This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
110
One intramuscular injection into the deltoid region of the non-dominant arm
GSK Investigational Site
Sherbrooke, Quebec, Canada
Hemagglutination Inhibition (HI) Antibody Titers
Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.
Time frame: At Day 0 and 21
Number of Seroconverted Subjects
Seroconversion, defined as a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.
Time frame: At Day 21
Number of Seroprotected Subjects
Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.
Time frame: At Day 0 and 21
Fold Increase From Baseline in Serum HI Antibody Titer
The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.
Time frame: At Day 21
Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.
Time frame: During the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Time frame: During the 21-day (Day 0-20) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: During the 21-day (Day 0-20) post-vaccination period