The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
325
Baloxavir marboxil will be administered to the HHCs as per the schedule specified in the protocol.
Baloxavir marboxil matching placebo will be administered to the HHCs as per the schedule specified in the protocol.
Percentage of Participants who are Infected With Influenza Virus (Reverse Transcription - Polymerase Chain Reaction [RT-PCR] Positive), and Present With Fever and at Least one Respiratory Symptom
Time frame: From Day 1 up to Day 10
Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive), and Present With Fever or at Least one Influenza Symptom (Respiratory or Systemic)
Time frame: From Day 1 up to Day 10
Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive) Regardless of Body Temperature or Influenza Symptoms
Time frame: From Day 1 up to Day 10
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 21
Roche Pharma (Schweiz) AG Reference Study ID Number: YV46459, https://forpatients.roche.com/
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