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

NCT06060457 | Completed Phase 3 Results FDA Drug

• 1 other identifier: mRNA-1345-P304
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 34

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 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.

Conditions

Respiratory Syncytial Virus

Keywords

Viral Diseases; Messenger RNA; Moderna; mRNA-1345; Respiratory syncytial virus; Vaccines; RSV Vaccine

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection

  Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Within 7 days after Day 1 injection

• Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection

  Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Within 7 days after Day 22 injection

• Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection

  An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Up to 21 days after Day 1 injection

• Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection

  An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or PT/PTT) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Up to 21 days after Day 22 injection

• Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation

  A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Day 1 through Day 202

• Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs)

  Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B.

  Day 22 (for Arm 1) and Day 43 (for Arm 2)

• GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay

  Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B.

  Day 22

Secondary Outcomes (5)

• Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay

  Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2)

• Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay

  Day 22 (for Arm 1) or Day 43 (for Arm 2)

• Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs

  Day 22 (Arm 1) or Day 43 (Arm 2)

• Percentage of Participants With Seroconversion, as Measured by HAI Assay

  Day 22

• GMFR of Serum Ab Level, as Measured by HAI Assay

  Day 22

Other Outcomes (1)

• Number of Deaths Related to Study Drug

  Day 1 through Day 202

Study Arms (2)

Fluzone HD + mRNA-1345

EXPERIMENTAL

Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22.

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

Fluzone HD Followed by mRNA-1345

EXPERIMENTAL

Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.

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

Interventions

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Fluzone HD + mRNA-1345; Fluzone HD Followed by mRNA-1345

mRNA-1345 BIOLOGICAL

Suspension for injection

Fluzone HD + mRNA-1345; Fluzone HD Followed by mRNA-1345

Fluzone HD BIOLOGICAL

Suspension for injection

Fluzone HD + mRNA-1345; Fluzone HD Followed by mRNA-1345

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (34)

Scottsdale Clinical Trials

Scottsdale, Arizona, 85258, United States

Location

Headlands Research, Inc.

Scottsdale, Arizona, 85260, United States

Location

West Coast Research LLC

Dublin, California, 94568, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Peninsula Research Associates (PRA)

Rolling Hills Estates, California, 90274, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Neoclinical Research

Hialeah, Florida, 33016, United States

Location

Health Awareness INC

Jupiter, Florida, 33458, United States

Location

South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

Suncoast Research Associates, LLC

Miami, Florida, 33173, United States

Location

Headlands Research - Orlando

Orlando, Florida, 32819, United States

Location

New Tampa Health, Inc

Tampa, Florida, 33603, United States

Location

Clinical Research Atlanta/Headlands

Stockbridge, Georgia, 30281, United States

Location

Bingham Memorial Hospital

Blackfoot, Idaho, 83221, United States

Location

DM Clinical Research- River Forest

River Forest, Illinois, 60305, United States

Location

Velocity Clinical Research-Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

DelRicht Research @ Neighborhood Health

Prairieville, Louisiana, 70769, United States

Location

DM Clinical Research - Brookline

Brookline, Massachusetts, 02445, United States

Location

DM Clinical Research - Southfield

Southfield, Michigan, 48076, United States

Location

Delricht Research at Gulfport Memorial

Gulfport, Mississippi, 39503, United States

Location

Delricht Research

Springfield, Missouri, 65807, United States

Location

Be Well Clinical Studies, LLC

Lincoln, Nebraska, 68516, United States

Location

Velocity Clinical Research-Norfolk

Norfolk, Nebraska, 68701, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

Synexus AES - Akron

Akron, Ohio, 44311, United States

Location

Centricity Research

Columbus, Ohio, 43213, United States

Location

Delricht Tate

Tulsa, Oklahoma, 74133, United States

Location

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Delricht Moyer

Hendersonville, Tennessee, 37075, United States

Location

DM Clinical Research - Houston

Houston, Texas, 77065, United States

Location

DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE

McKinney, Texas, 75070, United States

Location

Javara Inc. /Privia Medical Group Gulf Coast, PLLC

Sugar Land, Texas, 77054, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

MeSH Terms

Conditions

Virus Diseases

Interventions

mRNA-1345 respiratory syncytial virus vaccine; Influenza Vaccines

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

+1-866-663-3762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 29, 2023
• Study Start: September 25, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Locations

US (34)