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

Moderna

Status

Completed

Conditions

Respiratory Syncytial Virus

Treatments

Biological: Placebo

Biological: mRNA-1345

Study type

Observational

Funder types

Industry

Identifiers

NCT05572658

mRNA-1345-P901

Details and patient eligibility

About

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

Full 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).

Enrollment

10,994 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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.