A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
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
Who can join
3 Weeks – 11 Years · All sexes
Full eligibility criteria
Inclusion Criteria (Part A): * 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 start of pre-dose examinations at screening is 48 hours or less Inclusion Criteria (Part B): \[A\] IP: * Eligible to take part in Part A * Lives in a household with a HHC willing to be recruited as full HHC \[B\] 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 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 HHC" criteria \[D\] Full-study HHC: * Fulfills the "partial HHC" 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 Exclusion Criteria (Part A): * Participants with severe influenza virus infection requiring inpatient treatment * Severely immunocompromised participants (including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus \[HIV\] infection) as defined by the investigator * Participants with concurrent (non-influenza) infections requiring systemic anti-microbial and/or anti-viral therapy at the pre-dose examinations * Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening * Treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives, whichever is longer, prior to screening * Treatment with an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening * Known hypersensitivity to baloxavir marboxil or the drug product excipients * Females who have commenced menarche (i.e., child-bearing potential) Exclusion Criteria (Part B): * IPs who fulfil an exclusion criterion for Part A * HHCs deemed to require influenza post-exposure prophylaxis with influenza antiviral treatment due to their risk of developing influenza-related complications in accordance with local guidelines or clinical practice * HHCs diagnosed with influenza by health care professional in the past 4 weeks
About the 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.
What is being tested
- Baloxavir Marboxil (drug)
Sponsor: Hoffmann-La Roche · Participants: 1,100 · Started: Nov 22, 2023
Contact the study team
- Reference Study ID Number: CV44536 https://forpatients.roche.com/ · Phone: 888-662-6728 (U.S. Only)
Official record on ClinicalTrials.gov — NCT06094010
Locations in the U.S.
| Alabama | Central Alabama Research, Birmingham |
| Arkansas | Harrisburg Family Medical Center, Harrisburg |
| Florida | Kendall South Medical Center Inc., Miami |
| Idaho | Clinical Research Prime, Idaho Falls |
| Indiana | Mishawaka Osteopathic Clinic, Mishawaka |
| Kentucky | Kentucky Pediatric Research Center, Bardstown |
| Louisiana | Velocity Clinical Research Lafayette, Lafayette |
| Ohio | Helios Clinical Research, Inc (former Ventavia Research Group), Middleburg Heights |
| Pennsylvania | Frontier Clinical Research, Smithfield |
| Texas | Tekton Research - Beaumont, Beaumont Pioneer Research Solutions, Houston Siena Research Network, Sugar Land |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.