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Can an mRNA vaccine shield vulnerable children from RSV?

NCT ID NCT06097299

Vaccine Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This phase 2 trial evaluates an experimental mRNA vaccine (mRNA-1345) designed to protect against respiratory syncytial virus (RSV) in children aged 2 to under 18 who are at high risk of severe RSV disease. The study will assess the vaccine's safety, side effects, and immune response in two age groups. It also includes follow-up monitoring for RSV illness during the next RSV season. The goal is to determine if this vaccine can help prevent serious RSV infections in vulnerable children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1345, an mRNA vaccine targeting respiratory syncytial virus (RSV)
What this could lead to
If successful, this vaccine could help protect high-risk children from severe RSV disease, potentially reducing hospitalizations and serious complications.
What could go wrong
This is an early-phase trial, so the vaccine may not prove effective or safe in this age group. Possible side effects include injection site reactions and systemic symptoms like fever or fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

349 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Part A Cohort 1: * 2 to \<5 years of age at Day 1. * Healthy, or with stable chronic conditions increasing the risk of RSV disease, per the clinical judgment of the Investigator. Cohort 2: * 5 to \<18 years of age at Day 1. * Participants with stable chronic conditions increasing the risk of RSV disease. * Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of injection (Day 1); 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to Day 1; 3) has agreed to continue adequate contraception through 90 days following injection; and 4) is not currently breastfeeding. Part B: Cohort 1 Re-enrollment Participants are eligible to be included in the study only if all of the following criteria apply: 1. Enrolled and dosed in Part A of Cohort 1; either reached EoS for Part A or were dosed and subsequently discontinued from study for various reasons. This includes participants who were lost to follow-up, if they can be re-engaged. 2. Participant's parent(s)/LAR(s) has provided written informed consent for participation in this study. Key Exclusion Criteria (All Cohorts): * Acutely ill or febrile (temperature ≥38.0°Celsius \[100.4°Fahrenheit\]) within 72 hours prior to or at the Screening Visit or Day 1. * History of a diagnosis or condition that, in the judgment of the Investigator, may affect study assessment or compromise participant safety. * Has received or plans to receive any licensed or authorized vaccine ≤14 days prior to the study vaccine injection (Day 1) or plans to receive a licensed or authorized vaccine within 14 days after the study vaccine injection. * Receipt of any prior systemic immunosuppressants. Short courses (\<7 days) of oral corticosteroids are allowed if completed at least 3 months prior to enrollment. * Receipt of RSV monoclonal antibodies within 6 months prior to enrollment in the study. * Participated in an interventional clinical study within 28 days (6 months for a study assessing a product unlicensed/unauthorized in this age group in country of residence at time of enrollment) prior to the day of enrollment or plans to do so while enrolled in this study. Part B: Cohort 1 Re-enrollment 1\. Participant is currently enrolled in another interventional clinical study. Note: Other protocol-defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease viral infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus

Contacts and locations

Locations

  • ASCADA Research, LLC - Family Medicine

    Fullerton, California, 92835, United States

  • Accel Clinical

    Largo, Florida, 33777, United States

  • Accel Research Sites - Nona Pediatric Center

    Orlando, Florida, 32829, United States

  • Alliance for Multispeciality Research, LLC

    El Dorado, Kansas, 67042, United States

  • Ark Clinical Research

    Long Beach, California, 90815, United States

  • CEVAXIN 24 de Diciembre

    Panama City, 07114, Panama

  • CEVAXIN Avenida Mexico

    Panama City, 07093, Panama

  • CEVAXIN Chorrera

    La Chorrera, 07066, Panama

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402, United States

  • Clinical Research Partners

    Richmond, Virginia, 23226, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414, United States

  • D&H Tamarac Research Center

    Tamarac, Florida, 33321, United States

  • D&amp;H Doral Research Center, LLC

    Doral, Florida, 33122, United States

  • DM Clinical Research - CyFair

    Houston, Texas, 77065, United States

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • Elligo Clinical Research Center

    Austin, Texas, 78704, United States

  • Great Lakes Research Institute

    Southfield, Michigan, 48075, United States

  • Headlands Research - Scottsdale

    Scottsdale, Arizona, 85260, United States

  • Javara Inc (Conroe)

    Conroe, Texas, 77384, United States

  • Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas

    Stephenville, Texas, 76401, United States

  • Javara, Inc.

    Fayetteville, Georgia, 30214, United States

  • Kissimmee Clinical Research

    Kissimmee, Florida, 34741, United States

  • Med-Care Research

    Miami, Florida, 33125, United States

  • National Clinical Research, Inc.

    Richmond, Virginia, 23294, United States

  • PI-Coor Clinical Research, LLC

    Annandale, Virginia, 22003, United States

  • Pediatric &amp; Adolescent Center

    Southgate, Michigan, 48195-1896, United States

  • Peninsula Research Associates (PRA)

    Rolling Hills Estates, California, 90274, United States

  • REX Clinical Trials, LLC

    Beaumont, Texas, 77701, United States

  • SEC Clinical Research

    Pensacola, Florida, 32501, United States

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • The Children's Hospital of Philadelphia - Pediatrics

    Philadelphia, Pennsylvania, 19104-4318, United States

  • Tribe Clinical Research

    Simpsonville, South Carolina, 29680, United States

  • University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)

    Rochester, New York, 14620, United States

  • Velocity Clinical Research - Banning

    Banning, California, 92220, United States

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research - Lafayette

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research - Providence

    Providence, Rhode Island, 02886, United States

  • Velocity Clinical Research - Salt Lake City

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research Metairie

    Metairie, Louisiana, 70006, United States

  • Velocity Clinical Research, Gulfport

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research, Phoenix

    Phoenix, Arizona, 85006, United States

  • Velocity Clinical Research- Albuquerque

    Albuquerque, New Mexico, 87107, United States

  • Velocity Clinical Research-Binghamton

    Binghamton, New York, 13905, United States

  • Velocity Clinical Research-Kansas City

    Overland Park, Kansas, 66210, United States

  • Velocity Clinical Research-Primary Pediatrics, Macon

    Macon, Georgia, 31210, United States

  • Victoria Clinical Research Group

    Victoria, Texas, 77901, United States

  • Village Pediatrics

    Plano, Texas, 75024, United States

  • West Houston Clinical Research Service

    Houston, Texas, 77055, United States

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