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Re: DewDiligence post# 244373

Tuesday, 11/01/2022 10:35:20 AM

Tuesday, November 01, 2022 10:35:20 AM

Post# of 257473

Although the statistical success criterion was not met for the second primary endpoint [prevention of hospitalization] clinically meaningful efficacy was observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first 90 days of life.



It looks like prevention of hospitalization was a secondary endpoint:

Secondary Outcome Measures :
The percentage reduction in the incidence of hospitalizations due to RSV in infants through 360 days of life



https://www.clinicaltrials.gov/ct2/show/NCT04424316

I think the other primary efficacy endpoint that was not met was "The percentage reduction in the incidence of medically attended LRTI (MA-LRTI) due to RSV in infants through 180 days of life" , which showed numerical benefit but probably had a CI whose lower bound was below the prespecified statistical threshold

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