A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
Public ClinicalTrials.gov record NCT04528719. 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 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04528719
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 651 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Months to 79 Years
- 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
- Sep 29, 2020
- Primary completion
- Jul 17, 2024
- Completion
- Jul 17, 2024
- Last update posted
- Aug 6, 2024
2020 – 2024
United States locations
- U.S. sites
- 31
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Paradigm Clinical Research Institute Inc - ClinEdge - PPDS | La Mesa | California | 91942-3189 | — |
| Mills Clinical Research | West Hollywood | California | 90046 | — |
| Accel Research Site - Angel Kids Pediatrics - ERN - PPDS | DeLand | Florida | 32720-0834 | — |
| Accel Research Sites - Nona Pediatric Center - ERN - PPDS | Orlando | Florida | 32806-2908 | — |
| Palm Beach Research - ClinEdge - PPDS | West Palm Beach | Florida | 33409-3401 | — |
| Centricity Research - Roswell - HyperCore - PPDS | Columbus | Georgia | 31904-8946 | — |
| IResearch Atlanta LLC | Decatur | Georgia | 30030-3438 | — |
| Velocity Clinical Research (Savannah - Georgia) - PPDS | Savannah | Georgia | 31406-2675 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814-4526 | — |
| Synexus - Optimal Research - Peoria | Peoria | Illinois | 61614 | — |
| Velocity Clinical Research (Sioux City - Iowa) - PPDS | Sioux City | Iowa | 51106-4233 | — |
| Michael W. Simon, M.D., PSC | Nicholasville | Kentucky | 40517 | — |
| Velocity Clinical Research (Lafayette - Louisiana) - PPDS | Lafayette | Louisiana | 70508-5173 | — |
| Velocity Clinical Research (Metaire - Louisiana) - PPDS | Metairie | Louisiana | 70006 | — |
| Velocity Clinical Research (Slidell - Louisiana) - PPDS | Slidell | Louisiana | 70458-5334 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Alliance for Multispecialty Research - Kansas City | Kansas City | Missouri | 64114-4866 | — |
| Velocity Clinical Research (Grand Island - Nebraska) - PPDS | Grand Island | Nebraska | 68803 | — |
| Velocity Clinical Research (Hastings - Nebraska) - PPDS | Hastings | Nebraska | 68901 | — |
| Velocity Clinical Research (Norfolk - Nebraska) - PPDS | Norfolk | Nebraska | 68701 | — |
| Velocity Clinical Research (Omaha - Nebraska) - PPDS | Omaha | Nebraska | 68134 | — |
| Velocity Clinical Research (Albuquerque - New Mexico) - PPDS | Albuquerque | New Mexico | 87102-3876 | — |
| Velocity Clinical Research (Binghamton - New York) - PPDS | Binghamton | New York | 13901-1046 | — |
| Velocity Clinical Research - Medford - ERN - PPDS | Medford | Oregon | 97504-9741 | — |
| Velocity Clinical Research - Columbia - PPDS | Columbia | South Carolina | 29204 | — |
| Velocity Clinical Research (Greenville - South Carolina) - PPDS | Greenville | South Carolina | 29615-4833 | — |
| Cyfair Clinical Research Center - ERN - PPDS | Houston | Texas | 77065 | — |
| Flourish Research - San Antonio - PPDS | San Antonio | Texas | 78229-3539 | — |
| DM Clinical Research | Tomball | Texas | 77375-6543 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| Clinical Research Partners LLC | Richmond | Virginia | 23226-3787 | — |
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 NCT04528719, 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 6, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04528719 live on ClinicalTrials.gov.