Clinical trial NCT05572658: Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
Official title: mRNA-1345-P901 Study: RSV Outcomes Study Extension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus
Keywords: Viral Diseases
Messenger RNA
Moderna
mRNA-1345
Effectiveness
Vaccines
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 10994
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: Inclusion Criteria:

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.

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 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.

Primary outcomes:
measure: Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV
timeFrame: From Day 15 up to 1 year
Secondary outcomes:
measure: Length of Stay of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV
timeFrame: From Day 15 up to 1 year
measure: Mean Total Cost of Hospitalizations and Mean Total Healthcare Cost Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV
timeFrame: From Day 15 up to 1 year
measure: 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
timeFrame: From Day 15 up to 1 year
measure: Number of Participants with Antibiotic or Corticosteroid Treatment
timeFrame: From Day 15 up to 1 year
measure: Number of Participants with Chronic Obstructive Pulmonary Disease (COPD), Congestive heart failure (CHF), and Asthma
timeFrame: From Day 15 up to 1 year
measure: Number of Participants with First Incidence of Asthma, COPD, and CHF Exacerbations
timeFrame: From Day 15 up to 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Site - Achieve - Birmingham - ERN - PPDS
state: Alabama
city: Birmingham
country: United States
facility: AES - DRS - Simon Williamson Clinic, PC - Birmingham
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Huntsville
country: United States
facility: AES - DRS - Optimal Research Alabama - Huntsville
state: Alabama
city: Mesa
country: United States
facility: Desert Clinical Research, LLC
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute LLC - Phoenix - Hunt - PPDS
state: Arizona
city: Phoenix
country: United States
facility: AES - DRS - Phoenix Southeast - Chandler
state: Arizona
city: Phoenix
country: United States
facility: AES - DRS - Central Phoenix Medical Clinic, LLC
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute LLC - Hunt - PPDS
state: Arizona
city: Tempe
country: United States
facility: Hope Research Institute LLC - Hunt - PPDS
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research - M3 WR
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research, LLC
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research - Chula Vista - ERN - PPDS
state: California
city: La Mesa
country: United States
facility: Paradigm Research
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research - Chula Vista - PPDS
state: California
city: Los Alamitos
country: United States
facility: PRI, LLC - Los Alamitos - M3 WR - ERN - PPDS
state: California
city: Newport Beach
country: United States
facility: PRI, LLC - Newport Beach - M3 WR - ERN - PPDS
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research - FOMAT - HyperCore - PPDS
state: California
city: Pomona
country: United States
facility: Reddy Care Medical
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
state: California
city: San Diego
country: United States
facility: Medical Center For Clinical Research - M3 WR - ERN - PPDS
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver - ERN - PPDS
state: Colorado
city: Fort Collins
country: United States
facility: Tekton Research - Fort Collins - Platinum - PPDS
state: Colorado
city: Longmont
country: United States
facility: Tekton Research - Longmont - Platinum - PPDS
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
state: Colorado
city: Edgewater
country: United States
facility: Velocity Clinical Research - New Smyrna Beach - ERN - PPDS
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center For Clinical Research - ERN-PPDS
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach - ERN - PPDS
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research - ERN - PPDS
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc. M3 WR
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites - Maitland - ERN - PPDS
state: Florida
city: Pinellas Park
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
state: Florida
city: The Villages
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - The Villages
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research - ClinEdge - PPDS
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners - Winter Park - HyperCore - PPDS
state: Florida
city: Augusta
country: United States
facility: Masters of Clinical Research Inc.
state: Georgia
city: Columbus
country: United States
facility: Centricity Research - Roswell - HyperCore - PPDS
state: Georgia
city: Decatur
country: United States
facility: IResearch Atlanta LLC - ClinEdge - PPDS
state: Georgia
city: Fayetteville
country: United States
facility: Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - ERN-PPDS
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise - PPDS
state: Idaho
city: Chicago
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Chicago
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Health (Oak Brook)
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research - Chicago - ERN - PPDS
state: Illinois
city: Evansville
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Evansville
state: Indiana
city: Valparaiso
country: United States
facility: Velocity Clinical Research - Valparaiso - ERN - PPDS
state: Indiana
city: Versailles
country: United States
facility: Versailles Family Medicine, PLLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS
state: Louisiana
city: Covington
country: United States
facility: Benchmark Research - Covington - HyperCore - PPDS
state: Louisiana
city: Metairie
country: United States
facility: Benchmark Research - Metairie - HyperCore - PPDS
state: Louisiana
city: Monroe
country: United States
facility: Clinical Trials of America, LLC
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC - Internal - Covington - PPDS
state: Louisiana
city: Annapolis
country: United States
facility: Javara Research Inc. - Annapolis - Javara - PPDS
state: Maryland
city: Gaithersburg
country: United States
facility: CBH Health - CenExcel CBH - PPDS
state: Maryland
city: Rockville
country: United States
facility: Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS
state: Maryland
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Southfield
country: United States
facility: DM Clinical Research - Southfield - ERN - PPDS
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute, Inc - CRN - PPDS
state: Minnesota
city: Richfield
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
state: Minnesota
city: Saint Louis
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Elkhorn
country: United States
facility: Skyline Medical Center, PC
state: Nebraska
city: Fremont
country: United States
facility: Methodist Physicians Clinic - Prairie - CCT Research
state: Nebraska
city: Grand Island
country: United States
facility: Meridian Clinical Research (Grand Island) - Platinum - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS
state: Nebraska
city: Papillion
country: United States
facility: CCT Research
state: Nebraska
city: Las Vegas
country: United States
facility: HEALOR Primary Care - Physicians Las Vegas
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research - Las Vegas
state: Nevada
city: East Syracuse
country: United States
facility: Velocity Clinical Research - East Syracuse - ERN - PPDS
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research (Dakota Dunes-South Dakota) - Platinum - PPDS
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New York
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - New York
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research - M3 WR - ERN - PPDS
state: North Carolina
city: Blue Ash
country: United States
facility: Velocity Clinical Research - Cincinnati - ERN - PPDS
state: Ohio
city: Cincinnati
country: United States
facility: Meridian Clinical Research - Cincinnati - Platinum - PPDS
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center - PPDS
state: Ohio
city: Cincinnati
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
state: Ohio
city: Yukon
country: United States
facility: Tekton Research - Oklahoma - Platinum - PPDS
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research Inc.
state: Oklahoma
city: Hatboro
country: United States
facility: Hatboro Medical Associates PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia - ERN - PPDS
state: Pennsylvania
city: Austin
country: United States
facility: Tekton Research Inc.
state: Texas
city: Brownsville
country: United States
facility: PanAmerican Clinical Research LLC
state: Texas
city: Carrollton
country: United States
facility: Family Medicine Associates of Texas - Hunt - PPDS
state: Texas
city: Fort Worth
country: United States
facility: Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Javara - PPDS
state: Texas
city: Friendswood
country: United States
facility: Allure Health LLC
state: Texas
city: Frisco
country: United States
facility: Village Health Partners Frisco Medical Village
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
state: Texas
city: Humble
country: United States
facility: DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
state: Texas
city: Keller
country: United States
facility: Ventavia Research Group - Platinum - PPDS
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. - PPDS
state: Texas
city: Stephenville
country: United States
facility: Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Stephenville - Ja
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugarland - ERN - PPDS
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - ERN
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - ERN - PPDS
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine - Ogden Clinic - CCT
state: Utah
city: Holladay
country: United States
facility: Olympus Family Medicine - CCT Research
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine/Ogden Clinic - CCT Research
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research - Banning - ERN - PPDS
state: Utah
city: Portsmouth
country: United States
facility: Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Womens: Health, Research, Gynecology
state: Washington
Study officials:
References: