A Phase III, Randomized, Double-blinded, Placebo-controlled Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis of Influenza Virus Infection in Chinese Participants
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).
⁃ Index Participants (Participants With Influenza Virus Infection):
• First participant in a household with influenza virus infection in the current influenza season
• Fewer than 6 HHCs
• Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study
• Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result
• Onset of symptoms within 48 hours or less at time of signing Informed Consent Form (ICF)/Assent Form
• PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care or local laboratory test
⁃ HHCs of Index Participants:
• Lived with the index participant for 48 hours or more prior to informed consent/assent
• Meet all the following criteria and are judged not to have influenza virus infection by the investigator: body temperature (tympanic) \<37.5 degrees Celsius (°C); no influenza-like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, or fatigue) at screening; negative RIDT or PCR result for influenza
• For participants 12 years of age or older, ability to evaluate influenza symptoms by using a participant influenza symptoms diary; For participants under 12 years of age, capability of parents/caregivers to evaluate influenza symptoms by using a participant influenza symptoms diary
• PCR (-) or antigen test (-) for SARS-CoV-2 using point-of-care or local laboratory test