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

Influenza

Part A (Surveillance) 1. Incidence of resistance-associated pre-treatment substitutions determined at baseline (Day 1), Part A (Surveillance) 2. Incidence of resistance-associated treatment-emergent substitutions based on sampling on Days 4, 6 and 10

Part A (Surveillance) 1. Incidence of resistance-associated treatment-emergent substitutions by age groups (< 5 years [also < 1 year, ≥ 1 year to < 5 years], and 5 to < 12 years), Part A (Surveillance) 2. Incidence of novel treatment-emergent mutations in PA, Part A (Surveillance) 3. Incidence of resistance-associated treatment-emergent substitutions by baseline vaccination status of patient (vaccinated vs not vaccinated in the last 6 months), Part A (Surveillance) 4. Incidence of influenza virus type (A or B) and subtype (A/H1 or A/H3) in participants by study period, Part A (Surveillance) 5. Viral titers by quantitative reverse transcriptase-polymerase chain react (RT-PCR) at baseline and post-baseline timepoints, Part A (Surveillance) 6. The susceptibility to baloxavir marboxil by phenotyping of virus with novel PA substitutions, Part A (Surveillance) 7. Incidence and severity of adverse events, serious adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Part B (Transmission) 8. Incidence of transmission of influenza virus by Day 6 confirmed by central RT-PCR, with virus subtype consistent with the IP., Part B (Transmission) 9. Incidence of transmission of influenza virus by Day 10 confirmed by central RT-PCR, with virus subtype consistent with the IP., Part B (Transmission) 10. Incidence of influenza transmission to HHC by Day 6, confirmed by RT-PCR with a virus subtype matching the IP. Transmission is defined as: • For ≥ 12 year olds: Fever (38.0 C or higher) and one respiratory symptom, OR one respiratory and one systemic symptom. • For <12 year olds: Fever (38.0 C or higher) and signs of an upper respiratory tract infection., Part B (Transmission) 11. Incidence of influenza transmission to HHC by Day 10, confirmed by RT-PCR with a virus subtype matching the index patient. Transmission is defined as: For ≥ 12 year old: Fever (38.0 C or higher) and one respiratory symptom, OR one respiratory and one systemic symptom. For <12 year old: Fever (38.0 C or higher) and signs of an upper respiratory tract infection.

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