Clinical Trial

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Study acronym: Pebblestone
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' \<12 years with influenza treated with baloxavir marboxil. Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.
Protocol Amendment History 1 change
notable Enrollment increased: 750 -> 1100 participants 2026-05-02
Trial Details
NCT Number NCT06094010
Lead Sponsor Hoffmann-La Roche
Conditions Influenza
Enrollment 1,100 participants
Start Date 2023-11-22
Primary Completion 2027-05-11 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-01