Respiratory Syncytial Virus
Conditions
Keywords
Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Effectiveness, Vaccines
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).
Interventions
BIOLOGICALmRNA-1345
Sterile liquid for injection
BIOLOGICALPlacebo
0.9% sodium chloride (normal saline) injection
Sponsors
ModernaTX, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV | From Day 15 up to 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 | From Day 15 up to 1 year |
| Length of Stay of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV | From 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 RSV | From Day 15 up to 1 year |
| Number of Participants with Chronic Obstructive Pulmonary Disease (COPD), Congestive heart failure (CHF), and Asthma | From Day 15 up to 1 year |
| Number of Participants with First Incidence of Asthma, COPD, and CHF Exacerbations | From Day 15 up to 1 year |
| Number of Participants with Antibiotic or Corticosteroid Treatment | From Day 15 up to 1 year |
Countries
United States
Outcome results
None listed