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A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06094010•Hoffmann-La Roche

View on ClinicalTrials.gov

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' 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.

Eligibility

Age

0 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+10 more criteria

Exclusion Criteria

•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)
•IPs who fulfill 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
+1 more criteria

Locations (51)

Central Alabama Research

Birmingham, Alabama, United States

Harrisburg Family Medical Center

Harrisburg, Arkansas, United States

Kendall South Medical Center Inc.

Miami, Florida, United States

Avanza Medical Research Center

Pensacola, Florida, United States

Tekton Research - Chamblee Georgia

Chamblee, Georgia, United States

Tekton Research Lawrenceville

Lawrenceville, Georgia, United States

Velocity Clinical Research at Primary Pediatrics Macon

Macon, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Mishawaka Osteopathic Clinic

Mishawaka, Indiana, United States

Kentucky Pediatric Research Center

Bardstown, Kentucky, United States

Key Dates

Start Date

November 22, 2023

Primary Completion Date

May 11, 2027

Completion Date

June 30, 2027

Last Updated

March 6, 2026

Enrollment

750

ESTIMATED participants

Conditions

Influenza

Interventions

Baloxavir Marboxil

DRUG

Contacts

Reference Study ID Number: CV44536 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Inclusion Criteria

Exclusion Criteria

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