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
- Influenza
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Hoffmann-La Roche
- Enrolment target
- 1,100
- Started
- 22 November 2023
- Main results due
- 11 May 2027
- Study sites
- 51
- Registry updated
- 24 September 2026
Can you take part?
- Ages 3 weeks to 11 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(51)
Central Alabama Research
Birmingham, Alabama, United States
Recruiting
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Recruiting
Kendall South Medical Center Inc.
Miami, Florida, United States
Recruiting
Avanza Medical Research Center
Pensacola, Florida, United States
Withdrawn
Tekton Research - Chamblee Georgia
Chamblee, Georgia, United States
Withdrawn
Tekton Research Lawrenceville
Lawrenceville, Georgia, United States
Withdrawn
Velocity Clinical Research at Primary Pediatrics Macon
Macon, Georgia, United States
Completed
Clinical Research Prime
Idaho Falls, Idaho, United States
Recruiting
Mishawaka Osteopathic Clinic
Mishawaka, Indiana, United States
Recruiting
Kentucky Pediatric Research Center
Bardstown, Kentucky, United States
Recruiting
Velocity Clinical Research Lafayette
Lafayette, Louisiana, United States
Recruiting
Velocity Clinical Research, Slidell
Slidell, Louisiana, United States
Completed
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Completed
Machuca Family Medicine
Las Vegas, Nevada, United States
Completed
Ohio Pediatric Research Association
Dayton, Ohio, United States
Completed
Helios Clinical Research, Inc (former Ventavia Research Group)
Middleburg Heights, Ohio, United States
Recruiting
Frontier Clinical Research
Smithfield, Pennsylvania, United States
Recruiting
Coastal Pediatric Research
Charleston, South Carolina, United States
Completed
Tekton Research - Beaumont
Beaumont, Texas, United States
Recruiting
Oak Cliff Research Company, LLC
Dallas, Texas, United States
Completed
Mercury Clinical Research
Houston, Texas, United States
Completed
Pioneer Research Solutions
Houston, Texas, United States
Recruiting
Oak Cliff Research Company, LLC
Richardson, Texas, United States
Completed
Sun Research Institute
San Antonio, Texas, United States
Withdrawn
Tekton Research
San Antonio, Texas, United States
Completed
Siena Research Network
Sugar Land, Texas, United States
Recruiting
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Withdrawn
Frontier Clinical Research, LLC
Kingwood, West Virginia, United States
Active, not recruiting
Medical Centre "Asklepii", OOD
Dupnitsa, Bulgaria
Completed
MHAT " St. Ivan Rilski " Kozloduy
Kozloduy, Bulgaria
Completed
MHAT Stamen Iliev AD
Montana, Bulgaria
Completed
MHAT City Clinic - Saint George
Montana, Bulgaria
Completed
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, Bulgaria
Completed
MHAT Sliven - Military Medial Academy
Sliven, Bulgaria
Completed
AGPSMP Pediatric diseases South park OOD
Sofia, Bulgaria
Recruiting
Medical Center Hera Sofia
Sofia, Bulgaria
Completed
IN VIVO Sp. z o.o.
Bydgoszcz, Poland
Recruiting
NZOZ Vitamed
Bydgoszcz, Poland
Recruiting
Centrum Medyczne Pratia Częstochowa
Częstochowa, Poland
Recruiting
Niepubliczny Zaklad Opieki Zdrowotnej "Amed"
Grójec, Poland
Recruiting
Vita Longa Sp. z o.o.
Katowice, Poland
Recruiting
Centrum Medyczne K2J2
Lodz, Poland
Completed
NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska
Siemianowice Śląskie, Poland
Recruiting
Jaroslaw Kierkus Prywatna Prakyka Lekarska
Warsaw, Poland
Withdrawn
Centrum Medyczne K2J2
Wo?omin, Poland
Withdrawn
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
Wroclaw, Poland
Recruiting
NZOZ Salmed
Łęczna, Poland
Recruiting
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, Spain
Withdrawn
Hospital Infantil Universitario Nino Jesus
Madrid, Spain
Withdrawn
Hospital Universitario 12 de Octubre
Madrid, Spain
Withdrawn
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Completed
Showing 51 of 51 sites. 21 of the 51 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06094010. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me