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

March 7, 2024 updated by: ModernaTX, Inc.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
Time Frame: Baseline (Day 1), 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
Time Frame: Baseline (Day 1), Day 29
Baseline (Day 1), Day 29
Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29
Time Frame: Baseline (Day 1), Day 29
Baseline (Day 1), Day 29
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
Time Frame: Baseline (Day 1), Day 29
Baseline (Day 1), Day 29
Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29
Time Frame: Baseline (Day 1), Day 29
Baseline (Day 1), Day 29
Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29
Time Frame: Baseline (Day 1), Day 29
Baseline (Day 1), Day 29
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
Time Frame: 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.
Baseline (Day 1) to Day 29
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)
Time Frame: 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).
Baseline (Day 1) to Day 29
RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay
Time Frame: 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.
Baseline (Day 1) to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2022

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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