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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06060457
Other study ID # mRNA-1345-P304
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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