Trial reportThe Pediatric infectious disease journal2020
Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2).
Trial report in The Pediatric infectious disease journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 58 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
A Feasibility Study of Xofluza Treatment of Influenza in Pediatric Transplant Recipients, Waitlisted Subjects and Household Members After Early Infection Alerting Using Wearable Devices
Who cites it
58 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Comprehensive evaluation of therapeutic effectiveness and safety profiles of baloxavir marboxil for managing influenza virus infection in pediatric populations: a systematic review with pooled meta-analytic data.Frontiers in pediatrics · 2025Pooled it
- Comparison of the efficacy and safety of baloxavir versus those of oseltamivir in pediatric patients with influenza: a meta-analysis.Frontiers in microbiology · 2025Pooled it
- Pooled it
- Clinical efficacy of antiviral agents against coronavirus disease 2019: A systematic review of randomized controlled trials.Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi · 2021Pooled it
- Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial.Nature medicine · 2025Trial
- Comparative Effectiveness of Baloxavir Marboxil and Oseltamivir Treatment in Reducing Household Transmission of Influenza: A Post Hoc Analysis of the BLOCKSTONE Trial.Influenza and other respiratory viruses · 2024Trial
- Baloxavir safety and clinical and virologic outcomes in influenza virus-infected pediatric patients by age group: age-based pooled analysis of two pediatric studies conducted in Japan.BMC pediatrics · 2023Trial
- Baloxavir Marboxil 2% Granules in Japanese Children With Influenza: An Open-label Phase 3 Study.The Pediatric infectious disease journal · 2020Trial
- Pharmacokinetics, Safety, and Exploratory Efficacy of Onradivir in Children with Acute Uncomplicated Influenza: A Multicenter, Dose-Ranging, Phase 2 Study.Infectious diseases and therapy · 2026Article
- Clinical impact of baloxavir-induced PA I38T/M substitutions in diverse influenza populations: a systematic review and meta-analysis.Virus research · 2026Article
- Baloxavir marboxil versus oseltamivir for influenza A in children aged 5 years and older: a community-based prospective cohort study.BMC infectious diseases · 2026Observational
- Influenza Antiviral Prescriptions in the US Inpatient and Outpatient Settings During the 2015-2022 Influenza Seasons.Influenza and other respiratory viruses · 2026Article
- In vitro efficacy of anti-influenza active compounds against clinical isolates with high growth capability.Archives of virology · 2026Article
- Antiviral Resistance in Influenza: Clinical and Public Health Implications.Influenza and other respiratory viruses · 2026Review
- Structural and temporal dynamics of pediatric influenza prevention and treatment: a comprehensive bibliometric analysis of historical evolution and emerging trends.Translational pediatrics · 2026Article
- Population Pharmacokinetic and Exposure-Efficacy Analysis of Baloxavir Marboxil for Influenza Treatment and Post-Exposure Prophylaxis in Children.Clinical pharmacology and therapeutics · 2026Article
- Baloxavir Acid-Induced Mitochondrial Toxicity and Cell Cycle Arrest Contribute to Its Adverse Effects.International journal of molecular sciences · 2026Article
- Update on Influenza.The American journal of the medical sciences · 2026Review
- Anti-influenza drugs targeting trimeric RNA polymerase complex: From development to clinics.Acta pharmaceutica Sinica. B · 2026Review
- Development of Antiviral Drugs for Influenza.Internal medicine (Tokyo, Japan) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBaloxavir marboxil (baloxavir) is a novel, cap-dependent endonuclease inhibitor that has previously demonstrated efficacy in the treatment of influenza in adults and adolescents. We assessed the safety and efficacy of baloxavir in otherwise healthy children with acute influenza.
methodsMiniSTONE-2 (Clinicaltrials.gov: NCT03629184) was a double-blind, randomized, active controlled trial enrolling children 1-<12 years old with a clinical diagnosis of influenza. Children were randomized 2:1 to receive either a single dose of oral baloxavir or oral oseltamivir twice daily for 5 days. The primary endpoint was incidence, severity and timing of adverse events (AEs); efficacy was a secondary endpoint.
resultsIn total, 173 children were randomized and dosed, 115 to the baloxavir group and 58 to the oseltamivir group. Characteristics of participants were similar between treatment groups. Overall, 122 AEs were reported in 84 (48.6%) children. Incidence of AEs was similar between baloxavir and oseltamivir groups (46.1% vs. 53.4%, respectively). The most common AEs were gastrointestinal (vomiting/diarrhea) in both groups [baloxavir: 12 children (10.4%); oseltamivir: 10 children (17.2%)]. No deaths, serious AEs or hospitalizations were reported. Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir.
conclusionsOral baloxavir is well tolerated and effective at alleviating symptoms in otherwise healthy children with acute influenza. Baloxavir provides a new therapeutic option with a simple oral dosing regimen.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.