Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

Heart Failure Clinical Trial

— IVVE:Pilot  

Official title:

A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945268
• Other study ID #: RCT IVVE Pilot
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Influenza, Human

Intervention

Drug:
• inactivated trivalent influenza vaccine
0.5 ml dose injected intramuscularly

Other:
• Sterile saline
0.5 ml dose injected intramuscularly

Locations

Country	Name	City	State
Mozambique	Maputo Central Hospital	Maputo
Philippines	University of Philippines	Manila	Emita
Uganda	Mulago Hospital	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Population Health Research Institute

Countries where clinical trial is conducted

Mozambique,  Philippines,  Uganda, 

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* Note: There are 64 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	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.	Six months
Secondary	Adverse cardiovascular event	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.	Six months
Secondary	Cardiovascular death	CV death alone will be a secondary outcome.	Six months

External Links

•   Mark Loeb Research Group-McMaster University