Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01945268
• Date of registration: 13/09/2013
• Prospective Registration: Yes
• Primary sponsor: McMaster University
• Public title: Influenza Vaccine To Prevent Adverse Vascular Events:Pilot IVVE:Pilot
• Scientific title: A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study
• Date of first enrolment: April 2015
• Target sample size: 107
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01945268
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Argentina, Brazil, Chile, China, Colombia, Egypt, India, Malaysia, Mozambique, Nigeria, Philippines, Qatar, Saudi Arabia, South Africa, Sudan, Uganda

Contacts

• Name: Mark Loeb, MD, MSc
• Affiliation: McMaster University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Drug: inactivated trivalent influenza vaccine

Other: Sterile saline

Primary Outcome(s)

Feasibility [Time Frame: Six months]

Secondary Outcome(s)

Cardiovascular death [Time Frame: Six months]

Adverse cardiovascular event [Time Frame: Six months]

Secondary ID(s)

RCT IVVE Pilot

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Population Health Research Institute