Influenza Clinical Trial
Official title:
A Pilot Study for a Randomized Controlled Trial to Compare Trivalent Split Virus Influenza Vaccine to Seasonal Antiviral Prophylaxis in Healthcare and Other Healthy Adults: Assessment of Zanamivir Versus Vaccine (Stop-Flu-2)
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.
Several studies have demonstrated that zanamivir and oseltamivir are effective in preventing
influenza infection and illness when used either as prophylaxis after exposure to a
household contact with influenza or when taken for several weeks at the height of influenza
activity in the general community. However, the longest duration of prophylaxis with
neuraminidase inhibitors in two clinical trials, to date, has been six weeks.
Antiviral medication will likely have an important role in the response to the next
influenza pandemic. Additionally, there may be indications for use during seasons when the
major infecting strain of influenza in not one whose antigen is well covered by the vaccine.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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