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
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' susceptibility \<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 with symptoms suggestive of influenza based on investigator's judgement with diagnosis confirmed by a positive local influenza test within 24 hours before full study screening
• Participants with a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test within 48 hours before full study screening
• Time interval between onset of influenza symptoms and the pre-dose examinations at screening is 48 hours or less
⁃ \[A\] IP:
• Eligible to take part in Part A
• Lives in a household with a HHC willing to be recruited as full household contact
⁃ \[B\] HHCs:
⁃ \- Each HHC living in the home of an IP at the time of IP treatment must be screened for partial or full-study HHC eligibility
⁃ \[C\] Partial HHC:
• Starts screening within 1 calendar day after IP treatment
• Negative influenza and SARS-CoV-2 test at screening after IP's treatment with baloxavir marboxil
• HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements AND at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening
• HHC lives with other HHCs (if applicable) who fulfill all the Partial household contact criteria
⁃ \[D\] Full-study HHC:
• Fulfills the Partial household contact criteria
• Agrees to participate in the full study
• Will reside in the IP's house for at least 12 of the next 15 days and will be present for scheduled study visits
• No influenza symptoms within 7 days prior to screening
• Does not have a moderate or worse active infections OR infections requiring systemic or otherwise internally administered or otherwise internally administered antibiotic/antiviral/antifungal therapy