | New York | 10467-2401 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| DM Clinical Research - Philadelphia - ERN - PPDS | Philadelphia | Pennsylvania | 19107-1530 | United States |
| Benchmark Research - Fort Worth - HyperCore - PPDS | Fort Worth | Texas | 76135-5283 | United States |
| DM Clinical Research - Cyfair Clinical Research Center | Houston | Texas | 77065-5685 | United States |
| Benchmark Research - San Angelo - HyperCore - PPDS | San Angelo | Texas | 76904-7610 | United States |
| DM Clinical Research - ERN - PPDS | Tomball | Texas | 77375-6543 | United States |
| Springville Dermatology - CCT - PPDS | Springville | Utah | 84663 | United States |
| Velocity Clinical Research - Hampton - PPDS | Hampton | Virginia | 23666-6262 | United States |
| Centricity Research Suffolk Family Medicine | Suffolk | Virginia | 23435-3763 | United States |
| Velocity Clinical Research - Family Practice - Suffolk - PPDS | Suffolk | Virginia | 23435 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2B7 | Canada |
| OCT Research ULC (dba Okanagan Clinical Trials) | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Canadian Center for Vaccinology | Halifax | Nova Scotia | L7 8XZ | Canada |
| Colchester Research Group | Truro | Nova Scotia | B2N 1L2 | Canada |
| Diex Recherche - Sherbrooke - PPDS | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Diex Recherche - Québec - PPDS | Québec | G1V 4T3 | Canada |
| Caribbean Medical Research Center | San Juan | 00918 | Puerto Rico |
| Royal Devon and Exeter Hospital | Exeter | Devon | EX2 5DW | United Kingdom |
| Fylde Coast Clinical Research | Blackpool | Lancashire | FY3 7EN | United Kingdom |
| Liverpool School of Tropical Medicine | Liverpool | Merseyside | L7 8XZ | United Kingdom |
| Aberdeen Royal Infirmary - PPDS | Aberdeen | AB25 2ZD | United Kingdom |
| The Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Mayer EF, Falsey AR, Clark R, Ferguson M, Cardona J, She F, Jones B, Reuter C, Collins A, Mannan A, Kapoor A, Slobod K, Stoszek SK, Du J, Mou J, Lan L, Zhou H, Wilson E, Goswami J, Das R, Priddy F. Safety, Tolerability, and Immunogenicity of mRNA-1345 in Adults at Increased Risk for Respiratory Syncytial Virus Disease Aged 18-59 Years. Clin Infect Dis. 2026 Feb 4;81(6):e708-e716. doi: 10.1093/cid/ciaf292. |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722749 | mRNA-1345 respiratory syncytial virus vaccine |
Not provided
Not provided
Not provided