Influenza
Conditions
Keywords
H5N1, influenza, vaccine
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALPandemic influenza vaccine (GSK1562902A) (adjuvanted or not)
intramuscular injection
BIOLOGICALFluarix
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female aged 61 years or above at the time of the first vaccination. * Written informed consent obtained from the subject. * Healthy subjects or subjects with well controlled underlying disease.
Exclusion criteria
* Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season. * Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. * Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of chronic alcohol consumption and/or drug abuse. * History of hypersensitivity to vaccines. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy). * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Acute disease at the time of enrolment. * Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. * Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period. * Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | At Days 0, 21 and 42 | 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. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | At Days 21 and 42 | 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). |
| Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | At Days 0, 21 and 42 | 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). |
| Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | At Days 0 and 42 | 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. |
| Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | At Days 21 and 42 | 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). |
| Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | At Day 42 | 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. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | At Month 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events of Specific Interest (AESIs) | During the entire study period (Day 0 to Month 24) | 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. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 7-day follow-up period (Days 0 to 6) after any vaccination | 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. |
| Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | At Days 0, 2, 21 and 23 | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (Day 0 to Month 24). | 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. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | 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 | 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. |
| Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | At Month 12 | 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 \[IFN-γ\]. |
| Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | At Day 180 | 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 \[IFN-γ\]. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day follow-up period (Days 0 to 6) after any vaccination | 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. |
Countries
Belgium, Italy
Participant flow
Pre-assignment details
Subjects not previously vaccinated with an influenza vaccine for the 2006-2007 season were administered FluarixTM vaccine intramuscularly at least 3 weeks before administration of the first dose(s) of the GSK1562902A vaccine.
Participants by arm
| Arm | Count |
|---|---|
| GSK1562902A 1 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. | 165 |
| GSK1562902A 2 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. | 61 |
| GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm. | 159 |
| GSK1562902A 4 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm. | 52 |
| Total | 437 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Month 0 (Day 0) | Adverse Event | 0 | 1 | 0 | 0 |
| Month 0 (Day 0) | Other | 4 | 1 | 3 | 3 |
| Month 0 (Day 0) | Withdrawal by Subject | 3 | 3 | 3 | 1 |
| Month 6 (Day 180) | Adverse Event | 0 | 3 | 2 | 0 |
| Month 6 (Day 180) | Other | 2 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | GSK1562902A 1 Group | GSK1562902A 2 Group | GSK1562902A 3 Group | GSK1562902A 4 Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 69.7 Years STANDARD_DEVIATION 6.33 | 69.9 Years STANDARD_DEVIATION 6.38 | 69.7 Years STANDARD_DEVIATION 6.51 | 70.8 Years STANDARD_DEVIATION 7.35 | 70.0 Years STANDARD_DEVIATION 6.64 |
| Sex: Female, Male Female | 72 Participants | 28 Participants | 77 Participants | 23 Participants | 200 Participants |
| Sex: Female, Male Male | 93 Participants | 33 Participants | 82 Participants | 29 Participants | 237 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 165 | 2 / 61 | 3 / 159 | 0 / 52 |
| other Total, other adverse events | 69 / 164 | 8 / 61 | 75 / 159 | 6 / 51 |
| serious Total, serious adverse events | 19 / 165 | 11 / 61 | 16 / 159 | 5 / 52 |
Outcome results
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 391.0 Titer |
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005 | 75.4 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 382.8 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005 | 84.9 Titer |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 274.7 Titer |
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005 | 82.5 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 268.8 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005 | 119.8 Titer |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 218.2 Titer |
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005 | 97.8 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 260.9 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005 | 134.5 Titer |
Primary
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 0 | 121.1 Titer |
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 | 447.3 Titer |
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005, Day 0 | 44.2 Titer |
| GSK1562902A 1 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005, Day 42 | 107.5 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005, Day 42 | 169.6 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 0 | 112.5 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonesia/5/2005, Day 0 | 39.7 Titer |
| GSK1562902A 2 Group | Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 | 595.8 Titer |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 24 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 17 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 6 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 2 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 24 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 22 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 3 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 4 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 52 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 5 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 1 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 6 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 70 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 8 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 6 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 0 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 21 (N=152,54,145,44) | 69 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 (N=152,54,145,44) | 110 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 (N=152,54,145,44) | 5 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 (N=152,54,145,44) | 35 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 (N=152,54,145,44) | 12 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 (N=152,54,145,44) | 1 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 (N=152,54,145,44) | 2 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 21 (N=152,54,145,44) | 8 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 (N=152,54,145,44) | 13 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 (N=152,54,145,44) | 128 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 (N=152,54,145,44) | 58 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 21 (N=152,54,145,44) | 76 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 (N=152,54,145,44) | 2 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 (N=152,54,145,44) | 10 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 21 (N=152,54,145,44) | 8 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 (N=152,54,145,44) | 1 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 8 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 4 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 1 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 2 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 9 Subjects |
| GSK1562902A 3 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 4 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 2 Subjects |
| GSK1562902A 4 Group | Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 0 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 18 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Indonesia/5/2005 | 13 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 21 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Indonesia/5/2005 | 28 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Vitenam/1194/2004, Day 42 | 39 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Indonesia/5/2005, Day 42 | 25 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Vitenam/1194/2004, Day 42 | 46 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Indonesia/5/2005, Day 42 | 40 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 16 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Indonesia/5/2005 | 20 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 21 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Indonesia/5/2005 | 32 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 18 Subjects |
| GSK1562902A 1 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Indonesia/5/2005 | 6 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Vietnam/1194/2004 | 22 Subjects |
| GSK1562902A 2 Group | Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. | A/Indonesia/5/2005 | 16 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 0 | 0 Subjects |
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 21 | 5 Subjects |
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 21 | 93 Subjects |
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 0 | 28 Subjects |
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 42 | 35 Subjects |
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 42 | 127 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 42 | 19 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 21 | 1 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 0 | 7 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 21 | 15 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 0 | 0 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 42 | 2 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 42 | 139 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 0 | 23 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 21 | 90 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 0 | 0 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 21 | 13 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 42 | 59 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 42 | 2 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 21 | 1 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 21 | 15 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 0 | 2 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005, Day 0 | 0 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004, Day 42 | 17 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 74 Subjects |
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 5 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 13 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 91 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 8 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 9 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 0 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 49 Subjects |
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 17 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 2 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 11 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 45 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 22 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 7 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 3 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 32 Subjects |
| GSK1562902A 1 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 4 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1 Subjects |
| GSK1562902A 2 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 6 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 25 Subjects |
| GSK1562902A 3 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 5 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Vietnam/1194/2004 | 2 Subjects |
| GSK1562902A 4 Group | Number of Seroprotected Subjects Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 0 Subjects |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Vietnam/1994/2004 | 1.8 Fold |
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1.9 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1.3 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Vietnam/1994/2004 | 1.3 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Vietnam/1994/2004 | 2.5 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 2.6 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Vietnam/1994/2004 | 1.5 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1.4 Fold |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Vietnam/1994/2004 | 1.5 Fold |
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1.4 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1.1 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Vietnam/1994/2004 | 1.3 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Vietnam/1994/2004 | 1.9 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1.4 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Vietnam/1994/2004 | 1.4 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease | A/Indonezia/5/2005 | 1.0 Fold |
Primary
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004, Day 21 | 4.4 Fold |
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004, Day 42 | 11.2 Fold |
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 | 1.4 Fold |
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 | 2.7 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004, Day 42 | 2.3 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 | 1.0 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 | 1.2 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004, Day 21 | 1.7 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 | 1.7 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004, Day 42 | 23.2 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 | 4.8 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004, Day 21 | 6.8 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 | 1.3 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004, Day 42 | 2.9 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004, Day 21 | 2.4 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 | 1.1 Fold |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004 | 3.3 Fold |
| GSK1562902A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 1.3 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 1.1 Fold |
| GSK1562902A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004 | 1.6 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004 | 5.4 Fold |
| GSK1562902A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 1.7 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Vietnam/1994/2004 | 1.8 Fold |
| GSK1562902A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. | A/Indonezia/5/2005 | 1.0 Fold |
Primary
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 0 | 11.3 Titer |
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 21 | 50.0 Titer |
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 | 126.8 Titer |
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 0 | 5.1 Titer |
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 | 6.9 Titer |
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 | 13.7 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 | 6.1 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 0 | 5.2 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 0 | 9.7 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 | 22.7 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 21 | 16.8 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 | 5.3 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 21 | 69.4 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 | 237.3 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 0 | 5.1 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 | 24.4 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 | 8.6 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 0 | 10.2 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 21 | 5.6 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 42 | 6.3 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 21 | 20.8 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005, Day 0 | 5.0 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 0 | 8.8 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004, Day 42 | 25.3 Titer |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 38.5 Titers |
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 6.6 Titers |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 5.5 Titers |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 16.3 Titers |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 53.5 Titers |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 8.6 Titers |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 13.1 Titers |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 5.2 Titers |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 21.4 Titer |
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 9.8 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 6.6 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 13.3 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 26.5 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 13.1 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 11.4 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 6.9 Titer |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 17.6 Titer |
| GSK1562902A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 7.0 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 5.6 Titer |
| GSK1562902A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 12.3 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 18.4 Titer |
| GSK1562902A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 7.3 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Vietnam/1194/2004 | 9.8 Titer |
| GSK1562902A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. | A/Indonezia/5/2005 | 5.0 Titer |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4 All doubles [N=132,47,122,41] | 1247.34 Cells | Standard Deviation 1000.47 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-CD40L [N=132,47,122,41] | 1188.86 Cells | Standard Deviation 939.31 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-IL-2 [N=132,47,122,41] | 1172.16 Cells | Standard Deviation 957.55 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-INF-g [N=132,47,122,41] | 654.11 Cells | Standard Deviation 661.08 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-TNF-a [N=132,47,122,41] | 937.82 Cells | Standard Deviation 839.91 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8 All doubles [N=132,47,121,41] | 32.11 Cells | Standard Deviation 293.81 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-CD40L [N=132,47,121,41] | 2.04 Cells | Standard Deviation 26.32 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-IL-2 [N=132,47,121,41] | 18.78 Cells | Standard Deviation 178.46 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-INF-g [N=132,47,121,41] | 26.37 Cells | Standard Deviation 288.43 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-TNF-a [N=132,47,121,41] | 22.3 Cells | Standard Deviation 270.88 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-IL-2 [N=132,47,122,41] | 704.32 Cells | Standard Deviation 596.04 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-INF-g [N=132,47,121,41] | 28.27 Cells | Standard Deviation 365.36 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-INF-g [N=132,47,122,41] | 461.8 Cells | Standard Deviation 494.66 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-TNF-a [N=132,47,122,41] | 585.7 Cells | Standard Deviation 578.22 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8 All doubles [N=132,47,121,41] | 23.66 Cells | Standard Deviation 370.71 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-CD40L [N=132,47,121,41] | 1.93 Cells | Standard Deviation 31.43 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-TNF-a [N=132,47,121,41] | 20.94 Cells | Standard Deviation 289.74 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-IL-2 [N=132,47,121,41] | 18.86 Cells | Standard Deviation 269.95 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4 All doubles [N=132,47,122,41] | 760.03 Cells | Standard Deviation 637.84 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-CD40L [N=132,47,122,41] | 729.72 Cells | Standard Deviation 583.83 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-IL-2 [N=132,47,121,41] | 23.7 Cells | Standard Deviation 704.78 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-CD40L [N=132,47,121,41] | 2.47 Cells | Standard Deviation 499.31 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-TNF-a [N=132,47,121,41] | 36.68 Cells | Standard Deviation 390.84 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4 All doubles [N=132,47,122,41] | 1515.07 Cells | Standard Deviation 1982.71 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-INF-g [N=132,47,122,41] | 763.06 Cells | Standard Deviation 1243.6 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8 All doubles [N=132,47,121,41] | 41.28 Cells | Standard Deviation 753.94 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-INF-g [N=132,47,121,41] | 41.21 Cells | Standard Deviation 663.4 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-CD40L [N=132,47,122,41] | 1455.68 Cells | Standard Deviation 1789.27 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-TNF-a [N=132,47,122,41] | 1143.69 Cells | Standard Deviation 1444.11 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-IL-2 [N=132,47,122,41] | 1433.08 Cells | Standard Deviation 1921.82 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-TNF-a [N=132,47,122,41] | 636 Cells | Standard Deviation 713.19 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-IL-2 [N=132,47,121,41] | 18.95 Cells | Standard Deviation 465.37 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8 All doubles [N=132,47,121,41] | 36.77 Cells | Standard Deviation 685.05 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-TNF-a [N=132,47,121,41] | 40.55 Cells | Standard Deviation 588.74 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-CD40L [N=132,47,121,41] | 1.8 Cells | Standard Deviation 23.59 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-CD40L [N=132,47,122,41] | 808.25 Cells | Standard Deviation 678.83 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-IL-2 [N=132,47,122,41] | 774.93 Cells | Standard Deviation 742.9 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4-INF-g [N=132,47,122,41] | 558.99 Cells | Standard Deviation 654.35 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD4 All doubles [N=132,47,122,41] | 850.48 Cells | Standard Deviation 764.04 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells | CD8-INF-g [N=132,47,121,41] | 28.29 Cells | Standard Deviation 688.23 |
Secondary
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 0 [N=129,44,121,40] | 3.37 Cells | Standard Deviation 52.35 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 0 [N=129,44,121,40] | 83.30 Cells | Standard Deviation 407.94 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 21 [N=112,42,110,34] | 685.44 Cells | Standard Deviation 884.75 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 42 [N=120,43,118,29] | 55.71 Cells | Standard Deviation 506.29 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 42 [N=120,43,118,30] | 1595.64 Cells | Standard Deviation 1798.95 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 42 [N=120,43,118,30] | 1123.16 Cells | Standard Deviation 1356.18 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 21 [N=112,42,110,34] | 932.64 Cells | Standard Deviation 974.72 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 42 [N=120,43,118,29] | 77.73 Cells | Standard Deviation 499.25 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 42 [N=120,43,118,30] | 2086.84 Cells | Standard Deviation 2086.66 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 42 [N=120,43,118,30] | 2198.66 Cells | Standard Deviation 2165.46 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 42 [N=120,43,118,30] | 2260.19 Cells | Standard Deviation 2242.14 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 21 [N=111,41,109,34] | 55.42 Cells | Standard Deviation 306.06 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 0 [N=129,44,122,40] | 270.99 Cells | Standard Deviation 500.13 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 0 [N=129,44,122,40] | 388.69 Cells | Standard Deviation 571.91 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 21 [N=111,41,109,34] | 61.44 Cells | Standard Deviation 390.6 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 0 [N=129,44,122,40] | 393.71 Cells | Standard Deviation 590.66 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 0 [N=129,44,122,40] | 310.91 Cells | Standard Deviation 486.27 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 42 [N=120,43,118,29] | 59.51 Cells | Standard Deviation 434.37 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 21 [N=111,41,109,34] | 45.48 Cells | Standard Deviation 251.49 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 21 [N=111,41,109,34] | 3.9 Cells | Standard Deviation 52.29 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 21 [N=112,42,110,34] | 1407.29 Cells | Standard Deviation 1354.44 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 42 [N=120,43,118,29] | 42.77 Cells | Standard Deviation 261.13 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 21 [N=111,41,109,34] | 70.23 Cells | Standard Deviation 391.63 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 0 [N=129,44,121,40] | 63.19 Cells | Standard Deviation 355.75 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 21 [N=112,42,110,34] | 1374.26 Cells | Standard Deviation 1304.02 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 42 [N=120,43,118,29] | 5.32 Cells | Standard Deviation 100.78 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 0 [N=129,44,121,40] | 83.14 Cells | Standard Deviation 394.32 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 0 [N=129,44,121,40] | 53.90 Cells | Standard Deviation 241.03 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 21 [N=112,42,110,34] | 1318.03 Cells | Standard Deviation 1250.79 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 0 [N=129,44,122,40] | 376.03 Cells | Standard Deviation 545.75 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 21 [N=111,41,109,34] | 57.71 Cells | Standard Deviation 422.85 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 0 [N=129,44,122,40] | 494.27 Cells | Standard Deviation 518.93 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 0 [N=129,44,122,40] | 461.29 Cells | Standard Deviation 513.7 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 0 [N=129,44,122,40] | 448.43 Cells | Standard Deviation 500.03 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 0 [N=129,44,122,40] | 322.17 Cells | Standard Deviation 349.01 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 0 [N=129,44,122,40] | 369.54 Cells | Standard Deviation 427.12 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 21 [N=112,42,110,34] | 943.54 Cells | Standard Deviation 1034.54 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 21 [N=112,42,110,34] | 944.17 Cells | Standard Deviation 1015.89 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 21 [N=112,42,110,34] | 868.24 Cells | Standard Deviation 967.47 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 21 [N=112,42,110,34] | 579.45 Cells | Standard Deviation 828.17 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 21 [N=112,42,110,34] | 708.15 Cells | Standard Deviation 915.15 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 42 [N=120,43,118,30] | 920.9 Cells | Standard Deviation 745.36 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 42 [N=120,43,118,30] | 944.59 Cells | Standard Deviation 728.39 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 42 [N=120,43,118,30] | 854.9 Cells | Standard Deviation 727.62 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 42 [N=120,43,118,30] | 671.86 Cells | Standard Deviation 552.02 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 42 [N=120,43,118,30] | 701.35 Cells | Standard Deviation 691.26 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 0 [N=129,44,121,40] | 52.25 Cells | Standard Deviation 497.68 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 0 [N=129,44,121,40] | 2.94 Cells | Standard Deviation 34.07 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 0 [N=129,44,121,40] | 43.45 Cells | Standard Deviation 334.22 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 0 [N=129,44,121,40] | 44.71 Cells | Standard Deviation 489.55 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 0 [N=129,44,121,40] | 36.83 Cells | Standard Deviation 414.08 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 21 [N=111,41,109,34] | 80.16 Cells | Standard Deviation 643.85 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 21 [N=111,41,109,34] | 3.45 Cells | Standard Deviation 30.93 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 21 [N=111,41,109,34] | 62.56 Cells | Standard Deviation 629.74 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 21 [N=111,41,109,34] | 75.79 Cells | Standard Deviation 579.85 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 42 [N=120,43,118,29] | 63.45 Cells | Standard Deviation 462.64 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 42 [N=120,43,118,29] | 3.51 Cells | Standard Deviation 24.09 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 42 [N=120,43,118,29] | 40.01 Cells | Standard Deviation 296.52 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 42 [N=120,43,118,29] | 64.19 Cells | Standard Deviation 434.7 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 42 [N=120,43,118,29] | 40.62 Cells | Standard Deviation 375.13 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 21 [N=111,41,109,34] | 45.97 Cells | Standard Deviation 342.71 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 21 [N=112,42,110,34] | 1651.88 Cells | Standard Deviation 1776.72 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 0 [N=129,44,122,40] | 343.35 Cells | Standard Deviation 549.24 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 42 [N=120,43,118,29] | 59.1 Cells | Standard Deviation 689.32 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 21 [N=111,41,109,34] | 55.07 Cells | Standard Deviation 661.84 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 42 [N=120,43,118,29] | 50.37 Cells | Standard Deviation 413.85 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 0 [N=129,44,121,40] | 45.34 Cells | Standard Deviation 573.91 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 42 [N=120,43,118,29] | 63.71 Cells | Standard Deviation 767.88 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 21 [N=111,41,109,34] | 63.94 Cells | Standard Deviation 609.54 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 0 [N=129,44,122,40] | 485.71 Cells | Standard Deviation 594.88 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 0 [N=129,44,122,40] | 461.23 Cells | Standard Deviation 552.91 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 21 [N=112,42,110,34] | 1793.92 Cells | Standard Deviation 1867.92 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 42 [N=120,43,118,30] | 3049.03 Cells | Standard Deviation 4208.17 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 0 [N=129,44,121,40] | 59.70 Cells | Standard Deviation 340.6 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 21 [N=111,41,109,34] | 77.7 Cells | Standard Deviation 661.43 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 42 [N=120,43,118,29] | 79.56 Cells | Standard Deviation 765.47 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 42 [N=120,43,118,30] | 2971.34 Cells | Standard Deviation 4076.52 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 0 [N=129,44,121,40] | 71.93 Cells | Standard Deviation 626.44 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 21 [N=112,42,110,34] | 1207.95 Cells | Standard Deviation 1527.86 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 21 [N=112,42,110,34] | 1731.58 Cells | Standard Deviation 1828.74 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 42 [N=120,43,118,30] | 2762.65 Cells | Standard Deviation 3720.42 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 0 [N=129,44,121,40] | 3.58 Cells | Standard Deviation 48.88 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 21 [N=111,41,109,34] | 5.61 Cells | Standard Deviation 34.07 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 0 [N=129,44,121,40] | 80.54 Cells | Standard Deviation 618.55 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 42 [N=120,43,118,30] | 1535.37 Cells | Standard Deviation 2864.48 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 0 [N=129,44,122,40] | 358.27 Cells | Standard Deviation 538.07 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 21 [N=112,42,110,34] | 997.15 Cells | Standard Deviation 1023.96 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 0 [N=129,44,122,40] | 495.77 Cells | Standard Deviation 606.84 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 42 [N=120,43,118,30] | 2170.46 Cells | Standard Deviation 3380.48 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 42 [N=120,43,118,29] | 5.23 Cells | Standard Deviation 51.86 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 42 [N=120,43,118,30] | 918.5 Cells | Standard Deviation 822.2 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 0 [N=129,44,121,40] | 94.74 Cells | Standard Deviation 1903.91 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 42 [N=120,43,118,29] | 3.41 Cells | Standard Deviation 253.17 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 0 [N=129,44,121,40] | 4.30 Cells | Standard Deviation 322.83 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 21 [N=112,42,110,34] | 1230.48 Cells | Standard Deviation 989.52 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 0 [N=129,44,121,40] | 56.29 Cells | Standard Deviation 1426.27 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 42 [N=120,43,118,29] | 72.24 Cells | Standard Deviation 2394.5 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 0 [N=129,44,121,40] | 98.30 Cells | Standard Deviation 1888.61 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 21 [N=112,42,110,34] | 1284.19 Cells | Standard Deviation 1058.55 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 0 [N=129,44,121,40] | 82.77 Cells | Standard Deviation 1532.47 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 42 [N=120,43,118,29] | 97.06 Cells | Standard Deviation 1832.58 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 21 [N=111,41,109,34] | 115.83 Cells | Standard Deviation 1790.72 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 0 [N=129,44,122,40] | 382.79 Cells | Standard Deviation 641.28 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 0 [N=129,44,122,40] | 545.37 Cells | Standard Deviation 820.3 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L, Day 21 [N=111,41,109,34] | 4.86 Cells | Standard Deviation 162.75 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 0 [N=129,44,122,40] | 371.67 Cells | Standard Deviation 695.33 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2, Day 21 [N=111,41,109,34] | 77.59 Cells | Standard Deviation 1217.04 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 21 [N=111,41,109,34] | 95.39 Cells | Standard Deviation 1777.86 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 0 [N=129,44,122,40] | 510.47 Cells | Standard Deviation 700.7 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a, Day 21 [N=111,41,109,34] | 82.29 Cells | Standard Deviation 1468.85 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g, Day 42 [N=120,43,118,29] | 119.73 Cells | Standard Deviation 2845.99 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles, Day 42 [N=120,43,118,30] | 1316.8 Cells | Standard Deviation 1060.97 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a, Day 21 [N=112,42,110,34] | 910.69 Cells | Standard Deviation 861.04 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 42 [N=120,43,118,30] | 1254.99 Cells | Standard Deviation 974.2 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles, Day 42 [N=120,43,118,29] | 141.31 Cells | Standard Deviation 2816.12 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 42 [N=120,43,118,30] | 1242.26 Cells | Standard Deviation 976.18 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 21 [N=112,42,110,34] | 852.75 Cells | Standard Deviation 823.22 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L, Day 0 [N=129,44,122,40] | 540.73 Cells | Standard Deviation 771.32 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g, Day 42 [N=120,43,118,30] | 828.99 Cells | Standard Deviation 732.58 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2, Day 21 [N=112,42,110,34] | 1178.95 Cells | Standard Deviation 1001.08 |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles [N=73,34,72,22] | 779.93 Cells | Standard Deviation 771.46 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L [N=73,34,72,22] | 710.53 Cells | Standard Deviation 712.25 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2 [N=73,34,72,22] | 769.56 Cells | Standard Deviation 718.28 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g [N=73,34,72,22] | 455.05 Cells | Standard Deviation 608.16 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a [N=73,34,72,22] | 500.82 Cells | Standard Deviation 555.63 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles [N=73,33,72,22] | 8.05 Cells | Standard Deviation 94.19 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L [N=73,33,72,22] | 1.94 Cells | Standard Deviation 29.28 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2 [N=73,33,72,22] | 5.04 Cells | Standard Deviation 65.04 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g [N=73,33,72,22] | 7.43 Cells | Standard Deviation 93.13 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a [N=73,33,72,22] | 4.76 Cells | Standard Deviation 65.03 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2 [N=73,34,72,22] | 509.21 Cells | Standard Deviation 1039.78 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g [N=73,33,72,22] | 9.05 Cells | Standard Deviation 79.82 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g [N=73,34,72,22] | 391.45 Cells | Standard Deviation 923.81 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a [N=73,34,72,22] | 374.53 Cells | Standard Deviation 962.01 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles [N=73,33,72,22] | 8.06 Cells | Standard Deviation 60.49 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L [N=73,33,72,22] | 2.65 Cells | Standard Deviation 33.03 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a [N=73,33,72,22] | 4.05 Cells | Standard Deviation 51.49 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2 [N=73,33,72,22] | 4.16 Cells | Standard Deviation 69.59 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles [N=73,34,72,22] | 569.84 Cells | Standard Deviation 1058.95 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L [N=73,34,72,22] | 454.56 Cells | Standard Deviation 1060.83 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2 [N=73,33,72,22] | 8.16 Cells | Standard Deviation 181.28 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L [N=73,33,72,22] | 2.58 Cells | Standard Deviation 32.7 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a [N=73,33,72,22] | 17.22 Cells | Standard Deviation 231.77 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles [N=73,34,72,22] | 1126.86 Cells | Standard Deviation 1375.31 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g [N=73,34,72,22] | 651.02 Cells | Standard Deviation 947.13 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles [N=73,33,72,22] | 21.67 Cells | Standard Deviation 258.83 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g [N=73,33,72,22] | 23.39 Cells | Standard Deviation 257.7 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L [N=73,34,72,22] | 1041.16 Cells | Standard Deviation 1356.01 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a [N=73,34,72,22] | 806.94 Cells | Standard Deviation 1012.4 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2 [N=73,34,72,22] | 1043.95 Cells | Standard Deviation 1333.41 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a [N=73,34,72,22] | 598.88 Cells | Standard Deviation 860.46 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2 [N=73,33,72,22] | 6.51 Cells | Standard Deviation 310.91 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles [N=73,33,72,22] | 14.92 Cells | Standard Deviation 381.27 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a [N=73,33,72,22] | 15.3 Cells | Standard Deviation 325.83 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L [N=73,33,72,22] | 1.48 Cells | Standard Deviation 18.2 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L [N=73,34,72,22] | 740.77 Cells | Standard Deviation 820.93 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2 [N=73,34,72,22] | 783.88 Cells | Standard Deviation 868.28 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g [N=73,34,72,22] | 563.18 Cells | Standard Deviation 849.25 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles [N=73,34,72,22] | 832.74 Cells | Standard Deviation 908.25 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g [N=73,33,72,22] | 12.47 Cells | Standard Deviation 382.05 |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles | 898.52 Cells | Standard Deviation 1050.39 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L | 934.35 Cells | Standard Deviation 1020.83 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2 | 902.69 Cells | Standard Deviation 1006.77 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g | 442.66 Cells | Standard Deviation 743.99 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a | 678.6 Cells | Standard Deviation 870.28 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles | 34.28 Cells | Standard Deviation 275.22 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L | 2.08 Cells | Standard Deviation 28.46 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2 | 18.84 Cells | Standard Deviation 167.58 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g | 29.13 Cells | Standard Deviation 271.12 |
| GSK1562902A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a | 35.67 Cells | Standard Deviation 251.66 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2 | 623.44 Cells | Standard Deviation 623.44 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g | 24.45 Cells | Standard Deviation 285.49 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g | 442.16 Cells | Standard Deviation 419.92 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a | 515.7 Cells | Standard Deviation 484.61 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles | 29.42 Cells | Standard Deviation 283.23 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L | 2.22 Cells | Standard Deviation 20.24 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a | 32.59 Cells | Standard Deviation 230.03 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2 | 24.72 Cells | Standard Deviation 153.94 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles | 693.48 Cells | Standard Deviation 668.33 |
| GSK1562902A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L | 675.52 Cells | Standard Deviation 655.85 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2 | 19.95 Cells | Standard Deviation 164.36 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L | 2.99 Cells | Standard Deviation 28.9 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a | 28.15 Cells | Standard Deviation 246.49 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles | 1170.36 Cells | Standard Deviation 1021.43 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g | 586.6 Cells | Standard Deviation 577.71 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles | 27.88 Cells | Standard Deviation 261.68 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g | 20.75 Cells | Standard Deviation 260.19 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L | 1146.47 Cells | Standard Deviation 1002.22 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a | 884.64 Cells | Standard Deviation 847.51 |
| GSK1562902A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2 | 1118.63 Cells | Standard Deviation 973.32 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-TNF-a | 647.75 Cells | Standard Deviation 528.32 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-IL-2 | 28.85 Cells | Standard Deviation 598.65 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8 All doubles | 34.21 Cells | Standard Deviation 838.37 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-TNF-a | 31.35 Cells | Standard Deviation 595.41 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-CD40L | 2.48 Cells | Standard Deviation 31.11 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-CD40L | 850.8 Cells | Standard Deviation 612.75 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-IL-2 | 798.58 Cells | Standard Deviation 598.14 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4-INF-g | 542.62 Cells | Standard Deviation 471.58 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD4 All doubles | 869.43 Cells | Standard Deviation 632.5 |
| GSK1562902A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. | CD8-INF-g | 32.99 Cells | Standard Deviation 829.25 |
Secondary
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.
Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Below (N=163,61,158,52) | 148 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Above (N=163,57,155,52) | 9 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Normal (N=163,57,155,52) | 133 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Above (N=163,57,156,52) | 72 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Above(N=163,57,155,52) | 6 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Below (N=163,57,155,52) | 33 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Normal (N=163,57,156,52) | 91 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Normal (N=163,57,155,52) | 127 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Above (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Below (N=163,57,155,51) | 148 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Normal (N=165,61,159,52) | 90 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Below (N=163,57,155,52) | 24 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Above (N=164,61,158,52) | 67 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Above (N=165,61,159,52) | 75 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Below (N=164,61,158,52) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Normal (N=163,57,155,52) | 150 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Normal (N=164,61,158,52) | 96 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Normal (N=163,57,155,51) | 14 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Above (N=163,57,155,51) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Below (N=165,61,158,52) | 149 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Below (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Below (N=163,61,159,52) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Normal (N=163,61,159,52) | 145 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Normal (N=163,61,158,52) | 13 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Above (N=165,61,158,52) | 9 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Above (N=163,61,159,52) | 14 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Normal (N=163,57,155,52) | 145 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Below (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Normal (N=165,61,158,52) | 13 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Normal (N=165,61,158,52) | 152 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Normal (N=165,61,158,52) | 152 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Above (N=165,61,158,52) | 11 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Below (N=165,61,158,52) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Below (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Normal (N=163,57,155,52) | 147 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Above (N=165,61,158,52) | 3 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Above (N=163,61,159,52) | 6 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Above (N=163,57,155,52) | 13 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Below (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Normal (N=163,61,159,52) | 152 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Normal (N=163,57,155,52) | 150 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Below (N=163,57,155,52) | 6 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Above (N=163,57,155,52) | 11 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Below (N=163,57,155,52) | 147 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Below (N=163,61,159,52) | 5 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Below (N=163,61,159,52) | 21 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Normal (N=163,61,159,52) | 132 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Above (N=163,57,155,52) | 12 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Above (N=163,57,155,52) | 58 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Above (N=163,61,159,52) | 10 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Below (N=165,61,158,52) | 25 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Normal (N=163,57,155,52) | 14 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Normal (N=163,57,155,52) | 105 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Normal (N=165,61,158,52) | 134 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Above (N=165,61,158,52) | 6 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Above (N=163,61,158,52) | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Above (N=165,61,158,52) | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Below (N=163,57,155,52) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Below (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Above (N=163,57,156,52) | 27 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Below (N=163,61,159,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Normal (N=163,57,155,52) | 47 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Above (N=163,61,159,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Normal (N=165,61,158,52) | 51 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Above(N=163,57,155,52) | 4 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Above (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Normal (N=163,57,156,52) | 30 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Normal (N=165,61,158,52) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Below (N=163,57,155,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Above (N=163,61,158,52) | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Below (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Normal (N=163,57,155,52) | 47 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Normal (N=163,57,155,52) | 53 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Above (N=165,61,158,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Normal (N=163,61,158,52) | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Normal (N=163,57,155,52) | 36 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Normal (N=165,61,158,52) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Below (N=163,57,155,51) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Above (N=164,61,158,52) | 23 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Below (N=163,57,155,52) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Normal (N=165,61,159,52) | 36 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Below (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Above (N=163,61,159,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Below (N=163,61,159,52) | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Above (N=165,61,159,52) | 25 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Above (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Normal (N=164,61,158,52) | 38 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Normal (N=163,57,155,52) | 49 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Below (N=164,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Below (N=163,57,155,52) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Above (N=163,57,155,52) | 21 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Below (N=165,61,158,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Normal (N=163,57,155,51) | 4 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Normal (N=163,57,155,52) | 49 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Below (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Above (N=163,57,155,51) | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Normal (N=163,61,159,52) | 56 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Normal (N=163,61,159,52) | 54 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Below (N=163,61,159,52) | 4 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Below (N=165,61,158,52) | 55 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Above (N=165,61,158,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Below (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Normal (N=163,61,159,52) | 51 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Below (N=163,61,158,52) | 55 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Normal (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Above (N=163,61,159,52) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Normal (N=163,57,155,52) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Normal (N=165,61,158,52) | 56 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Normal (N=165,61,159,52) | 101 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Below (N=163,61,158,52) | 141 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Normal (N=163,61,158,52) | 17 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Above (N=163,61,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Below (N=165,61,158,52) | 141 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Normal (N=165,61,158,52) | 17 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Below (N=163,57,155,52) | 138 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Normal (N=163,57,155,52) | 15 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Below (N=163,57,155,51) | 138 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Normal (N=163,57,155,51) | 17 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Below (N=163,61,159,52) | 3 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Normal (N=163,61,159,52) | 148 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Above (N=163,61,159,52) | 8 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Below (N=165,61,158,52) | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Normal (N=165,61,158,52) | 147 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Above (N=165,61,158,52) | 7 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Below (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Normal (N=163,57,155,52) | 145 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Above (N=163,57,155,52) | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Below (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Normal (N=163,57,155,52) | 147 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Above (N=163,57,155,52) | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Below (N=163,61,159,52) | 21 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Normal (N=163,61,159,52) | 125 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Above (N=163,61,159,52) | 13 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Below (N=165,61,158,52) | 20 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Normal (N=165,61,158,52) | 133 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Above (N=165,61,158,52) | 5 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Below (N=163,57,155,52) | 20 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Normal (N=163,57,155,52) | 127 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Above(N=163,57,155,52) | 8 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Below (N=163,57,155,52) | 19 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Normal (N=163,57,155,52) | 134 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Below (N=165,61,159,52) | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Above (N=165,61,159,52) | 54 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Below (N=164,61,158,52) | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Normal (N=164,61,158,52) | 114 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Above (N=164,61,158,52) | 40 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Below (N=163,57,156,52) | 3 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Normal (N=163,57,156,52) | 100 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Above (N=163,57,156,52) | 53 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Below (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Normal (N=163,57,155,52) | 106 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Above (N=163,57,155,52) | 47 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Below (N=163,61,159,52) | 3 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Normal (N=163,61,159,52) | 155 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Above (N=163,61,159,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Below (N=165,61,158,52) | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Normal (N=165,61,158,52) | 152 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Above (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Below (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Normal (N=163,57,155,52) | 149 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Above (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Below (N=163,57,155,52) | 7 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Normal (N=163,57,155,52) | 148 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Above (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Normal (N=165,61,158,52) | 43 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Below (N=163,57,155,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 2), Below (N=165,61,158,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Above (N=163,61,159,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Normal (N=163,61,158,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Normal (N=163,57,155,52) | 36 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Normal (N=163,61,159,52) | 42 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, PRE (Day 0), Below (N=163,61,159,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 23), Above (N=163,57,155,52) | 16 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Above (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Normal (N=163,57,155,52) | 48 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Above (N=165,61,158,52) | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Below (N=163,61,159,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Above (N=163,57,155,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Normal (N=165,61,158,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Normal (N=163,61,159,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Normal (N=163,57,155,52) | 46 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 21), Below (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Below (N=163,61,158,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, PRE (Day 0), Above (N=163,61,159,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Above (N=165,61,158,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Normal (N=165,61,158,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Below (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Below (N=165,61,158,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, POST (Day 2), Below (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Above (N=163,61,159,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 2), Below (N=165,61,158,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Normal (N=165,61,158,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Normal (N=163,61,159,52) | 46 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | PLA, PRE (Day 0), Below (N=163,61,159,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, PRE (Day 0), Above (N=163,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 2), Above (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Normal (N=163,57,155,51) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Below (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Below (N=164,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Above (N=165,61,159,52) | 18 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 23), Below (N=163,57,155,51) | 46 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Normal (N=164,61,158,52) | 32 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Normal (N=165,61,159,52) | 34 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Above (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 2), Above (N=164,61,158,52) | 20 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Above (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Normal (N=163,57,155,52) | 43 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 23), Normal (N=163,57,155,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day23), Below (N=163,57,155,52) | 8 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Above(N=163,57,155,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | WBC, POST (Day 21), Normal (N=163,57,155,52) | 49 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Normal (N=163,57,156,52) | 32 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Normal (N=163,57,155,52) | 42 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | RBC, POST (Day 21), Below (N=163,57,155,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | NEU, POST (Day 21), Normal (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | URE, POST (Day 21), Above (N=163,57,156,52) | 20 Subjects |
Secondary
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Above (N=163,57,156,52) | 10 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Below (N=163,57,155,51) | 163 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Below (N=163, 57,155,51) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Above (N=163,57,156,52) | 9 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day2), Normal (N=165,61,158,52) | 152 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Normal (N=163,57,155,52) | 163 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Above (N=163,57,156,52) | 22 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Above (N=165,61,158,52) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Normal (N=163,57,155,52) | 153 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Normal (N=163,57,156,52) | 140 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Normal (N=165,61,158,52) | 164 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Above (N=163,57,155,52) | 10 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Normal (N=163,61,159,52) | 163 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Below (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Above (N=165,61,159.52) | 13 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Below (N=163,57,156,52) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Above (N=165,61,158,52) | 15 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 23), Normal (N=163,57,155,52) | 152 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Normal (N=165,61,159,52) | 152 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Normal (N=165,61,158,52) | 150 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 23), Above (N=163,57,155,52) | 11 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Above (N=165,60,158,52) | 16 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Normal (N=165,60,158,52) | 149 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Below (N=165,60,158,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Above (N=163,57,155,52) | 20 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Normal (N=165,61,159,52) | 154 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Normal (N=163,57,155,52) | 142 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Below (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Above (N=165,61,159,52) | 11 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Above (N=163,57,155,52) | 17 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Above (N=163,57,156,52) | 29 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Normal (N=163,57,156,52) | 134 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Normal (N=163,57,156,52) | 153 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Above (N=165,61,158,51) | 20 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Normal (N=165,61,158,52) | 154 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 2), Above (N=165,61,158,52) | 13 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Normal (N=165,61,158,51) | 144 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Below (N=165,61,158,51) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Above (N=165,61,158,52) | 11 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Normal (N=163,57,155,52) | 146 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Above (N=165,61,159,52) | 21 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Normal (N=165,61,159,52) | 144 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Normal (N=163,57,156,52) | 154 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day2), Normal (N=165,61,158,52) | 59 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 2), Above (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Normal (N=163,57,156,52) | 54 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Above (N=163,57,156,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 23), Normal (N=163,57,155,52) | 55 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 23), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Normal (N=165,61,159,52) | 57 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Above (N=165,61,159,52) | 4 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Normal (N=165,61,158,52) | 59 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Above (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Normal (N=163,57,156,52) | 51 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Above (N=163,57,156,52) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Normal (N=163,57,155,52) | 54 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Above (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Below (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Normal (N=163,61,159,52) | 61 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Normal (N=165,61,158,52) | 61 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Normal (N=163,57,155,52) | 57 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Below (N=163, 57,155,51) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Below (N=163,57,155,51) | 57 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Below (N=165,61,159,52) | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Normal (N=165,61,159,52) | 54 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Above (N=165,61,159,52) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Below (N=165,61,158,51) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Normal (N=165,61,158,51) | 55 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Above (N=165,61,158,51) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Normal (N=163,57,156,52) | 51 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Above (N=163,57,156,52) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Normal (N=163,57,155,52) | 49 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Above (N=163,57,155,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Below (N=165,60,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Normal (N=165,60,158,52) | 45 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Above (N=165,60,158,52) | 15 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Normal (N=165,61,158,52) | 49 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Above (N=165,61,158,52) | 12 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Normal (N=163,57,156,52) | 45 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Above (N=163,57,156,52) | 12 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Normal (N=163,57,155,52) | 49 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Above (N=163,57,155,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Normal (N=165,61,159,52) | 58 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Above (N=165,61,159.52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Below (N=163,57,155,51) | 155 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Above (N=165,61,159.52) | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Normal (N=165,61,159,52) | 148 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Above (N=165,61,158,52) | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Above (N=165,61,159,52) | 11 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Normal (N=163,57,156,52) | 144 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Below (N=165,61,158,51) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Normal (N=165,61,158,52) | 152 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Normal (N=165,61,158,51) | 146 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Normal (N=163,57,155,52) | 136 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Above (N=165,61,158,51) | 11 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Below (N=163,57,156,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Normal (N=163,57,156,52) | 142 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Above (N=165,61,159,52) | 9 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Above (N=163,57,156,52) | 13 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Above (N=163,57,155,52) | 19 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Below (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Normal (N=165,61,159,52) | 150 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Normal (N=163,57,155,52) | 139 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Below (N=163,57,156,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Above (N=163,57,155,52) | 15 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day2), Normal (N=165,61,158,52) | 151 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Below (N=165,60,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Below (N=165,61,159,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Normal (N=165,60,158,52) | 136 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 23), Above (N=163,57,155,52) | 8 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Above (N=165,60,158,52) | 22 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Below (N=165,61,158,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 23), Normal (N=163,57,155,52) | 146 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day2), Below (N=165,61,158,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Normal (N=165,61,158,52) | 141 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Normal (N=165,61,159,52) | 152 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Above (N=165,61,158,52) | 16 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day23), Below (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Below (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Normal (N=163,61,159,52) | 159 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Above (N=163,57,155,52) | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Normal (N=163,57,155,52) | 149 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 2), Above (N=165,61,158,52) | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Normal (N=165,61,158,52) | 158 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Normal (N=163,57,156,52) | 130 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Above (N=163,57,156,52) | 11 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Normal (N=163,57,155,52) | 155 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Above (N=163,57,156,52) | 10 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Above (N=163,57,156,52) | 26 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Below (N=163, 57,155,51) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Normal (N=163,57,156,52) | 146 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Normal (N=163,57,155,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Below (N=163,57,155,51) | 51 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Normal (N=163,57,156,52) | 48 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Normal (N=165,60,158,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Above (N=163,57,156,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Above (N=165,61,158,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Above (N=165,60,158,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 23), Normal (N=163,57,155,52) | 49 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Normal (N=165,61,159,52) | 43 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 2), Above (N=165,61,158,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, PRE (Day 0), Above (N=165,61,159,52) | 9 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Normal (N=165,61,158,52) | 49 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Below (N=165,61,158,51) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Above (N=163,57,156,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Above (N=165,61,159.52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 23), Below (N=163, 57,155,51) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Normal (N=165,61,158,51) | 42 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Normal (N=165,61,158,52) | 44 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 2), Above (N=165,61,158,51) | 9 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Normal (N=165,61,158,52) | 52 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Normal (N=163,57,155,52) | 44 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Above (N=165,61,159,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 2), Above (N=165,61,158,52) | 8 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Normal (N=163,57,156,52) | 42 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day2), Normal (N=165,61,158,52) | 48 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, PRE (Day 0), Normal (N=165,61,159,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 21), Above (N=163,57,156,52) | 10 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Normal (N=165,61,159,52) | 48 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 21), Normal (N=163,57,155,52) | 52 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Below (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 23), Above (N=163,57,155,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 23), Above (N=163,57,155,52) | 8 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Normal (N=163,57,155,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, PRE (Day 0), Below (N=165,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | AST, POST (Day 21), Normal (N=163,57,156,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | BAS, PRE (Day 0), Normal (N=163,61,159,52) | 52 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CREA, POST (Day 23), Above (N=163,57,155,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Normal (N=163,57,156,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Below (N=163,57,156,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, POST (Day 21), Above (N=163,57,156,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | CRPH, PRE (Day 0), Below (N=165,60,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | ALT, POST (Day 23), Above (N=163,57,155,52) | 3 Subjects |
Secondary
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.
Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Below (N=162,57,156,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Normal (N=162,57,156,52) | 151 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Above (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Above (N=162,57,156,52) | 11 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Below (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Normal (N=163,57,155,52) | 19 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Normal (N=163,57,155,52) | 147 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Above (N=163,57,155,52) | 12 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Below (N=163,57,155,51) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Below (N=163,57,155,52) | 144 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Below (N=163,61,159,52) | 145 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Normal (N=163,61,159,52) | 18 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Below (N=163,61,159,52) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Below (N=165,61,158,52) | 148 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Normal (N=163,57,155,52) | 23 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Normal (N=165,61,158,52) | 17 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Normal (N=163,57,155,51) | 159 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Below (N=165,61,158,52) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Below (N=163,57,155,52) | 140 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Below (N=163,61,159,52) | 11 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Normal (N=163,61,159,52) | 137 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Above (N=165,61,158,52) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Above (N=163,61,159,52) | 15 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Normal (N=163,57,155,51) | 19 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Below (N=165,61,158,52) | 21 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Normal (N=165,61,158,52) | 161 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Normal (N=165,61,158,52) | 21 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Normal (N=165,61,158,52) | 139 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Above (N=165,61,158,52) | 5 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Normal (N=163,61,159,52) | 159 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Below (N=165,61,158,52) | 143 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Below (N=163,57,155,52) | 13 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Normal (N=163,57,155,52) | 144 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Above (N=163,57,155,52) | 6 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Below (N=163,57,155,52) | 20 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Normal (N=163,61,159,52) | 20 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Normal (N=163,57,155,52) | 139 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Below (N=163,57,155,51) | 141 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Above (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Below (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Below (N=163,61,159,52) | 143 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Below (N=164,61,156,52) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Normal (N=164,61,156,52) | 147 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Above (N=163,57,155,51) | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Above (N=164,61,156,52) | 16 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 2), Below (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Normal (N=163,57,155,52) | 158 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Normal (N=163,57,155,51) | 17 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 2), Normal (N=165,61,158,52) | 148 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 2), Above (N=165,61,158,52) | 15 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Above (N=163,57,155,51) | 3 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Below (N=163,57,155,51) | 145 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Above (N=164,61,156,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Below (N=162,57,156,52) | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Below (N=165,61,158,52) | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Below (N=163,61,159,52) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Normal (N=162,57,156,52) | 44 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Normal (N=165,61,158,52) | 53 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Above (N=162,57,156,52) | 12 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Normal (N=163,57,155,52) | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Normal (N=165,61,158,52) | 58 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Below (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Below (N=165,61,158,52) | 53 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Normal (N=163,57,155,51) | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Above (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Normal (N=163,57,155,52) | 54 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Normal (N=163,57,155,52) | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Below (N=163,57,155,52) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 2), Normal (N=165,61,158,52) | 56 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 2), Below (N=165,61,158,52) | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Below (N=164,61,156,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Below (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Below (N=163,61,159,52) | 53 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Below (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Below (N=163,57,155,51) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Normal (N=163,61,159,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Normal (N=163,57,155,52) | 53 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Normal (N=165,61,158,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Below (N=165,61,158,52) | 53 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Normal (N=163,57,155,52) | 57 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Normal (N=164,61,156,52) | 51 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Normal (N=163,57,155,51) | 57 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Normal (N=163,57,155,51) | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Below (N=163,57,155,52) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Normal (N=163,61,159,52) | 9 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Below (N=163,61,159,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Below (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Below (N=163,61,159,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Below (N=165,61,158,52) | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Normal (N=163,61,159,52) | 58 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Normal (N=163,61,159,52) | 50 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Below (N=163,57,155,51) | 52 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 2), Above (N=165,61,158,52) | 4 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Above (N=163,61,159,52) | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Normal (N=163,57,155,52) | 54 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Normal (N=165,61,158,52) | 8 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Normal (N=163,61,159,52) | 22 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Below (N=163,61,159,52) | 5 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Normal (N=163,61,159,52) | 153 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Above (N=163,61,159,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Below (N=165,61,158,52) | 5 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Normal (N=165,61,158,52) | 152 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Above (N=165,61,158,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Below (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Normal (N=163,57,155,52) | 150 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Above (N=163,57,155,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Below (N=163,57,155,51) | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Normal (N=163,57,155,51) | 149 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Above (N=163,57,155,51) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Below (N=163,61,159,52) | 14 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Normal (N=163,61,159,52) | 130 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Above (N=163,61,159,52) | 15 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Below (N=165,61,158,52) | 16 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Normal (N=165,61,158,52) | 135 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Above (N=165,61,158,52) | 7 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Below (N=163,57,155,52) | 15 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Normal (N=163,57,155,52) | 130 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Above (N=163,57,155,52) | 10 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Below (N=163,57,155,52) | 17 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Normal (N=163,57,155,52) | 133 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Above (N=163,57,155,52) | 5 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Below (N=164,61,156,52) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Normal (N=164,61,156,52) | 136 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Above (N=164,61,156,52) | 18 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 2), Below (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 2), Normal (N=165,61,158,52) | 144 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 2), Above (N=165,61,158,52) | 12 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Below (N=162,57,156,52) | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Normal (N=162,57,156,52) | 142 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Above (N=162,57,156,52) | 13 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Below (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Normal (N=163,57,155,52) | 141 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Above (N=163,57,155,52) | 12 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Below (N=163,61,159,52) | 137 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Below (N=165,61,158,52) | 136 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Normal (N=165,61,158,52) | 22 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Below (N=163,57,155,52) | 135 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Normal (N=163,57,155,52) | 20 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Below (N=163,57,155,51) | 135 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Normal (N=163,57,155,51) | 20 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Below (N=163,61,159,52) | 136 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Normal (N=163,61,159,52) | 23 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Below (N=165,61,158,52) | 134 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Normal (N=165,61,158,52) | 24 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Below (N=163,57,155,52) | 134 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Normal (N=163,57,155,52) | 21 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Below (N=163,57,155,51) | 134 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Normal (N=163,57,155,51) | 17 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Above (N=163,57,155,51) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 2), Above (N=165,61,158,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 2), Normal (N=165,61,158,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Below (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Below (N=163,57,155,51) | 44 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 2), Below (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Above (N=164,61,156,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Normal (N=163,61,159,52) | 50 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Normal (N=163,57,155,51) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Normal (N=164,61,156,52) | 49 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, PRE (Day 0), Below (N=164,61,156,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Above (N=163,57,155,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Normal (N=163,57,155,52) | 44 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Below (N=163,61,159,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 23), Below (N=163,57,155,52) | 5 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Above (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Normal (N=165,61,158,52) | 49 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Normal (N=163,61,159,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Normal (N=163,57,155,52) | 44 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 21), Below (N=163,57,155,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Below (N=163,61,159,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Above (N=165,61,158,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Normal (N=165,61,158,52) | 47 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Below (N=163,57,155,51) | 44 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Below (N=165,61,158,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, POST (Day 2), Below (N=165,61,158,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Above (N=163,61,159,52) | 6 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 2), Below (N=165,61,158,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Normal (N=165,61,158,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Normal (N=163,61,159,52) | 43 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | HEM, PRE (Day 0), Below (N=163,61,159,52) | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Normal (N=163,57,155,51) | 49 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Above (N=163,57,155,51) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Below (N=163,57,155,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Below (N=165,61,158,52) | 46 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Above (N=163,61,159,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 23), Below (N=163,57,155,51) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Normal (N=165,61,158,52) | 6 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Normal (N=163,61,159,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, PRE (Day 0), Below (N=163,61,159,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 2), Above (N=165,61,158,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Above (N=163,57,155,52) | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Normal (N=163,57,155,52) | 50 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 23), Normal (N=163,57,155,51) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Below (N=163,57,155,52) | 45 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 23), Below (N=163,57,155,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Above (N=162,57,156,52) | 4 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | MON, POST (Day 21), Normal (N=163,57,155,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Normal (N=163,57,155,52) | 7 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Normal (N=162,57,156,52) | 48 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LDE, POST (Day 21), Below (N=162,57,156,52) | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | EOS, POST (Day 21), Normal (N=163,57,155,52) | 50 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. | LYM, POST (Day 21), Above (N=163,57,155,52) | 0 Subjects |
Secondary
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)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, on a subset of subjects enrolled for this study in Belgium.
Secondary
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
Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness >100mm | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Induration >100mm | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain | 69 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness | 19 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling >100mm | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling | 19 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis >100mm | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Induration | 10 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling >100mm | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis >100mm | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Induration | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Induration >100mm | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness >100mm | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain | 6 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness | 30 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness >100mm | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling >100mm | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis >100mm | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain | 75 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis | 5 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling | 15 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Induration >100mm | 0 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Induration | 15 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling >100mm | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Induration | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis >100mm | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Induration >100mm | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness >100mm | 0 Subjects |
Secondary
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
Population: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Sweating | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Arthralgia | 13 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue | 32 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (Axillary) >38.0°C | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (Axillary) ≥39.0°C | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache | 27 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Myalgia | 24 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering | 2 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 0 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Sweating | 16 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Sweating | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Sweating | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Arthralgia | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Sweating | 8 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Myalgia | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (Axillary) ≥39.0°C | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue | 7 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Sweating | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (Axillary) >38.0°C | 1 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue | 39 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 8 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (Axillary) >38.0°C | 5 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (Axillary) ≥39.0°C | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache | 34 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 6 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Sweating | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Myalgia | 28 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Sweating | 19 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 4 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Sweating | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Arthralgia | 13 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering | 9 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Sweating | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Sweating | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (Axillary) ≥39.0°C | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (Axillary) >38.0°C | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue | 6 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Arthralgia | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Sweating | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Myalgia | 3 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 Subjects |
Secondary
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
Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AEs | 36 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AEs | 9 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AEs | 5 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AEs | 16 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AEs | 2 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AEs | 2 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AEs | 3 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AEs | 28 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AEs | 10 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AEs | 8 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AEs | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AEs | 1 Subjects |
Secondary
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).
Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1562902A 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Days 0-51 [N=165,61,159,52] | 1 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Days 52-180 [N=164,58,158,51] | 5 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Months 6-12 [N=130,48,125,42] | 4 Subjects |
| GSK1562902A 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Months 12-24 [N=122,45,117,36] | 9 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Days 52-180 [N=164,58,158,51] | 3 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Months 6-12 [N=130,48,125,42] | 0 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Months 12-24 [N=122,45,117,36] | 7 Subjects |
| GSK1562902A 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Days 0-51 [N=165,61,159,52] | 1 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Months 6-12 [N=130,48,125,42] | 3 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Days 52-180 [N=164,58,158,51] | 5 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Months 12-24 [N=122,45,117,36] | 7 Subjects |
| GSK1562902A 3 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Days 0-51 [N=165,61,159,52] | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Months 12-24 [N=122,45,117,36] | 2 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Days 52-180 [N=164,58,158,51] | 0 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Days 0-51 [N=165,61,159,52] | 1 Subjects |
| GSK1562902A 4 Group | Number of Subjects With Serious Adverse Events (SAEs) | Subjects with SAEs Months 6-12 [N=130,48,125,42] | 2 Subjects |