Overview

Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)

Status:
Unknown status

Trial end date:
2020-12-01

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. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

McMaster University

Treatments:

Vaccines

Criteria

Inclusion Criteria:

- Age ≥ 18 years and NYHA (New York Heart Association) functional class II, III and IV

Exclusion Criteria:

- Anaphylactic reaction to a previous dose of TIV(trivalent influenza vaccine)

- Known IgE( Immunoglobulin E)-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