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Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE) (RCT-IVVE)

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ClinicalTrials.gov Identifier: NCT02762851
Recruitment Status : Unknown
Verified October 2018 by McMaster University.
Recruitment status was:  Recruiting
First Posted : May 5, 2016
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
McMaster University

Study Description
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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. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.

Condition or disease Intervention/treatment Phase
Heart Failure Influenza Other: Sterile saline Drug: inactivated trivalent influenza vaccine 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 each year for three consecutive years. They will be followed over six months for a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. Rigorous demonstration of influenza vaccine leading to a reduction in major adverse vascular events in patients with heart failure would lead to a major change in how these patients are managed. Given the large burden of disease both in Canada and globally, the possibility to reduce cardiovascular and stroke related death is a compelling reason to conduct this trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 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
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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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 prior to the influenza season.
 Drug: inactivated trivalent influenza vaccine
0.5 ml dose injected intramuscularly
Other Name: VAXIGRIP vaccine
Placebo Comparator: Placebo vaccine
Participants at high risk for adverse vascular events will be vaccinated with a 0.5 ml dose of sterile saline prior to the influenza season.
 Other: Sterile saline
0.5 ml dose injected intramuscularly


Outcome Measures
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Primary 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.


Secondary Outcome Measures :
  1. Cardiovascular (CV) death [ Time Frame: Six months ]
    CV death alone will be a secondary outcome.


Eligibility Criteria
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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 (New York Heart Association) functional class II, III and IV

Exclusion Criteria:

  • Anaphylactic reaction to a previous dose of TIV(trivalent influenza vaccine)
  • Known IgE( Immunoglobulin E)-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
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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): NCT02762851


Contacts
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Contact: Mark Loeb, MD, MSc. 905-525-9140 ext 26066 loebm@mcmaster.ca

Locations
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Cameroon
Douala General Hospital Terminated
Douala, Cameroon
China, Xicheng District
Fuwai Hospital Recruiting
Beijing, Xicheng District, China, 100037
Contact: Yan Liang, MD       yan.liang@phri.ca   
Contact: Jun Zhu, MD       junzhuld@hotmail.com   
India
Centre for Chronic Disease Control Recruiting
New Delhi, India
Contact: Dorairaj Prabhakaran, MD       dprabhakaran@ccdcindia.org   
Sub-Investigator: Ambuj Roy, MD         
Kenya
Aga Khan University Recruiting
Nairobi, Kenya
Contact: Gerald Yonga, MD       gerald.yonga@aku.edu   
Lebanon
American University of Beirut Medical Center Not yet recruiting
Beirut, Lebanon
Contact: Marwan Refaat, MD    +961-1-350000 ext 5825    mr48@aub.edu.lb   
Mozambique
Maputo Central Hospital (Full Trial) Recruiting
Maputo, Mozambique
Contact: Albertino Damasceno, MD    258 2131 0828    tino_7117@yahoo.com.br   
Nigeria
Bayero University and Aminu Kano Teaching Hospital Recruiting
Kano, Nigeria
Contact: Kamilu Karaye, MD    234 803 704 2171    kkaraye@yahoo.co.uk   
Philippines
University of Philippines Recruiting
Manila, Emita, Philippines
Contact: Lia Palileo, MD       liapalileo@gmail.com   
Sub-Investigator: Antonio Dans, MD         
Saudi Arabia
King Saud Univeristy Recruiting
Riyadh, Saudi Arabia
Contact: Khalid Al-Habib, MD    966 1 288 9999    khalidalhabib13@hotmail.com   
Sudan
AlShaab Teaching Hospital Terminated
Khartoum, Sudan
Uganda
Mulago Hospital Recruiting
Kampala, Uganda
Contact: Charles Mondo, MD    256 772 462370    charles_mondo@yahoo.com.au   
United Arab Emirates
Sheikh Khalifa Medical City Recruiting
Abu Dhabi, United Arab Emirates
Contact: Wael Almahmeed, MD       wmahmeed@emirates.net.ae   
Zambia
University of Zambia School of Medicine Recruiting
Lusaka, Zambia
Contact: Fastone Goma, MD       gomafm@yahoo.co.uk   
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Mark Loeb, MD, MSc. McMaster University
More Information
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Publications:
Causes of death 2008, World Health Organization, Geneva, http://www.who.int/healthinfo/ global_burden_disease/ cod_2008_sources_methods.pdf.
Statistics Canada. Morality, Summary List of Causes 2008. Released October 18, 2011.
Tracking Heart Disease and Stroke in Canada. Released June 2009
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.
Canadian Communicable Disease Report 2012. Statement on seasonal influenza vaccine for 2012-2013; 38: 2012.
Population Health Research Institute http://www.phri.ca/
DataFax - Data Management Software for Clinical Trials. http://www.datafax.com/; accessed February 15, 2013.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02762851    
Other Study ID Numbers: RCT-IVVE 2015
First Posted: May 5, 2016    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:
Influenza
Vaccine
Heart failure
Vascular
Additional relevant MeSH terms:
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Influenza, Human
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs