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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

Primary Purpose

Respiratory Syncytial Virus

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
mRNA-1345
Fluzone HD
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus focused on measuring Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Vaccines, RSV Vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Scottsdale Clinical Trials
  • Headlands Research, Inc.Recruiting
  • West Coast Research LLC
  • Artemis Institute for Clinical ResearchRecruiting
  • Peninsula Research Associates (PRA)Recruiting
  • Acclaim Clinical Research
  • Health Awareness INC
  • Homestead Associates in Research, IncRecruiting
  • Suncoast Research Associates, LLC
  • Headlands Research - Orlando
  • New Tampa Health, IncRecruiting
  • Clinical Research Atlanta/HeadlandsRecruiting
  • Bingham Memorial Hospital
  • DM Clinical Research- River ForestRecruiting
  • Velocity Clinical Research-Baton Rouge
  • DelRicht Research @ Neighborhood HealthRecruiting
  • DM Clinical Research - BrooklineRecruiting
  • DM Clinical Research - SouthfieldRecruiting
  • Delricht Research at Gulfport MemorialRecruiting
  • Delricht ResearchRecruiting
  • Be Well Clinical Studies, LLC
  • Velocity Clinical Research-Norfolk
  • Trial Management Associates, LLC
  • Synexus AES - Akron
  • Aventiv Research, Inc.Recruiting
  • Delricht TateRecruiting
  • DM Clinical Research - PhiladelphiaRecruiting
  • Spartanburg Medical ResearchRecruiting
  • Delricht Moyer
  • DM Clinical Research - HoustonRecruiting
  • DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINERecruiting
  • Javara Inc. /Privia Medical Group Gulf Coast, PLLCRecruiting
  • DM Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fluzone HD + mRNA-1345

Fluzone HD Followed by mRNA-1345

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants With Medically Attended AEs (MAAEs)
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With AEs Leading to Discontinuation
Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies (Abs)
GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza

Secondary Outcome Measures

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 <LLOQ or a ≥4-fold increase from baseline if baseline is ≥LLOQ.
Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Serum RSV-A and RSV-B Neutralizing Abs
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)
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.
GMFR of Serum Ab Level, as Measured by HAI Assay

Full Information

First Posted
September 23, 2023
Last Updated
October 18, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06060457
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
June 10, 2024 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus
Keywords
Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Vaccines, RSV Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluzone HD + mRNA-1345
Arm Type
Experimental
Arm Description
Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22.
Arm Title
Fluzone HD Followed by mRNA-1345
Arm Type
Experimental
Arm Description
Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride (normal saline) injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1345
Intervention Description
Suspension for injection
Intervention Type
Biological
Intervention Name(s)
Fluzone HD
Intervention Description
Suspension for injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
7 days after each injection
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
21 days after each injection
Title
Number of Participants With Medically Attended AEs (MAAEs)
Time Frame
Day 1 through end of study (EOS; Day 202)
Title
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame
Day 1 through EOS (Day 202)
Title
Number of Participants With Serious Adverse Events (SAEs)
Time Frame
Day 1 through EOS (Day 202)
Title
Number of Participants With AEs Leading to Discontinuation
Time Frame
Day 1 through EOS (Day 202)
Title
Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies (Abs)
Time Frame
Day 22 (for Arm 1) and Day 43 (for Arm 2)
Title
GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
Time Frame
Day 22
Secondary Outcome Measure Information:
Title
Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2)
Description
Seroresponse is defined as postvaccination titers ≥4× lower limit of quantification (LLOQ) if baseline is <LLOQ or a ≥4-fold increase from baseline if baseline is ≥LLOQ.
Time Frame
Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
Title
Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Serum RSV-A and RSV-B Neutralizing Abs
Time Frame
Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
Title
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)
Time Frame
Baseline to Day 22 (for Arm 1) or 43 (for Arm 2)
Title
Percentage of Participants with Seroconversion as Measured by HAI Assay
Description
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.
Time Frame
Baseline to Day 22
Title
GMFR of Serum Ab Level, as Measured by HAI Assay
Time Frame
Baseline to Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
Scottsdale Clinical Trials
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Headlands Research, Inc.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Name
West Coast Research LLC
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Artemis Institute for Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Individual Site Status
Recruiting
Facility Name
Peninsula Research Associates (PRA)
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Individual Site Status
Recruiting
Facility Name
Acclaim Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Health Awareness INC
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Homestead Associates in Research, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Suncoast Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Headlands Research - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
New Tampa Health, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Atlanta/Headlands
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Name
Bingham Memorial Hospital
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DM Clinical Research- River Forest
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research-Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DelRicht Research @ Neighborhood Health
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research - Brookline
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research - Southfield
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Individual Site Status
Recruiting
Facility Name
Delricht Research at Gulfport Memorial
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Individual Site Status
Recruiting
Facility Name
Delricht Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Name
Be Well Clinical Studies, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Velocity Clinical Research-Norfolk
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Synexus AES - Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Aventiv Research, Inc.
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Individual Site Status
Recruiting
Facility Name
Delricht Tate
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Name
Delricht Moyer
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DM Clinical Research - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting
Facility Name
DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Individual Site Status
Recruiting
Facility Name
Javara Inc. /Privia Medical Group Gulf Coast, PLLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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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