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
NCT ID: NCT05585632
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
392 participants
INTERVENTIONAL
2022-10-14
2024-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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mRNA-1010
Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
mRNA-1010
Sterile liquid for injection
mRNA-1345
Participants will receive a dose of mRNA-1345 by IM injection on Day 1.
mRNA-1345
Sterile liquid for injection
mRNA-1273.214
Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.
mRNA-1273.214
Sterile liquid for injection
mRNA-1045 Dose Level A
Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.
mRNA-1045
Formulation for injection
mRNA-1045 Dose Level B
Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.
mRNA-1045
Formulation for injection
mRNA-1045 Dose Level C
Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.
mRNA-1045
Formulation for injection
mRNA-1230 Dose Level A
Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.
mRNA-1230
Formulation for injection
mRNA-1230 Dose Level B
Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.
mRNA-1230
Formulation for injection
mRNA-1230 Dose Level C
Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.
mRNA-1230
Formulation for injection
Interventions
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mRNA-1010
Sterile liquid for injection
mRNA-1345
Sterile liquid for injection
mRNA-1273.214
Sterile liquid for injection
mRNA-1045
Formulation for injection
mRNA-1230
Formulation for injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
75 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Accel Research Sites
DeLand, Florida, United States
Research Centers of America (cenexel)
Hollywood, Florida, United States
Accel Research Sites
St. Petersburg, Florida, United States
Atlanta Center for Medical Research - Family Medicine
Atlanta, Georgia, United States
Centricity Research
Columbus, Georgia, United States
Cenexel IRA (iResearch Atlanta)
Decatur, Georgia, United States
Optimal Research
Peoria, Illinois, United States
DM Clinical Research
Southfield, Michigan, United States
Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)
Morehead City, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
Velocity Clinical Research
Anderson, South Carolina, United States
Trial Management Associates
Myrtle Beach, South Carolina, United States
DM Clinical Research
Houston, Texas, United States
DM Clinical Research
Sugar Land, Texas, United States
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Paratus Clinical Kanwal
Kanwal, New South Wales, Australia
Paratus Clinical Research Brisbane
Albion, Queensland, Australia
Nucleus Network Brisbane Clinic - Centre For Clinical Studies
Herston, Queensland, Australia
University of the Sunshine Coast
South Brisbane, Queensland, Australia
AusTrials Taringa
Taringa, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
Newcastle University - Institute of Cellular Medicine (ICM)
Newcastle, England, United Kingdom
Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus
Nottingham, Nottinghamshire, United Kingdom
University of Oxford
Oxford, Oxfordshire, United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
St George's Healthcare NHS Trust - University of London - Th
London, , United Kingdom
National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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2022-002138-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
mRNA-1230-P101
Identifier Type: -
Identifier Source: org_study_id
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