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 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06060457
• Other study ID #: mRNA-1345-P304
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 25, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: February 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1900
• Est. completion date: June 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus
• Virus Diseases

Intervention

Biological:
• Placebo
0.9% sodium chloride (normal saline) injection
• mRNA-1345
Suspension for injection
• Fluzone HD
Suspension for injection

Locations

Country	Name	City	State
United States	Synexus AES - Akron	Akron	Ohio
United States	Velocity Clinical Research-Baton Rouge	Baton Rouge	Louisiana
United States	Bingham Memorial Hospital	Blackfoot	Idaho
United States	DM Clinical Research - Brookline	Brookline	Massachusetts
United States	Centricity Research	Columbus	Ohio
United States	West Coast Research LLC	Dublin	California
United States	Delricht Research at Gulfport Memorial	Gulfport	Mississippi
United States	Delricht Moyer	Hendersonville	Tennessee
United States	Neoclinical Research	Hialeah	Florida
United States	DM Clinical Research - Houston	Houston	Texas
United States	Health Awareness INC	Jupiter	Florida
United States	Be Well Clinical Studies, LLC	Lincoln	Nebraska
United States	DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE	McKinney	Texas
United States	South Florida Research Center, Inc.	Miami	Florida
United States	Suncoast Research Associates, LLC	Miami	Florida
United States	Velocity Clinical Research-Norfolk	Norfolk	Nebraska
United States	Headlands Research - Orlando	Orlando	Florida
United States	DM Clinical Research - Philadelphia	Philadelphia	Pennsylvania
United States	DelRicht Research @ Neighborhood Health	Prairieville	Louisiana
United States	DM Clinical Research- River Forest	River Forest	Illinois
United States	Artemis Institute for Clinical Research	Riverside	California
United States	Peninsula Research Associates (PRA)	Rolling Hills Estates	California
United States	Acclaim Clinical Research	San Diego	California
United States	Headlands Research, Inc.	Scottsdale	Arizona
United States	Scottsdale Clinical Trials	Scottsdale	Arizona
United States	DM Clinical Research - Southfield	Southfield	Michigan
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Delricht Research	Springfield	Missouri
United States	Clinical Research Atlanta/Headlands	Stockbridge	Georgia
United States	Javara Inc. /Privia Medical Group Gulf Coast, PLLC	Sugar Land	Texas
United States	New Tampa Health, Inc	Tampa	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Delricht Tate	Tulsa	Oklahoma
United States	Trial Management Associates, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)		7 days after each injection
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		21 days after each injection
Primary	Number of Participants With Medically Attended AEs (MAAEs)		Day 1 through end of study (EOS; Day 202)
Primary	Number of Participants With Adverse Events of Special Interest (AESIs)		Day 1 through EOS (Day 202)
Primary	Number of Participants With Serious Adverse Events (SAEs)		Day 1 through EOS (Day 202)
Primary	Number of Participants With AEs Leading to Discontinuation		Day 1 through EOS (Day 202)
Primary	Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies (Abs)		Day 22 (for Arm 1) and Day 43 (for Arm 2)
Primary	GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza		Day 22
Secondary	Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2)	Seroresponse is defined as postvaccination titers =4× lower limit of quantification (LLOQ) if baseline is	Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
Secondary	Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Serum RSV-A and RSV-B Neutralizing Abs		Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
Secondary	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)		Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
Secondary	Percentage of Participants with Seroconversion as Measured by HAI Assay	Seroconversion is defined as postvaccination titer =1:40 if baseline is <1:10 or a =4-fold rise in postvaccination HAI Ab titer if baseline is =1:10.	Baseline to Day 22
Secondary	GMFR of Serum Ab Level, as Measured by HAI Assay		Baseline to Day 22