A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Public ClinicalTrials.gov record NCT06094010. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06094010
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Weeks to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 21, 2023
- Primary completion
- May 10, 2027
- Completion
- Jun 29, 2027
- Last update posted
- Apr 30, 2026
2023 – 2027
United States locations
- U.S. sites
- 28
- U.S. states
- 16
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209 | Recruiting |
| Harrisburg Family Medical Center | Harrisburg | Arkansas | 72432 | Recruiting |
| Kendall South Medical Center Inc. | Miami | Florida | 33185 | Recruiting |
| Avanza Medical Research Center | Pensacola | Florida | 32503 | Recruiting |
| Tekton Research - Chamblee Georgia | Chamblee | Georgia | 30341 | Withdrawn |
| Tekton Research Lawrenceville | Lawrenceville | Georgia | 30043 | Withdrawn |
| Velocity Clinical Research at Primary Pediatrics Macon | Macon | Georgia | 31210 | Completed |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | Recruiting |
| Mishawaka Osteopathic Clinic | Mishawaka | Indiana | 46544 | Recruiting |
| Kentucky Pediatric Research Center | Bardstown | Kentucky | 40004 | Recruiting |
| Velocity Clinical Research Lafayette | Lafayette | Louisiana | 70508 | Recruiting |
| Velocity Clinical Research, Slidell | Slidell | Louisiana | 31210 | Completed |
| Velocity Clinical Research, Grand Island | Grand Island | Nebraska | 68803 | Recruiting |
| Machuca Family Medicine | Las Vegas | Nevada | 89104 | Recruiting |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | Recruiting |
| Helios Clinical Research, Inc (former Ventavia Research Group) | Middleburg Heights | Ohio | 44130-3643 | Recruiting |
| Frontier Clinical Research | Smithfield | Pennsylvania | 15478 | Recruiting |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | Recruiting |
| Tekton Research - Beaumont | Beaumont | Texas | 77706 | Recruiting |
| Oak Cliff Research Company, LLC | Dallas | Texas | 75287 | Completed |
| Mercury Clinical Research | Houston | Texas | 77087 | Completed |
| Pioneer Research Solutions | Houston | Texas | 77099 | Recruiting |
| Oak Cliff Research Company, LLC | Richardson | Texas | 75287 | Recruiting |
| Sun Research Institute | San Antonio | Texas | 78215 | Withdrawn |
| Tekton Research | San Antonio | Texas | 78229 | Completed |
| Siena Research Network | Sugar Land | Texas | 77479 | Recruiting |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | Recruiting |
| Frontier Clinical Research, LLC | Kingwood | West Virginia | 26537 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06094010, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06094010 live on ClinicalTrials.gov.