Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Drug: inactivated trivalent influenza vaccine; Other: Sterile saline

• Registration Number: NCT01945268
• Lead Sponsor: McMaster University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-18
• Study Start: 2015-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
influenza vaccine	inactivated trivalent influenza vaccine	Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine
placebo vaccination	Sterile saline	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.

Primary Outcome Measures

Name	Time	Method
Feasibility	Six months	If no more than 5% of all recruited subjects crossed over from one study group to the other, and if there is at least 98% follow up.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	Six months	CV death alone will be a secondary outcome.
Adverse cardiovascular event	Six months	The primary outcome will be a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria.

Trial Locations

Locations (3)

Mulago Hospital; 🇺🇬 Kampala, Uganda

Maputo Central Hospital; 🇲🇿 Maputo, Mozambique

University of Philippines; 🇵🇭 Manila, Emita, Philippines