A Phase 3 Safety and Efficacy Study of Baloxavir Marboxil in Children Less Than 1 Year Old With Suspected or Confirmed Influenza
Bibliographic record
Abstract
BACKGROUND: Baloxavir marboxil (baloxavir) inhibits influenza virus cap-dependent endonuclease and has demonstrated safety and efficacy in children 1-<12 years of age. This study assessed the safety and efficacy of baloxavir in children <1 year old. METHODS: miniSTONE-1 (NCT03653364) was a Phase III, global, multicenter, single-arm study to evaluate patients <1 year of age who received a single dose of baloxavir (age ≥3 months: 2 mg/kg; <3 months 1 mg/kg). The primary endpoint was safety; secondary endpoints included pharmacokinetics and efficacy (time to alleviation of signs and symptoms, duration of fever and symptoms, antibiotic use and cessation of viral shedding). RESULTS: Overall, 48/49 enrolled patients received baloxavir, of whom 15 had positive centralized influenza reverse transcription polymerase chain reaction tests and comprised the intent-to-treat influenza-infected population. The median age was 6 months and 79.2% of patients were not influenza-vaccinated. Overall, 51 adverse events (AEs) were reported in 23 patients; most were grade 1-2. The most common AEs were diarrhea (16.7%) and vomiting (12.5%). Two patients experienced serious AEs unrelated to treatment. In the intent-to-treat influenza-infected population, median time to alleviation of signs and symptoms was 163.7 hours [95% confidence interval (CI): 122.5-not estimable], median duration of fever was 23.1 hours (95% CI: 22.3-44.6) and median time to cessation of viral shedding was 24.5 hours (95% CI: 24.2-68.6). CONCLUSIONS: Baloxavir was well tolerated in children <1 year of age, with no new safety signals identified. Clinical, virological and safety outcomes were consistent with established profiles in adults, adolescents and children 1-<12 years old.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".