Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study

June 7, 2023 updated by: ModernaTX, Inc.

mRNA-1345-P901 Study: RSV Outcomes Study Extension (ROSE)

The main goal of this observational study is to evaluate the real-world effectiveness of the Moderna mRNA-1345 vaccine for protection against RSV lower respiratory tract disease (RSV-LRTD) and to study additional health and economic outcomes.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate real-world data (RWD) and data from eligible United States (US) based participants from Study mRNA-1345-P301 (NCT05127434) for the short- and long-term effectiveness of the mRNA-1345 vaccine in preventing RSV-associated health outcomes such as hospitalizations, death, healthcare resource utilization, and costs. The results from the current study (mRNA-1345-P901) are intended to complement the results from the mRNA-1345-P301 study. No interventions will be administered during the current study (mRNA-1345-P901).

Study Type

Observational

Enrollment (Actual)

11010

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209-6898
        • Accel Research Site - Achieve - Birmingham - ERN - PPDS
      • Birmingham, Alabama, United States, 35211-1320
        • AES - DRS - Simon Williamson Clinic, PC - Birmingham
      • Guntersville, Alabama, United States, 35976-2206
        • Lakeview Clinical Research
      • Huntsville, Alabama, United States, 35802-2569
        • AES - DRS - Optimal Research Alabama - Huntsville
    • Arizona
      • Mesa, Arizona, United States, 85213-5226
        • Desert Clinical Research, LLC
      • Phoenix, Arizona, United States, 85018-2657
        • Hope Research Institute LLC - Phoenix - Hunt - PPDS
      • Phoenix, Arizona, United States, 85020-4327
        • AES - DRS - Phoenix Southeast - Chandler
      • Phoenix, Arizona, United States, 85020-4348
        • AES - DRS - Central Phoenix Medical Clinic, LLC
      • Phoenix, Arizona, United States, 85023
        • Hope Research Institute LLC - Hunt - PPDS
      • Tempe, Arizona, United States, 85284-3499
        • Hope Research Institute LLC - Hunt - PPDS
      • Tucson, Arizona, United States, 85710-6152
        • Tucson Neuroscience Research - M3 WR
    • California
      • Canoga Park, California, United States, 91303-1844
        • Hope Clinical Research, LLC
      • Chula Vista, California, United States, 91911-6660
        • Velocity Clinical Research - Chula Vista - ERN - PPDS
      • La Mesa, California, United States, 91942-3189
        • Paradigm Research
      • La Mesa, California, United States, 91942-3189
        • Velocity Clinical Research - Chula Vista - PPDS
      • Los Alamitos, California, United States, 90720-3589
        • PRI, LLC - Los Alamitos - M3 WR - ERN - PPDS
      • Newport Beach, California, United States, 92660
        • PRI, LLC - Newport Beach - M3 WR - ERN - PPDS
      • Oxnard, California, United States, 93030-5841
        • FOMAT Medical Research - FOMAT - HyperCore - PPDS
      • Pomona, California, United States, 91768-3027
        • Reddy Care Medical
      • Redding, California, United States, 96001-0172
        • Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
      • San Diego, California, United States, 92108-5899
        • Medical Center For Clinical Research - M3 WR - ERN - PPDS
    • Colorado
      • Aurora, Colorado, United States, 80012-4520
        • Lynn Institute of Denver - ERN - PPDS
      • Fort Collins, Colorado, United States, 80525
        • Tekton Research - Fort Collins - Platinum - PPDS
      • Longmont, Colorado, United States, 80501-6461
        • Tekton Research - Longmont - Platinum - PPDS
      • Wheat Ridge, Colorado, United States, 80033-6168
        • Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
    • Florida
      • Edgewater, Florida, United States, 32132-2720
        • Velocity Clinical Research - New Smyrna Beach - ERN - PPDS
      • Fleming Island, Florida, United States, 32003-4816
        • Fleming Island Center For Clinical Research - ERN-PPDS
      • Hallandale Beach, Florida, United States, 33009
        • Velocity Clinical Research - Hallandale Beach - ERN - PPDS
      • Jacksonville, Florida, United States, 32216-4362
        • Jacksonville Center For Clinical Research - ERN - PPDS
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates, Inc. M3 WR
      • Maitland, Florida, United States, 32751-7258
        • Accel Research Sites - Maitland - ERN - PPDS
      • Pinellas Park, Florida, United States, 33781-3228
        • AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
      • The Villages, Florida, United States, 32162-7116
        • AES - DRS - Synexus Clinical Research US, Inc. - The Villages
      • West Palm Beach, Florida, United States, 33409-3401
        • Palm Beach Research - ClinEdge - PPDS
      • Winter Park, Florida, United States, 32789-4681
        • Clinical Site Partners - Winter Park - HyperCore - PPDS
    • Georgia
      • Augusta, Georgia, United States, 30909-1854
        • Masters of Clinical Research Inc.
      • Columbus, Georgia, United States, 31904-5067
        • Centricity Research - Roswell - HyperCore - PPDS
      • Decatur, Georgia, United States, 30030-3438
        • IResearch Atlanta LLC - ClinEdge - PPDS
      • Fayetteville, Georgia, United States, 30214-1578
        • Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
      • Sandy Springs, Georgia, United States, 30328-4277
        • Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
      • Stockbridge, Georgia, United States, 30281-9054
        • Clinical Research Atlanta - ERN-PPDS
    • Idaho
      • Meridian, Idaho, United States, 83642-6246
        • Velocity Clinical Research - Boise - PPDS
    • Illinois
      • Chicago, Illinois, United States, 60654-4855
        • AES - DRS - Synexus Clinical Research US, Inc. - Chicago
      • Oak Brook, Illinois, United States, 60523-4655
        • Affinity Health (Oak Brook)
      • River Forest, Illinois, United States, 60305-1898
        • DM Clinical Research - Chicago - ERN - PPDS
    • Indiana
      • Evansville, Indiana, United States, 47714-8009
        • AES - DRS - Synexus Clinical Research US, Inc. - Evansville
      • Valparaiso, Indiana, United States, 46383-2196
        • Velocity Clinical Research - Valparaiso - ERN - PPDS
    • Kentucky
      • Versailles, Kentucky, United States, 40383-1947
        • Versailles Family Medicine, PLLC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809-3416
        • Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS
      • Covington, Louisiana, United States, 70433
        • Benchmark Research - Covington - HyperCore - PPDS
      • Metairie, Louisiana, United States, 70006-5322
        • Benchmark Research - Metairie - HyperCore - PPDS
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of America, LLC
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Clinical Research, LLC - Internal - Covington - PPDS
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Javara Research Inc. - Annapolis - Javara - PPDS
      • Gaithersburg, Maryland, United States, 20877-1409
        • CBH Health - CenExcel CBH - PPDS
      • Rockville, Maryland, United States, 20854-2957
        • Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS
    • Michigan
      • Southfield, Michigan, United States, 48075-5405
        • Great Lakes Research Institute
      • Southfield, Michigan, United States, 48076-5412
        • DM Clinical Research - Southfield - ERN - PPDS
    • Minnesota
      • Plymouth, Minnesota, United States, 55441-2680
        • Clinical Research Institute, Inc - CRN - PPDS
      • Richfield, Minnesota, United States, 55423-2590
        • AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
    • Missouri
      • Saint Louis, Missouri, United States, 63141-7083
        • AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
    • Montana
      • Missoula, Montana, United States, 59804
        • Montana Medical Research
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022-2889
        • Skyline Medical Center, PC
      • Fremont, Nebraska, United States, 68025-2592
        • Methodist Physicians Clinic - Prairie - CCT Research
      • Grand Island, Nebraska, United States, 68803-3345
        • Meridian Clinical Research (Grand Island) - Platinum - PPDS
      • Omaha, Nebraska, United States, 68114
        • Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
      • Omaha, Nebraska, United States, 68134-3664
        • Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS
      • Papillion, Nebraska, United States, 68046
        • CCT Research
    • Nevada
      • Las Vegas, Nevada, United States, 89109-6209
        • Excel Clinical Research - Las Vegas
      • Las Vegas, Nevada, United States, 89102
        • HEALOR Primary Care - Physicians Las Vegas
    • New York
      • East Syracuse, New York, United States, 13057
        • Velocity Clinical Research - East Syracuse - ERN - PPDS
      • Endwell, New York, United States, 13760-3646
        • Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
      • Endwell, New York, United States, 13760-3661
        • Meridian Clinical Research (Dakota Dunes-South Dakota) - Platinum - PPDS
      • Hartsdale, New York, United States, 10530-1911
        • Drug Trials America
      • New York, New York, United States, 10017-4008
        • AES - DRS - Synexus Clinical Research US, Inc. - New York
      • Rochester, New York, United States, 14609-3173
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Fayetteville, North Carolina, United States, 28303-5537
        • Carolina Institute for Clinical Research - M3 WR - ERN - PPDS
    • Ohio
      • Blue Ash, Ohio, United States, 45242-3762
        • Velocity Clinical Research - Cincinnati - ERN - PPDS
      • Cincinnati, Ohio, United States, 45219-2975
        • Meridian Clinical Research - Cincinnati - Platinum - PPDS
      • Cincinnati, Ohio, United States, 45227-2172
        • CTI Clinical Research Center - PPDS
      • Cincinnati, Ohio, United States, 45236-3669
        • AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099-6396
        • Tekton Research - Oklahoma - Platinum - PPDS
      • Yukon, Oklahoma, United States, 73099-9518
        • Tekton Research Inc.
    • Pennsylvania
      • Hatboro, Pennsylvania, United States, 19040-2045
        • Hatboro Medical Associates PC
      • Philadelphia, Pennsylvania, United States, 19107-1530
        • DM Clinical Research - Philadelphia - ERN - PPDS
    • Texas
      • Austin, Texas, United States, 78745-1470
        • Tekton Research Inc.
      • Brownsville, Texas, United States, 78520-7256
        • PanAmerican Clinical Research LLC
      • Carrollton, Texas, United States, 75010-4632
        • Family Medicine Associates of Texas - Hunt - PPDS
      • Fort Worth, Texas, United States, 76132
        • Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Javara - PPDS
      • Friendswood, Texas, United States, 77546
        • Allure Health LLC
      • Frisco, Texas, United States, 75033-4135
        • Village Health Partners Frisco Medical Village
      • Houston, Texas, United States, 77081
        • DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
      • Humble, Texas, United States, 77338-4205
        • DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
      • Keller, Texas, United States, 76248-4235
        • Ventavia Research Group - Platinum - PPDS
      • Plano, Texas, United States, 75093-8346
        • AIM Trials
      • San Antonio, Texas, United States, 78229-3539
        • Clinical Trials of Texas, Inc. - PPDS
      • Stephenville, Texas, United States, 76401-1860
        • Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Stephenville - Ja
      • Sugar Land, Texas, United States, 77478-4913
        • DM Clinical Research - Sugarland - ERN - PPDS
      • Tomball, Texas, United States, 77375-3332
        • DM Clinical Research - ERN
      • Tomball, Texas, United States, 77375-6543
        • DM Clinical Research - ERN - PPDS
    • Utah
      • Bountiful, Utah, United States, 84010-4862
        • Cope Family Medicine - Ogden Clinic - CCT
      • Holladay, Utah, United States, 84117-7054
        • Olympus Family Medicine - CCT Research
      • South Ogden, Utah, United States, 84405
        • South Ogden Family Medicine/Ogden Clinic - CCT Research
      • West Jordan, Utah, United States, 84088-8865
        • Velocity Clinical Research - Banning - ERN - PPDS
    • Virginia
      • Portsmouth, Virginia, United States, 23703-3200
        • Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS
    • Washington
      • Renton, Washington, United States, 98057-4927
        • Rainier Clinical Research Center
      • Seattle, Washington, United States, 98105-4028
        • Seattle Womens: Health, Research, Gynecology

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The population of interest will include P301 participants randomized in the US who provide informed consent and meet eligibility criteria and the RWD-matched unvaccinated population.

Description

Inclusion Criteria:

P901 inclusion criteria:

  • RWD-matched unvaccinated
  • Must be a participant in P301
  • Must be based in the US
  • Must provide informed consent for P901

P301 key inclusion criteria:

  • Adults who are primarily responsible for self-care and activities of daily living.
  • Participants may have one or more chronic medical diagnoses (specifically chronic heart failure and chronic obstructive pulmonary disease) but should be medically stable in the opinion of the investigator.
  • Body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2.

Exclusion Criteria:

P901 exclusion criteria:

  • Receipt of any future licensed RSV vaccine at baseline.
  • Receipt of any future licensed RSV vaccines during the study follow-up period will result in censorship on the date the vaccine was received.

All inclusion and exclusion criteria from P301 that are available in the RWD will be applied to the enriched RWD control population.

P301 key exclusion criteria:

  • Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.
  • Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).
  • History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
  • Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection. The exceptions are seasonal influenza vaccines, pneumococcal vaccines, or authorized or approved vaccines for the prevention of COVID-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the Day 1 study injection. Efforts should be made to space study injection and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.

Other inclusion and/or 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mRNA-1345: Exposed
Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.
Biological: mRNA-1345
Sterile liquid for injection
Placebo/Control: Referent
Eligible US participants from the P301 study who received placebo and eligible US-based, matched, unvaccinated RWD participants.
Biological: Placebo
0.9% sodium chloride (normal saline) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence Rate of Hospitalizations for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV
Time Frame: From Day 15 up to 1, 2, or 3 years
From Day 15 up to 1, 2, or 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Death Rate Within 30 Days, 31-365 Days, and up to 3 Years After mRNA-1345 Exposure
Time Frame: From Day 15 to Day 30, 31-365, and up to 3 years
From Day 15 to Day 30, 31-365, and up to 3 years
Incidence Rate of Discharge to Long-term or Short-term Institutional Care Following Hospitalization for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV
Time Frame: From Day 15 up to 1, 2, or 3 years
From Day 15 up to 1, 2, or 3 years
Length of Stay of Hospitalizations for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, Or RSV
Time Frame: From Day 15 up to 3 years
From Day 15 up to 3 years
Length of Stay of Hospitalizations Related to All-Causes, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV
Time Frame: Up to 1 year
Up to 1 year
Mean Total Cost of Hospitalizations Related to All-Causes, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV
Time Frame: Up to 1 Year
Up to 1 Year

Collaborators and Investigators

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

Sponsor

ModernaTX, Inc.

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)

September 15, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • mRNA-1345-P901

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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