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NCT05743881

PHASE1

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to \<24 months.

Official title: A Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and Immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Key Details

Gender

All

Age Range

5 Months - 24 Months

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2023-02-15

Completion Date

2026-09-30

Last Updated

2025-11-24

Healthy Volunteers

Conditions

Respiratory Syncytial Virus Human Metapneumovirus

Interventions

BIOLOGICAL

mRNA-1345

Sterile liquid for injection

BIOLOGICAL

mRNA-1365

Sterile liquid for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) solution for injection

DRUG

Nimenrix

Solution for injection

Inclusion Criteria: * The participant is 8 months to \<24 months (Part A), 5 months to \<8 months (Part B), or 8 months to \<12 months (Part C) of age at the time of randomization (Day 1/Baseline visit), who is in good general health, in the opinion of the Investigator, based on review of medical history and screening physical examination. * 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: * Has a known history of symptomatic RSV (Part A: within 3 months; Part B and Part C: since birth) or hMPV infection (Part A: within 3 months; Part B: since birth) prior to administration of the first dose of investigational product (IP) or has a known close contact with anyone with laboratory-confirmed RSV (Parts A, B, and C) or hMPV infection (Parts A or B) within 14 days prior to administration of the first dose of IP. * 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. Note: Other protocol-defined inclusion/exclusion criteria apply.

Locations (50)

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

Clinical Research Directory

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (50)