Clinical trial NCT01945268: Influenza Vaccine To Prevent Adverse Vascular Events:Pilot
Official title: A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: vascular, influenza, vaccine, heart failure
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
First posted: 2013-09-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasibility
timeFrame: Six months
Secondary outcomes:
measure: Adverse cardiovascular event
timeFrame: Six months
measure: Cardiovascular death
timeFrame: Six months
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: Maputo Central Hospital
city: Manila
country: Philippines
facility: University of Philippines
state: Emita
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
affiliation: McMaster University
name: Mark Loeb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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