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ACTIVE NOT RECRUITING

NCT06067230

PHASE3

A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).

Official title: A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1153

Start Date

2023-10-06

Completion Date

2026-07-30

Last Updated

2025-08-08

Healthy Volunteers

Conditions

Respiratory Syncytial Virus

Interventions

BIOLOGICAL

mRNA-1345

Sterile liquid for injection

Key Inclusion Criteria: Part A: * Adults ≥18 to \<60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living. * Documented confirmation by a physician of the diagnosis of at least one of the following conditions: 1. Coronary artery disease and/or congestive heart failure. 2. Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma). 3. Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day 1. Part B: * Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living. * Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection. Parts A and B: \- Able to comply with study requirements. Key Exclusion Criteria: Part A: * Participation in an another clinical research trial where the participant has received an investigational product 180 days prior to Day 1. Participation in an RSV trial at any time prior to Day 1 is exclusionary. * History of a diagnosis or condition, that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. * Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 injection or any components of the mRNA-1345 injection. * Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to Day 1. * History of myocarditis, pericarditis, or myopericarditis. Part B: * Previous treatment with alemtuzumab or rituximab within 2 years prior to Day 1. * Previous treatment with plasmapheresis within 30 days prior to Day 1. * A history of complications of immunosuppression. * A history of biopsy proven or clinically diagnosed rejection within 90 days prior to Day 1 or suspected active chronic rejection according to the Investigator's judgment. Note: Other protocol-defined inclusion/exclusion criteria apply

Locations (44)

Lenzmeier Family Medicine - CCT - PPDS

Glendale, Arizona, United States

Foothills Research Center - CCT - PPDS

Phoenix, Arizona, United States

Fiel Family & Sports Medicine - PC - CCT - PPDS

Tempe, Arizona, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS

San Diego, California, United States

Critical Care, Pulmonary and Sleep Associates / CCT Research

Lakewood, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Excel Medical Clinical Trials DBA Flourish

Boca Raton, Florida, United States

Indago Research and Health Center

Hialeah, Florida, United States

CenExel RCA - Hollywood

Hollywood, Florida, United States

Clinical Research Atlanta - Headlands - PPDS

Stockbridge, Georgia, United States

Snake River Research, PLLC

Idaho Falls, Idaho, United States

University of Chicago

Chicago, Illinois, United States

AES - DRS - Optimal Research Illinois - Peoria

Peoria, Illinois, United States

Benchmark Research - Covington - HyperCore - PPDS

Covington, Louisiana, United States

Velocity Clinical Research (Rockville - Maryland) - PPDS

Rockville, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

DM Clinical Research - Southfield - ERN - PPDS

Southfield, Michigan, United States

Velocity Clinical Research (Lincoln - Nebraska) - PPDS

Lincoln, Nebraska, United States

University of Rochester - Rochester General Hospital - PPDS

Rochester, New York, United States

Montefiore Medical Center - BRANY - PPDS

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

DM Clinical Research - Philadelphia - ERN - PPDS

Philadelphia, Pennsylvania, United States

Benchmark Research - Fort Worth - HyperCore - PPDS

Fort Worth, Texas, United States

DM Clinical Research - Cyfair Clinical Research Center

Houston, Texas, United States

Benchmark Research - San Angelo - HyperCore - PPDS

San Angelo, Texas, United States

DM Clinical Research - ERN - PPDS

Tomball, Texas, United States

Springville Dermatology - CCT - PPDS

Springville, Utah, United States

Velocity Clinical Research - Hampton - PPDS

Hampton, Virginia, United States

Centricity Research Suffolk Family Medicine

Suffolk, Virginia, United States

Velocity Clinical Research - Family Practice - Suffolk - PPDS

Suffolk, Virginia, United States

University of Alberta

Edmonton, Alberta, Canada

OCT Research ULC (dba Okanagan Clinical Trials)

Kelowna, British Columbia, Canada

Canadian Center for Vaccinology

Halifax, Nova Scotia, Canada

Colchester Research Group

Truro, Nova Scotia, Canada

Diex Recherche - Sherbrooke - PPDS

Sherbrooke, Quebec, Canada

Diex Recherche - Québec - PPDS

Québec, Canada

Caribbean Medical Research Center

San Juan, Puerto Rico

Royal Devon and Exeter Hospital

Exeter, Devon, United Kingdom

Fylde Coast Clinical Research

Blackpool, Lancashire, United Kingdom

Liverpool School of Tropical Medicine

Liverpool, Merseyside, United Kingdom

Aberdeen Royal Infirmary - PPDS

Aberdeen, United Kingdom

The Royal Free Hospital

London, United Kingdom