CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
Fluviral +1 morebiological
Likely dose
Zanamivir 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00784784
NCT00784784Phase 3Completed
CompareCT.gov

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)

Mount Sinai Hospital, Canada·interventional·Posted Nov 4, 2008·Updated Nov 21, 2014

In Brief

A Phase 3 clinical trial evaluating Fluviral and Zanamivir for Influenza. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.7 years ago

Interventions

Fluviralbiological

One dose

Zanamivirdrug

10 mg, OD, for duration of influenza season (10-23 weeks)