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

Completed
Conditions
Respiratory Syncytial Virus
Interventions
Biological: Placebo
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
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Placebo/Control: ReferentPlaceboEligible US participants from the P301 study who received placebo.
mRNA-1345: ExposedmRNA-1345Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.
Primary Outcome Measures
NameTimeMethod
Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSVFrom Day 15 up to 1 year
Secondary Outcome Measures
NameTimeMethod
Length of Stay of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSVFrom 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 RSVFrom 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 RSVFrom Day 15 up to 1 year
Number of Participants with Antibiotic or Corticosteroid TreatmentFrom Day 15 up to 1 year
Number of Participants with Chronic Obstructive Pulmonary Disease (COPD), Congestive heart failure (CHF), and AsthmaFrom Day 15 up to 1 year
Number of Participants with First Incidence of Asthma, COPD, and CHF ExacerbationsFrom Day 15 up to 1 year

Trial Locations

Locations (106)

Accel Research Site - Achieve - Birmingham - ERN - PPDS

🇺🇸

Birmingham, Alabama, United States

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

🇺🇸

Tempe, Arizona, United States

Tucson Neuroscience Research - M3 WR

🇺🇸

Tucson, Arizona, United States

Scroll for more (96 remaining)
Accel Research Site - Achieve - Birmingham - ERN - PPDS
🇺🇸Birmingham, Alabama, United States

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