The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.
The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the candidate vaccine in healthy elderly persons. The candidate vaccine will be administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of H5N1 influenza antibodies will also be evaluated up to two years after vaccination (neutralizing antibodies will only be evaluated in a subset of subjects in the adjuvanted groups). Single and double dose of H5N1 vaccine non-adjuvanted vaccine will be used as comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
437
intramuscular injection
Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.
GSK Investigational Site
Dour, Belgium
GSK Investigational Site
Gozée, Belgium
GSK Investigational Site
Libramont, Belgium
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Days 0, 21 and 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Days 21 and 42
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Days 0, 21 and 42
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Time frame: At Days 0 and 42
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Days 21 and 42
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GSK Investigational Site
Mont-Godinne, Belgium
GSK Investigational Site
Sprimont, Belgium
GSK Investigational Site
Tessenderlo, Belgium
GSK Investigational Site
Watermael-Boitsfort, Belgium
GSK Investigational Site
Genoa, Liguria, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Monserrato Cagliari, Sardinia, Italy
...and 2 more locations
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Time frame: At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Day 180
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Month 12
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Month 24
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Day 180
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Month 12
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Month 24
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Day 180
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Month 24
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Day 180
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Month 12
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Time frame: At Month 24
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Time frame: At Day 180
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Time frame: At Month 12
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
Time frame: At Month 24
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Time frame: At Month 12
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Time frame: At Month 24
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
Time frame: At Day 180
Number of Subjects With Adverse Events of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Note: No AESIs were reported during the entire study period.
Time frame: During the entire study period (Day 0 to Month 24)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day follow-up period (Days 0 to 6) after any vaccination
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT, AST, BAS, CREA and CRPH.
Time frame: At Days 0, 2, 21 and 23
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: The study period was divided into 4 consecutive periods (Days 0-51, Days 52-180 \[Month 6\], Months 6-12 and Months 12-24), for which SAEs were collected.
Time frame: During the entire study period (Day 0 to Month 24).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents EOS, HEM, LDE, LYM and MON results.
Time frame: At Days 0, 2, 21 and 23.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand \[CD40L\], interleukin-2 \[IL-2\], tumor necrosis factor-alpha \[TNF-α\] or interferon-gamma \[IFN-γ\].
Time frame: At Month 12
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand \[CD40L\], interleukin-2 \[IL-2\], tumor necrosis factor-alpha \[TNF-α\] or interferon-gamma \[IFN-γ\].
Time frame: At Month 24
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (HEM), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents NEU, PLA, RBC, URE and WBC results.
Time frame: At Days 0, 2, 21 and 23.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand \[CD40L\], interleukin-2 \[IL-2\], interferon gamma \[INF-g\] and tumor necrosis factor-alpha \[TNF-α\].
Time frame: At Days 0, 21 and 42
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells
The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand \[CD40L\], interleukin-2 \[IL-2\], tumor necrosis factor-alpha \[TNF-α\] or interferon-gamma \[IFN-γ\].
Time frame: At Day 180
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day follow-up period (Days 0 to 6) after any vaccination