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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
750
Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms (kg): 80 milligrams (mg); ≥20 kg to \< 80 kg: 40 mg; \<20 kg: 2 mg/kg).
Central Alabama Research
Birmingham, Alabama, United States
RECRUITINGHarrisburg Family Medical Center
Harrisburg, Arkansas, United States
RECRUITINGKendall South Medical Center Inc.
Miami, Florida, United States
RECRUITINGAvanza Medical Research Center
Pensacola, Florida, United States
Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions
Time frame: Day 1 (Baseline)
Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions
Time frame: Days 4, 6 and 10
Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Age Groups (<5 Years [< 1 Year, ≥ 1 Year to < 5 Years], and 5 to < 12 Years)
Time frame: Days 4, 6 and 10
Part A: Percentage of IPs With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA)
Time frame: Days 4, 6 and 10
Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status
Time frame: Days 4, 6 and 10
Part A: Percentage of IPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)
Time frame: Day 1 (Baseline)
Part A: Change From Baseline in Viral Titers by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Time frame: Baseline (Day 1); Days 4, 6 and 10
Part A: Susceptibility to Baloxavir Marboxil by Phenotyping of Virus With Novel Genotypic PA Substitutions
Time frame: Days 4, 6 and 10
Part A: Number of IPs with Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Time frame: Up to Day 29
Part B: Percentage of HHCs With Transmission of Influenza Virus by Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP
Time frame: Day 6, Day 10
Part B: Percentage of HHCs Who Develops Influenza Symptoms With Transmission of Influenza Virus Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP
Time frame: Day 6, Day 10
Reference Study ID Number: CV44536 https://forpatients.roche.com/
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Tekton Research - Chamblee Georgia
Chamblee, Georgia, United States
WITHDRAWNTekton Research Lawrenceville
Lawrenceville, Georgia, United States
WITHDRAWNVelocity Clinical Research at Primary Pediatrics Macon
Macon, Georgia, United States
COMPLETEDClinical Research Prime
Idaho Falls, Idaho, United States
RECRUITINGMishawaka Osteopathic Clinic
Mishawaka, Indiana, United States
RECRUITINGKentucky Pediatric Research Center
Bardstown, Kentucky, United States
RECRUITING...and 41 more locations