The trial is taking place at:
S

Suncoast Research Associates, LLC | Miami, FL

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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

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Moderna

Status and phase

Active, not recruiting
Phase 3

Conditions

Respiratory Syncytial Virus

Treatments

Biological: Fluzone HD
Biological: Placebo
Biological: mRNA-1345

Study type

Interventional

Funder types

Industry

Identifiers

NCT06060457
mRNA-1345-P304

Details and patient eligibility

About

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 adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.

Enrollment

1,900 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

1,900 participants in 2 patient groups

Fluzone HD + mRNA-1345
Experimental group
Description:
Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22.
Treatment:
Biological: mRNA-1345
Biological: Placebo
Biological: Fluzone HD
Fluzone HD Followed by mRNA-1345
Experimental group
Description:
Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
Treatment:
Biological: mRNA-1345
Biological: Placebo
Biological: Fluzone HD

Trial contacts and locations

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Central trial contact

Moderna Clinical Trials Support Center

Data sourced from clinicaltrials.gov

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