Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

NCT01945268 | Completed Phase 4

• 1 other identifier: RCT IVVE Pilot
• Study Type: interventional
• Target: 107
• Locations: 3 countries
• Sites: 3

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. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.

Conditions

Heart Failure

Keywords

vascular, influenza, vaccine, heart failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse cardiovascular event

  Six months

• Cardiovascular death

  Six months

Study Arms (2)

influenza vaccine

EXPERIMENTAL

Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine

Drug: inactivated trivalent influenza vaccine

placebo vaccination

PLACEBO COMPARATOR

Participants at high risk for adverse vascular events will be immunized with a 0.5 ml dose of sterile saline inactivated during the influenza season.

Other: Sterile saline

Interventions

inactivated trivalent influenza vaccine DRUG

0.5 ml dose injected intramuscularly

Also known as: VAXIGRIP vaccine

influenza vaccine

Sterile saline OTHER

0.5 ml dose injected intramuscularly

placebo vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and NYHA functional class II, III and IV

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Population Health Research Institute: collaborator

Study Sites (3)

Maputo Central Hospital

Maputo, Mozambique

Location

University of Philippines

Manila, Emita, Philippines

Location

Mulago Hospital

Kampala, Uganda

Location

Related Publications (64)

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  BACKGROUND

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MeSH Terms

Conditions

Heart Failure; Influenza, Human

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Mark Loeb, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); MO (1); PH (1)