Safety and Efficacy of Baloxavir Marboxil in Influenza-infected Children 5-11 Years of Age: A Post Hoc Analysis of a Phase 3 Study.

ABSTRACT:

Background

miniSTONE-2 (NCT03629184) was a global, phase 3, randomized, controlled study that investigated the safety and efficacy of single-dose baloxavir marboxil in otherwise healthy children 1-<12 years of age and showed a positive risk-benefit profile. This post hoc analysis evaluated the safety and efficacy of baloxavir versus oseltamivir in children 5-11 years old with influenza.

Methods

Children received single-dose baloxavir or twice-daily oseltamivir for 5 days. Safety was the primary objective. Efficacy and virological outcomes included time to alleviation of symptoms, duration of fever and time to cessation of viral shedding by titer. Data were summarized descriptively.

Results

Ninety-four children 5-11 years old were included (61 baloxavir and 33 oseltami

SUBMITTER: Baker JB 

PROVIDER: S-EPMC10569673 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature