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

NCT06094010

RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Influenza

Interventions: Baloxavir Marboxil

Countries: United States, Bulgaria, Poland, Spain

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.

Eligibility overview

Sex: ALL

Age: 3 Weeks to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (51)
  • Birmingham, Alabama, United States
  • Harrisburg, Arkansas, United States
  • Miami, Florida, United States
  • Pensacola, Florida, United States
  • Chamblee, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Macon, Georgia, United States
  • Idaho Falls, Idaho, United States
  • Mishawaka, Indiana, United States
  • Bardstown, Kentucky, United States
  • Lafayette, Louisiana, United States
  • Slidell, Louisiana, United States
  • Grand Island, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Dayton, Ohio, United States
  • Middleburg Heights, Ohio, United States
  • Smithfield, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Beaumont, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Richardson, Texas, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • Sugar Land, Texas, United States
  • West Jordan, Utah, United States
  • Kingwood, West Virginia, United States
  • Dupnitsa, Bulgaria
  • Kozloduy, Bulgaria
  • + 21 more on CT.gov