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COMPLETED
NCT05127434
PHASE2/PHASE3

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

Official title: A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36814

Start Date

2021-11-17

Completion Date

2025-07-28

Last Updated

2026-09-29

Healthy Volunteers

Yes

Interventions

DRUG

Placebo

0.9% sodium chloride (normal saline) injection

DRUG

mRNA-1345

Sterile liquid for injection

Locations (269)

AES - DRS - Synexus Clinical Research US, Inc. - Birmingham

Birmingham, Alabama, United States

Accel Research Site - Achieve - Birmingham

Birmingham, Alabama, United States

Lakeview Clinical Research

Guntersville, Alabama, United States

AES - DRS - Optimal Research Alabama - Huntsville

Huntsville, Alabama, United States

Hope Research Institute LLC - Hunt - PPDS

Hunt, Arizona, United States

Hope Research Institute LLC - Hunt - PPDS

Hunt, Arizona, United States

Desert Clinical Research, LLC - CCT

Mesa, Arizona, United States

Hope Research Institute LLC - Phoenix - Hunt - PPDS

Phoenix, Arizona, United States

AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central

Phoenix, Arizona, United States

Synexus Clinical Research US, Inc. - Phoenix Southeast

Phoenix, Arizona, United States

Tucson Neuroscience Research - M3 WR

Tucson, Arizona, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Velocity Clinical Research, Banning

Banning, California, United States

Hope Clinical Research, LLC

Canoga Park, California, United States

Velocity Clinical Research - Chula Vista - PPDS

Chula Vista, California, United States

PPD Virtual - Science 37, Inc

Culver City, California, United States

Velocity Clinical Research, San Diego

La Mesa, California, United States

PRI, LLC - Los Alamitos - M3 WR

Los Alamitos, California, United States

PRI, LLC - Newport Beach - M3 WR

Newport Beach, California, United States

FOMAT Medical Research - FOMAT - HyperCore - PPDS

Oxnard, California, United States

Reddy Care Medical

Pomona, California, United States

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

Redding, California, United States

Medical Center For Clinical Research - M3 WR

San Diego, California, United States

Lynn Institute of Denver

Aurora, Colorado, United States

Tekton Research - Fort Collins - PPDS

Fort Collins, Colorado, United States

Tekton Research - Longmont - PPDS

Longmont, Colorado, United States

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

Wheat Ridge, Colorado, United States

Clinical Research Consultants LLC - ClinEdge - PPDS

Milford, Connecticut, United States

Washington Health Institute

Washington D.C., District of Columbia, United States

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, United States

Fleming Island Clinical Research Center

Fleming Island, Florida, United States

Velocity Clinical Research - Hallandale Beach - PPDS

Hallandale, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Multi-Specialty Research Associates, Inc. M3 WR

Lake City, Florida, United States

Accel Research Sites - Maitland - ERN - PPDS

Maitland, Florida, United States

Spotlight Research Center, LLC

Miami, Florida, United States

IMA Clinical Research - Manhattan - PPDS

Miami Beach, Florida, United States

AES - DRS - Synexus Clinical Research US, Inc. - The Villages

Orlando, Florida, United States

Health Awareness Inc

Port Saint Lucie, Florida, United States

IMA Clinical Research - Saint Petersburg - PPDS

St. Petersburg, Florida, United States

AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg

St. Petersburg, Florida, United States

Clinical Trials of Tampa

Tampa, Florida, United States

Palm Beach Research - ClinEdge - PPDS

West Palm Beach, Florida, United States

Clinical Site Partners - Winter Park - HyperCore -PPDS

Winter Park, Florida, United States

Mount Vernon Clinical Research, LLC - M3 WR

Atlanta, Georgia, United States

Masters of Clinical Research Inc

Augusta, Georgia, United States

Centricity Research - Roswell - HyperCore - PPDS

Columbus, Georgia, United States

iResearch Atlanta

Decatur, Georgia, United States

Javara, Inc./Privia Medical Group Georgia, LLC

Fayetteville, Georgia, United States

Drug Studies America - ClinEdge - PPDS

Marietta, Georgia, United States

Randomize Now -Commerce Dr

Peachtree City, Georgia, United States

Velocity Clinical Research (Savannah - Georgia) - PPDS

Savannah, Georgia, United States

Clinical Research Atlanta - ERN-PPDS

Stockbridge, Georgia, United States

East West Medical Research Institute

Honolulu, Hawaii, United States

Velocity Clinical Research - Boise - PPDS

Meridian, Idaho, United States

AES - DRS - Synexus Clinical Research US, Inc. - Chicago

Chicago, Illinois, United States

Affinity Health (Oak Brook)

Oak Brook, Illinois, United States

DM Clinical - Chicago

River Forest, Illinois, United States

AES - DRS - Synexus Clinical Research US, Inc. - Evansville

Evansville, Indiana, United States

Velocity Clinical Research - Valparaiso - PPDS

Valparaiso, Indiana, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Versailles Family Medicine - CCT - PPDS

Versailles, Kentucky, United States

Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS

Baton Rouge, Louisiana, United States

Benchmark Research - Covington - HyperCore - PPDS

Covington, Louisiana, United States

Benchmark Research - Metairie - HyperCore - PPDS

Metairie, Louisiana, United States

IMA Clinical Research - Monroe, LA - PPDS

Monroe, Louisiana, United States

DelRicht Clinical Research, LLC - Internal - Covington - PPDS

New Orleans, Louisiana, United States

Privia Medical Group, LLC - Annapolis - Javara - PPDS

Annapolis, Maryland, United States

CBH Health - CenExel CBH - PPDS

Gaithersburg, Maryland, United States

Velocity Clinical Research (Rockville - Maryland) - PPDS

Rockville, Maryland, United States

Great Lakes Research Institute

Southfield, Michigan, United States

DM Clinical Research - Southfield - ERN - PPDS

Southfield, Michigan, United States

Clinical Research Institute, Inc - CRN - PPDS

Minneapolis, Minnesota, United States

AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis

Richfield, Minnesota, United States

AES - DRS - Synexus Clinical Research US, Inc. - St. Louis

Creve Coeur, Missouri, United States

Montana Medical Research

Missoula, Montana, United States

Boeson Research MSO - Missoula - ERN - PPDS

Missoula, Montana, United States

Skyline Medical Center, PC - CCT Research

Elkhorn, Nebraska, United States

Methodist Physicians Clinic - CCT Research - PPDS

Fremont, Nebraska, United States

Velocity Clinical Research (Grand Island - Nebraska) - PPDS

Grand Island, Nebraska, United States

Velocity Clinical Research (Lincoln - Nebraska) - PPDS

Lincoln, Nebraska, United States

Velocity Clinical Research (Omaha - Nebraska) - PPDS

Omaha, Nebraska, United States

CCT Research

Papillion, Nebraska, United States

HEALOR Primary Care - Physicians Las Vegas - CCT

Las Vegas, Nevada, United States

Excel Clinical Research - Las Vegas

Las Vegas, Nevada, United States

IMA Clinical Research - Raritan - PPDS

Raritan, New Jersey, United States

Riverside Medical Group - Circuit - PPDS

Secaucus, New Jersey, United States

Velocity Clinical Research - East Syracuse - PPDS

East Syracuse, New York, United States

Velocity Clinical Research (Endwell - New York) - PPDS

Endwell, New York, United States

Drug Trials America

Hartsdale, New York, United States

AES - DRS - Synexus Clinical Research US, Inc. - New York

New York, New York, United States

Rochester Clinical Research, Inc

Rochester, New York, United States

Carolina Institute for Clinical Research - M3 WR

Fayetteville, North Carolina, United States

Triad Clinical Trials

Greensboro, North Carolina, United States

Trial Management Associates, LLC

Wilmington, North Carolina, United States

CTI Clinical Research

Cincinnati, Ohio, United States

Velocity Clinical Research (Cincinnati - Ohio) - PPDS

Cincinnati, Ohio, United States

Velocity Clinical Research - Cincinnati - PPDS

Cincinnati, Ohio, United States

AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati

Cincinnati, Ohio, United States

Tekton Research - Oklahoma - PPDS

Edmond, Oklahoma, United States

And 169 more locations on ClinicalTrials.gov