A Phase IIIb Multicenter, Single-arm, Open-label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts

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.

Eligibility

Age range

0–11 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Baloxavir Marboxil

  Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms \[kg\]: 80 milligrams \[mg\]; ≥20 kg to \< 80 kg: 40 mg; \<20 kg: 2 milligrams per kilogram \[mg/kg\]).

Locations (51)