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
Respiratory Syncytial Virus
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus focused on measuring Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Vaccines, RSV Vaccine
Eligibility Criteria
Key Inclusion Criteria: Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: 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. Key Exclusion Criteria: Close contact with someone with laboratory-confirmed influenza and/or RSV infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1. 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. Note: Other protocol-defined inclusion and/or exclusion criteria may apply.
Sites / Locations
- Scottsdale Clinical Trials
- Headlands Research, Inc.Recruiting
- West Coast Research LLC
- Artemis Institute for Clinical ResearchRecruiting
- Peninsula Research Associates (PRA)Recruiting
- Acclaim Clinical Research
- Health Awareness INC
- Homestead Associates in Research, IncRecruiting
- Suncoast Research Associates, LLC
- Headlands Research - Orlando
- New Tampa Health, IncRecruiting
- Clinical Research Atlanta/HeadlandsRecruiting
- Bingham Memorial Hospital
- DM Clinical Research- River ForestRecruiting
- Velocity Clinical Research-Baton Rouge
- DelRicht Research @ Neighborhood HealthRecruiting
- DM Clinical Research - BrooklineRecruiting
- DM Clinical Research - SouthfieldRecruiting
- Delricht Research at Gulfport MemorialRecruiting
- Delricht ResearchRecruiting
- Be Well Clinical Studies, LLC
- Velocity Clinical Research-Norfolk
- Trial Management Associates, LLC
- Synexus AES - Akron
- Aventiv Research, Inc.Recruiting
- Delricht TateRecruiting
- DM Clinical Research - PhiladelphiaRecruiting
- Spartanburg Medical ResearchRecruiting
- Delricht Moyer
- DM Clinical Research - HoustonRecruiting
- DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINERecruiting
- Javara Inc. /Privia Medical Group Gulf Coast, PLLCRecruiting
- DM Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Fluzone HD + mRNA-1345
Fluzone HD Followed by 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.
Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.