Overview
The goal of this phase III study is to learn if JKN2301 Dry Suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.
Eligibility
Inclusion Criteria:
- Pediatric patients within the specified age range.
- Clinical presentation consistent with influenza, confirmed by a positive local rapid test or central laboratory PCR test.
- Presentation for treatment within the early symptomatic phase of influenza illness.
- Presence of fever and at least one respiratory symptom.
- Ability to swallow oral suspension.
- Parent/guardian and patient (as age-appropriate) able to provide informed consent/assent.
Exclusion Criteria:
- Clinical signs suggestive of severe or complicated influenza infection
- requiring inpatient management.
- Presence of a concurrent bacterial infection requiring systemic therapy.
- Significant immunocompromised, or severe/uncontrolled comorbid conditions.
- History of hypersensitivity to any component of the investigational products.
- Use of prohibited medications (including other anti-influenza antivirals) within a specified period prior to enrollment.
- Recent participation in another interventional clinical trial.
- Any condition that, in the opinion of the investigator, would jeopardize patient safety or compliance with the study protocol.