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NCT05572658 Clinical Trial

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

Respiratory Syncytial Virus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05572658
Other study ID # mRNA-1345-P901
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 15, 2022
Est. completion date June 30, 2026

Study information
Verified date June 2023
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 11010
Est. completion date June 30, 2026
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• mRNA-1345
Sterile liquid for injection
• Placebo
0.9% sodium chloride (normal saline) injection

Locations
Country Name City State
United States Javara Research Inc. - Annapolis - Javara - PPDS Annapolis Maryland
United States Masters of Clinical Research Inc. Augusta Georgia
United States Lynn Institute of Denver - ERN - PPDS Aurora Colorado
United States Tekton Research Inc. Austin Texas
United States Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS Baton Rouge Louisiana
United States Accel Research Site - Achieve - Birmingham - ERN - PPDS Birmingham Alabama
United States AES - DRS - Simon Williamson Clinic, PC - Birmingham Birmingham Alabama
United States Velocity Clinical Research - Cincinnati - ERN - PPDS Blue Ash Ohio
United States Cope Family Medicine - Ogden Clinic - CCT Bountiful Utah
United States PanAmerican Clinical Research LLC Brownsville Texas
United States Hope Clinical Research, LLC Canoga Park California
United States Family Medicine Associates of Texas - Hunt - PPDS Carrollton Texas
United States AES - DRS - Synexus Clinical Research US, Inc. - Chicago Chicago Illinois
United States Velocity Clinical Research - Chula Vista - ERN - PPDS Chula Vista California
United States AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati Cincinnati Ohio
United States CTI Clinical Research Center - PPDS Cincinnati Ohio
United States Meridian Clinical Research - Cincinnati - Platinum - PPDS Cincinnati Ohio
United States Centricity Research - Roswell - HyperCore - PPDS Columbus Georgia
United States Benchmark Research - Covington - HyperCore - PPDS Covington Louisiana
United States IResearch Atlanta LLC - ClinEdge - PPDS Decatur Georgia
United States Velocity Clinical Research - East Syracuse - ERN - PPDS East Syracuse New York
United States Velocity Clinical Research - New Smyrna Beach - ERN - PPDS Edgewater Florida
United States Skyline Medical Center, PC Elkhorn Nebraska
United States Meridian Clinical Research (Dakota Dunes-South Dakota) - Platinum - PPDS Endwell New York
United States Meridian Clinical Research (Endwell-New York) - Platinum - PPDS Endwell New York
United States AES - DRS - Synexus Clinical Research US, Inc. - Evansville Evansville Indiana
United States Carolina Institute for Clinical Research - M3 WR - ERN - PPDS Fayetteville North Carolina
United States Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS Fayetteville Georgia
United States Fleming Island Center For Clinical Research - ERN-PPDS Fleming Island Florida
United States Tekton Research - Fort Collins - Platinum - PPDS Fort Collins Colorado
United States Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Javara - PPDS Fort Worth Texas
United States Methodist Physicians Clinic - Prairie - CCT Research Fremont Nebraska
United States Allure Health LLC Friendswood Texas
United States Village Health Partners Frisco Medical Village Frisco Texas
United States CBH Health - CenExcel CBH - PPDS Gaithersburg Maryland
United States Meridian Clinical Research (Grand Island) - Platinum - PPDS Grand Island Nebraska
United States Lakeview Clinical Research Guntersville Alabama
United States Velocity Clinical Research - Hallandale Beach - ERN - PPDS Hallandale Beach Florida
United States Drug Trials America Hartsdale New York
United States Hatboro Medical Associates PC Hatboro Pennsylvania
United States Olympus Family Medicine - CCT Research Holladay Utah
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 AES - DRS - Optimal Research Alabama - Huntsville Huntsville Alabama
United States Jacksonville Center For Clinical Research - ERN - PPDS Jacksonville Florida
United States Health Awareness, Inc. Jupiter Florida
United States Ventavia Research Group - Platinum - PPDS Keller Texas
United States Paradigm Research La Mesa California
United States Velocity Clinical Research - Chula Vista - PPDS La Mesa California
United States Multi-Specialty Research Associates, Inc. M3 WR Lake City Florida
United States Excel Clinical Research - Las Vegas Las Vegas Nevada
United States HEALOR Primary Care - Physicians Las Vegas Las Vegas Nevada
United States Tekton Research - Longmont - Platinum - PPDS Longmont Colorado
United States PRI, LLC - Los Alamitos - M3 WR - ERN - PPDS Los Alamitos California
United States Accel Research Sites - Maitland - ERN - PPDS Maitland Florida
United States Velocity Clinical Research - Boise - PPDS Meridian Idaho
United States Desert Clinical Research, LLC Mesa Arizona
United States Benchmark Research - Metairie - HyperCore - PPDS Metairie Louisiana
United States Montana Medical Research Missoula Montana
United States Clinical Trials of America, LLC Monroe Louisiana
United States DelRicht Clinical Research, LLC - Internal - Covington - PPDS New Orleans Louisiana
United States AES - DRS - Synexus Clinical Research US, Inc. - New York New York New York
United States PRI, LLC - Newport Beach - M3 WR - ERN - PPDS Newport Beach California
United States Affinity Health (Oak Brook) Oak Brook Illinois
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 FOMAT Medical Research - FOMAT - HyperCore - PPDS Oxnard California
United States CCT Research Papillion Nebraska
United States DM Clinical Research - Philadelphia - ERN - PPDS Philadelphia Pennsylvania
United States AES - DRS - Central Phoenix Medical Clinic, LLC Phoenix Arizona
United States AES - DRS - Phoenix Southeast - Chandler Phoenix Arizona
United States Hope Research Institute LLC - Hunt - PPDS Phoenix Arizona
United States Hope Research Institute LLC - Phoenix - Hunt - PPDS Phoenix Arizona
United States AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg Pinellas Park Florida
United States AIM Trials Plano Texas
United States Clinical Research Institute, Inc - CRN - PPDS Plymouth Minnesota
United States Reddy Care Medical Pomona California
United States Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS Portsmouth Virginia
United States Paradigm Clinical Research Institute Inc - ClinEdge - PPDS Redding California
United States Rainier Clinical Research Center Renton Washington
United States AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis Richfield Minnesota
United States DM Clinical Research - Chicago - ERN - PPDS River Forest Illinois
United States Rochester Clinical Research, Inc. Rochester New York
United States Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS Rockville Maryland
United States AES - DRS - Synexus Clinical Research US, Inc. - St. Louis Saint Louis Missouri
United States Clinical Trials of Texas, Inc. - PPDS San Antonio Texas
United States Medical Center For Clinical Research - M3 WR - ERN - PPDS San Diego California
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 Seattle Womens: Health, Research, Gynecology Seattle Washington
United States South Ogden Family Medicine/Ogden Clinic - CCT Research South Ogden Utah
United States DM Clinical Research - Southfield - ERN - PPDS Southfield Michigan
United States Great Lakes Research Institute Southfield Michigan
United States Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Stephenville - Ja Stephenville Texas
United States Clinical Research Atlanta - ERN-PPDS Stockbridge Georgia
United States DM Clinical Research - Sugarland - ERN - PPDS Sugar Land Texas
United States Hope Research Institute LLC - Hunt - PPDS Tempe Arizona
United States AES - DRS - Synexus Clinical Research US, Inc. - The Villages The Villages Florida
United States DM Clinical Research - ERN Tomball Texas
United States DM Clinical Research - ERN - PPDS Tomball Texas
United States Tucson Neuroscience Research - M3 WR Tucson Arizona
United States Velocity Clinical Research - Valparaiso - ERN - PPDS Valparaiso Indiana
United States Versailles Family Medicine, PLLC Versailles Kentucky
United States Velocity Clinical Research - Banning - ERN - PPDS West Jordan Utah
United States Palm Beach Research - ClinEdge - PPDS West Palm Beach Florida
United States Paradigm Clinical Research Institute Inc - ClinEdge - PPDS Wheat Ridge Colorado
United States Clinical Site Partners - Winter Park - HyperCore - PPDS Winter Park Florida
United States Tekton Research - Oklahoma - Platinum - PPDS Yukon Oklahoma
United States Tekton Research Inc. Yukon Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence Rate of Hospitalizations for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV From Day 15 up to 1, 2, or 3 years
Secondary Death Rate Within 30 Days, 31-365 Days, and up to 3 Years After mRNA-1345 Exposure From Day 15 to Day 30, 31-365, and up to 3 years
Secondary Incidence Rate of Discharge to Long-term or Short-term Institutional Care Following Hospitalization for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV From Day 15 up to 1, 2, or 3 years
Secondary Length of Stay of Hospitalizations for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, Or RSV From Day 15 up to 3 years
Secondary Length of Stay of Hospitalizations Related to All-Causes, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV Up to 1 year
Secondary Mean Total Cost of Hospitalizations Related to All-Causes, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV Up to 1 Year
See also
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Active, not recruiting NCT04528719 - A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive Phase 1
Terminated NCT02508194 - A Study to Evaluate the Efficacy of MEDI7510 in Older Adults Phase 2
Active, not recruiting NCT06060457 - A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age Phase 3
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Completed NCT00100373 - RSV Challenge in Healthy Adults N/A
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Recruiting NCT06067230 - A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults Phase 3
Completed NCT00246480 - RSV Disease in the Elderly
Active, not recruiting NCT06097299 - A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus Phase 2
Completed NCT00889070 - Respiratory Events Among Premature Infants N/A
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Completed NCT05559905 - Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017) Phase 2
Active, not recruiting NCT05127434 - A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age Phase 2/Phase 3
Terminated NCT04978337 - A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Phase 2
Recruiting NCT06143046 - A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers Phase 2
Active, not recruiting NCT05397223 - A Study of Modified mRNA Vaccines in Healthy Adults Phase 1
Completed NCT02472548 - A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine Phase 1
Completed NCT01562938 - MEDI-557 Adult Dosing Phase 1
Completed NCT01734668 - Sofia RSV FIA Field Study N/A
Recruiting NCT06325657 - A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants Phase 3