Influenza Vaccine To Prevent Adverse Vascular Events:Pilot (IVVE:Pilot)

October 25, 2018 updated by: McMaster University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mozambique
      • Maputo, Mozambique
        • Maputo Central Hospital
  • Philippines
    • Emita
      • Manila, Emita, Philippines
        • University of Philippines
  • Uganda
      • Kampala, Uganda
        • Mulago Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: influenza vaccine
Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine
Drug: inactivated trivalent influenza vaccine
0.5 ml dose injected intramuscularly
Other Names:
  • VAXIGRIP vaccine
Placebo Comparator: placebo vaccination
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.
Other: Sterile saline
0.5 ml dose injected intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months
Cardiovascular death
Time Frame: Six months
CV death alone will be a secondary outcome.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Population Health Research Institute

Investigators

  • Principal Investigator: Mark Loeb, MD, MSc, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 13, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT IVVE Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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