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

• Sponsor: ModernaTX, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06060457
• Collaborator: (none)
• Enrollment: 1,900
• Locations: 33
• Arms: 2
• Anticipated Duration (Months): 8.5
• Patients Per Site: 57.6
• Patients Per Site Per Month: 6.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus	Biological: Placebo; Biological: mRNA-1345; Biological: Fluzone HD	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1900 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: Sep 25, 2023
• Anticipated Primary Completion Date: Jun 10, 2024
• Anticipated Study Completion Date: Jun 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluzone HD + mRNA-1345 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; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1345; Suspension for injection; Biological: Fluzone HD; Suspension for injection
Experimental: Fluzone HD Followed by mRNA-1345 Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1345; Suspension for injection; Biological: Fluzone HD; Suspension for injection

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [7 days after each injection]

2. Number of Participants with Unsolicited Adverse Events (AEs) [21 days after each injection]

3. Number of Participants With Medically Attended AEs (MAAEs) [Day 1 through end of study (EOS; Day 202)]

4. Number of Participants With Adverse Events of Special Interest (AESIs) [Day 1 through EOS (Day 202)]

5. Number of Participants With Serious Adverse Events (SAEs) [Day 1 through EOS (Day 202)]

6. Number of Participants With AEs Leading to Discontinuation [Day 1 through EOS (Day 202)]

7. 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)]

8. GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza [Day 22]

Secondary Outcome Measures

1. Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2) [Baseline to Day 22 (for Arm 1) or 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.

2. 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)]

3. 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)]

4. Percentage of Participants with Seroconversion as Measured by HAI Assay [Baseline to Day 22]

   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.

5. GMFR of Serum Ab Level, as Measured by HAI Assay [Baseline to Day 22]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Clinical Trials	Scottsdale	Arizona	United States	85258
2	Headlands Research, Inc.	Scottsdale	Arizona	United States	85260
3	West Coast Research LLC	Dublin	California	United States	94568
4	Artemis Institute for Clinical Research	Riverside	California	United States	92503
5	Peninsula Research Associates (PRA)	Rolling Hills Estates	California	United States	90274
6	Acclaim Clinical Research	San Diego	California	United States	92120
7	Health Awareness INC	Jupiter	Florida	United States	33458
8	Homestead Associates in Research, Inc	Miami	Florida	United States	33032
9	Suncoast Research Associates, LLC	Miami	Florida	United States	33173
10	Headlands Research - Orlando	Orlando	Florida	United States	32819
11	New Tampa Health, Inc	Tampa	Florida	United States	33603
12	Clinical Research Atlanta/Headlands	Stockbridge	Georgia	United States	30281
13	Bingham Memorial Hospital	Blackfoot	Idaho	United States	83221
14	DM Clinical Research- River Forest	River Forest	Illinois	United States	60305
15	Velocity Clinical Research-Baton Rouge	Baton Rouge	Louisiana	United States	70809
16	DelRicht Research @ Neighborhood Health	Prairieville	Louisiana	United States	70769
17	DM Clinical Research - Brookline	Brookline	Massachusetts	United States	02445
18	DM Clinical Research - Southfield	Southfield	Michigan	United States	48076
19	Delricht Research at Gulfport Memorial	Gulfport	Mississippi	United States	39503
20	Delricht Research	Springfield	Missouri	United States	65807
21	Be Well Clinical Studies, LLC	Lincoln	Nebraska	United States	68516
22	Velocity Clinical Research-Norfolk	Norfolk	Nebraska	United States	68701
23	Trial Management Associates, LLC	Wilmington	North Carolina	United States	28403
24	Synexus AES - Akron	Akron	Ohio	United States	44311
25	Aventiv Research, Inc.	Dublin	Ohio	United States	43016
26	Delricht Tate	Tulsa	Oklahoma	United States	74133
27	DM Clinical Research - Philadelphia	Philadelphia	Pennsylvania	United States	19107
28	Spartanburg Medical Research	Spartanburg	South Carolina	United States	29303
29	Delricht Moyer	Hendersonville	Tennessee	United States	37075
30	DM Clinical Research - Houston	Houston	Texas	United States	77065
31	DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE	McKinney	Texas	United States	75070
32	Javara Inc. /Privia Medical Group Gulf Coast, PLLC	Sugar Land	Texas	United States	77054
33	DM Clinical Research	Tomball	Texas	United States	77375

Sponsors and Collaborators

• ModernaTX, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ModernaTX, Inc.
• ClinicalTrials.gov Identifier: NCT06060457
• Other Study ID Numbers: mRNA-1345-P304
• First Posted: Sep 29, 2023
• Last Update Posted: Sep 29, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ModernaTX, Inc.: Viral Diseases; Messenger RNA; Moderna; mRNA-1345; Respiratory syncytial virus; Vaccines; RSV Vaccine
• Additional relevant MeSH terms: Virus Diseases

Study Results

No Results Posted as of Sep 29, 2023