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

Sponsor
McMaster University (Other)
Overall Status
Completed
CT.gov ID
NCT01945268
Collaborator
Population Health Research Institute (Other)
107
Enrollment
3
Locations
2
Arms
8
Duration (Months)
35.7
Patients Per Site
4.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: inactivated trivalent influenza vaccine
  • Other: Sterile saline
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Cardiovascular death [Six months]

      CV death alone will be a secondary outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maputo Central Hospital Maputo Mozambique
    2 University of Philippines Manila Emita Philippines
    3 Mulago Hospital Kampala Uganda

    Sponsors and Collaborators

    • McMaster University
    • Population Health Research Institute

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    McMaster University
    ClinicalTrials.gov Identifier:
    NCT01945268
    Other Study ID Numbers:
    • RCT IVVE Pilot
    First Posted:
    Sep 18, 2013
    Last Update Posted:
    Oct 26, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by McMaster University
    vascular, influenza, vaccine, heart failure
    Additional relevant MeSH terms:
    Influenza, Human
    Heart Failure
    Vaccines

    Study Results

    No Results Posted as of Oct 26, 2018