Clinical trial NCT06060457: 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
Official title: A Phase 3, Randomized, Observer-Blind Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, When Coadministered With a High-Dose, Quadrivalent Seasonal Influenza Vaccine in Adults ≥65 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus
Keywords: Viral Diseases
Messenger RNA
Moderna
mRNA-1345
Respiratory syncytial virus
Vaccines
RSV Vaccine
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-29
Enrollment: 1900
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: 7 days after each injection
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: 21 days after each injection
measure: Number of Participants With Medically Attended AEs (MAAEs)
timeFrame: Day 1 through end of study (EOS; Day 202)
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 through EOS (Day 202)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Day 1 through EOS (Day 202)
measure: Number of Participants With AEs Leading to Discontinuation
timeFrame: Day 1 through EOS (Day 202)
measure: Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies (Abs)
timeFrame: Day 22 (for Arm 1) and Day 43 (for Arm 2)
measure: GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
timeFrame: Day 22
Secondary outcomes:
measure: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2)
timeFrame: Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
measure: Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Serum RSV-A and RSV-B Neutralizing Abs
timeFrame: Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
measure: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B Neutralizing Ab Titers at Day 22 (for Arm 1) or Day 43 (for Arm 2)
timeFrame: Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
measure: Percentage of Participants with Seroconversion as Measured by HAI Assay
timeFrame: Baseline to Day 22
measure: GMFR of Serum Ab Level, as Measured by HAI Assay
timeFrame: Baseline to Day 22
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research, Inc.
state: Arizona
city: Dublin
country: United States
facility: West Coast Research LLC
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates (PRA)
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Hialeah
country: United States
facility: Neoclinical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness INC
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Orlando
country: United States
facility: Headlands Research - Orlando
state: Florida
city: Tampa
country: United States
facility: New Tampa Health, Inc
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta/Headlands
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: River Forest
country: United States
facility: DM Clinical Research- River Forest
state: Illinois
city: Baton Rouge
country: United States
facility: Velocity Clinical Research-Baton Rouge
state: Louisiana
city: Prairieville
country: United States
facility: DelRicht Research @ Neighborhood Health
state: Louisiana
city: Brookline
country: United States
facility: DM Clinical Research - Brookline
state: Massachusetts
city: Southfield
country: United States
facility: DM Clinical Research - Southfield
state: Michigan
city: Gulfport
country: United States
facility: Delricht Research at Gulfport Memorial
state: Mississippi
city: Springfield
country: United States
facility: Delricht Research
state: Missouri
city: Lincoln
country: United States
facility: Be Well Clinical Studies, LLC
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research-Norfolk
state: Nebraska
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Akron
country: United States
facility: Synexus AES - Akron
state: Ohio
city: Columbus
country: United States
facility: Centricity Research
state: Ohio
city: Tulsa
country: United States
facility: Delricht Tate
state: Oklahoma
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Hendersonville
country: United States
facility: Delricht Moyer
state: Tennessee
city: Houston
country: United States
facility: DM Clinical Research - Houston
state: Texas
city: McKinney
country: United States
facility: DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
state: Texas
city: Sugar Land
country: United States
facility: Javara Inc. /Privia Medical Group Gulf Coast, PLLC
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
Study officials:
References: