Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE) (RCT-IVVE)
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| ClinicalTrials.gov Identifier: NCT02762851 |
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Recruitment Status :
Recruiting
First Posted : May 5, 2016
Last Update Posted : October 26, 2018
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Sponsor:
McMaster University
Information provided by (Responsible Party):
McMaster University
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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 |
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 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
Drug Information available for:
Influenza Vaccines
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: inactivated trivalent influenza vaccine
0.5 ml dose injected intramuscularly
Other Name: VAXIGRIP vaccine |
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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.
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Other: Sterile saline
0.5 ml dose injected intramuscularly |
Primary Outcome Measures :
- 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 :
- Cardiovascular (CV) 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 (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
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
| Contact: Mark Loeb, MD, MSc. | 905-525-9140 ext 26066 | loebm@mcmaster.ca |
Locations
| 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
| Principal Investigator: | Mark Loeb, MD, MSc. | McMaster University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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):
| 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:
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Influenza Vaccine Heart failure Vascular |
Additional relevant MeSH terms:
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Influenza, Human Heart Failure Heart Diseases Cardiovascular Diseases Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |