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

Completed · Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus

In brief

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.

Key facts

Study ID

NCT06097299

Run by

ModernaTX, Inc.

People needed

346

Starts

2023-10-24

Expected to finish

2025-06-27

Last updated by the study team

2025-07-10

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: accepted.

Where it is running

• Velocity Clinical Research, Phoenix — Phoenix, Arizona, United States
• Headlands Research - Scottsdale — Scottsdale, Arizona, United States
• Velocity Clinical Research - Banning — Banning, California, United States
• ASCADA Research, LLC - Family Medicine — Fullerton, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Peninsula Research Associates (PRA) — Rolling Hills Estates, California, United States
• D&amp;H Doral Research Center, LLC — Doral, Florida, United States
• Kissimmee Clinical Research — Kissimmee, Florida, United States
• Accel Clinical — Largo, Florida, United States
• Med-Care Research — Miami, Florida, United States
• Accel Research Sites - Nona Pediatric Center — Orlando, Florida, United States
• SEC Clinical Research — Pensacola, Florida, United States
• D&H Tamarac Research Center — Tamarac, Florida, United States
• Javara, Inc. — Fayetteville, Georgia, United States
• Velocity Clinical Research-Primary Pediatrics, Macon — Macon, Georgia, United States
• CenExel iResearch, LLC — Savannah, Georgia, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Velocity Clinical Research - Boise — Meridian, Idaho, United States
• Alliance for Multispeciality Research, LLC — El Dorado, Kansas, United States
• Velocity Clinical Research-Kansas City — Overland Park, Kansas, United States
• Velocity Clinical Research - Lafayette — Lafayette, Louisiana, United States
• Velocity Clinical Research Metairie — Metairie, Louisiana, United States
• Great Lakes Research Institute — Southfield, Michigan, United States
• Pediatric &amp; Adolescent Center — Southgate, Michigan, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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