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Evaluating the effectiveness of baloxavir marboxil for treating influenza in young children

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

Phase 3 Interventional Hoffmann-La Roche · NCT06094010

This study is testing if a new flu medication works well in young children aged 1 to under 12 who have been diagnosed with influenza.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1100 (estimated)
Ages3 Weeks to 11 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Locations51 sites (Birmingham, Alabama and 50 other locations)
Trial IDNCT06094010 on ClinicalTrials.gov

What this trial studies

This study aims to assess the susceptibility of baloxavir marboxil in children aged 1 to less than 12 years who have been diagnosed with influenza. Participants will be evaluated before treatment and after a single dose of the medication to determine its effectiveness. The study will include children with confirmed influenza symptoms and will exclude those with severe infections or other complicating health issues. The goal is to gather data on how well this antiviral works in a pediatric population.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1 to less than 12 years with confirmed influenza symptoms.

Not a fit: Patients with severe influenza requiring hospitalization or those who are severely immunocompromised may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for young children suffering from influenza.

How similar studies have performed: Other studies have shown promising results with baloxavir marboxil in treating influenza, indicating that this approach is supported by prior evidence.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Influenza
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.