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

Study Overview
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Brief Summary
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The main goal of this observational study is to evaluate the real-world effectiveness of the Moderna mRNA-1345 vaccine for protection against RSV lower respiratory tract disease (RSV-LRTD) and to study additional health and economic outcomes.

Detailed Description
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This study will evaluate real-world data (RWD) and data from eligible United States (US) based participants from Study mRNA-1345-P301 (NCT05127434) for the short- and long-term effectiveness of the mRNA-1345 vaccine in preventing RSV-associated health outcomes such as hospitalizations, death, healthcare resource utilization, and costs. 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).

Official Title
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mRNA-1345-P901 Study: RSV Outcomes Study Extension (ROSE)

Conditions
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Respiratory Syncytial Virus

Intervention / Treatment
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* Biological: mRNA-1345
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: P901 inclusion criteria: RWD-matched unvaccinated 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 enriched RWD control population. 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mRNA-1345: Exposed<br>Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine. | Biological: mRNA-1345<br>* Sterile liquid for injection<br>|
| Placebo/Control: Referent<br>Eligible US participants from the P301 study who received placebo and eligible US-based, matched, unvaccinated RWD participants. | Biological: Placebo<br>* 0.9% sodium chloride (normal saline) injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Hospitalizations for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV |  | From Day 15 up to 1, 2, or 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death Rate Within 30 Days, 31-365 Days, and up to 3 Years After mRNA-1345 Exposure |  | From Day 15 to Day 30, 31-365, and up to 3 years | 
| Incidence Rate of Discharge to Long-term or Short-term Institutional Care Following Hospitalization for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV |  | From Day 15 up to 1, 2, or 3 years | 
| Length of Stay of Hospitalizations for All-cause, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, Or RSV |  | From Day 15 up to 3 years | 
| Length of Stay of Hospitalizations Related to All-Causes, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV |  | Up to 1 year | 
| Mean Total Cost of Hospitalizations Related to All-Causes, Cardiopulmonary/Cardiovascular, Pneumonia/Influenza, or RSV |  | Up to 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderna, Viral Diseases, Messenger RNA, mRNA-1345, Effectiveness, Vaccines