Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: Population Health Research Institute
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Age ≥ 18 years and NYHA functional class II, III and IV

Exclusion Criteria:

• Anaphylactic reaction to a previous dose of TIV

• Known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock

• Guillain-Barré syndrome within eight weeks of a previous influenza vaccine

• Anaphylactic reaction to neomycin

• Patients who have had influenza vaccine in two of the three previous years