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Completed

NCT Number: NCT01945268

Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maputo Central Hospital, Maputo, Mozambique

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inactivated trivalent influenza vaccine

Drug

0.5 ml dose injected intramuscularly

Other names: VAXIGRIP vaccine

sterile saline

Other

0.5 ml dose injected intramuscularly

Primary outcomes

  1. Feasibility

    Time frame: 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 outcomes

  1. Adverse cardiovascular event

    Time frame: 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.

  2. Cardiovascular death

    Time frame: Six months

    CV death alone will be a secondary outcome.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Population Health Research Institute

Registry information

Official study title

A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study

Acronym: IVVE:Pilot

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2013
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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