Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Biological: PlaceboBiological: mRNA-1345
- Registration Number
- NCT05572658
- Lead Sponsor
- ModernaTX, Inc.
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10994
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.
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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo/Control: Referent Placebo Eligible US participants from the P301 study who received placebo. Placebo/Control: Referent Placebo Eligible US participants from the P301 study who received placebo and eligible US-based, matched, unvaccinated RWD participants. mRNA-1345: Exposed mRNA-1345 Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine. mRNA-1345: Exposed mRNA-1345 Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.
- Primary Outcome Measures
Name Time Method Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV From Day 15 up to 1 year
- Secondary Outcome Measures
Name Time Method Length of Stay of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV From Day 15 up to 1 year Mean Total Cost of Hospitalizations and Mean Total Healthcare Cost Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV From Day 15 up to 1 year 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 From Day 15 up to 1 year Number of Participants with Antibiotic or Corticosteroid Treatment From Day 15 up to 1 year Number of Participants with Chronic Obstructive Pulmonary Disease (COPD), Congestive heart failure (CHF), and Asthma From Day 15 up to 1 year Number of Participants with First Incidence of Asthma, COPD, and CHF Exacerbations From Day 15 up to 1 year
Trial Locations
- Locations (106)
Tekton Research - Longmont - Platinum - PPDS
🇺🇸Longmont, Colorado, United States
Seattle Womens: Health, Research, Gynecology
🇺🇸Seattle, Washington, United States
Hope Research Institute LLC - Hunt - PPDS
🇺🇸Tempe, Arizona, United States
Tucson Neuroscience Research - M3 WR
🇺🇸Tucson, Arizona, United States
Fleming Island Center For Clinical Research - ERN-PPDS
🇺🇸Fleming Island, Florida, United States
Jacksonville Center For Clinical Research - ERN - PPDS
🇺🇸Jacksonville, Florida, United States
Velocity Clinical Research - Hallandale Beach - ERN - PPDS
🇺🇸Hallandale Beach, Florida, United States
Palm Beach Research - ClinEdge - PPDS
🇺🇸West Palm Beach, Florida, United States
Methodist Physicians Clinic - Prairie - CCT Research
🇺🇸Fremont, Nebraska, 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
Skyline Medical Center, PC
🇺🇸Elkhorn, Nebraska, United States
Montana Medical Research
🇺🇸Missoula, Montana, United States
Meridian Clinical Research (Grand Island) - Platinum - PPDS
🇺🇸Grand Island, Nebraska, 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
Centricity Research - Roswell - HyperCore - PPDS
🇺🇸Columbus, Georgia, 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
Clinical Site Partners - Winter Park - HyperCore - PPDS
🇺🇸Winter Park, Florida, United States
IResearch Atlanta LLC - ClinEdge - PPDS
🇺🇸Decatur, Georgia, United States
Multi-Specialty Research Associates, Inc. M3 WR
🇺🇸Lake City, Florida, United States
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
🇺🇸Fayetteville, Georgia, United States
Clinical Research Atlanta - ERN-PPDS
🇺🇸Stockbridge, Georgia, United States
Accel Research Sites - Maitland - ERN - PPDS
🇺🇸Maitland, Florida, United States
Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS
🇺🇸Baton Rouge, Louisiana, United States
Javara Research Inc. - Annapolis - Javara - PPDS
🇺🇸Annapolis, Maryland, United States
DM Clinical Research - ERN - PPDS
🇺🇸Tomball, Texas, United States
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
🇺🇸Chicago, Illinois, United States
Meridian Clinical Research - Cincinnati - Platinum - PPDS
🇺🇸Cincinnati, Ohio, United States
Family Medicine Associates of Texas - Hunt - PPDS
🇺🇸Carrollton, Texas, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
🇺🇸Richfield, Minnesota, United States
CCT Research
🇺🇸Papillion, Nebraska, United States
AIM Trials
🇺🇸Plano, Texas, United States
Velocity Clinical Research - New Smyrna Beach - ERN - PPDS
🇺🇸Edgewater, Florida, United States
Masters of Clinical Research Inc.
🇺🇸Augusta, Georgia, United States
DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
🇺🇸Houston, Texas, United States
CTI Clinical Research Center - PPDS
🇺🇸Cincinnati, Ohio, United States
Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS
🇺🇸Sandy Springs, Georgia, United States
Velocity Clinical Research - Boise - PPDS
🇺🇸Meridian, Idaho, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
PanAmerican Clinical Research LLC
🇺🇸Brownsville, Texas, United States
Village Health Partners Frisco Medical Village
🇺🇸Frisco, Texas, United States
Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Javara - PPDS
🇺🇸Fort Worth, Texas, United States
Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS
🇺🇸Portsmouth, Virginia, United States
DM Clinical Research - Chicago - ERN - PPDS
🇺🇸River Forest, Illinois, United States
Benchmark Research - Covington - HyperCore - PPDS
🇺🇸Covington, Louisiana, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
🇺🇸Saint Louis, Missouri, United States
Meridian Clinical Research (Dakota Dunes-South Dakota) - Platinum - PPDS
🇺🇸Endwell, New York, United States
Ventavia Research Group - Platinum - PPDS
🇺🇸Keller, Texas, United States
Excel Clinical Research - Las Vegas
🇺🇸Las Vegas, Nevada, United States
HEALOR Primary Care - Physicians Las Vegas
🇺🇸Las Vegas, Nevada, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Lakeview Clinical Research
🇺🇸Guntersville, Alabama, United States
AES - DRS - Optimal Research Alabama - Huntsville
🇺🇸Huntsville, Alabama, United States
PRI, LLC - Newport Beach - M3 WR - ERN - PPDS
🇺🇸Newport Beach, California, United States
Medical Center For Clinical Research - M3 WR - ERN - PPDS
🇺🇸San Diego, California, United States
FOMAT Medical Research - FOMAT - HyperCore - PPDS
🇺🇸Oxnard, California, United States
Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
🇺🇸Savannah, Georgia, United States
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
🇺🇸Evansville, Indiana, United States
Versailles Family Medicine, PLLC
🇺🇸Versailles, Kentucky, United States
Velocity Clinical Research - East Syracuse - ERN - PPDS
🇺🇸East Syracuse, New York, United States
AES - DRS - Synexus Clinical Research US, Inc. - New York
🇺🇸New York, New York, United States
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
🇺🇸Endwell, New York, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Carolina Institute for Clinical Research - M3 WR - ERN - PPDS
🇺🇸Fayetteville, North Carolina, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Tekton Research - Oklahoma - Platinum - PPDS
🇺🇸Yukon, Oklahoma, United States
Velocity Clinical Research - Cincinnati - ERN - PPDS
🇺🇸Blue Ash, Ohio, United States
DM Clinical Research - Philadelphia - ERN - PPDS
🇺🇸Philadelphia, Pennsylvania, United States
Hatboro Medical Associates PC
🇺🇸Hatboro, Pennsylvania, United States
Allure Health LLC
🇺🇸Friendswood, Texas, United States
DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
🇺🇸Humble, Texas, United States
DM Clinical Research - Sugarland - ERN - PPDS
🇺🇸Sugar Land, Texas, United States
DM Clinical Research - ERN
🇺🇸Tomball, Texas, United States
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
🇺🇸Wheat Ridge, Colorado, United States
Tekton Research - Fort Collins - Platinum - PPDS
🇺🇸Fort Collins, Colorado, 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
Clinical Trials of Texas, Inc. - PPDS
🇺🇸San Antonio, Texas, United States
Accel Research Site - Achieve - Birmingham - ERN - PPDS
🇺🇸Birmingham, Alabama, United States
AES - DRS - Simon Williamson Clinic, PC - Birmingham
🇺🇸Birmingham, Alabama, 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
Desert Clinical Research, LLC
🇺🇸Mesa, 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
PRI, LLC - Los Alamitos - M3 WR - ERN - PPDS
🇺🇸Los Alamitos, California, United States
Velocity Clinical Research - Chula Vista - PPDS
🇺🇸La Mesa, California, United States
Reddy Care Medical
🇺🇸Pomona, California, United States
Cope Family Medicine - Ogden Clinic - CCT
🇺🇸Bountiful, Utah, United States
Lynn Institute of Denver - ERN - PPDS
🇺🇸Aurora, Colorado, United States
DelRicht Clinical Research, LLC - Internal - Covington - PPDS
🇺🇸New Orleans, Louisiana, United States
Tekton Research Inc.
🇺🇸Austin, Texas, United States
Benchmark Research - Metairie - HyperCore - PPDS
🇺🇸Metairie, Louisiana, United States
Clinical Trials of America, LLC
🇺🇸Monroe, Louisiana, United States
Affinity Health (Oak Brook)
🇺🇸Oak Brook, Illinois, United States
Velocity Clinical Research - Valparaiso - ERN - PPDS
🇺🇸Valparaiso, Indiana, United States
Clinical Research Institute, Inc - CRN - PPDS
🇺🇸Plymouth, Minnesota, United States
Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Stephenville - Ja
🇺🇸Stephenville, Texas, United States