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Completed Phase 3 Interventional Results available

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms

ClinicalTrials.gov ID: NCT03629184

Public ClinicalTrials.gov record NCT03629184. 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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 6:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to \<12 years of age) with influenza-like symptoms.

Study identification

NCT ID
NCT03629184
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
173 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
1 Year 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 20, 2018 (Actual)
Primary completion
Apr 3, 2019 (Actual)
Completion
Apr 3, 2019 (Actual)
Last update posted
Apr 29, 2020

2018 – 2019

United States locations

U.S. sites
27
U.S. states
16
U.S. cities
25
Facility City State ZIP Site status
Central Alabama Research; Pediatrics Birmingham Alabama 35209 —
Harrisburg Family Medical Center Harrisburg Arkansas 72432 —
The Children's Clinic of Jonesboro, P.A. Jonesboro Arkansas 72401 —
The Probe Medical Research Los Angeles California 90004 —
Orange County Research Institute Ontario California 91762 —
Khruz Biotechnology Research Institute San Diego California 92102 —
Avanza Medical Research Center Pensacola Florida 32503 —
Clinical Research Prime Idaho Falls Idaho 83404 —
Cotton O'Neil Clinic; Stormont-Vail Hlth Care Topeka Kansas 66606 —
Kentucky Pediatric Research Center Bardstown Kentucky 40004 —
Spiegel, Craig Bridgeton Missouri 63044 —
Meridian Clinical Research, Llc Omaha Nebraska 68134 —
Machuca Family Medicine Las Vegas Nevada 89104 —
OnSite Clinical Solutions LLC Charlotte North Carolina 28203 —
Montgomery Medical Research /Frontier Clinical Research Smithfield North Carolina 15478 —
Ohio Pediatric Research Association Dayton Ohio 45414 —
Coastal Pediatric Research Charleston South Carolina 29414 —
AFC Urgent Care- Cleveland Cleveland Tennessee 37312 —
Holston Medical Group Kingsport Tennessee 37660 —
Oak Cliff Research Company, LLC Dallas Texas 75243 —
HD Research Corp Houston Texas 77004 —
Mercury Clinical Research Houston Texas 77036-3316 —
Tekton Research San Antonio Texas 78240 —
DM Clinical Research Tomball Texas 77375 —
ClinPoint Trials Waxahachie Texas 75165 —
FirstMed East (J Lewis Research) Salt Lake City Utah 84121 —
Advanced Clinical Research - Jordan Ridge Family Medicine Salt Lake City Utah 84123 —

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 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03629184, 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 29, 2020 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03629184 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →