Moderna mRNA-1345 Initiates Pivotal Phase 3 Clinical Study in Seniors 60 Years and Above

Moderna today announced that the RSV Program’s Data and Safety Monitoring Board (DSMB) has approved the initiation of a pivotal Phase 3 clinical study (ConquerRSV) of mRNA-1345 in the elderly population 60 years and older
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The approval of the DSMB follows an independent review of preliminary Phase 2 clinical trial data
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RSV is a common respiratory virus that usually causes cold-like symptoms
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The burden of disease caused by RSV is enormous; each year in the United States, RSV causes approximately 177,000 hospitalizations, 14,000 deaths in adults 65 and older, and an estimated $3 billion in annual healthcare costs
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RSV is generally a seasonal disease, with infection primarily occurring in the fall, winter, and spring in the United States and countries with similar climates
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mRNA-1345, a vaccine against RSV, encodes a prefusion F glycoprotein that induces higher neutralizing antibody responses compared to the postfusion state
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The primary objective of the pivotal Phase 3 clinical study ConquerRSV is to determine the safety and efficacy of the mRNA-1345 vaccine in adults over the age of 60 to support the marketing application
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