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NCT06097299

PHASE2

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

349

Start Date

2023-10-24

Completion Date

2025-06-27

Last Updated

2026-08-18

Healthy Volunteers

Yes

Conditions

Respiratory Syncytial Virus

Interventions

BIOLOGICAL

mRNA-1345

Sterile liquid for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

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.

Locations (50)

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&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 & Adolescent Center

Southgate, Michigan, United States

Clinical Research Institute

Minneapolis, Minnesota, United States

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, United States

Velocity Clinical Research- Albuquerque

Albuquerque, New Mexico, United States

Velocity Clinical Research-Binghamton

Binghamton, New York, United States

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

Rochester, New York, United States

Senders Pediatrics

South Euclid, Ohio, United States

The Children's Hospital of Philadelphia - Pediatrics

Philadelphia, Pennsylvania, United States

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, United States

Velocity Clinical Research - Providence

Providence, Rhode Island, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

Tribe Clinical Research

Simpsonville, South Carolina, United States

Elligo Clinical Research Center

Austin, Texas, United States

REX Clinical Trials, LLC

Beaumont, Texas, United States

Javara Inc (Conroe)

Conroe, Texas, United States

West Houston Clinical Research Service

Houston, Texas, United States

DM Clinical Research - CyFair

Houston, Texas, United States

Village Pediatrics

Plano, Texas, United States

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

Stephenville, Texas, United States

Victoria Clinical Research Group

Victoria, Texas, United States

Velocity Clinical Research - Salt Lake City

West Jordan, Utah, United States

PI-Coor Clinical Research, LLC

Annandale, Virginia, United States

Clinical Research Partners

Richmond, Virginia, United States

National Clinical Research, Inc.

Richmond, Virginia, United States

CEVAXIN Chorrera

La Chorrera, Panama

CEVAXIN Avenida Mexico

Panama City, Panama

CEVAXIN 24 de Diciembre