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Study identifier: NCT05572658 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: CompletedROSE

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

Condition: Respiratory Syncytial Virus  ·  Sponsor: ModernaTX, Inc.

PhaseN/A
Planned participants10994
Who can joinAll sexes, 60 Years to no upper limit
Healthy volunteersYesCheck eligibility criteria ↓
Where109 locations
For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (109)

Accel Research Site - Achieve - Birmingham - ERN - PPDSBirmingham, Alabama, United States
AES - DRS - Simon Williamson Clinic, PC - BirminghamBirmingham, Alabama, United States
Lakeview Clinical ResearchGuntersville, Alabama, United States
AES - DRS - Optimal Research Alabama - HuntsvilleHuntsville, Alabama, United States
Desert Clinical Research, LLCMesa, Arizona, United States
Hope Research Institute LLC - Phoenix - Hunt - PPDSPhoenix, Arizona, United States
AES - DRS - Phoenix Southeast - ChandlerPhoenix, Arizona, United States
AES - DRS - Central Phoenix Medical Clinic, LLCPhoenix, Arizona, United States
Hope Research Institute LLC - Hunt - PPDSPhoenix, Arizona, United States
Hope Research Institute LLC - Hunt - PPDSTempe, Arizona, United States
Tucson Neuroscience Research - M3 WRTucson, Arizona, United States
Hope Clinical Research, LLCCanoga Park, California, United States

+ 97 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

BirminghamGuntersvilleHuntsvilleMesa

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