Conditions: Influenza
Keywords: Influenza treatment pediatric laninamivir
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.

Detailed description:
Approximately 48 subjects aged 5-17 years inclusive will be randomised into the study.

Subjects with recent onset of presumptive influenza will have influenza A or B infection confirm by Rapid Antigen Test.

The study will be conducted on an outpatient basis. The dose is administered in a single session in the clinic on Day 1. The subject will return to the clinic for assessments and follow up.

Arms:
arm 1: Dry Powder plus placebo arm 2: Dry Powder

Interventions: intervention 1: 20 mg laninamivir octanoate intervention 2: Placebo intervention 3: 40 mg laninamivir octanoate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: