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an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥ 60 Years of Age

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Study Design

To describe the effect of a single dose of mRNA-1345 vaccine on the number of participants with first episode of RSV-LRTD by baseline comorbidities such as COPD, asthma, any chronic respiratory or pulmonary disease, diabetes mellitus type 1 or 2, CHF, and advanced liver or renal disease.
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CLINICAL STUDY PROTOCOL

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  • Adults ≥ 60 years of age who are primarily responsible for self-care and activities of daily living.
  • Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
  • Able to comply with study requirements.
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Purpose of Study

Primary

  • To evaluate the safety and tolerability of the mRNA-1345 vaccine

Secondary

  • To evaluate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated acute respiratory disease (RSV-ARD) as compared with placebo within the period of 14 days post injection up to 12 months post injection.
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Participation

Benefits of Study Participation

  • Participants who receive mRNA-1345 may or may not directly benefit from vaccination as the efficacy of mRNA-1345 is yet to be established.
  • Participants will be contributing to the process of developing a new potentially prophylactic measure in an area of unmet medical need.
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