A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05585632

Collaborator

(none)

675

Enrollment

Locations

Arms

13.5

Anticipated Duration (Months)

22.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Influenza RSV	Biological: mRNA-1010 Biological: mRNA-1345 Biological: mRNA-1273.214 Biological: mRNA-1045 Biological: mRNA-1230	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

675 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

All participants will be unblinded at Day 29 (1 month following study injection) to seek immunization with licensed influenza and/or SARS-CoV-2 vaccines, outside of the study, per local standard of care.

Primary Purpose:

Prevention

Official Title:

Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA-1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years of Age

Actual Study Start Date :

Oct 14, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mRNA-1010 Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.	Biological: mRNA-1010 Sterile liquid for injection
Experimental: mRNA-1345 Participants will receive a dose of mRNA-1345 by IM injection on Day 1.	Biological: mRNA-1345 Sterile liquid for injection
Experimental: mRNA-1273.214 Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.	Biological: mRNA-1273.214 Sterile liquid for injection
Experimental: mRNA-1045 Dose Level A Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.	Biological: mRNA-1045 Formulation for injection
Experimental: mRNA-1045 Dose Level B Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.	Biological: mRNA-1045 Formulation for injection
Experimental: mRNA-1045 Dose Level C Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.	Biological: mRNA-1045 Formulation for injection
Experimental: mRNA-1230 Dose Level A Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.	Biological: mRNA-1230 Formulation for injection
Experimental: mRNA-1230 Dose Level B Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.	Biological: mRNA-1230 Formulation for injection
Experimental: mRNA-1230 Dose Level C Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.	Biological: mRNA-1230 Formulation for injection

Outcome Measures

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [Up to Day 8 (7 days post vaccination)]
Number of Participants with Unsolicited Adverse Events (AEs) [Up to Day 29 (28 days post vaccination)]
Number of Participants with Medically-Attended AEs (MAAEs) [Day 1 through Day 361]
Number of Participants with Adverse Events of Special Interest (AESIs) [Day 1 through Day 361]
Number of Participants with Serious Adverse Events (SAEs) [Day 1 through Day 361]
Number of Participants with AEs Leading to Discontinuation [Day 1 through Day 361]

Secondary Outcome Measures

Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 [Baseline (Day 1), Day 29]
Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29 [Baseline (Day 1), Day 29]
Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29 [Baseline (Day 1), Day 29]
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 [Baseline (Day 1), Day 29]
Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29 [Baseline (Day 1), Day 29]
Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29 [Baseline (Day 1), Day 29]
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay [Baseline (Day 1) to Day 29]
Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay) [Baseline (Day 1) to Day 29]
Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in nAb titers measured by PsVNA (or binding antibody assay).
RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay [Baseline (Day 1) to Day 29]
Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥LLOQ or ≥4*LLOQ if baseline titer is <LLOQ in nAb titers measured by RSV neutralization assay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Investigator assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
Body mass index of 18 to 35 kilograms/square meter (kg/m^2) (inclusive) at the Screening Visit(s).
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception or abstinence through 3 months following the vaccination, and not currently breastfeeding.
Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. The most recent COVID-19 vaccine (primary series or booster) must be ≥120 days before (or less per local guidance) Day 1.

Exclusion Criteria:

Acutely ill or febrile (temperature ≥38.0°Celsius/[100.4°Fahrenheit]) 72 hours before or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window for re-evaluation and will retain their initially assigned participant number.
Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months before screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days before study injections (Day 1) or within 28 days after the study injection.
Received a licensed seasonal influenza vaccine or any other investigational influenza or RSV vaccine within ≤180 days before Day 1.
Tested positive for influenza or RSV by local health authority-approved testing methods within ≤180 days before Day 1.
Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the United States Center for Disease Control (CDC) or the European Centre for Disease Prevention and Control as a high risk (close contact) of a COVID-19 case or known history of SARS-CoV-2 infection within the past 90 days before Day 1.
Donated ≥450 mL of blood products within 28 days before the Screening Visit or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Accel Research Sites	DeLand	Florida	United States	32720
2	Research Centers of America (cenexel)	Hollywood	Florida	United States	33024
3	Accel Research Sites	Saint Petersburg	Florida	United States	33709
4	Atlanta Center for Medical Research - Family Medicine	Atlanta	Georgia	United States	30331
5	Centricity Research	Columbus	Georgia	United States	31904
6	Cenexel IRA (iResearch Atlanta)	Decatur	Georgia	United States	30030
7	Optimal Research	Peoria	Illinois	United States	61614
8	DM Clinical Research	Southfield	Michigan	United States	48076
9	Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)	Morehead City	North Carolina	United States	28557
10	Trial Management Associates	Wilmington	North Carolina	United States	28403
11	Velocity Clinical Research	Anderson	South Carolina	United States	29621
12	Trial Management Associates	Myrtle Beach	South Carolina	United States	29572
13	DM Clinical Research	Houston	Texas	United States	77081
14	DM Clinical Research	Sugar Land	Texas	United States	77478
15	Paratus Clinical Research Western Sydney	Blacktown	New South Wales	Australia	2148
16	Paratus Clinical Kanwal	Kanwal	New South Wales	Australia	2259
17	Paratus Clinical Research Brisbane	Albion	Queensland	Australia	4010
18	Nucleus Network Brisbane Clinic - Centre For Clinical Studies	Herston	Queensland	Australia	4006
19	University of the Sunshine Coast	South Brisbane	Queensland	Australia	4101
20	AusTrials Taringa	Taringa	Queensland	Australia	QLD 4068
21	Emeritus Research	Camberwell	Victoria	Australia	3124
22	Newcastle University - Institute of Cellular Medicine (ICM)	Newcastle	England	United Kingdom	NE2 4HH
23	Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus	Nottingham	Nottinghamshire	United Kingdom	NG7 2UH
24	University of Oxford	Oxford	Oxfordshire	United Kingdom	OX3 7LJ
25	Bristol Royal Hospital for Children	Bristol		United Kingdom	BS2 8BJ
26	Royal Devon & Exeter Hospital	Exeter		United Kingdom	EX25DW
27	Chelsea and Westminster Hospital	London		United Kingdom	SW10 9NH
28	St George's Healthcare NHS Trust - University of London - Th	London		United Kingdom	SW17 0RE
29	National Hospital for Neurology and Neurosurgery	London		United Kingdom	WC1N 3GB
30	Southampton General Hospital	Southampton		United Kingdom	SO16 6YD