NCT00607217

The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

This study wishes to understand: 1. whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects; 2. whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.

Detailed description

Influenza infection may become complicated in patients with chronic conditions, including coronary artery disease (CAD) \[1\]. Influenza vaccination is now recommended as part of comprehensive secondary prevention in individuals with coronary and other atherosclerotic vascular disease (evidence level: Class I, Level B) \[2\]. Although there is controversial evidence pro \[3,4\] and against \[5\] the efficacy of influenza vaccination in protecting CAD population against cardiovascular events, the efficacy of vaccine in actual reduction in episodes of influenza infection and its fatal complications in CAD patients has not been, to our knowledge, well studied before. Furthermore, we found no report comparing serologic response to the influenza vaccine antigens between CAD patients and healthy controls. This study aims to identify the efficacy of influenza vaccination in CAD individuals in terms of both serologic response (as compared with healthy individuals) and clinical outcomes (as compared with CAD patients not vaccinated).

Conditions

• Coronary Artery Diseases
• Myocardial Infarction
• Stable Angina

Interventions

Type	Name	Description
BIOLOGICAL	influenza vaccine	Intramuscular injection of one 0.5-mL dose of influenza vaccine
BIOLOGICAL	placebo for influenza vaccine	Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
BIOLOGICAL	influenza vaccine	Intramuscular injection of one 0.5-mL dose of influenza vaccine

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-02-05
• Last updated: 2009-01-22

Locations

1 site across 1 country: Iran