This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Intramuscular injection, one dose
GSK Investigational Site
Sherbrooke, Quebec, Canada
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.
The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
Time frame: At Day 0 before vaccination
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.
The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
Time frame: At Day 21 after vaccination
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.
A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
Time frame: At Day 0 before vaccination
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.
A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
Time frame: At Day 21 after vaccination
Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.
A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: At Day 21 after vaccination
Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).
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Time frame: At Day 21 after vaccination
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.
Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)
Time frame: During a 4-days (Day 0-3) follow-up period after vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination.
Time frame: Within the 21-day post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within the 21-day post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the entire study period