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Clinical Trial Summary

The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.


Clinical Trial Description

Yearly influenza (flu) epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly. Injectable flu vaccines are generally believed to be effective, but formal studies using modern culture methods to prove this are limited. This study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults (a group at low risk for serious influenza complications) who have received Fluviral (an injectable flu vaccine) with the rate of such illnesses in healthy younger adults who have received an injection of saline (salt water). The rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups, and the immune responses to the vaccine measured. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


NCT number NCT00216242
Study type Interventional
Source ID Biomedical Corporation, Quebec
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 2005
Completion date May 2007

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