CompletedPhase 3

Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms

United States49 participantsStarted 2019-01-23

Plain-language summary

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to \<1 year with influenza like symptoms

Who can participate

Age range1 Year

SexALL

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Inclusion criteria

✓. In the investigator's judgement there is a clinical suspicion of influenza
✓. At least one respiratory symptom (either cough or coryza)

What they're measuring

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 29

Trial details

NCT IDNCT03653364

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-03

Results submitted2024-03-28

View on ClinicalTrials.gov More Influenza trials