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

Sponsor

McMaster University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02762851

Collaborator

(none)

5,000

Enrollment

Locations

Arms

Duration (Months)

384.6

Patients Per Site

7.1

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. 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

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2020

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 prior to the influenza season.	Drug: inactivated trivalent influenza vaccine 0.5 ml dose injected intramuscularly Other Names: 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

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 Names:

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

Primary Outcome Measures

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.

Secondary Outcome Measures

Cardiovascular (CV) 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:

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

Locations

	Site	City	State	Country	Postal Code
1	Douala General Hospital	Douala		Cameroon
2	Fuwai Hospital	Beijing	Xicheng District	China	100037
3	Centre for Chronic Disease Control	New Delhi		India
4	Aga Khan University	Nairobi		Kenya
5	American University of Beirut Medical Center	Beirut		Lebanon
6	Maputo Central Hospital (Full Trial)	Maputo		Mozambique
7	Bayero University and Aminu Kano Teaching Hospital	Kano		Nigeria
8	University of Philippines	Manila	Emita	Philippines
9	King Saud Univeristy	Riyadh		Saudi Arabia
10	AlShaab Teaching Hospital	Khartoum		Sudan
11	Mulago Hospital	Kampala		Uganda
12	Sheikh Khalifa Medical City	Abu Dhabi		United Arab Emirates
13	University of Zambia School of Medicine	Lusaka		Zambia