Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over

Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.

Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.

A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.

Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.

A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.

Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm 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. Any for ecchymosis, redness and swelling was >20mm.

Duration was defined as number of days with any grade of local symptoms.

Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral 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 a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.

Duration was defined as number of days with any grade of general symptoms.

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 an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.

MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.

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 or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.