A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
NCT ID: NCT06060457
Last Updated: 2025-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1900 participants
INTERVENTIONAL
2023-09-25
2024-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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Fluzone HD + mRNA-1345
Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22.
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1345
Suspension for injection
Fluzone HD
Suspension for injection
Fluzone HD Followed by mRNA-1345
Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1345
Suspension for injection
Fluzone HD
Suspension for injection
Interventions
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Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1345
Suspension for injection
Fluzone HD
Suspension for injection
Eligibility Criteria
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Inclusion Criteria
* Absence of changes in medical therapy within 60 days of Day 1 due to treatment failure or toxicity,
* Absence of serious or significant medical events within 30 days of Day 1, and
* Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
* A participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential.
Exclusion Criteria
* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
* Participant has tested positive for influenza or RSV by local health authority-approved testing methods ≤6 months prior to Day 1.
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1 and Day 22) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study injections.
* Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤6 months prior to Day 1.
* Participant has received any RSV vaccine (authorized/approved by local health agency or investigational) prior to Day 1.
65 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Headlands Research, Inc.
Scottsdale, Arizona, United States
West Coast Research LLC
Dublin, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, United States
Acclaim Clinical Research
San Diego, California, United States
Neoclinical Research
Hialeah, Florida, United States
Health Awareness INC
Jupiter, Florida, United States
South Florida Research Center, Inc.
Miami, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Headlands Research - Orlando
Orlando, Florida, United States
New Tampa Health, Inc
Tampa, Florida, United States
Clinical Research Atlanta/Headlands
Stockbridge, Georgia, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
DM Clinical Research- River Forest
River Forest, Illinois, United States
Velocity Clinical Research-Baton Rouge
Baton Rouge, Louisiana, United States
DelRicht Research @ Neighborhood Health
Prairieville, Louisiana, United States
DM Clinical Research - Brookline
Brookline, Massachusetts, United States
DM Clinical Research - Southfield
Southfield, Michigan, United States
Delricht Research at Gulfport Memorial
Gulfport, Mississippi, United States
Delricht Research
Springfield, Missouri, United States
Be Well Clinical Studies, LLC
Lincoln, Nebraska, United States
Velocity Clinical Research-Norfolk
Norfolk, Nebraska, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Synexus AES - Akron
Akron, Ohio, United States
Centricity Research
Columbus, Ohio, United States
Delricht Tate
Tulsa, Oklahoma, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Delricht Moyer
Hendersonville, Tennessee, United States
DM Clinical Research - Houston
Houston, Texas, United States
DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
McKinney, Texas, United States
Javara Inc. /Privia Medical Group Gulf Coast, PLLC
Sugar Land, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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mRNA-1345-P304
Identifier Type: -
Identifier Source: org_study_id
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