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

Completed · Has a placebo group

Conditions studied: Respiratory Syncytial Virus

In brief

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

Key facts

Study ID

NCT05572658

Run by

ModernaTX, Inc.

People needed

10994

Starts

2022-09-15

Expected to finish

2023-09-30

Last updated by the study team

2025-01-24

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Accel Research Site - Achieve - Birmingham - ERN - PPDS — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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