> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-surveillance-study-of-susceptibility-to-baloxavir-marboxil-8e98c9ac-5cb9-438c-a7ac-5f191b754eea > Record changed: 2026-10-13 # A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts NCT06094010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) Participants 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) Start date 2023-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) Number of sites 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Acronym** Pebblestone Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Short title** A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Dates **Completion date** 2027-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **First posted** 2023-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Registry last updated** 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Primary completion date** 2027-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Start date** 2023-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Size and sites **Participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Planned participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Number of sites** 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Identifiers **Registry ID** NCT06094010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **ClinicalTrials.gov ID** NCT06094010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Outcomes ### Primary outcomes 1. Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions Timeframe: Day 1 (At Baseline) 2. Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions Timeframe: Days 4, 6 and 10 ### Secondary outcomes 1. Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Age Groups (<5 Years \[< 1 Year, ≥ 1 Year to < 5 Years\], and 5 to < 12 Years) Timeframe: Days 4, 6 and 10 2. Part A: Percentage of IPs With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA) Timeframe: Days 4, 6 and 10 3. Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status Timeframe: Days 4, 6 and 10 4. Part A: Percentage of IPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3) Timeframe: Day 1 (At Baseline) 5. Part A: Change From Baseline in Viral Titers by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Timeframe: At Baseline (Day 1); Days 4, 6 and 10 6. Part A: Susceptibility to Baloxavir Marboxil by Phenotyping of Virus With Novel Genotypic PA Substitutions Timeframe: Days 4, 6 and 10 7. Part A: Number of IPs with Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Up to Day 29 AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). 8. Part B: Percentage of HHCs With Transmission of Influenza Virus by Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP Timeframe: Day 6, Day 10 9. Part B: Percentage of HHCs Who Develops Influenza Symptoms With Transmission of Influenza Virus Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP Timeframe: Day 6, Day 10 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 3 Weeks **Maximum age** 11 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Sites - Central Alabama ResearchBirmingham, United StatesRecruiting - Harrisburg Family Medical CenterHarrisburg, United StatesRecruiting - Kendall South Medical Center Inc.Miami, United StatesRecruiting - Avanza Medical Research CenterPensacola, United StatesRecruiting - Tekton Research - Chamblee GeorgiaChamblee, United StatesWithdrawn - Tekton Research LawrencevilleLawrenceville, United StatesWithdrawn - Velocity Clinical Research at Primary Pediatrics MaconMacon, United StatesCompleted - Clinical Research PrimeIdaho Falls, United StatesRecruiting - Mishawaka Osteopathic ClinicMishawaka, United StatesRecruiting - Kentucky Pediatric Research CenterBardstown, United StatesRecruiting - Velocity Clinical Research LafayetteLafayette, United StatesRecruiting - Velocity Clinical Research, SlidellSlidell, United StatesCompleted - Velocity Clinical Research, Grand IslandGrand Island, United StatesRecruiting - Machuca Family MedicineLas Vegas, United StatesRecruiting - Ohio Pediatric Research AssociationDayton, United StatesRecruiting - Helios Clinical Research, Inc (former Ventavia Research Group)Middleburg Heights, United StatesRecruiting - Frontier Clinical ResearchSmithfield, United StatesRecruiting - Coastal Pediatric ResearchCharleston, United StatesRecruiting - Tekton Research - BeaumontBeaumont, United StatesRecruiting - Oak Cliff Research Company, LLCDallas, United StatesCompleted - Mercury Clinical ResearchHouston, United StatesCompleted - Pioneer Research SolutionsHouston, United StatesRecruiting - Oak Cliff Research Company, LLCRichardson, United StatesRecruiting - Sun Research InstituteSan Antonio, United StatesWithdrawn - Tekton ResearchSan Antonio, United StatesCompleted And 26 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## References ### Other registry identifiers (2) - 2023 - 2023-504672-22-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) ## Related records ### Drugs (1) - [Baloxavir marboxil](https://trialight.com/data/asset/baloxavir-marboxil-95bb0047-8ebb-4242-af68-67848f77b384.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (1) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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