ConditionRespiratory Viral Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-11
SponsorJoincare Pharmaceutical Group Industry Co., Ltd
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- JKN2301 Dry Suspension
- Oseltamivir Placebo
- Oseltamivir
- JKN2301 Placebo
Treatment groups
177 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov