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Respiratory Syncytial VirusROSENCT05572658

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

An observational study of Respiratory Syncytial Virus, run by ModernaTX, Inc. at 109 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main goal of this observational study is to describe the health and economic outcomes associated with use of the Moderna mRNA-1345 vaccine. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus
What is being tested?
mRNA-1345
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,994 participants
Where
109 sitesUnited States
Study dates
15 Sep 2022to 30 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The population of interest will include P301 participants randomized in the US who provide informed consent and meet eligibility criteria.

Who may be able to join

  • P901 inclusion criteria:
  • 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.

Who cannot join

  • 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 RWD controls, if built.
  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

109 sites in 1 country.

109 sites in 1 country

United States109 sites

  • Javara Research Inc. - Annapolis - Javara - PPDS

    Annapolis, Maryland, 21401

  • Masters of Clinical Research Inc.

    Augusta, Georgia, 30909-1854

  • Lynn Institute of Denver - ERN - PPDS

    Aurora, Colorado, 80012-4520

  • Tekton Research Inc.

    Austin, Texas, 78745-1470

  • Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS

    Baton Rouge, Louisiana, 70809-3416

  • Accel Research Site - Achieve - Birmingham - ERN - PPDS

    Birmingham, Alabama, 35209-6898

  • AES - DRS - Simon Williamson Clinic, PC - Birmingham

    Birmingham, Alabama, 35211-1320

  • Velocity Clinical Research - Cincinnati - ERN - PPDS

    Blue Ash, Ohio, 45242-3762

  • Cope Family Medicine - Ogden Clinic - CCT

    Bountiful, Utah, 84010-4862

  • PanAmerican Clinical Research LLC

    Brownsville, Texas, 78520-7256

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303-1844

  • Family Medicine Associates of Texas - Hunt - PPDS

    Carrollton, Texas, 75010-4632

  • AES - DRS - Synexus Clinical Research US, Inc. - Chicago

    Chicago, Illinois, 60654-4855

  • Velocity Clinical Research - Chula Vista - ERN - PPDS

    Chula Vista, California, 91911-6660

  • Meridian Clinical Research - Cincinnati - Platinum - PPDS

    Cincinnati, Ohio, 45219-2975

  • CTI Clinical Research Center - PPDS

    Cincinnati, Ohio, 45227-2172

  • AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati

    Cincinnati, Ohio, 45236-3669

  • Centricity Research - Roswell - HyperCore - PPDS

    Columbus, Georgia, 31904-5067

  • Benchmark Research - Covington - HyperCore - PPDS

    Covington, Louisiana, 70433

  • IResearch Atlanta LLC - ClinEdge - PPDS

    Decatur, Georgia, 30030-3438

  • Velocity Clinical Research - East Syracuse - ERN - PPDS

    East Syracuse, New York, 13057

  • Velocity Clinical Research - New Smyrna Beach - ERN - PPDS

    Edgewater, Florida, 32132-2720

  • Skyline Medical Center, PC

    Elkhorn, Nebraska, 68022-2889

  • Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

    Endwell, New York, 13760-3646

  • Meridian Clinical Research (Dakota Dunes-South Dakota) - Platinum - PPDS

    Endwell, New York, 13760-3661

  • AES - DRS - Synexus Clinical Research US, Inc. - Evansville

    Evansville, Indiana, 47714-8009

  • Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS

    Fayetteville, Georgia, 30214-1578

  • Carolina Institute for Clinical Research - M3 WR - ERN - PPDS

    Fayetteville, North Carolina, 28303-5537

  • Fleming Island Center For Clinical Research - ERN-PPDS

    Fleming Island, Florida, 32003-4816

  • Tekton Research - Fort Collins - Platinum - PPDS

    Fort Collins, Colorado, 80525

  • Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Javara - PPDS

    Fort Worth, Texas, 76132

  • Methodist Physicians Clinic - Prairie - CCT Research

    Fremont, Nebraska, 68025-2592

  • Allure Health LLC

    Friendswood, Texas, 77546

  • Village Health Partners Frisco Medical Village

    Frisco, Texas, 75033-4135

  • CBH Health - CenExcel CBH - PPDS

    Gaithersburg, Maryland, 20877-1409

  • Meridian Clinical Research (Grand Island) - Platinum - PPDS

    Grand Island, Nebraska, 68803-3345

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976-2206

  • Velocity Clinical Research - Hallandale Beach - ERN - PPDS

    Hallandale, Florida, 33009

  • Drug Trials America

    Hartsdale, New York, 10530-1911

  • Hatboro Medical Associates PC

    Hatboro, Pennsylvania, 19040-2045

  • Olympus Family Medicine - CCT Research

    Holladay, Utah, 84117-7054

  • DM Clinical Research - Texas Center For Drug Development - ERN - PPDS

    Houston, Texas, 77081

  • DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS

    Humble, Texas, 77338-4205

  • AES - DRS - Optimal Research Alabama - Huntsville

    Huntsville, Alabama, 35802-2569

  • Jacksonville Center For Clinical Research - ERN - PPDS

    Jacksonville, Florida, 32216-4362

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Ventavia Research Group - Platinum - PPDS

    Keller, Texas, 76248-4235

  • Paradigm Research

    La Mesa, California, 91942-3189

  • Velocity Clinical Research - Chula Vista - PPDS

    La Mesa, California, 91942-3189

  • Multi-Specialty Research Associates, Inc. M3 WR

    Lake City, Florida, 32055

  • HEALOR Primary Care - Physicians Las Vegas

    Las Vegas, Nevada, 89102

  • Excel Clinical Research - Las Vegas

    Las Vegas, Nevada, 89109-6209

  • Tekton Research - Longmont - Platinum - PPDS

    Longmont, Colorado, 80501-6461

  • PRI, LLC - Los Alamitos - M3 WR - ERN - PPDS

    Los Alamitos, California, 90720-3589

  • Accel Research Sites - Maitland - ERN - PPDS

    Maitland, Florida, 32751-7258

  • Velocity Clinical Research - Boise - PPDS

    Meridian, Idaho, 83642-6246

  • Desert Clinical Research, LLC

    Mesa, Arizona, 85213-5226

  • Benchmark Research - Metairie - HyperCore - PPDS

    Metairie, Louisiana, 70006-5322

  • Montana Medical Research

    Missoula, Montana, 59804

  • Clinical Trials of America, LLC

    Monroe, Louisiana, 71201

  • DelRicht Clinical Research, LLC - Internal - Covington - PPDS

    New Orleans, Louisiana, 70115

  • AES - DRS - Synexus Clinical Research US, Inc. - New York

    New York, New York, 10017-4008

  • PRI, LLC - Newport Beach - M3 WR - ERN - PPDS

    Newport Beach, California, 92660

  • Affinity Health (Oak Brook)

    Oak Brook, Illinois, 60523-4655

  • Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS

    Omaha, Nebraska, 68114

  • Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS

    Omaha, Nebraska, 68134-3664

  • FOMAT Medical Research - FOMAT - HyperCore - PPDS

    Oxnard, California, 93030-5841

  • CCT Research

    Papillion, Nebraska, 68046

  • DM Clinical Research - Philadelphia - ERN - PPDS

    Philadelphia, Pennsylvania, 19107-1530

  • Hope Research Institute LLC - Phoenix - Hunt - PPDS

    Phoenix, Arizona, 85018-2657

  • AES - DRS - Phoenix Southeast - Chandler

    Phoenix, Arizona, 85020-4327

  • AES - DRS - Central Phoenix Medical Clinic, LLC

    Phoenix, Arizona, 85020-4348

  • Hope Research Institute LLC - Hunt - PPDS

    Phoenix, Arizona, 85023

  • AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg

    Pinellas Park, Florida, 33781-3228

  • AIM Trials

    Plano, Texas, 75093-8346

  • Clinical Research Institute, Inc - CRN - PPDS

    Plymouth, Minnesota, 55441-2680

  • Reddy Care Medical

    Pomona, California, 91768-3027

  • Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS

    Portsmouth, Virginia, 23703-3200

  • Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

    Redding, California, 96001-0172

  • Rainier Clinical Research Center

    Renton, Washington, 98057-4927

  • AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis

    Richfield, Minnesota, 55423-2590

  • DM Clinical Research - Chicago - ERN - PPDS

    River Forest, Illinois, 60305-1898

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609-3173

  • Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS

    Rockville, Maryland, 20854-2957

  • Clinical Trials of Texas, Inc. - PPDS

    San Antonio, Texas, 78229-3539

  • Medical Center For Clinical Research - M3 WR - ERN - PPDS

    San Diego, California, 92108-5899

  • Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS

    Sandy Springs, Georgia, 30328-4277

  • Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS

    Savannah, Georgia, 31406

  • Seattle Womens: Health, Research, Gynecology

    Seattle, Washington, 98105-4028

  • South Ogden Family Medicine/Ogden Clinic - CCT Research

    South Ogden, Utah, 84405

  • Great Lakes Research Institute

    Southfield, Michigan, 48075-5405

  • DM Clinical Research - Southfield - ERN - PPDS

    Southfield, Michigan, 48076-5412

  • AES - DRS - Synexus Clinical Research US, Inc. - St. Louis

    St Louis, Missouri, 63141-7083

  • Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Stephenville - Ja

    Stephenville, Texas, 76401-1860

  • Clinical Research Atlanta - ERN-PPDS

    Stockbridge, Georgia, 30281-9054

  • DM Clinical Research - Sugarland - ERN - PPDS

    Sugar Land, Texas, 77478-4913

  • Hope Research Institute LLC - Hunt - PPDS

    Tempe, Arizona, 85284-3499

  • AES - DRS - Synexus Clinical Research US, Inc. - The Villages

    The Villages, Florida, 32162-7116

  • DM Clinical Research - ERN

    Tomball, Texas, 77375-3332

  • DM Clinical Research - ERN - PPDS

    Tomball, Texas, 77375-6543

  • Tucson Neuroscience Research - M3 WR

    Tucson, Arizona, 85710-6152

  • Velocity Clinical Research - Valparaiso - ERN - PPDS

    Valparaiso, Indiana, 46383-2196

  • Versailles Family Medicine, PLLC

    Versailles, Kentucky, 40383-1947

  • Velocity Clinical Research - Banning - ERN - PPDS

    West Jordan, Utah, 84088-8865

  • Palm Beach Research - ClinEdge - PPDS

    West Palm Beach, Florida, 33409-3401

  • Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

    Wheat Ridge, Colorado, 80033-6168

  • Clinical Site Partners - Winter Park - HyperCore - PPDS

    Winter Park, Florida, 32789-4681

  • Tekton Research - Oklahoma - Platinum - PPDS

    Yukon, Oklahoma, 73099-6396

  • Tekton Research Inc.

    Yukon, Oklahoma, 73099-9518

Other trials in United States

About this study

Official title: mRNA-1345-P901 Study: RSV Outcomes Study Extension

The main goal of this observational study is to describe the health and economic outcomes associated with use of the Moderna mRNA-1345 vaccine.

Read the 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 additional health and economic outcomes such as hospitalizations, healthcare resource utilization, disease exacerbations, and costs, associated with usage of the mRNA-1345 vaccine. 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).

Being tested
mRNA-1345, Placebo
Keywords
Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Effectiveness, Vaccines
Medical subject headings
Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1345Biological

    Sterile liquid for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT05572658
Study groupRoleWhat they receive
mRNA-1345: ExposedEligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.
Receives: Biological: mRNA-1345
Placebo/Control: ReferentEligible US participants from the P301 study who received placebo.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV

    Measured: From Day 15 up to 1 year

Secondary outcomes (6)

  1. Length of Stay of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV

    Measured: From Day 15 up to 1 year

  2. Mean Total Cost of Hospitalizations and Mean Total Healthcare Cost Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV

    Measured: From Day 15 up to 1 year

  3. Number of Participants with Use of Mechanical Ventilation, Supplemental Oxygen, and Intensive Care Unit Admissions During Hospitalizations Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV

    Measured: From Day 15 up to 1 year

  4. Number of Participants with Antibiotic or Corticosteroid Treatment

    Measured: From Day 15 up to 1 year

  5. Number of Participants with Chronic Obstructive Pulmonary Disease (COPD), Congestive heart failure (CHF), and Asthma

    Measured: From Day 15 up to 1 year

  6. Number of Participants with First Incidence of Asthma, COPD, and CHF Exacerbations

    Measured: From Day 15 up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start15 Sep 2022
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,994 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05572658
Sponsor's protocol ID
mRNA-1345-P901
Acronym
ROSE
Status last verified
Jan 2025
First submitted
5 Oct 2022
Last updated
24 Jan 2025
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Syncytial Virus, run by ModernaTX, Inc. at 109 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV (time frame: From Day 15 up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05572658.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.

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