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COMPLETED 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

NCT06097299 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL mRNA-1345

Study Locations (20)

Florida

  • D&amp;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

FieldValue
Enrollment Target 346 participants
Start Date 2023-10-24
Est. Completion 2025-06-27
Phase Phase 2

Sponsor

ModernaTX

67 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06097299

The ClinicalTrials.gov registry entry for NCT06097299 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 346 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06097299 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06097299?

The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1345 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06097299?

This trial is sponsored by ModernaTX, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial