Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.

MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.

A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.

A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.

Titers are presented as geometric mean titers (GMTs).

A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.

Titers are presented as geometric mean titers (GMTs).

A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.

MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm).

Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.

Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.

Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.

MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.

MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.

pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.

Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.

Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.

Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.

Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.

Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.

A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in 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.