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Study identifier: NCT06094010 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Influenza  ·  Sponsor: Hoffmann-La Roche

PhasePhase 3
Planned participants1100
Who can joinAll sexes, 3 Weeks to 11 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: CV44536 https://forpatients.roche.com/  ·  888-662-6728 (U.S. Only)  ·  global-roche-genentech-trials@gene.com

Always discuss trial participation with your own doctor first.

Locations (51)

Central Alabama ResearchBirmingham, Alabama, United StatesRecruiting
Harrisburg Family Medical CenterHarrisburg, Arkansas, United StatesRecruiting
Kendall South Medical Center Inc.Miami, Florida, United StatesRecruiting
Avanza Medical Research CenterPensacola, Florida, United StatesRecruiting
Tekton Research - Chamblee GeorgiaChamblee, Georgia, United StatesWithdrawn
Tekton Research LawrencevilleLawrenceville, Georgia, United StatesWithdrawn
Velocity Clinical Research at Primary Pediatrics MaconMacon, Georgia, United StatesCompleted
Clinical Research PrimeIdaho Falls, Idaho, United StatesRecruiting
Mishawaka Osteopathic ClinicMishawaka, Indiana, United StatesRecruiting
Kentucky Pediatric Research CenterBardstown, Kentucky, United StatesRecruiting
Velocity Clinical Research LafayetteLafayette, Louisiana, United StatesRecruiting
Velocity Clinical Research, SlidellSlidell, Louisiana, United StatesCompleted

+ 39 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06094010