At a glance
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A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients
In Brief
A Phase 4 clinical trial evaluating Oseltamivir and Placebo for Influenza. Completed, enrolled 477 participants across 78 sites in 14 countries.
Detailed Summary
This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.
Study Details
Timeline
Interventions
Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.