Zanamivir Versus Trivalent Split Virus Influenza Vaccine

Summary

This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers. The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.

Timeline

Start

2008-11

Primary completion

2009-05

Completion

2009-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Influenza Vaccine vs Antiviral Prophylaxis; p = 0.25; Odds Ratio (OR) 0.23 (95% CI 0.01 to 4.8); Fisher Exact NCT00784784 ↗

Drugs

Indications