Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
NCT ID: NCT05572658
Last Updated: 2025-01-24
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
10994 participants
OBSERVATIONAL
2022-09-15
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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mRNA-1345: Exposed
Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.
mRNA-1345
Sterile liquid for injection
Placebo/Control: Referent
Eligible US participants from the P301 study who received placebo.
Placebo
0.9% sodium chloride (normal saline) injection
Interventions
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mRNA-1345
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
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Inclusion Criteria
* Must be based in the US
* Must provide informed consent for P901
* 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
* Receipt of any future licensed RSV vaccines during the study follow-up period will result in censorship on the date the vaccine was received.
* 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.
60 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Accel Research Site - Achieve - Birmingham - ERN - PPDS
Birmingham, Alabama, United States
AES - DRS - Simon Williamson Clinic, PC - Birmingham
Birmingham, Alabama, United States
Lakeview Clinical Research
Guntersville, Alabama, United States
AES - DRS - Optimal Research Alabama - Huntsville
Huntsville, Alabama, United States
Desert Clinical Research, LLC
Mesa, Arizona, United States
Hope Research Institute LLC - Phoenix - Hunt - PPDS
Phoenix, Arizona, United States
AES - DRS - Phoenix Southeast - Chandler
Phoenix, Arizona, United States
AES - DRS - Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States
Hope Research Institute LLC - Hunt - PPDS
Phoenix, Arizona, United States
Hope Research Institute LLC - Hunt - PPDS
Tempe, Arizona, United States
Tucson Neuroscience Research - M3 WR
Tucson, Arizona, United States
Hope Clinical Research, LLC
Canoga Park, California, United States
Velocity Clinical Research - Chula Vista - ERN - PPDS
Chula Vista, California, United States
Paradigm Research
La Mesa, California, United States
Velocity Clinical Research - Chula Vista - PPDS
La Mesa, California, United States
PRI, LLC - Los Alamitos - M3 WR - ERN - PPDS
Los Alamitos, California, United States
PRI, LLC - Newport Beach - M3 WR - ERN - PPDS
Newport Beach, California, United States
FOMAT Medical Research - FOMAT - HyperCore - PPDS
Oxnard, California, United States
Reddy Care Medical
Pomona, California, United States
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
Redding, California, United States
Medical Center For Clinical Research - M3 WR - ERN - PPDS
San Diego, California, United States
Lynn Institute of Denver - ERN - PPDS
Aurora, Colorado, United States
Tekton Research - Fort Collins - Platinum - PPDS
Fort Collins, Colorado, United States
Tekton Research - Longmont - Platinum - PPDS
Longmont, Colorado, United States
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
Wheat Ridge, Colorado, United States
Velocity Clinical Research - New Smyrna Beach - ERN - PPDS
Edgewater, Florida, United States
Fleming Island Center For Clinical Research - ERN-PPDS
Fleming Island, Florida, United States
Velocity Clinical Research - Hallandale Beach - ERN - PPDS
Hallandale, Florida, United States
Jacksonville Center For Clinical Research - ERN - PPDS
Jacksonville, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Multi-Specialty Research Associates, Inc. M3 WR
Lake City, Florida, United States
Accel Research Sites - Maitland - ERN - PPDS
Maitland, Florida, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
Pinellas Park, Florida, United States
AES - DRS - Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, United States
Palm Beach Research - ClinEdge - PPDS
West Palm Beach, Florida, United States
Clinical Site Partners - Winter Park - HyperCore - PPDS
Winter Park, Florida, United States
Masters of Clinical Research Inc.
Augusta, Georgia, United States
Centricity Research - Roswell - HyperCore - PPDS
Columbus, Georgia, United States
IResearch Atlanta LLC - ClinEdge - PPDS
Decatur, Georgia, United States
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
Fayetteville, Georgia, United States
Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS
Sandy Springs, Georgia, United States
Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
Savannah, Georgia, United States
Clinical Research Atlanta - ERN-PPDS
Stockbridge, Georgia, United States
Velocity Clinical Research - Boise - PPDS
Meridian, Idaho, United States
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, United States
Affinity Health (Oak Brook)
Oak Brook, Illinois, United States
DM Clinical Research - Chicago - ERN - PPDS
River Forest, Illinois, United States
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
Evansville, Indiana, United States
Velocity Clinical Research - Valparaiso - ERN - PPDS
Valparaiso, Indiana, United States
Versailles Family Medicine, PLLC
Versailles, Kentucky, United States
Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS
Baton Rouge, Louisiana, United States
Benchmark Research - Covington - HyperCore - PPDS
Covington, Louisiana, United States
Benchmark Research - Metairie - HyperCore - PPDS
Metairie, Louisiana, United States
Clinical Trials of America, LLC
Monroe, Louisiana, United States
DelRicht Clinical Research, LLC - Internal - Covington - PPDS
New Orleans, Louisiana, United States
Javara Research Inc. - Annapolis - Javara - PPDS
Annapolis, Maryland, United States
CBH Health - CenExcel CBH - PPDS
Gaithersburg, Maryland, United States
Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS
Rockville, Maryland, United States
Great Lakes Research Institute
Southfield, Michigan, United States
DM Clinical Research - Southfield - ERN - PPDS
Southfield, Michigan, United States
Clinical Research Institute, Inc - CRN - PPDS
Plymouth, Minnesota, United States
AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
Richfield, Minnesota, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
St Louis, Missouri, United States
Montana Medical Research
Missoula, Montana, United States
Skyline Medical Center, PC
Elkhorn, Nebraska, United States
Methodist Physicians Clinic - Prairie - CCT Research
Fremont, Nebraska, United States
Meridian Clinical Research (Grand Island) - Platinum - PPDS
Grand Island, Nebraska, United States
Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
Omaha, Nebraska, United States
Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS
Omaha, Nebraska, United States
CCT Research
Papillion, Nebraska, United States
HEALOR Primary Care - Physicians Las Vegas
Las Vegas, Nevada, United States
Excel Clinical Research - Las Vegas
Las Vegas, Nevada, United States
Velocity Clinical Research - East Syracuse - ERN - PPDS
East Syracuse, New York, United States
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
Endwell, New York, United States
Meridian Clinical Research (Dakota Dunes-South Dakota) - Platinum - PPDS
Endwell, New York, United States
Drug Trials America
Hartsdale, New York, United States
AES - DRS - Synexus Clinical Research US, Inc. - New York
New York, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Carolina Institute for Clinical Research - M3 WR - ERN - PPDS
Fayetteville, North Carolina, United States
Velocity Clinical Research - Cincinnati - ERN - PPDS
Blue Ash, Ohio, United States
Meridian Clinical Research - Cincinnati - Platinum - PPDS
Cincinnati, Ohio, United States
CTI Clinical Research Center - PPDS
Cincinnati, Ohio, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, United States
Tekton Research - Oklahoma - Platinum - PPDS
Yukon, Oklahoma, United States
Tekton Research Inc.
Yukon, Oklahoma, United States
Hatboro Medical Associates PC
Hatboro, Pennsylvania, United States
DM Clinical Research - Philadelphia - ERN - PPDS
Philadelphia, Pennsylvania, United States
Tekton Research Inc.
Austin, Texas, United States
PanAmerican Clinical Research LLC
Brownsville, Texas, United States
Family Medicine Associates of Texas - Hunt - PPDS
Carrollton, Texas, United States
Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Javara - PPDS
Fort Worth, Texas, United States
Allure Health LLC
Friendswood, Texas, United States
Village Health Partners Frisco Medical Village
Frisco, Texas, United States
DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
Houston, Texas, United States
DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
Humble, Texas, United States
Ventavia Research Group - Platinum - PPDS
Keller, Texas, United States
AIM Trials
Plano, Texas, United States
Clinical Trials of Texas, Inc. - PPDS
San Antonio, Texas, United States
Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Stephenville - Ja
Stephenville, Texas, United States
DM Clinical Research - Sugarland - ERN - PPDS
Sugar Land, Texas, United States
DM Clinical Research - ERN
Tomball, Texas, United States
DM Clinical Research - ERN - PPDS
Tomball, Texas, United States
Cope Family Medicine - Ogden Clinic - CCT
Bountiful, Utah, United States
Olympus Family Medicine - CCT Research
Holladay, Utah, United States
South Ogden Family Medicine/Ogden Clinic - CCT Research
South Ogden, Utah, United States
Velocity Clinical Research - Banning - ERN - PPDS
West Jordan, Utah, United States
Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS
Portsmouth, Virginia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Seattle Womens: Health, Research, Gynecology
Seattle, Washington, United States
Countries
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Other Identifiers
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mRNA-1345-P901
Identifier Type: -
Identifier Source: org_study_id
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