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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01945268
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure 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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945268


Locations
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Mozambique
Maputo Central Hospital
Maputo, Mozambique
Philippines
University of Philippines
Manila, Emita, Philippines
Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
McMaster University
Population Health Research Institute
Investigators
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Principal Investigator: Mark Loeb, MD, MSc McMaster University

Additional Information:
Publications:
DataFax - Data Management Software for Clinical Trials. http://www.datafax.com/; accessed February 15, 2013.
Ontario Case Costing Initiative. Toronto, Ontario: Ontario Ministry of Health and Long-term Care, 2005. (Accessed January 29, 2011 at http://www.occp.com).
Canadian Community Health Survey: influenza immunization coverage results. http://www.bccdc.ca/imm-vac/BCImmunizationCov/flucoverage/default.htm.
Canadian Communicable Disease Report 2012. Statement on seasonal influenza vaccine for 2012-2013; 38: 2012.
Population Health Research Institute http://www.phri.ca/
Meyers D, Beahm D, Jurisich P, Milford C, Edlavich S. Influenza and pneumococcal vaccinations fail to prevent myocardial infarction. Heart Drug. 2004;4:96 -100.
Zheng Z, Mittelman M, Tofler G, Pomeroy C, Dampier C, Wides B, Muller J. Infections prior to acute myocardial infarction onset. J Am Coll Cardiol. 1998;31(suppl 1):132-133.
Tracking Heart Disease and Stroke in Canada. Released June 2009.
Statistics Canada. Morality, Summary List of Causes 2008. Released October 18, 2011.
Causes of death 2008, World Health Organization, Geneva, http://www.who.int/healthinfo/ global_burden_disease/ cod_2008_sources_methods.pdf.

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01945268     History of Changes
Other Study ID Numbers: RCT IVVE Pilot
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by McMaster University:
vascular, influenza, vaccine, heart failure

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Virus Diseases
Respiratory Tract Diseases
Heart Failure
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs