Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study, the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104887 are eligible for participation in this study.
This study is a year 2 revaccination study. First year revaccination was done in study 104887 (NCT00386698). Primary study was study 104886 (NCT00318149). This study involves 2 age groups (based on primary study): Subjects enrolled in the ≥ 65 years age group in the primary study. Subjects enrolled in the 18-40 years age group in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
133
Single dose, Intramuscular injection
Single dose, Intramuscular injection
GSK Investigational Site
Ghent, Belgium
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. \>100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Time frame: Day 0-6
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
Time frame: Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-6
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Time frame: Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time frame: Day 0-20
Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)
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MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.
Time frame: Day 0-20
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result 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. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-20
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time frame: At Days 0 and 21
The Number of Subjects Seropositive to HI Antibodies
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e. ≥ 1:10. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time frame: At Days 0 and 21
The Number of Subjects Seroconverted to HI Antibodies
Seroconversion was defined as either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time frame: At Day 21
HI Antibody Seroconversion Factors (SCF)
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time frame: At Day 21
The Number of Subjects Seroprotected to HI Antibodies
Seroprotection was defined as serum HI titer ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time frame: At Days 0 and 21
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD40 Ligand (CD40L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Time frame: At Days 0 and 21
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were CD8-All doubles, CD40L, IFN-γ, IL-2 and TNF-α.
Time frame: At Days 0 and 21