A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts (NCT06094010)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Central Alabama Research — Birmingham, Alabama
Age range: 3 Weeks to 11 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (51 Sites)
Showing the first 25 of 51 sites.
- Central Alabama Research — Birmingham, Alabama
- Harrisburg Family Medical Center — Harrisburg, Arkansas
- Kendall South Medical Center Inc. — Miami, Florida
- Avanza Medical Research Center — Pensacola, Florida
- Tekton Research - Chamblee Georgia — Chamblee, Georgia
- Tekton Research Lawrenceville — Lawrenceville, Georgia
- Velocity Clinical Research at Primary Pediatrics Macon — Macon, Georgia
- Clinical Research Prime — Idaho Falls, Idaho
- Mishawaka Osteopathic Clinic — Mishawaka, Indiana
- Kentucky Pediatric Research Center — Bardstown, Kentucky
- Velocity Clinical Research Lafayette — Lafayette, Louisiana
- Velocity Clinical Research, Slidell — Slidell, Louisiana
- Velocity Clinical Research, Grand Island — Grand Island, Nebraska
- Machuca Family Medicine — Las Vegas, Nevada
- Ohio Pediatric Research Association — Dayton, Ohio
- Helios Clinical Research, Inc (former Ventavia Research Group) — Middleburg Heights, Ohio
- Frontier Clinical Research — Smithfield, Pennsylvania
- Coastal Pediatric Research — Charleston, South Carolina
- Tekton Research - Beaumont — Beaumont, Texas
- Oak Cliff Research Company, LLC — Dallas, Texas
- Mercury Clinical Research — Houston, Texas
- Pioneer Research Solutions — Houston, Texas
- Oak Cliff Research Company, LLC — Richardson, Texas
- Sun Research Institute — San Antonio, Texas
- Tekton Research — San Antonio, Texas
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza — Anniston, Alabama
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.