Status:
COMPLETED
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
Lead Sponsor:
ModernaTX, Inc.
Conditions:
Respiratory Syncytial Virus
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in a...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2024
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT06060457
Start Date
September 25 2023
End Date
June 7 2024
Last Update
July 30 2025
Active Locations (34)
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1
Scottsdale Clinical Trials
Scottsdale, Arizona, United States, 85258
2
Headlands Research, Inc.
Scottsdale, Arizona, United States, 85260
3
West Coast Research LLC
Dublin, California, United States, 94568
4
Artemis Institute for Clinical Research
Riverside, California, United States, 92503