This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
118
single intramuscular dose on Day 0
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
Hemagglutination Inhibition (HI) Antibody Titer
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Time frame: Day 0 and Day 21
Number of Subjects With HI Antibody Titer Above the Cut-off Value
The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
Time frame: Day 0 and Day 21
Number of Seroprotected Subjects
A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
Time frame: Day 0 and Day 21
Number of Seroconverted Subjects
A seroconverted subject is a subject with 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 a fold increase (Day 21/Day 0) ≥ 4
Time frame: Day 21
Seroconversion Factor
Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
Time frame: Day 21
Seroprotection Power
Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40
Time frame: Day 21
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
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GSK Investigational Site
Freital, Saxony, Germany
Time frame: During the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, 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.
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 lifethreatening, 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 entire study period