A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
NCT ID: NCT05743881
Last Updated: 2025-11-24
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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ACTIVE_NOT_RECRUITING
PHASE1
186 participants
INTERVENTIONAL
2023-02-15
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months)
Participants will receive mRNA-1345 vaccine by intramuscular (IM) injection on Days 1, 57 and 113.
mRNA-1345
Sterile liquid for injection
Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months)
Participants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113.
mRNA-1365
Sterile liquid for injection
Part A: Placebo (Age Group: 8 to <24 months)
Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113.
Placebo
0.9% sodium chloride (normal saline) solution for injection
Nimenrix
Solution for injection
Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months)
Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.
mRNA-1345
Sterile liquid for injection
Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months)
Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.
mRNA-1365
Sterile liquid for injection
Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months)
Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.
mRNA-1345
Sterile liquid for injection
Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months)
Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.
mRNA-1365
Sterile liquid for injection
Part B: Placebo (Age Group: 5 to <8 months)
Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113.
Placebo
0.9% sodium chloride (normal saline) solution for injection
Nimenrix
Solution for injection
Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months exposed to nirsevimab)
Participants who have been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113.
mRNA-1345
Sterile liquid for injection
Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months not exposed to nirsevimab)
Participants who have not been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113.
mRNA-1345
Sterile liquid for injection
Interventions
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mRNA-1345
Sterile liquid for injection
mRNA-1365
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) solution for injection
Nimenrix
Solution for injection
Eligibility Criteria
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Inclusion Criteria
* In the Investigator's opinion, the parent(s)/ legally authorized representative (LAR)(s) understand and are willing and physically able to comply with protocol-mandated follow up, including all procedures, and provide written informed consent.
* The participant is growing normally for age in the opinion of the site clinician in the months prior to enrollment.
* The participant was born at full-term (≥37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).
* For Part C Cohort 7: participant must have received nirsevimab ≥6 months prior to Day 1 Visit.
* For Part C Cohort 8: participant was eligible at any time since birth, according to national guidelines, to receive nirsevimab prior to Day 1 Visit but did not do so.
Exclusion Criteria
* Is acutely ill or febrile 24 hours prior to or at the screening visit. Fever is defined as a body temperature ≥38.0°Celsius/≥100.4°Fahrenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows.
* Has previously been administered an investigational or approved vaccine for prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection during pregnancy.
* Has received investigational or approved agents for prophylaxis against RSV or hMPV (for example, monoclonal antibodies) or is intending to receive these during the course of the study. For Part C (Cohort 7 only), use of nirsevimab ≥6 months before Day 1 Visit is allowed.
* Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA vaccine or any of its components (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate).
* Has a medical condition that, according to the Investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.
5 Months
24 Months
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Matrix Clinical Research
Los Angeles, California, United States
Los Angeles Children's Hospital
Los Angeles, California, United States
Velocity Clinical Research, Denver
Englewood, Colorado, United States
Meridian Clinical Research
Washington D.C., District of Columbia, United States
Meridian Clinical Research
Washington D.C., District of Columbia, United States
University Of Florida Health Science Center
Jacksonville, Florida, United States
Accel Research Sites - Nona Pediatric Center
Orlando, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
MedPharmics - Platinum - PPDS
Lafayette, Louisiana, United States
Umass Memorial Medical Center
Worcester, Massachusetts, United States
UMASS Chan Medical School
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Great Lakes Research Institute
Southfield, Michigan, United States
Pediatric Specialty Care Discovery Clinic
Minneapolis, Minnesota, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Senders Pediatrics
South Euclid, Ohio, United States
Velocity Clinical Research - Providence
Providence, Rhode Island, United States
Palmetto Pediatrics, PA
North Charleston, South Carolina, United States
Vanderbilt Vaccine Research Program
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Mercury Clinical Research, Inc.
Houston, Texas, United States
CyFair
Houston, Texas, United States
Pediatric Associates
Houston, Texas, United States
Village Pediatrics
Plano, Texas, United States
Mercury Clinical Research, Inc.
Richmond, Texas, United States
Pediatric Center
Richmond, Texas, United States
North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas, United States
Childrens Hospital Regional Medical Center
Seattle, Washington, United States
Telethon Kids Institute
Nedlands, Western Australia, Australia
BC Children's Hospital - Vaccine Evaluation Centre - Neonatology
Vancouver, British Columbia, Canada
Dalhousie University IWK Health Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine
Montreal, Quebec, Canada
CEVAXIN David
David, Chiriquí Province, Panama
CEVAXIN Chorrera
La Chorrera, Panamá Oeste Province, Panama
CEVAXIN Avenida Mexico
Panama City, , Panama
CEVAXIN 24 de Diciembre
Panama City, , Panama
Shandukani Research CRS
Hillbrow, Gauteng, South Africa
Wits Health Consortium
Johannesburg, Gauteng, South Africa
Setshaba Research centre
Soshanguve, Gauteng, South Africa
Family Centre for Research with Ubuntu (FAMCRU)- Tygerberg
Cape Town, Western Cape, South Africa
Practice Dr Jan Vermeulen
Cape Town, Western Cape, South Africa
Alder Hey NHS Foundation Trust - Pharmacy Clinical Trials
Liverpool, , United Kingdom
St George's Hospital
London, , United Kingdom
Imperial College London and Imperial College Healthcare NHS
London, , United Kingdom
Norfolk and Norwich University Hospitals
Norwich, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Amodio D, Angelidou A, Cotugno N, Sherman AC, Levy O, Palma P; IPVC 2023 Speakers' group. Biomarkers of vaccine safety and efficacy in vulnerable populations: Lessons from the fourth international precision vaccines conference. Vaccine. 2025 Jan 1;43(Pt 2):126477. doi: 10.1016/j.vaccine.2024.126477. Epub 2024 Nov 28.
Other Identifiers
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2022-502022-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502022-41-00
Identifier Type: OTHER
Identifier Source: secondary_id
mRNA-1365-P101
Identifier Type: -
Identifier Source: org_study_id
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