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
NCT ID: NCT06097299
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
346 participants
INTERVENTIONAL
2023-10-24
2025-06-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Part A and Part B: Cohort 1 (2 to <5 Years of Age)
Part A: Participants 2 to \<5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1. Part B: Participants will have the option to be re-enrolled into a 6-month safety-follow up period.
mRNA-1345
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
Part A: Cohort 2 (5 to <18 Years of Age)
Participants 5 to \<18 years of age will receive a single IM injection of mRNA-1345 on Day 1.
mRNA-1345
Sterile liquid for injection
Interventions
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mRNA-1345
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
2 Years
17 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Panama City, , Panama
Countries
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Other Identifiers
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2024-000502-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
mRNA-1345-P202
Identifier Type: -
Identifier Source: org_study_id
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