ongoing

The objective of the IVVE study is to assess the feasibility of randomizing heart failure (HF) patients to either inactivated influenza vaccine or to placebo to assess whether influenza vaccine can reduce adverse vascular events in this population.

Demonstration of influenza vaccine leading to a reduction in major adverse vascular events in HF patients would lead to a major change in how these patients are managed.

Primary endpoint:

A composite of major adverse vascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.

This is the largest randomized trial to test if influenza vaccine compared to control reduces adverse vascular events in high risk individuals.

The Principal Investigator of the IVVE study is Mark Loeb, Division Director, Infectious Diseases, McMaster University.

Study Type

Interventional - Drug

Study Design

Multi-centre, placebo RCT

NO. of Countries

10

NO. of Sites

30

NO. of Participants

5139

Study Period

2015-2021

Sponsor

PHRI

MRC

McMaster University

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