A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
Public ClinicalTrials.gov record NCT06097299. 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, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to \<5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to \<18 years of age (Cohort 2) to inform the dose level selection for the next phase of development (Phase 3). Part B: The purpose is to provide surveillance for RSV disease for the next RSV season (6 months after re-enrollment) and safety follow-up for Cohort 1 participants that were enrolled and dosed in Part A.
Study identification
- NCT ID
- NCT06097299
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 349 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 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
- Oct 24, 2023 (Actual)
- Primary completion
- Jun 27, 2025 (Actual)
- Completion
- Jun 27, 2025 (Actual)
- Last update posted
- Aug 18, 2026
2023 – 2025
United States locations
- U.S. sites
- 47
- U.S. states
- 19
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Velocity Clinical Research, Phoenix | Phoenix | Arizona | 85006 | — |
| Headlands Research - Scottsdale | Scottsdale | Arizona | 85260 | — |
| Velocity Clinical Research - Banning | Banning | California | 92220 | — |
| ASCADA Research, LLC - Family Medicine | Fullerton | California | 92835 | — |
| Ark Clinical Research | Long Beach | California | 90815 | — |
| Peninsula Research Associates (PRA) | Rolling Hills Estates | California | 90274 | — |
| D&H Doral Research Center, LLC | Doral | Florida | 33122 | — |
| Kissimmee Clinical Research | Kissimmee | Florida | 34741 | — |
| Accel Clinical | Largo | Florida | 33777 | — |
| Med-Care Research | Miami | Florida | 33125 | — |
| Accel Research Sites - Nona Pediatric Center | Orlando | Florida | 32829 | — |
| SEC Clinical Research | Pensacola | Florida | 32501 | — |
| D&H Tamarac Research Center | Tamarac | Florida | 33321 | — |
| Javara, Inc. | Fayetteville | Georgia | 30214 | — |
| Velocity Clinical Research-Primary Pediatrics, Macon | Macon | Georgia | 31210 | — |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Velocity Clinical Research - Boise | Meridian | Idaho | 83642 | — |
| Alliance for Multispeciality Research, LLC | El Dorado | Kansas | 67042 | — |
| Velocity Clinical Research-Kansas City | Overland Park | Kansas | 66210 | — |
| Velocity Clinical Research - Lafayette | Lafayette | Louisiana | 70508 | — |
| Velocity Clinical Research Metairie | Metairie | Louisiana | 70006 | — |
| Great Lakes Research Institute | Southfield | Michigan | 48075 | — |
| Pediatric & Adolescent Center | Southgate | Michigan | 48195-1896 | — |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | — |
| Velocity Clinical Research, Gulfport | Gulfport | Mississippi | 39503 | — |
| Velocity Clinical Research- Albuquerque | Albuquerque | New Mexico | 87107 | — |
| Velocity Clinical Research-Binghamton | Binghamton | New York | 13905 | — |
| University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH) | Rochester | New York | 14620 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| The Children's Hospital of Philadelphia - Pediatrics | Philadelphia | Pennsylvania | 19104-4318 | — |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | — |
| Velocity Clinical Research - Providence | Providence | Rhode Island | 02886 | — |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | — |
| Tribe Clinical Research | Simpsonville | South Carolina | 29680 | — |
| Elligo Clinical Research Center | Austin | Texas | 78704 | — |
| REX Clinical Trials, LLC | Beaumont | Texas | 77701 | — |
| Javara Inc (Conroe) | Conroe | Texas | 77384 | — |
| West Houston Clinical Research Service | Houston | Texas | 77055 | — |
| DM Clinical Research - CyFair | Houston | Texas | 77065 | — |
| Village Pediatrics | Plano | Texas | 75024 | — |
| Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas | Stephenville | Texas | 76401 | — |
| Victoria Clinical Research Group | Victoria | Texas | 77901 | — |
| Velocity Clinical Research - Salt Lake City | West Jordan | Utah | 84088 | — |
| PI-Coor Clinical Research, LLC | Annandale | Virginia | 22003 | — |
| Clinical Research Partners | Richmond | Virginia | 23226 | — |
| National Clinical Research, Inc. | Richmond | Virginia | 23294 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06097299, 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, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06097299 live on ClinicalTrials.gov.