Moderna initiates phase 3 portion of pivotal trial for mrna respiratory syncytial virus (rsv) vaccine candidate, following independent safety review of interim data
Endorsement to proceed given by the independent data and safety monitoring board based on preliminary phase 2 safety and tolerability data moderna expects to enroll approximately 34,000 participants in multiple countries rsv causes severe disease burden among older adults and young children; there is no approved vaccine to prevent rsv cambridge, ma / accesswire / february 22, 2022 / moderna, inc. (nasdaq:mrna), a biotechnology company pioneering messenger rna (mrna) therapeutics and vaccines, today announced that the data and safety monitoring board (dsmb) for the rsv program has endorsed the start of the phase 3 portion of the pivotal clinical study of mrna-1345, the company's respiratory syncytial virus (rsv) vaccine candidate, in adults 60 years and older. the dsmb's endorsement comes after independent review of preliminary phase 2 data, which suggest that the vaccine has an acceptable safety profile in older adults at the selected dose.
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