A Multicenter, Randomized, Double-blind, Positive Controlled, Phase III Trial to Evaluate the Safety and Efficacy of ZX-7101A for Oral Suspension in Pediatric Participants Aged 2 to 11 With Influenza
The goal of this phase III study is to learn if ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years. The main question it aims to answer is: What medical problems do participants have when taking drug ZX-7101A for oral suspension or Oseltamivir phosphate for oral suspension? Researchers will compare drug ZX-7101A for oral suspension to active comparator: Oseltamivir phosphate for oral suspension to see if drug ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.
• ≥2 to\<12 years of age at the time of randomization, males or females.
• Patients in the screening period met the following criteria:
‣ Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive;
⁃ Axillary temperature ≥ 37.5℃ at screening; If taking antipyretics, axillary temperature ≥ 37.5℃ after taking the drug (more than 4 hours).
⁃ At least one of the influenza-related respiratory symptoms is moderate or greater in severity: nasal congestion/runny nose and coughing.
• The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization. The occurrence of symptoms is defined as:
‣ The body temperature first reached ≥ 37.5℃ (axillary/oral temperature) or 38.0℃ (rectal or tympanic temperature);
⁃ Or the occurrence of at least one systemic or respiratory symptom: nasal congestion, sore throat, cough, muscle pain, headache, etc.
• The guardian of the participants must agree to participate in the study and sign a written informed consent form. For participants aged 8 years old and above, they must sign the informed consent form voluntarily (for participant under the age of 8, only the informed consent form signed by the guardian is required.); The participant s and/or their guardians agree to comply with all study procedures, including filling out the participant diary cards (the guardians of the subjects may assist in the assessment/filling).