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The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose A in Younger Adults | Experimental | Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1. |
|
| Cohort 2: Dose B in Younger Adults | Experimental | Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1. |
|
| Cohort 3: Dose B in Younger Adults | Experimental | Three total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
|
| Cohort 4: Dose C in Younger Adults | Experimental | Single injection of Dose C of mRNA-1345 or matching-placebo on Day 1. |
|
| Cohort 5: Dose D in Children | Experimental | Three total injections, 1 injection of either Dose D of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1345 | Biological | Formulation for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 737 (7 days after each injection) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 758 (28 days after the last injection) | |
| Number of Participants with Serious AEs or Medically Attended AEs (MAAEs) | Up to Day 1095 (End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs) | Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11) | |
| Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers |
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Key Inclusion Criteria:
Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults [including Japanese older adults]):
Specific inclusion criteria for children 12 to 59 months of age:
Specific inclusion criteria for Japanese older adults:
Key Exclusion Criteria:
Has Screening laboratory values Grade ≥1 (younger adult, women of child-bearing potential, and pediatric participants) or >Grade 1 (older adult participants, including Japanese older adult participants).
Is acutely ill or febrile on the day of the first injection.
Has a significant medical history, including but not limited to:
Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤ 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Nonstudy vaccinations should not be delayed.
Has a history of myocarditis, pericarditis, or myopericarditis.
Specific exclusion criteria for older adults (Cohorts 7-11 and 15):
Specific exclusion criteria for children 12 to 59 months of age (Cohorts 5 and 6):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paradigm Clinical Research Institute Inc - ClinEdge - PPDS | La Mesa | California | 91942-3189 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953212 | Derived | Schnyder Ghamloush S, Fanning S, Essink B, Eder F, Snape MD, Stoszek SK, Guo R, Dhar R, Righi V, Morsy L, Kapoor A, El Asmar L, Shaw CA. Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12-59 months. Hum Vaccin Immunother. 2025 Dec;21(1):2557676. doi: 10.1080/21645515.2025.2557676. Epub 2025 Sep 15. | |
| 39255587 |
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For older adult Cohorts 7, 8, 9, 10, and 11, the second booster injection on Day 730 (Month 24) will be open-label.
| Cohort 6: Dose G in Children | Experimental | Three total injections, 1 injection of either Dose G of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
|
| Cohort 7: Dose A in Older Adults | Experimental | Two total injections, 1 injection of either Dose A of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
|
| Cohort 8: Dose B in Older Adults | Experimental | Two total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
|
| Cohort 9: Dose C in Older Adults | Experimental | Two total injections, 1 injection of either Dose C of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
|
| Cohort 10: Dose E in Older Adults | Experimental | Two total injections, 1 injection of either Dose E of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
|
| Cohort 11: Dose F in Older Adults | Experimental | Two total injections, 1 injection of either Dose F of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
|
| Cohort 12: Dose E in Women of Child-Bearing Potential | Experimental | Single injection of Dose E of mRNA-1345 or matching-placebo on Day 1. |
|
| Cohort 13: Dose F in Women of Child-Bearing Potential | Experimental | Single injection of Dose F of mRNA-1345 or matching-placebo on Day 1. |
|
| Cohort 14: Dose A in Women of Child-Bearing Potential | Experimental | Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1. |
|
| Cohort 15: Dose B in Japanese Older Adults | Experimental | Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1. |
|
| Placebo | Drug | 0.9% sodium chloride (normal saline) injection |
|
| Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11) |
| Proportion of Participants with ≥2-fold and ≥4-fold Increases in Ab Titers from Baseline | Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11) |
| Mills Clinical Research |
| West Hollywood |
| California |
| 90046 |
| United States |
| Accel Research Site - Angel Kids Pediatrics - ERN - PPDS | DeLand | Florida | 32720-0834 | United States |
| Accel Research Sites - Nona Pediatric Center - ERN - PPDS | Orlando | Florida | 32806-2908 | United States |
| Palm Beach Research - ClinEdge - PPDS | West Palm Beach | Florida | 33409-3401 | United States |
| Centricity Research - Roswell - HyperCore - PPDS | Columbus | Georgia | 31904-8946 | United States |
| IResearch Atlanta LLC | Decatur | Georgia | 30030-3438 | United States |
| Velocity Clinical Research (Savannah - Georgia) - PPDS | Savannah | Georgia | 31406-2675 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814-4526 | United States |
| Synexus - Optimal Research - Peoria | Peoria | Illinois | 61614 | United States |
| Velocity Clinical Research (Sioux City - Iowa) - PPDS | Sioux City | Iowa | 51106-4233 | United States |
| Michael W. Simon, M.D., PSC | Nicholasville | Kentucky | 40517 | United States |
| Velocity Clinical Research (Lafayette - Louisiana) - PPDS | Lafayette | Louisiana | 70508-5173 | United States |
| Velocity Clinical Research (Metaire - Louisiana) - PPDS | Metairie | Louisiana | 70006 | United States |
| Velocity Clinical Research (Slidell - Louisiana) - PPDS | Slidell | Louisiana | 70458-5334 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Alliance for Multispecialty Research - Kansas City | Kansas City | Missouri | 64114-4866 | United States |
| Velocity Clinical Research (Grand Island - Nebraska) - PPDS | Grand Island | Nebraska | 68803 | United States |
| Velocity Clinical Research (Hastings - Nebraska) - PPDS | Hastings | Nebraska | 68901 | United States |
| Velocity Clinical Research (Norfolk - Nebraska) - PPDS | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research (Omaha - Nebraska) - PPDS | Omaha | Nebraska | 68134 | United States |
| Velocity Clinical Research (Albuquerque - New Mexico) - PPDS | Albuquerque | New Mexico | 87102-3876 | United States |
| Velocity Clinical Research (Binghamton - New York) - PPDS | Binghamton | New York | 13901-1046 | United States |
| Velocity Clinical Research - Medford - ERN - PPDS | Medford | Oregon | 97504-9741 | United States |
| Velocity Clinical Research - Columbia - PPDS | Columbia | South Carolina | 29204 | United States |
| Velocity Clinical Research (Greenville - South Carolina) - PPDS | Greenville | South Carolina | 29615-4833 | United States |
| Cyfair Clinical Research Center - ERN - PPDS | Houston | Texas | 77065 | United States |
| Flourish Research - San Antonio - PPDS | San Antonio | Texas | 78229-3539 | United States |
| DM Clinical Research | Tomball | Texas | 77375-6543 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Clinical Research Partners LLC | Richmond | Virginia | 23226-3787 | United States |
| Fitz-Patrick D, Mihara H, Mills A, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Simorellis AK, Panozzo CA, Reuter C, Wilson E, Chen GL, Stoszek SK, Shaw CA, Goswami J. Safety and immunogenicity of an mRNA-based RSV vaccine in Japanese older adults aged >/=60 years: A phase 1, randomized, observer-blind, placebo-controlled trial. Respir Investig. 2024 Nov;62(6):1037-1043. doi: 10.1016/j.resinv.2024.08.011. Epub 2024 Sep 9. |
| 38385566 | Derived | Shaw CA, Essink B, Harper C, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Panozzo CA, Wilson E, Simorellis AK, Reuter C, Stoszek SK, Chen GL, Das R, Goswami J. Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults. J Infect Dis. 2024 Sep 23;230(3):e647-e656. doi: 10.1093/infdis/jiae081. |
| 38298125 | Derived | Shaw CA, Mithani R, Kapoor A, Dhar R, Wilson L, El Asmar L, Schnyder-Ghamloush S, Schaefers K, August A, Stoszek SK, Chen GL. Safety, Tolerability, and Immunogenicity of an mRNA-Based Respiratory Syncytial Virus Vaccine in Healthy Young Adults in a Phase 1 Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e637-e646. doi: 10.1093/infdis/jiae035. |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722749 | mRNA-1345 respiratory syncytial virus vaccine |
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