Common use of Efficacy Analyses Clause in Contracts

Efficacy Analyses. Efficacy analyses will be performed on the Efficacy Analysis Set. The primary endpoint, the incidence rate of laboratory confirmed influenza using RT-PCR on nasal swab samples, will be compared between vaccine groups using ▇▇▇▇▇▇’▇ Exact Test. Secondary efficacy endpoints assessing the incidence and severity of influenza-like symptoms will be performed by comparing the incidence of ILI (using the regulatory definition of ILI defined as feeling feverish or having a fever (temperature ≥37.8 C) and at least one of the following symptoms: a cough, and/or sore throat) by ▇▇▇▇▇▇’▇ test exact and symptom severity as an area-under-the- curve (AUC) using a ▇▇▇▇-▇▇▇▇▇▇▇ U Test.