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NCT06094010 · ClinicalTrials.gov registry record · Phase 3
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
A Phase 3 study of Influenza, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 750
- Enrollment target
- 20
- Study locations
NCT06094010: Recruiting Phase 3 study of Influenza, sponsored by Hoffmann-La Roche.
NCT06094010 is a Phase 3 study of Influenza that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 750 participants, below the 36,799-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06094010, a Phase 3 study of Influenza, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 750 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Baloxavir Marboxil
Study Locations (20)
Georgia
- Tekton Research - Chamblee Georgia - Chamblee
- Tekton Research Lawrenceville - Lawrenceville
- Velocity Clinical Research at Primary Pediatrics Macon - Macon
Florida
- Kendall South Medical Center Inc. - Miami
- Avanza Medical Research Center - Pensacola
Louisiana
- Velocity Clinical Research Lafayette - Lafayette
- Velocity Clinical Research, Slidell - Slidell
Ohio
- Ohio Pediatric Research Association - Dayton
- Helios Clinical Research, Inc (former Ventavia Research Group) - Middleburg Heights
Texas
- Tekton Research - Beaumont - Beaumont
- Oak Cliff Research Company, LLC - Dallas
Alabama
- Central Alabama Research - Birmingham
Arkansas
- Harrisburg Family Medical Center - Harrisburg
Idaho
- Clinical Research Prime - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2023-11-22 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
What NCT06094010 shows while recruiting
NCT06094010 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, below the 36,799-participant average among 156 other Influenza trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Baloxavir Marboxil is the first listed.
NCT06094010 names 20 study sites across 14 states, led by Georgia, Florida, Louisiana.
Frequently Asked Questions
What is clinical trial NCT06094010 about?
NCT06094010 is a clinical study titled "A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts". 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. P...
What is the current status of trial NCT06094010?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 2023-11-22. Estimated completion is 2027-06-30.
What conditions does trial NCT06094010 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT06094010?
The interventions under investigation include: Baloxavir Marboxil (DRUG).
Who is sponsoring clinical trial NCT06094010?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06094010 being conducted?
This trial has 20 study locations across Alabama, Arkansas, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06094010's enrollment target sits among peer trials
750 41st of 156 higher than 116 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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