Overview

This trial is active, not recruiting.

Condition heart failure
Treatments inactivated trivalent influenza vaccine, sterile saline
Phase phase 4
Sponsor McMaster University
Collaborator Population Health Research Institute
Start date April 2015
End date December 2016
Trial size 600 participants
Trial identifier NCT01945268, RCT IVVE Pilot

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine
inactivated trivalent influenza vaccine VAXIGRIP vaccine
0.5 ml dose injected intramuscularly
(Placebo Comparator)
Participants at high risk for adverse vascular events will be immunized with a 0.5 ml dose of sterile saline inactivated during the influenza season.
sterile saline
0.5 ml dose injected intramuscularly

Primary Outcomes

Measure
Feasibility
time frame: Six months

Secondary Outcomes

Measure
Adverse cardiovascular event
time frame: Six months
Cardiovascular death
time frame: Six months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study
Principal investigator Mark Loeb, MD, MSc
Description Cardiovascular disease is a major cause of morbidity and mortality. There is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. There is some evidence that influenza vaccination may prevent such events but the data are inconclusive. The investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. Adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo. This pilot study will provide needed data to establish the feasibility of a larger study.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by McMaster University.