Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE) (RCT-IVVE)
![]() |
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: 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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure Influenza | Other: Sterile saline Drug: inactivated trivalent influenza vaccine | Phase 4 |
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 |

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 |
- 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.
- Cardiovascular (CV) death [ Time Frame: Six months ]CV death alone will be a secondary outcome.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Mark Loeb, MD, MSc. | 905-525-9140 ext 26066 | loebm@mcmaster.ca |
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 |
Principal Investigator: | Mark Loeb, MD, MSc. | McMaster University |
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 |
Influenza Vaccine Heart failure Vascular |
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 |