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NCT06097299 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Respiratory Syncytial Virus, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 2
- Development phase
- 346
- Enrollment target
- 20
- Study locations
NCT06097299: Completed Phase 2 study of Respiratory Syncytial Virus, sponsored by ModernaTX.
NCT06097299 is a Phase 2 study of Respiratory Syncytial Virus that has completed, run by ModernaTX. The registered enrollment target is 346 participants, roughly in line with the 348-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target. The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06097299, a Phase 2 study of Respiratory Syncytial Virus, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 346 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs)
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1345
Study Locations (20)
Florida
- D&H Doral Research Center, LLC - Doral
- Kissimmee Clinical Research - Kissimmee
- Accel Clinical - Largo
- Med-Care Research - Miami
- Accel Research Sites - Nona Pediatric Center - Orlando
- SEC Clinical Research - Pensacola
- D&H Tamarac Research Center - Tamarac
California
- Velocity Clinical Research - Banning - Banning
- ASCADA Research, LLC - Family Medicine - Fullerton
- Ark Clinical Research - Long Beach
- Peninsula Research Associates (PRA) - Rolling Hills Estates
Georgia
- Javara, Inc. - Fayetteville
- Velocity Clinical Research-Primary Pediatrics, Macon - Macon
- CenExel iResearch, LLC - Savannah
Arizona
- Velocity Clinical Research, Phoenix - Phoenix
- Headlands Research - Scottsdale - Scottsdale
Idaho
- Clinical Research Prime - Idaho Falls
- Velocity Clinical Research - Boise - Meridian
Kansas
- Alliance for Multispeciality Research, LLC - El Dorado
- Velocity Clinical Research-Kansas City - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2023-10-24 |
| Est. Completion | 2025-06-27 |
| Phase | Phase 2 |
What the finished NCT06097299 record still lists
NCT06097299 is an interventional study that assigns participants to a tested intervention. The registered 346 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 348-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target.
The record links to 1 condition, with Respiratory Syncytial Virus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06097299 names 20 study sites across 6 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06097299 about?
NCT06097299 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06097299?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 346 participants. The study started on 2023-10-24. Estimated completion is 2025-06-27.
What conditions does trial NCT06097299 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus.
What interventions are being tested in trial NCT06097299?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1345 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06097299?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06097299 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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