Hepatitis B
Conditions
Keywords
Adjuvant Systems, Hepatitis B
Brief summary
The aim of this Observer-blind study is to compare different Adjuvant Systems with the same, well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by each of the Adjuvant System. This Protocol Posting has been updated following Protocol amendment 6, October 2009. The section impacted is Eligibility Criteria
Interventions
BIOLOGICALGSK Biologicals' Hepatitis B vaccines (GSK223192A)
2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group
BIOLOGICALHBsAg (Booster injection)
Single dose intramuscular injection
BIOLOGICALEngerix-B™
2 doses intramuscular injections
BIOLOGICALFendrix™
2 doses intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy the following criteria at study entry : * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female between, and including, 18 and 45 years at the time of the first vaccination. * Written informed consent obtained from the subject. * Healthy subjects as established by medical history, clinical examination and clinical laboratory assessment before entering into the study. * If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: * Previous vaccination against Hepatitis B. * Positive for anti-HBs antibodies, antiHBc antibodies, HBsAg, HCV antibodies and/or HIV. * Any previous administration of specific adjuvant components. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the influenza vaccine (pandemic or seasonal) which can be administered \> 21 days preceding or \> 21 days following each primary vaccine dose (Doses 1 and 2) AND \> 7 days preceding or \> 7 days following the booster dose. * Administration of immunoglobulins and/or any blood products within the last 3 months. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * Current serious neurologic or mental disease. * Any past or current malignancies and lymphoproliferative disorders. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, autoimmune disease or anemia, as determined by physical examination or laboratory screening tests at the discretion of the investigator. * Acute disease at the time of enrolment. * Pregnant or lactating female. * History of chronic alcohol consumption and/or drug abuse. * Other conditions that the principal investigator judges may interfere with study findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . | At Day 44 | The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | At Days 0, 14, 30, 44, and 60 | The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). |
| Number of HB Specific CD4+ T Cells . | At Days 0, 180 and 360 | The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). |
| Number of HB - Specific CD8+ T Cells. | At Days 0, 180 and 360 | The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). |
| Number of HB - Specific CD4+ T Cells. | At Days 0, 360 and 374 | The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). |
| Number of HB - Specific CD8+ T Cells | At Days 0, 360 and 374 | The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). |
| Number of HB - Specific CD4+ T Cells | At Days 0, 14, 30, 33, 37, 44 and 60 | The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium. |
| Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | At Days 0, 14, 30, 44 and 60 | The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). |
| Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | At Days 0 and 180 | The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). |
| Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | At Days 0, 30, 44, and 60 | Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | At Days 0, 180 and 360 | Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | At Days 0, 374 and 390 | Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Number of Hepatitis B (HB)-Specific Memory B Cells | At Days 0, 30, 37, 44 and 60. | The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Number of HB-specific Memory B Cells | At Days 180 and 360 | The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37. | Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60. | Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Normalized Levels of C-reactive Protein (CRP) | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37. | Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Normalized Levels of WBC and of CPK | At Days 0, 30, 37 and 60. | Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2. |
| Normalized Levels of CRP | At Days 0, 30 and 37. | Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2. |
| Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60. | Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Levels of WBC, NEU, LYM, MON, EOS and BAS | At Days 0, 30, 37 and 60. | Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2. |
| Normalized Levels of Red Blood Cells and Platelets | At Days 0, 30, 37 and 60. | Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count). |
| Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | At Days 0, 30, 37 and 60. | Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count). |
| Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | At Days 0, 30, 37 and 60. | Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count). |
| Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | At Day 0 and up to Day 60. | Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | At Day 0 and up to Day 60. | Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2. |
| Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | Post vaccination (up to Day 360) | Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated. |
| Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | At Days 360 and 390. | Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | At Day 0 and up to Day 60. | Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60). |
| Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | post vaccination (up to Day 360). | Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated. |
| Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | At Days 360 and 390. | Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines. | Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (\>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine. | Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (\>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (\>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens | Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (\>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens | Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (\>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (\>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2. | A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg. |
| Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2. | AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination. |
| Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | At Days 0, 1, 14, 30, 31, 33 and 37 | The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9). |
| mRNA Levels as Measured by qPCR | At Days 0, 1, 14, 30, 31, 33 and 37 | The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1). |
| Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | At Days 0, 14, 30 and 60 | The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). |
| Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | At Days 0, 1, 14, 30, 31, 33 and 37 | The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67). |
| Levels of mRNA as Measured by qPCR | At Days 0, 1, 14, 30, 31, 33 and 37 | The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B). |
| Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | At Days 0, 1, 14, 30, 31, 33 and 37 | The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1). |
| Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | At Days 0, 1, 14, 30, 31, 33 and 37 | The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ). |
| mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | At Days 0, 1, 14, 30, 31, 33 and 37 | The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1). |
Countries
Belgium, Germany
Participant flow
Recruitment details
Approximately 75 subjects in each group, approximately 23 and 52 subjects/group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I and II subtypes \[Subset 1 and 2, respectively\], received a booster dose of HBsAg at Day 360.
Pre-assignment details
Study duration was of 390 days for subjects in Subsets 1 and 2 (subjects identified with a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) vaccinated with an additional dose of Hepatitis B surface antigens (HBsAg)) and of 360 days for subjects not receiving this dose of HBsAg.
Participants by arm
| Arm | Count |
|---|---|
| GSK223192A 1 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. | 143 |
| GSK223192A 2 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. | 142 |
| GSK223192A 3 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. | 141 |
| Fendrix Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. | 145 |
| Engerix-B Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. | 142 |
| Total | 713 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 | 6 | 10 | 9 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 4 | 5 | 4 |
Baseline characteristics
| Characteristic | GSK223192A 1 Group | GSK223192A 2 Group | GSK223192A 3 Group | Fendrix Group | Engerix-B Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 34.7 Years STANDARD_DEVIATION 6.94 | 33.7 Years STANDARD_DEVIATION 7.28 | 32.9 Years STANDARD_DEVIATION 7.58 | 33.5 Years STANDARD_DEVIATION 7.41 | 32.9 Years STANDARD_DEVIATION 7.5 | 33.5 Years STANDARD_DEVIATION 7.34 |
| Race/Ethnicity, Customized White - Caucasian / European heritage | 135 Participants | 138 Participants | 138 Participants | 142 Participants | 136 Participants | 689 Participants |
| Sex: Female, Male Female | 66 Participants | 66 Participants | 64 Participants | 66 Participants | 65 Participants | 327 Participants |
| Sex: Female, Male Male | 77 Participants | 76 Participants | 77 Participants | 79 Participants | 77 Participants | 386 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 143 | 0 / 142 | 0 / 141 | 0 / 145 | 0 / 142 |
| other Total, other adverse events | 137 / 143 | 135 / 142 | 131 / 141 | 141 / 145 | 114 / 142 |
| serious Total, serious adverse events | 7 / 143 | 4 / 142 | 10 / 141 | 7 / 145 | 7 / 142 |
Outcome results
Primary
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .
The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.
Time frame: At Day 44
Population: Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 44 time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . | 1345 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . | 1257 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . | 647 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . | 391 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells . | 299 HB-CD4+ T cells (per million cells) |
Secondary
Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)
Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 0, 180 and 360
Population: Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK223192A 1 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 3.1 mIU/mL |
| GSK223192A 1 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 360 | 2150.7 mIU/mL |
| GSK223192A 1 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 180 | 3840.7 mIU/mL |
| GSK223192A 2 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 180 | 2657.5 mIU/mL |
| GSK223192A 2 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 360 | 1650.6 mIU/mL |
| GSK223192A 2 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 3.1 mIU/mL |
| GSK223192A 3 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 360 | 2122.5 mIU/mL |
| GSK223192A 3 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 3.3 mIU/mL |
| GSK223192A 3 Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 180 | 3330.2 mIU/mL |
| Fendrix Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 3.1 mIU/mL |
| Fendrix Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 180 | 254.5 mIU/mL |
| Fendrix Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 360 | 94.5 mIU/mL |
| Engerix-B Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 3.1 mIU/mL |
| Engerix-B Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 360 | 19.8 mIU/mL |
| Engerix-B Group | Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 180 | 39.0 mIU/mL |
Secondary
Anti-HB Antibody Concentrations in Serum, as Measured by CLIA
Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 0, 374 and 390
Population: Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK223192A 1 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 374 | 51509.0 mIU/mL |
| GSK223192A 1 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 0 | 3.1 mIU/mL |
| GSK223192A 1 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 390 | 43674.6 mIU/mL |
| GSK223192A 2 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 390 | 27035.7 mIU/mL |
| GSK223192A 2 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 0 | 3.1 mIU/mL |
| GSK223192A 2 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 374 | 31985.9 mIU/mL |
| GSK223192A 3 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 0 | 3.3 mIU/mL |
| GSK223192A 3 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 374 | 27135.3 mIU/mL |
| GSK223192A 3 Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 390 | 25105.7 mIU/mL |
| Fendrix Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 374 | 3788.4 mIU/mL |
| Fendrix Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 0 | 3.1 mIU/mL |
| Fendrix Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 390 | 3352.2 mIU/mL |
| Engerix-B Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 0 | 3.1 mIU/mL |
| Engerix-B Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 390 | 351.1 mIU/mL |
| Engerix-B Group | Anti-HB Antibody Concentrations in Serum, as Measured by CLIA | Anti HBs, Day 374 | 341.3 mIU/mL |
Secondary
Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)
Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 0, 30, 44, and 60
Population: Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK223192A 1 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 60 | 7454.3 mIU/mL |
| GSK223192A 1 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 44 | 11986.2 mIU/mL |
| GSK223192A 1 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 3.1 mIU/mL |
| GSK223192A 1 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 30 | 108.0 mIU/mL |
| GSK223192A 2 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 0 mIU/mL |
| GSK223192A 2 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 44 | 7942.6 mIU/mL |
| GSK223192A 2 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 30 | 59.6 mIU/mL |
| GSK223192A 2 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 60 | 5030.9 mIU/mL |
| GSK223192A 3 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 44 | 5525.4 mIU/mL |
| GSK223192A 3 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 60 | 4194.3 mIU/mL |
| GSK223192A 3 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 3.3 mIU/mL |
| GSK223192A 3 Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 30 | 66.3 mIU/mL |
| Fendrix Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 44 | 220.2 mIU/mL |
| Fendrix Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 30 | 6.1 mIU/mL |
| Fendrix Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 60 | 251.9 mIU/mL |
| Fendrix Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 0 mIU/mL |
| Engerix-B Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 60 | 21.5 mIU/mL |
| Engerix-B Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 30 | 3.5 mIU/mL |
| Engerix-B Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 0 | 0 mIU/mL |
| Engerix-B Group | Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) | Anti HBs, Day 44 | 19.2 mIU/mL |
Secondary
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum
Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.
Population: Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response \[i.e. cytokines in serum, gene expression signature, white blood cells counts\]) results available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0+ | 2.882 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 37 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0 | 1.291 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0+ | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 37 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 33 | 83 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30+ | 0.884 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30+ | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 1 | 2.004 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 31 | 0.705 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0+ | 1.161 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 33 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 37 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30 | 1.202 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 1 | 144 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 31 | 1.119 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30 | 3.704 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0+ | 112 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 33 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0 | 130 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 37 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 1 | 4.07 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 37 | 119 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 37 | 129 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30+ | 140 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 33 | 1.644 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 33 | 232 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 33 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 31 | 295 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 31 | 171 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30+ | 75 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0+ | 1.482 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0 | 3.704 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 31 | 0.881 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 1 | 3.704 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30 | 103 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30+ | 3.704 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 1 | 2.024 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 1 | 147 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 31 | 5.568 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0+ | 80 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 33 | 3.704 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 31 | 0.991 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30+ | 1.069 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30 | 0.969 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 37 | 3.704 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0 | 94 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 37 | 1.003 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0+ | 3.704 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0+ | 1.636 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 1 | 1.902 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 31 | 7.459 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30 | 1.232 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30+ | 1.292 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 1 | 0.977 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30+ | 3.195 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30 | 1.641 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 33 | 0.411 pg/mL |
| GSK223192A 1 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30 | 151 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 31 | 1.151 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30 | 0.879 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 37 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30+ | 63 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0 | 1.19 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 33 | 92 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 37 | 3.704 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 37 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 33 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0+ | 3.704 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 33 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 33 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 31 | 0.951 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30 | 1.023 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30+ | 0.916 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30+ | 1.08 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 37 | 138.5 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30+ | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0+ | 1.37 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 1 | 2.089 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0 | 1.262 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0 | 3.704 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 31 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 31 | 155 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 31 | 1.263 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0 | 1.379 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 1 | 1.08 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 37 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 1 | 3.704 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0+ | 1.873 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30 | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 1 | 139 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30+ | 114 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30 | 109 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0+ | 141 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 33 | 1.253 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 1 | 111 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 1 | 1.909 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30+ | 3.704 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0 | 168 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30+ | 1.099 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 37 | 0.934 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 37 | 100.5 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30 | 179 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30 | 1.377 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 1 | 2.578 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30 | 3.704 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 1 | 2.237 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0+ | 81 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 33 | 170 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 31 | 4.174 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0+ | 0.411 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0+ | 1.641 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 33 | 0.981 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 37 | 0.976 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0 | 92 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 31 | 3.704 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 33 | 3.704 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 31 | 211 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30+ | 2.53 pg/mL |
| GSK223192A 2 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0+ | 2.523 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0 | 3.704 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30 | 3.704 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0+ | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 33 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0+ | 0.905 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30+ | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 31 | 1.289 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 1 | 2.223 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30+ | 1.664 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 31 | 3.457 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 1 | 92.5 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30+ | 70.5 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 33 | 79 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0+ | 3.704 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 1 | 3.704 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30+ | 3.704 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 31 | 3.704 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 33 | 3.704 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 37 | 3.704 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0+ | 0.856 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 1 | 1.912 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30 | 1.017 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30+ | 0.856 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 31 | 1.117 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 33 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 37 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 1 | 1.055 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30+ | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 31 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 37 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0 | 0.905 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 1 | 1.83 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30 | 1.011 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 33 | 1.192 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 37 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0 | 1.291 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0+ | 1.605 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30 | 1.79 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 37 | 150 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0 | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0+ | 0.411 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 33 | 1.435 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 1 | 1.727 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 37 | 0.95 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0 | 101.5 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30 | 1.203 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30+ | 1.321 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0+ | 78 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30 | 106 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 31 | 1.081 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 31 | 176.5 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 33 | 1.129 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 33 | 156 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 37 | 90 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0 | 148.5 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0+ | 114 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 1 | 111.5 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30 | 164 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30+ | 121.5 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 31 | 114.5 pg/mL |
| GSK223192A 3 Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 37 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 37 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0+ | 131 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 33 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 31 | 1.159 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30+ | 0.992 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30 | 1.653 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30+ | 1.214 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30 | 0.925 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0 | 0.651 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 1 | 1.628 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 1 | 133.5 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0+ | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0+ | 0.947 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 31 | 2.538 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 1 | 1.579 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 37 | 1.321 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 37 | 3.704 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0 | 3.704 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30 | 165 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0 | 102 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 33 | 3.704 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30+ | 1.243 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 31 | 3.704 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30+ | 3.704 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0+ | 80 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 1 | 85.5 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30 | 3.704 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 1 | 3.704 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30 | 104 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 37 | 140.5 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30+ | 121 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30+ | 68 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 31 | 1.091 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 31 | 63 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 33 | 1.676 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30+ | 1.753 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 37 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 33 | 86 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 33 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 1 | 2.147 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0+ | 1.579 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 31 | 120 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 37 | 83.5 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0 | 1.26 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 37 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 33 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0+ | 3.704 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0 | 0.867 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 31 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0+ | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30+ | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0 | 143 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 1 | 1.77 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30 | 0.89 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 1 | 0.893 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 31 | 1.113 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 33 | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0+ | 0.411 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 33 | 122 pg/mL |
| Fendrix Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 37 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0 | 3.704 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 37 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 33 | 0.86 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30 | 107 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0+ | 95 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 1 | 1.739 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 31 | 1.135 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 33 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 31 | 105 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 37 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30 | 1.218 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30+ | 1.349 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0+ | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 37 | 133 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 30 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 30+ | 70 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 33 | 88 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 0 | 120 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 30+ | 1.394 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 1 | 1.885 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 37 | 0.841 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0+ | 1.146 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 37 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 31 | 1.375 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 0+ | 0.911 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 33 | 84 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-1B; Day 0 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 1 | 1.942 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 31 | 1.567 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30+ | 114.5 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 1 | 133 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 1 | 0.916 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 33 | 1.389 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 37 | 3.704 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 0+ | 3.704 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 31 | 76 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 37 | 1.158 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 31 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 31 | 0.99 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 1 | 1.701 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 33 | 3.704 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 30+ | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0 | 91 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 0 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | MCP-1; Day 30 | 161 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 33 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 31 | 3.704 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0+ | 1.418 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 0+ | 1.092 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-6; Day 0 | 1.055 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 0+ | 75.5 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30+ | 3.704 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 30 | 3.704 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-10; Day 30+ | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | TNF-a; Day 30+ | 1.323 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 1 | 85 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IL-5; Day 33 | 0.411 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IP-10; Day 37 | 85 pg/mL |
| Engerix-B Group | Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum | IFN-g; Day 1 | 3.704 pg/mL |
Secondary
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR
The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1).
Time frame: At Days 0, 1, 14, 30, 31, 33 and 37
Population: The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 37 | 0.87 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 1 | 1.09 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 0 | 0.84 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 33 | 0.97 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 14 | 1.07 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 37 | 0.91 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 0 | 1.06 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 30 | 1.14 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 1 | 1.25 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 31 | 1.34 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 31 | 1.66 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 30 | 1.03 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 33 | 0.97 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 14 | 0.95 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 30 | 0.94 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 37 | 0.94 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 33 | 0.84 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 1 | 1.1 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 0 | 1.01 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 31 | 1.3 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 0 | 0.96 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 14 | 0.85 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 33 | 0.85 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 14 | 0.92 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 31 | 1.33 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 37 | 0.94 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 1 | 1.15 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 30 | 0.81 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 31 | 1.05 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 1 | 1.16 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 14 | 1.01 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 30 | 1.02 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 31 | 1.11 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 33 | 0.82 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 37 | 0.91 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 0 | 1.02 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 1 | 1.12 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 14 | 1.2 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 30 | 0.92 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 33 | 0.81 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 37 | 0.95 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 0 | 1.07 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 30 | 0.86 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 33 | 1.18 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 14 | 1.07 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 14 | 1.06 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 1 | 1.05 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 37 | 0.94 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 30 | 0.98 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 31 | 1.08 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 0 | 0.89 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 31 | 1.31 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 37 | 0.96 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 0 | 1.06 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 1 | 1.14 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 33 | 1.07 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 1 | 0.85 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 0 | 0.9 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 14 | 1 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 31 | 1.04 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 30 | 0.96 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 30 | 1.09 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 14 | 1.13 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 31 | 0.94 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 1 | 0.95 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 33 | 0.99 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | DUSP1.mRNA, Day 37 | 1 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 0 | 1.04 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 37 | 1.15 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR | PTGS2.mRNA, Day 33 | 1.01 copies |
Secondary
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)
The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9).
Time frame: At Days 0, 1, 14, 30, 31, 33 and 37
Population: The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 0 | 1.18 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 1 | 1.14 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 37 | 0.82 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 0 | 1.04 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 33 | 0.67 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 14 | 0.95 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 31 | 1.14 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 30 | 1.03 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 37 | 0.77 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 30 | 1.06 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 31 | 1.31 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 1 | 1.33 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 14 | 0.98 copies |
| GSK223192A 1 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 33 | 0.99 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 33 | 1.04 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 31 | 1.26 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 30 | 1.21 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 37 | 1.04 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 1 | 1.08 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 0 | 1.11 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 1 | 1.14 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 0 | 1.09 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 33 | 0.7 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 30 | 1.02 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 14 | 1.02 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 14 | 1.07 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 37 | 1.01 copies |
| GSK223192A 2 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 31 | 1.09 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 33 | 1.12 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 0 | 1.24 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 1 | 1.1 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 14 | 1 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 30 | 1.25 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 31 | 1.41 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 37 | 1 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 0 | 1.14 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 1 | 1.24 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 14 | 1.19 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 30 | 1.08 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 31 | 1 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 33 | 0.73 copies |
| GSK223192A 3 Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 37 | 0.91 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 33 | 1.18 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 1 | 1.24 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 31 | 1.15 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 14 | 1.15 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 30 | 1.19 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 0 | 1.18 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 30 | 1.03 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 14 | 1.03 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 31 | 0.97 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 1 | 1 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 37 | 1.01 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 37 | 1.07 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 33 | 1.12 copies |
| Fendrix Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 0 | 1.14 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 37 | 1.06 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 37 | 1.14 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 1 | 1.01 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 31 | 1.1 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 0 | 1.11 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 0 | 1.18 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 31 | 1.07 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 14 | 1.02 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 30 | 1.09 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 1 | 1.06 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 33 | 0.97 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 33 | 1.07 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNFRSF9.mRNA, Day 30 | 1.14 copies |
| Engerix-B Group | Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) | TNF.mRNA, Day 14 | 1.13 copies |
Secondary
Levels of mRNA as Measured by qPCR
The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B).
Time frame: At Days 0, 1, 14, 30, 31, 33 and 37
Population: The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 37 | 0.97 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 30 | 1.08 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 33 | 1.31 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 14 | 0.94 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 37 | 0.91 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 31 | 6.25 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 14 | 0.88 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 0 | 0.92 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 30 | 1.2 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 1 | 1.56 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 33 | 1.35 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 1 | 0.96 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 0 | 1.04 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 31 | 2.02 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 37 | 1.02 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 31 | 2.93 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 37 | 0.87 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 33 | 1.07 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 0 | 1.12 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 30 | 1.03 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 1 | 1.31 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 31 | 1.47 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 14 | 0.95 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 14 | 0.93 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 33 | 1.06 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 1 | 1.14 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 30 | 0.98 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 0 | 0.97 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 33 | 0.86 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 37 | 0.94 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 0 | 1.02 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 1 | 1.21 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 14 | 0.97 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 30 | 1.04 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 31 | 1.23 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 33 | 0.93 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 37 | 0.85 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 0 | 0.92 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 1 | 1.06 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 14 | 1.06 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 30 | 0.88 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 31 | 1.59 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 31 | 0.95 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 1 | 1.24 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 1 | 0.97 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 30 | 0.94 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 30 | 1.1 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 14 | 1.23 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 0 | 1.04 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 0 | 0.97 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 37 | 1.03 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 33 | 1.02 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 14 | 0.9 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 33 | 1.13 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 37 | 0.83 copies |
| Fendrix Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 31 | 1.14 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 37 | 1.01 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 30 | 1.05 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 0 | 1.07 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 14 | 1 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 31 | 1.18 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 1 | 0.96 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 1 | 0.92 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 14 | 0.97 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 0 | 0.96 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 33 | 1.05 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 30 | 0.92 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | CXCL10.mRNA, Day 37 | 1.09 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 33 | 1.01 copies |
| Engerix-B Group | Levels of mRNA as Measured by qPCR | IL-1B.mRNA, Day 31 | 1.06 copies |
Secondary
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR)
The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ).
Time frame: At Days 0, 1, 14, 30, 31, 33 and 37
Population: The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 30 | 1.08 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 30 | 0.92 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 0 | 0.98 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 33 | 0.9 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 14 | 1 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 14 | 0.88 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 31 | 0.91 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 1 | 0.89 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 37 | 1.03 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 33 | 0.79 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 37 | 0.89 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 0 | 0.97 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 31 | 0.46 copies |
| GSK223192A 1 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 1 | 0.66 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 37 | 1.02 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 0 | 0.94 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 14 | 0.97 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 1 | 1.01 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 1 | 0.73 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 31 | 0.86 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 14 | 0.98 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 30 | 0.99 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 33 | 0.92 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 31 | 0.58 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 33 | 0.9 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 37 | 1.03 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 30 | 1.03 copies |
| GSK223192A 2 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 0 | 0.97 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 31 | 0.89 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 14 | 1.11 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 30 | 0.88 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 0 | 1.03 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 0 | 0.94 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 33 | 0.87 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 31 | 0.78 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 37 | 0.94 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 14 | 1.09 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 1 | 0.83 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 1 | 1.03 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 30 | 1 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 37 | 0.98 copies |
| GSK223192A 3 Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 33 | 0.83 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 30 | 1.13 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 33 | 1.13 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 37 | 1.09 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 0 | 0.93 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 1 | 0.83 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 14 | 0.89 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 30 | 1.05 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 37 | 1.16 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 0 | 0.97 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 1 | 0.97 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 31 | 0.87 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 33 | 1.05 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 14 | 0.82 copies |
| Fendrix Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 31 | 0.96 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 37 | 1.09 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 14 | 0.96 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 0 | 1.07 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 37 | 1.11 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 31 | 1.1 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 30 | 1.08 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 30 | 0.92 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 14 | 1.1 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 1 | 1.04 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 0 | 1.11 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 33 | 1.05 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 31 | 1.18 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | NFATC2.mRNA, Day 33 | 1.05 copies |
| Engerix-B Group | Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IFN-γ.mRNA, Day 1 | 0.96 copies |
Secondary
Levels of WBC, NEU, LYM, MON, EOS and BAS
Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2.
Time frame: At Days 0, 30, 37 and 60.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 30 | 0.45 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 0 | 0.408 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 60 | 0.47 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 30 | 0.457 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 60 | 0.44 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 30 | 0.492 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 37 | 0.417 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 0 | 0.304 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 60 | 0.463 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 30 | 0.3 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 37 | 0.409 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 37 | 0.471 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 30 | 0.556 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 0 | 0.534 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 37 | 0.351 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 30 | 0.4 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 0 | 0.52 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 37 | 0.455 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 0 | 0.263 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 60 | 0.3 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 60 | 0.429 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 60 | 0.45 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 0 | 0.426 IH normalized ratio |
| GSK223192A 1 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 37 | 0.514 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 37 | 0.456 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 0 | 0.286 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 30 | 0.294 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 37 | 0.294 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 0 | 0.559 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 60 | 0.2 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 30 | 0.524 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 37 | 0.5 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 60 | 0.496 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 30 | 0.426 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 0 | 0.388 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 30 | 0.404 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 37 | 0.433 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 60 | 0.388 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 0 | 0.473 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 37 | 0.574 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 30 | 0.471 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 60 | 0.324 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 60 | 0.41 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 0 | 0.413 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 0 | 0.29 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 30 | 0.4 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 60 | 0.44 IH normalized ratio |
| GSK223192A 2 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 37 | 0.35 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 37 | 0.465 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 37 | 0.377 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 0 | 0.3 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 0 | 0.497 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 0 | 0.5 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 60 | 0.444 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 30 | 0.35 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 37 | 0.436 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 60 | 0.578 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 60 | 0.299 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 37 | 0.605 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 30 | 0.491 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 30 | 0.538 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 60 | 0.4 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 60 | 0.389 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 37 | 0.405 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 37 | 0.329 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 30 | 0.316 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 0 | 0.275 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 0 | 0.552 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 60 | 0.439 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 30 | 0.428 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 0 | 0.426 IH normalized ratio |
| GSK223192A 3 Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 30 | 0.55 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 0 | 0.299 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 30 | 0.373 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 30 | 0.573 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 0 | 0.438 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 37 | 0.492 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 60 | 0.343 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 60 | 0.607 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 60 | 0.426 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 37 | 0.353 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 37 | 0.496 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 30 | 0.294 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 30 | 0.375 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 30 | 0.431 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 37 | 0.465 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 37 | 0.523 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 60 | 0.347 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 60 | 0.456 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 30 | 0.5 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 37 | 0.458 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 0 | 0.672 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 0 | 0.353 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 60 | 0.471 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 0 | 0.503 IH normalized ratio |
| Fendrix Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 0 | 0.37 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 60 | 0.286 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 0 | 0.465 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 30 | 0.455 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 37 | 0.426 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | WBC; Day 60 | 0.478 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 0 | 0.458 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 30 | 0.532 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 37 | 0.491 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | NEU; Day 60 | 0.474 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 0 | 0.45 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 30 | 0.43 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 37 | 0.43 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | LYM; Day 60 | 0.417 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 0 | 0.55 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 30 | 0.506 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 37 | 0.5 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | MON; Day 60 | 0.5 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 0 | 0.319 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 30 | 0.333 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 37 | 0.522 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | EOS; Day 60 | 0.388 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 0 | 0.353 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 30 | 0.316 IH normalized ratio |
| Engerix-B Group | Levels of WBC, NEU, LYM, MON, EOS and BAS | BAS; Day 37 | 0.3 IH normalized ratio |
Secondary
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.
Population: Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response \[i.e. cytokines in serum, gene expression signature, white blood cells counts\]) results available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30 | 0.452 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30+ | 0.456 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30+ | 0.3 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30 | 0.533 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 31 | -0.086 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 31 | 0.2 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 1 | 0.594 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 33 | 0.309 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 1 | 0.76 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0+ | 0.422 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 37 | 0.503 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0 | 0.5 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 60 | 0.452 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30+ | 0.25 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30 | 0.4 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 37 | 0.379 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 1 | 0.232 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 60 | 0.41 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30+ | 0.69 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 60 | 0.3 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0+ | 0.25 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 31 | 0.79 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 33 | 0.441 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 33 | 0.591 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0 | 0.25 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0 | 0.648 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 1 | 0.178 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 60 | 0.45 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0+ | 0.84 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 37 | 0.46 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 1 | 0.93 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30+ | 0.32 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 33 | 0.6 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30 | 0.604 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 31 | 0.145 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30+ | 0.9 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0 | 0.498 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30 | 0.45 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 31 | 1.161 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 1 | 0.291 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30 | 0.456 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0+ | 0.3 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 37 | 0.63 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 37 | 0.316 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0 | 0.5 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 60 | 0.656 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 60 | 0.5 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0 | 0.474 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 33 | 0.35 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 37 | 0.478 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0+ | 0.328 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0+ | 0.702 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 33 | 0.767 IH normalized ratio |
| GSK223192A 1 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 31 | 0.533 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 37 | 0.64 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30 | 0.51 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 60 | 0.4 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0 | 0.366 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30 | 0.411 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0+ | 0.752 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30+ | 0.386 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 31 | 0.3 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 37 | 0.421 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 1 | 0.522 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0 | 0.594 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 31 | -0.003 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 33 | 0.667 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30+ | 0.422 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0+ | 0.367 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 1 | 0.817 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 33 | 0.407 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 37 | 0.652 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 31 | 0.544 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0 | 0.311 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 31 | 0.38 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 37 | 0.357 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 1 | 0.756 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 33 | 0.578 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 60 | 0.376 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30 | 0.6 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30+ | 0.25 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30+ | 0.475 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30 | 0.35 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 60 | 0.467 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30 | 0.673 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 37 | 0.525 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 31 | 0.737 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 1 | 0.25 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 1 | 0.272 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30+ | 0.717 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 60 | 0.557 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 60 | 0.543 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30+ | 0.789 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 33 | 0.4 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0+ | 0.3 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 1 | 0.48 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0+ | 0.407 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0 | 0.35 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 31 | 0.959 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 33 | 0.491 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0 | 0.53 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30 | 0.596 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0 | 0.509 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 37 | 0.433 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 60 | 0.652 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0+ | 0.429 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 33 | 0.509 IH normalized ratio |
| GSK223192A 2 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0+ | 1.123 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 1 | 0.54 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 31 | 0.629 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 60 | 0.271 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0 | 0.341 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0+ | 0.578 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 37 | 0.468 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30+ | 0.574 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 33 | 0.404 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30 | 0.263 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0 | 0.58 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0+ | 0.693 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 1 | 0.727 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30 | 0.387 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30+ | 0.609 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 31 | 0.921 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 33 | 0.539 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 37 | 0.443 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 60 | 0.54 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0 | 0.531 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0+ | 0.543 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 1 | 0.412 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30 | 0.528 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30+ | 0.497 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 31 | 0.15 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 33 | 0.445 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 37 | 0.555 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 60 | 0.534 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0 | 0.439 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0+ | 0.367 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 1 | 0.522 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30 | 0.5 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30+ | 0.433 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 31 | 0.632 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 33 | 0.656 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 37 | 0.433 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 60 | 0.456 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0 | 0.37 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0+ | 0.25 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 1 | 0.313 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30 | 0.42 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30+ | 0.34 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 31 | 0.25 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 33 | 0.58 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 37 | 0.44 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 60 | 0.38 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0 | 0.325 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0+ | 0.232 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 1 | 0.286 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30 | 0.35 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30+ | 0.25 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 31 | 0.3 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 33 | 0.35 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 37 | 0.286 IH normalized ratio |
| GSK223192A 3 Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 60 | 0.4 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0+ | 0.423 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 33 | 0.549 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 37 | 0.69 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 31 | 0.78 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0 | 0.663 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 60 | 0.61 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0 | 0.43 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 60 | 0.709 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0+ | 0.361 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30 | 0.385 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 1 | 0.464 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0 | 0.51 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0 | 0.25 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0+ | 0.647 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30+ | 0.663 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30+ | 0.556 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 60 | 0.25 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0+ | 0.25 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 60 | 0.461 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0 | 0.403 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 37 | 0.354 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 37 | 0.286 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 1 | 0.179 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30 | 0.693 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 37 | 0.569 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 33 | 0.441 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 31 | 0.427 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30+ | 0.496 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 60 | 0.402 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 31 | 0.633 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 37 | 0.423 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30 | 0.578 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30 | 0.333 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0 | 0.596 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 33 | 0.405 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30+ | 0.211 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 31 | 0.505 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0+ | 0.439 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 33 | 0.587 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 31 | 0.302 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 1 | 0.769 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 37 | 0.472 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 1 | 0.477 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 33 | 0.3 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30+ | 0.413 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 33 | 0.645 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 1 | 0.698 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30 | 0.472 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 31 | 0.25 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30 | 0.433 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0+ | 0.767 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 60 | 0.42 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30+ | 0.443 IH normalized ratio |
| Fendrix Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 1 | 0.283 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30+ | 0.363 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0+ | 0.609 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 31 | 0.478 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 0 | 0.68 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30+ | 0.333 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 33 | 0.472 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 60 | 0.561 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0+ | 0.662 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 37 | 0.394 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 37 | 0.542 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 60 | 0.344 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 33 | 0.567 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0 | 0.495 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 31 | 0.589 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 0+ | 0.42 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30+ | 0.642 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 31 | 0.325 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 1 | 0.41 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 30 | 0.581 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30 | 0.517 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30 | 0.53 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 0 | 0.479 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 30+ | 0.38 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 1 | 0.654 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 60 | 0.308 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 31 | 0.43 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0+ | 0.654 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 33 | 0.443 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | NEU; Day 0 | 0.445 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 33 | 0.3 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 37 | 0.52 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 60 | 0.446 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | EOS; Day 60 | 0.465 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 31 | 0.536 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0 | 0.375 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 30+ | 0.76 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 0+ | 0.225 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 37 | 0.49 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 1 | 0.25 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 33 | 0.537 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 37 | 0.572 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 37 | 0.3 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 60 | 0.538 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 33 | 0.622 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0 | 0.489 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 31 | 0.54 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | BAS; Day 30 | 0.3 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 0+ | 0.389 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30+ | 0.54 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC; Day 1 | 0.607 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 1 | 0.45 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 30 | 0.536 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | MON; Day 30 | 0.422 IH normalized ratio |
| Engerix-B Group | Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | LYM; Day 1 | 0.478 IH normalized ratio |
Secondary
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR)
The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67).
Time frame: At Days 0, 1, 14, 30, 31, 33 and 37
Population: The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 0 | 1.01 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 1 | 0.89 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 37 | 1.14 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 0 | 0.91 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 33 | 0.96 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 14 | 0.97 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 31 | 0.84 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 30 | 1.01 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 37 | 1.52 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 30 | 1 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 31 | 1.32 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 1 | 1.04 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 14 | 1.06 copies |
| GSK223192A 1 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 33 | 0.94 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 33 | 0.85 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 31 | 1.2 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 30 | 1 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 37 | 1.08 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 1 | 1.01 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 0 | 0.89 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 1 | 0.9 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 0 | 0.97 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 33 | 1.02 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 30 | 0.92 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 14 | 1.14 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 14 | 0.97 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 37 | 1.56 copies |
| GSK223192A 2 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 31 | 0.83 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 33 | 0.86 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 0 | 0.95 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 1 | 1.04 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 14 | 1.09 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 30 | 0.87 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 31 | 1.04 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 37 | 0.95 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 0 | 0.98 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 1 | 0.99 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 14 | 1.18 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 30 | 1.1 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 31 | 0.97 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 33 | 1.14 copies |
| GSK223192A 3 Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 37 | 1.38 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 33 | 0.89 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 1 | 0.94 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 31 | 0.9 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 14 | 0.99 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 30 | 1.1 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 0 | 0.9 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 30 | 0.98 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 14 | 0.77 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 31 | 0.95 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 1 | 0.94 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 37 | 1.06 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 37 | 1.09 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 33 | 0.89 copies |
| Fendrix Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 0 | 0.83 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 37 | 1.22 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 37 | 1.08 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 1 | 1.03 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 31 | 1.01 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 0 | 1.03 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 0 | 1.07 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 31 | 1.12 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 14 | 1.07 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 30 | 1.03 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 1 | 1.06 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 33 | 1.05 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 33 | 1.03 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MKI67.mRNA, Day 30 | 0.97 copies |
| Engerix-B Group | Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IL-12A.mRNA, Day 14 | 0.96 copies |
Secondary
mRNA Levels as Measured by qPCR
The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1).
Time frame: At Days 0, 1, 14, 30, 31, 33 and 37
Population: The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 33 | 2.03 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 31 | 0.6 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 31 | 4.95 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 37 | 0.93 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 33 | 0.85 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 0 | 1.08 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 30 | 0.96 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 1 | 0.83 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 37 | 0.87 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 14 | 1.02 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 14 | 1.05 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 1 | 2.31 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 30 | 0.93 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 0 | 0.92 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 30 | 1.03 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 37 | 0.97 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 14 | 1.06 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 31 | 0.67 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 1 | 0.88 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 37 | 0.89 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 33 | 0.95 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 14 | 0.96 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 33 | 1.25 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 0 | 0.99 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 1 | 2.88 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 0 | 1.02 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 31 | 3.83 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 30 | 0.88 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 30 | 0.96 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 33 | 1.12 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 37 | 0.86 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 0 | 1.06 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 1 | 0.89 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 14 | 0.97 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 30 | 1.03 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 31 | 0.83 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 33 | 0.94 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 37 | 0.97 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 0 | 0.97 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 1 | 1.31 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 14 | 0.98 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 31 | 3.13 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 37 | 0.97 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 14 | 1.04 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 30 | 0.99 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 14 | 1 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 0 | 1.06 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 31 | 0.88 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 30 | 0.89 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 1 | 0.92 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 33 | 1.01 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 37 | 0.95 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 33 | 1.01 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 0 | 0.96 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 31 | 0.9 copies |
| Fendrix Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 1 | 0.93 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 30 | 1.02 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 37 | 1.07 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 0 | 0.95 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 14 | 1.01 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 1 | 0.95 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 1 | 1.08 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 31 | 0.96 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 14 | 0.96 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 0 | 1.07 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 37 | 1.02 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 30 | 0.96 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 31 | 1.02 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | FAF1.mRNA, Day 33 | 0.98 copies |
| Engerix-B Group | mRNA Levels as Measured by qPCR | STAT1.mRNA, Day 33 | 1 copies |
Secondary
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR)
The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1).
Time frame: At Days 0, 1, 14, 30, 31, 33 and 37
Population: The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 33 | 1.33 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 30 | 1 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 0 | 0.96 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 31 | 3.14 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 33 | 2.92 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 1 | 1.51 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 30 | 0.96 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 31 | 3.06 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 14 | 0.95 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 1 | 1.61 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 14 | 1.02 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 37 | 0.93 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 0 | 1 copies |
| GSK223192A 1 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 37 | 0.99 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 30 | 0.93 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 0 | 0.99 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 1 | 1.59 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 14 | 1.01 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 31 | 2.63 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 33 | 1.03 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 37 | 0.93 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 0 | 1.01 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 1 | 1.59 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 14 | 1.03 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 31 | 2.19 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 33 | 1.83 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 37 | 0.9 copies |
| GSK223192A 2 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 30 | 0.92 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 1 | 1.18 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 33 | 0.9 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 1 | 1.24 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 33 | 1.87 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 37 | 0.86 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 14 | 0.91 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 14 | 1.02 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 30 | 0.92 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 31 | 1.73 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 0 | 0.98 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 37 | 0.9 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 30 | 0.92 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 31 | 2.06 copies |
| GSK223192A 3 Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 0 | 0.95 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 0 | 1.01 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 14 | 1.14 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 37 | 0.97 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 0 | 1.03 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 33 | 1.11 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 1 | 1.01 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 1 | 1.08 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 14 | 1.11 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 30 | 0.96 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 37 | 1.07 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 31 | 0.96 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 30 | 0.96 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 31 | 1.05 copies |
| Fendrix Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 33 | 1.07 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 31 | 0.99 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 31 | 0.92 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 0 | 1 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 37 | 1.08 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 14 | 0.97 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 30 | 0.99 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 0 | 0.98 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 37 | 1 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 14 | 1.08 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 33 | 0.98 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 30 | 0.94 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | MX1.mRNA, Day 1 | 0.9 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 33 | 1.05 copies |
| Engerix-B Group | mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) | IRF1.mRNA, Day 1 | 0.95 copies |
Secondary
Normalized Levels of C-reactive Protein (CRP)
Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.
Population: Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response \[i.e. cytokines in serum, gene expression signature, white blood cells counts\]) results available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 37 | 0.319 IH Center normlized ratio |
| GSK223192A 1 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 1 | 1.97 IH Center normlized ratio |
| GSK223192A 1 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0 | 0.248 IH Center normlized ratio |
| GSK223192A 1 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0+ | 0.248 IH Center normlized ratio |
| GSK223192A 1 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 33 | 2.6 IH Center normlized ratio |
| GSK223192A 1 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 31 | 1.521 IH Center normlized ratio |
| GSK223192A 1 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30+ | 0.248 IH Center normlized ratio |
| GSK223192A 1 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30 | 0.248 IH Center normlized ratio |
| GSK223192A 2 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0 | 0.248 IH Center normlized ratio |
| GSK223192A 2 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 37 | 0.248 IH Center normlized ratio |
| GSK223192A 2 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0+ | 0.248 IH Center normlized ratio |
| GSK223192A 2 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 1 | 0.962 IH Center normlized ratio |
| GSK223192A 2 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 33 | 1.2 IH Center normlized ratio |
| GSK223192A 2 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30 | 0.248 IH Center normlized ratio |
| GSK223192A 2 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30+ | 0.248 IH Center normlized ratio |
| GSK223192A 2 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 31 | 1.047 IH Center normlized ratio |
| GSK223192A 3 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30 | 0.248 IH Center normlized ratio |
| GSK223192A 3 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0 | 0.248 IH Center normlized ratio |
| GSK223192A 3 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 37 | 0.248 IH Center normlized ratio |
| GSK223192A 3 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30+ | 0.248 IH Center normlized ratio |
| GSK223192A 3 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0+ | 0.248 IH Center normlized ratio |
| GSK223192A 3 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 33 | 0.707 IH Center normlized ratio |
| GSK223192A 3 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 1 | 0.486 IH Center normlized ratio |
| GSK223192A 3 Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 31 | 0.61 IH Center normlized ratio |
| Fendrix Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 1 | 0.462 IH Center normlized ratio |
| Fendrix Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30 | 0.248 IH Center normlized ratio |
| Fendrix Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 31 | 0.486 IH Center normlized ratio |
| Fendrix Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 37 | 0.248 IH Center normlized ratio |
| Fendrix Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 33 | 0.486 IH Center normlized ratio |
| Fendrix Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30+ | 0.248 IH Center normlized ratio |
| Fendrix Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0 | 0.248 IH Center normlized ratio |
| Fendrix Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0+ | 0.248 IH Center normlized ratio |
| Engerix-B Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 37 | 0.248 IH Center normlized ratio |
| Engerix-B Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0 | 0.248 IH Center normlized ratio |
| Engerix-B Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 0+ | 0.248 IH Center normlized ratio |
| Engerix-B Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 1 | 0.248 IH Center normlized ratio |
| Engerix-B Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30 | 0.248 IH Center normlized ratio |
| Engerix-B Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 30+ | 0.248 IH Center normlized ratio |
| Engerix-B Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 31 | 0.248 IH Center normlized ratio |
| Engerix-B Group | Normalized Levels of C-reactive Protein (CRP) | CRP; Day 33 | 0.248 IH Center normlized ratio |
Secondary
Normalized Levels of CRP
Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.
Time frame: At Days 0, 30 and 37.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Normalized Levels of CRP | CRP; Day 30 | 0.248 IH Center normalized levels |
| GSK223192A 1 Group | Normalized Levels of CRP | CRP; Day 0 | 0.33 IH Center normalized levels |
| GSK223192A 1 Group | Normalized Levels of CRP | CRP; Day 37 | 0.486 IH Center normalized levels |
| GSK223192A 2 Group | Normalized Levels of CRP | CRP; Day 37 | 0.523 IH Center normalized levels |
| GSK223192A 2 Group | Normalized Levels of CRP | CRP; Day 0 | 0.486 IH Center normalized levels |
| GSK223192A 2 Group | Normalized Levels of CRP | CRP; Day 30 | 0.371 IH Center normalized levels |
| GSK223192A 3 Group | Normalized Levels of CRP | CRP; Day 0 | 0.253 IH Center normalized levels |
| GSK223192A 3 Group | Normalized Levels of CRP | CRP; Day 30 | 0.38 IH Center normalized levels |
| GSK223192A 3 Group | Normalized Levels of CRP | CRP; Day 37 | 0.486 IH Center normalized levels |
| Fendrix Group | Normalized Levels of CRP | CRP; Day 30 | 0.277 IH Center normalized levels |
| Fendrix Group | Normalized Levels of CRP | CRP; Day 0 | 0.296 IH Center normalized levels |
| Fendrix Group | Normalized Levels of CRP | CRP; Day 37 | 0.363 IH Center normalized levels |
| Engerix-B Group | Normalized Levels of CRP | CRP; Day 0 | 0.365 IH Center normalized levels |
| Engerix-B Group | Normalized Levels of CRP | CRP; Day 37 | 0.248 IH Center normalized levels |
| Engerix-B Group | Normalized Levels of CRP | CRP; Day 30 | 0.319 IH Center normalized levels |
Secondary
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase
Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).
Time frame: At Days 0, 30, 37 and 60.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 60 | 21.161 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 30 | 21.32 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 37 | 21.221 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 60 | 20.72 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 30 | 13.35 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 37 | 20.881 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 30 | 20.72 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 37 | 13.05 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 0 | 13.4 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 0 | 21 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 60 | 13.275 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 0 | 21.086 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 60 | 17.447 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 0 | 18.792 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 0 | 13.35 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 37 | 18.767 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 30 | 19.24 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 30 | 18.743 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 0 | 20 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 60 | 13.136 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 37 | 19.097 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 37 | 12.957 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 30 | 13.186 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 60 | 17.986 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 37 | 20.043 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 60 | 18.07 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 0 | 13.4 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 30 | 13.275 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 37 | 13.025 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 0 | 18.636 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 30 | 19.897 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 37 | 18.596 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 0 | 20 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 30 | 20.188 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 60 | 13.1 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 60 | 20.76 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 37 | 20.7 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 60 | 12.975 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 60 | 20.541 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 37 | 13.05 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 0 | 21 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 30 | 20 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 30 | 13.121 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 60 | 21 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 37 | 20 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 30 | 20.5 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 0 | 21.8 cells/mL |
| Fendrix Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 0 | 13.275 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 30 | 18.743 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 60 | 13.163 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 30 | 19.097 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 37 | 20 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 60 | 18.518 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 37 | 13.05 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 0 | 13.35 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 37 | 19.8 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 0 | 20.478 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | Hgb; Day 30 | 13.35 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | ALT; Day 0 | 21.32 cells/mL |
| Engerix-B Group | Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase | AST; Day 60 | 19.339 cells/mL |
Secondary
Normalized Levels of Red Blood Cells and Platelets
Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).
Time frame: At Days 0, 30, 37 and 60.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 30 | 261363.64 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 0 | 269318.18 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 0 | 4.45 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 37 | 295000 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 37 | 4.372 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 60 | 263333.33 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 30 | 4.461 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 60 | 4.421 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 30 | 262000 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 60 | 4.393 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 60 | 267045.46 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 30 | 4.382 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 0 | 270833.33 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 37 | 274431.82 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 37 | 4.346 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 0 | 4.433 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 0 | 4.464 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 60 | 259000 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 30 | 4.423 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 37 | 4.395 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 60 | 4.364 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 0 | 270000 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 30 | 260470.78 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 37 | 269000 cells/mL |
| Fendrix Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 30 | 274431.82 cells/mL |
| Fendrix Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 37 | 282477.27 cells/mL |
| Fendrix Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 37 | 4.37 cells/mL |
| Fendrix Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 60 | 4.371 cells/mL |
| Fendrix Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 0 | 4.38 cells/mL |
| Fendrix Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 30 | 4.388 cells/mL |
| Fendrix Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 60 | 273239.44 cells/mL |
| Fendrix Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 0 | 267187.5 cells/mL |
| Engerix-B Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 37 | 4.388 cells/mL |
| Engerix-B Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 60 | 262588.03 cells/mL |
| Engerix-B Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 30 | 258333.33 cells/mL |
| Engerix-B Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 30 | 4.486 cells/mL |
| Engerix-B Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 0 | 259000 cells/mL |
| Engerix-B Group | Normalized Levels of Red Blood Cells and Platelets | PLA; Day 37 | 268622.45 cells/mL |
| Engerix-B Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 0 | 4.456 cells/mL |
| Engerix-B Group | Normalized Levels of Red Blood Cells and Platelets | RBC; Day 60 | 4.4 cells/mL |
Secondary
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase
Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).
Time frame: At Days 0, 30, 37 and 60.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 60 | 29.8 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 37 | 348.894 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 0 | 0.893 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 60 | 0.92 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 30 | 30.127 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 60 | 341.975 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 30 | 343.75 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 37 | 0.906 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 0 | 29.5 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 37 | 29.5 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA, at Day 30 | 0.9 cells/mL |
| GSK223192A 1 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 0 | 336.364 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 60 | 335.141 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 30 | 28.667 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA, at Day 30 | 0.84 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 37 | 27.833 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 0 | 0.841 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 37 | 342.857 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 37 | 0.83 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 60 | 28.905 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 30 | 329.6 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 60 | 0.84 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 0 | 335.281 cells/mL |
| GSK223192A 2 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 0 | 28.667 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 37 | 331.967 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 0 | 0.889 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA, at Day 30 | 0.874 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 37 | 0.883 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 60 | 0.873 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 0 | 30.095 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 30 | 30.462 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 37 | 30.333 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 60 | 29.5 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 0 | 328.3 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 30 | 330.32 cells/mL |
| GSK223192A 3 Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 60 | 324.675 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 30 | 30.048 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 0 | 0.86 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 60 | 30.095 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 0 | 30 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 0 | 336.054 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 60 | 0.934 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 60 | 348.438 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 30 | 337.428 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 37 | 0.92 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA, at Day 30 | 0.888 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 37 | 340.606 cells/mL |
| Fendrix Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 37 | 31 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 30 | 30.095 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 30 | 320.671 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 0 | 0.85 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 60 | 29.65 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA, at Day 30 | 0.87 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 60 | 0.915 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 60 | 320.927 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 0 | 29.202 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 0 | 325.85 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | UREA; Day 37 | 28.667 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA; Day 37 | 0.909 cells/mL |
| Engerix-B Group | Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase | LHD; Day 37 | 319.048 cells/mL |
Secondary
Normalized Levels of WBC and of CPK
Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.
Time frame: At Days 0, 30, 37 and 60.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Normalized Levels of WBC and of CPK | WBC; Day 37 | 6736.842 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of WBC and of CPK | WBC; Day 30 | 6870.05 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of WBC and of CPK | CPK; Day 30 | 108.617 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of WBC and of CPK | CPK; Day 0 | 105.529 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of WBC and of CPK | WBC; Day 0 | 6627.764 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of WBC and of CPK | CPK; Day 37 | 105.351 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of WBC and of CPK | WBC; Day 60 | 6738.636 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of WBC and of CPK | CPK; Day 60 | 112.842 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of WBC and of CPK | CPK; Day 37 | 99.399 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of WBC and of CPK | WBC; Day 0 | 6748.689 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of WBC and of CPK | WBC; Day 30 | 6454.545 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of WBC and of CPK | WBC; Day 37 | 7196.579 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of WBC and of CPK | WBC; Day 60 | 6330 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of WBC and of CPK | CPK; Day 60 | 104 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of WBC and of CPK | CPK; Day 0 | 102.696 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of WBC and of CPK | CPK; Day 30 | 103.647 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of WBC and of CPK | WBC; Day 0 | 6782.414 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of WBC and of CPK | WBC; Day 30 | 6600 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of WBC and of CPK | WBC; Day 37 | 6550 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of WBC and of CPK | CPK; Day 37 | 109.294 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of WBC and of CPK | WBC; Day 60 | 6625.789 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of WBC and of CPK | CPK; Day 0 | 109.756 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of WBC and of CPK | CPK; Day 30 | 114 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of WBC and of CPK | CPK; Day 60 | 107.6 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of WBC and of CPK | WBC; Day 0 | 7590 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of WBC and of CPK | WBC; Day 37 | 6673.182 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of WBC and of CPK | CPK; Day 30 | 102.1 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of WBC and of CPK | CPK; Day 60 | 102.4 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of WBC and of CPK | WBC; Day 60 | 7175.909 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of WBC and of CPK | CPK; Day 37 | 122.66 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of WBC and of CPK | CPK; Day 0 | 114 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of WBC and of CPK | WBC; Day 30 | 6950.82 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of WBC and of CPK | CPK; Day 0 | 120.857 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of WBC and of CPK | WBC; Day 60 | 6740 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of WBC and of CPK | CPK; Day 37 | 124.667 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of WBC and of CPK | CPK; Day 60 | 120.989 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of WBC and of CPK | WBC; Day 0 | 6810 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of WBC and of CPK | CPK; Day 30 | 113.079 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of WBC and of CPK | WBC; Day 30 | 6590 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of WBC and of CPK | WBC; Day 37 | 6440 IH Center normalized ratio |
Secondary
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK)
Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.
Population: Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response \[i.e. cytokines in serum, gene expression signature, white blood cells counts\]) results available for at least one post-vaccination time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 60 | 6400 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 37 | 6219.048 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 33 | 6450 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30+ | 7570 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 31 | 8160 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 33 | 107 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0+ | 7729.231 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0 | 6840 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 31 | 109 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 30+ | 120 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK, at Day 30 | 123.263 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 1 | 8265 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 60 | 120 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 1 | 109 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0+ | 117 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0 | 113 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30 | 5960 IH Center normalized ratio |
| GSK223192A 1 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 37 | 112.118 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30+ | 7350 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0 | 6090 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0+ | 7670 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 1 | 7850 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30 | 6090 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 31 | 7533.333 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 33 | 6080 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 37 | 6464.341 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 60 | 6320 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0 | 93 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0+ | 99.297 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 1 | 89.784 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK, at Day 30 | 90 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 30+ | 91.772 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 31 | 90 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 33 | 87 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 37 | 93.986 IH Center normalized ratio |
| GSK223192A 2 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 60 | 85 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 60 | 114 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 1 | 7610 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 33 | 104 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 1 | 104 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 37 | 6760 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 31 | 106.973 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0+ | 7520 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 30+ | 115.73 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK, at Day 30 | 115.73 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30 | 6290 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0 | 6650 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0 | 110 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 33 | 6290 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30+ | 7120 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 60 | 6090 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 37 | 118 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0+ | 112 IH Center normalized ratio |
| GSK223192A 3 Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 31 | 7422.222 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 31 | 7980 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 37 | 6740 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0 | 6523.81 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 60 | 6540 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 60 | 110.647 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0 | 114 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 1 | 8400 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0+ | 114.842 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 37 | 106.311 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 1 | 102 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK, at Day 30 | 99 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0+ | 7620 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 30+ | 106 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 31 | 103.614 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30+ | 7371.429 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30 | 6421.053 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 33 | 101 IH Center normalized ratio |
| Fendrix Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 33 | 7150 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 1 | 86 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30 | 6076.923 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 31 | 98 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0 | 6480 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0+ | 94 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 0 | 84.108 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 33 | 6170 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 30+ | 7625 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 1 | 7130 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 60 | 5970 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 37 | 6870 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 33 | 91.772 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK, at Day 30 | 93 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 37 | 93.689 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 31 | 6550 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 30+ | 93 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | WBC; Day 0+ | 7210 IH Center normalized ratio |
| Engerix-B Group | Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) | CPK; Day 60 | 96 IH Center normalized ratio |
Secondary
Number of HB - Specific CD4+ T Cells
The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.
Time frame: At Days 0, 14, 30, 33, 37, 44 and 60
Population: Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 37 | 844 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 60 | 1291 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 44 | 2021 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 0 | 68 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 30 | 313 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 33 | 114 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 14 | 425 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 60 | 1477 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 33 | 270 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 44 | 2890 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 14 | 498 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 0 | 98 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 30 | 314 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 37 | 869 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 44 | 1253 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 60 | 768 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 14 | 149 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 30 | 243 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 33 | 110 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 0 | 25 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 37 | 486 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 30 | 67 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 44 | 271 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 60 | 200 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 37 | 67 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 0 | 48 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 33 | 63 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 14 | 75 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 60 | 247 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 0 | 31 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 14 | 85 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 33 | 126 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 37 | 174 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 44 | 265 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells | HB-CD4+, at Day 30 | 110 HB-CD4+ T cells (per million cells) |
Secondary
Number of HB - Specific CD4+ T Cells.
The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: At Days 0, 360 and 374
Population: Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 360 | 1029 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 0 | 228 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 374 | 1006 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 374 | 1037 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 0 | 233 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 360 | 770 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 0 | 254 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 360 | 538 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 374 | 688 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 360 | 300 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 0 | 234 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 374 | 401 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 0 | 266 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 374 | 353 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD4+ T Cells. | HB-CD4+, at Day 360 | 360 HB-CD4+ T cells (per million cells) |
Secondary
Number of HB Specific CD4+ T Cells .
The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: At Days 0, 180 and 360
Population: Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 0 | 230 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 360 | 960 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 180 | 1090 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 180 | 954 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 0 | 231 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 360 | 829 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 180 | 546 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 0 | 248 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 360 | 564 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 0 | 223 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 360 | 388 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 180 | 360 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 180 | 334 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 0 | 240 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB Specific CD4+ T Cells . | HB-CD4+, at Day 360 | 350 HB-CD4+ T cells (per million cells) |
Secondary
Number of HB - Specific CD8+ T Cells
The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.
Time frame: At Days 0, 14, 30, 44, 60 and 180
Population: Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 0 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 33 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 60 | 37 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 44 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 30 | 64 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 14 | 12 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 37 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 37 | 103 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 33 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 60 | 102 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 14 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 0 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 44 | 99 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 30 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 33 | 41 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 30 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 0 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 14 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 37 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 44 | 11 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 60 | 11 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 30 | 11 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 37 | 11 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 14 | 11 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 60 | 11 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 44 | 11 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 0 | 11 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 33 | 11 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 30 | 11 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 60 | 11 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 44 | 11 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 37 | 42 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 14 | 11 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 0 | 11 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD4+, at Day 33 | 11 HB-CD8+ T cells (per million cells) |
Secondary
Number of HB - Specific CD8+ T Cells
The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: At Days 0, 360 and 374
Population: Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 0 | 187 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 374 | 107 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 360 | 109 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 360 | 118 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 0 | 161 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 374 | 111 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 360 | 121 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 0 | 196 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 374 | 122 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 0 | 244 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 374 | 121 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 360 | 99 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 360 | 90 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 0 | 168 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells | HB-CD8+, at Day 374 | 111 HB-CD8+ T cells (per million cells) |
Secondary
Number of HB - Specific CD8+ T Cells.
The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: At Days 0, 180 and 360
Population: Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 0 | 175 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 360 | 114 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 180 | 120 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 180 | 124 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 0 | 169 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 360 | 115 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 180 | 92 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 0 | 176 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 360 | 112 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 0 | 191 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 360 | 104 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 180 | 102 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 180 | 110 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 0 | 184 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of HB - Specific CD8+ T Cells. | HB-CD8+, at Day 360 | 90 HB-CD8+ T cells (per million cells) |
Secondary
Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile
The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: At Days 0 and 180
Population: Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 0 | 66 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 180 | 129 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 0 | 51 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 180 | 54 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 0 | 63 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 180 | 63 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 180 | 137 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 0 | 64 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 180 | 46 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 180 | 76 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 0 | 57 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 0 | 53 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 0 | 65 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 180 | 68 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 180 | 54 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 0 | 50 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 180 | 49 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th2, at Day 0 | 48 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 180 | 70 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile | HB-CD4+, Th1, at Day 0 | 64 HB-CD4+ T cells (per million cells) |
Secondary
Number of HB-specific Memory B Cells
The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 180 and 360
Population: Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 180 | 1454 HB mem-B cells (per million cells) |
| GSK223192A 1 Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 360 | 1070 HB mem-B cells (per million cells) |
| GSK223192A 2 Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 180 | 1013 HB mem-B cells (per million cells) |
| GSK223192A 2 Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 360 | 1437 HB mem-B cells (per million cells) |
| GSK223192A 3 Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 180 | 1410 HB mem-B cells (per million cells) |
| GSK223192A 3 Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 360 | 1473 HB mem-B cells (per million cells) |
| Fendrix Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 360 | 66 HB mem-B cells (per million cells) |
| Fendrix Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 180 | 24 HB mem-B cells (per million cells) |
| Engerix-B Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 180 | 1 HB mem-B cells (per million cells) |
| Engerix-B Group | Number of HB-specific Memory B Cells | HB-mem B cells, at Day 360 | 21 HB mem-B cells (per million cells) |
Secondary
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells
The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: At Days 0, 14, 30 and 60
Population: Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30 or 60 time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 0 | 228 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 14 | 408 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 30 | 277 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 60 | 965 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 0 | 230 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 60 | 958 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 14 | 447 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 30 | 333 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 60 | 587 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 14 | 460 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 30 | 314 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 0 | 234 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 0 | 234 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 14 | 289 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 60 | 393 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 30 | 255 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 60 | 308 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 30 | 249 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 14 | 245 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells | HB-CD4+, at Day 0 | 235 HB-CD4+ T cells (per million cells) |
Secondary
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile
The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: At Days 0, 14, 30, 44 and 60
Population: Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 14 | 52 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 0 | 50 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 60 | 78 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 14 | 64 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 0 | 65 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 44 | 85 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 30 | 61 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 30 | 39 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 44 | 155 HB-CD4+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 60 | 119 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 14 | 58 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 60 | 141 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 60 | 58 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 0 | 63 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 30 | 52 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 44 | 174 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 44 | 77 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 30 | 66 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 14 | 75 HB-CD4+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 0 | 62 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 30 | 75 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 0 | 53 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 14 | 68 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 44 | 95 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 60 | 90 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 0 | 55 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 14 | 60 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 30 | 56 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 44 | 87 HB-CD4+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 60 | 71 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 14 | 81 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 14 | 42 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 60 | 53 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 44 | 55 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 44 | 74 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 30 | 45 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 60 | 94 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 0 | 70 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 0 | 53 HB-CD4+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 30 | 64 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 0 | 52 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 14 | 57 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 30 | 72 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 14 | 66 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 60 | 59 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 30 | 47 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 0 | 67 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th2, at Day 44 | 74 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 60 | 61 HB-CD4+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile | HB-CD4+, Th1, at Day 44 | 64 HB-CD4+ T cells (per million cells) |
Secondary
Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells.
The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: At Days 0, 14, 30, 44, and 60
Population: Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 44 | 212 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 0 | 176 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 60 | 209 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 14 | 174 HB-CD8+ T cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 30 | 185 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 44 | 213 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 30 | 173 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 14 | 160 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 60 | 228 HB-CD8+ T cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 0 | 174 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 30 | 160 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 0 | 172 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 14 | 174 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 44 | 177 HB-CD8+ T cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 60 | 171 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 60 | 184 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 0 | 201 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 44 | 157 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 30 | 191 HB-CD8+ T cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 14 | 193 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 30 | 173 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 44 | 169 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 0 | 184 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 60 | 166 HB-CD8+ T cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. | HB-CD8+, at Day 14 | 177 HB-CD8+ T cells (per million cells) |
Secondary
Number of Hepatitis B (HB)-Specific Memory B Cells
The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 0, 30, 37, 44 and 60.
Population: Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 44 | 4656 HB mem-B cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 0 | 14 HB mem-B cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 30 | 296 HB mem-B cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 60 | 3742 HB mem-B cells (per million cells) |
| GSK223192A 1 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 37 | 3817 HB mem-B cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 44 | 4808 HB mem-B cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 37 | 3577 HB mem-B cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 30 | 186 HB mem-B cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 0 | 1 HB mem-B cells (per million cells) |
| GSK223192A 2 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 60 | 3383 HB mem-B cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 37 | 2597 HB mem-B cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 0 | 1 HB mem-B cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 30 | 265 HB mem-B cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 44 | 2498 HB mem-B cells (per million cells) |
| GSK223192A 3 Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 60 | 1806 HB mem-B cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 60 | 47 HB mem-B cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 0 | 1 HB mem-B cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 44 | 51 HB mem-B cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 37 | 71 HB mem-B cells (per million cells) |
| Fendrix Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 30 | 28 HB mem-B cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 37 | 19 HB mem-B cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 44 | 28 HB mem-B cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 0 | 1 HB mem-B cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 60 | 44 HB mem-B cells (per million cells) |
| Engerix-B Group | Number of Hepatitis B (HB)-Specific Memory B Cells | HB-mem B cells, at Day 30 | 1 HB mem-B cells (per million cells) |
Secondary
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.
Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 360 and 390.
Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Abn. Day 390 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Nor. Day 390 | 47 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Nor. Day 390 | 55 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Abn. Day 390 | 6 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Nor. Day 390 | 44 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Nor. Day 390 | 56 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Nor. Day 390 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Nor. Day 390 | 56 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Abn. Day 390 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Nor. Day 390 | 39 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Nor. Day 390 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Nor. Day 390 | 6 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Abn. Day 390 | 5 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Abn. Day 390 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Nor. Day 390 | 5 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Nor. Day 390 | 47 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Abn. Day 390 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Abn. Day 390 | 5 Participants |
| GSK223192A 1 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Abn. Day 390 | 10 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Nor. Day 390 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Nor. Day 390 | 54 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Nor. Day 390 | 48 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Nor. Day 390 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Abn. Day 390 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Nor. Day 390 | 50 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Nor. Day 390 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Abn. Day 390 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Nor. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Nor. Day 390 | 50 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Nor. Day 390 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Nor. Day 390 | 47 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Nor. Day 390 | 52 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Nor. Day 390 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Abn. Day 390 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Nor. Day 390 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Nor. Day 390 | 46 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Abn. Day 390 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Nor. Day 390 | 50 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Abn. Day 390 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Nor. Day 390 | 7 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Abn. Day 390 | 7 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Nor. Day 390 | 38 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Nor. Day 390 | 53 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Abn. Day 390 | 5 Participants |
| GSK223192A 3 Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Nor. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Nor. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Nor. Day 390 | 52 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Abn. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Nor. Day 390 | 47 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Nor. Day 390 | 0 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Nor. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Abn. Day 390 | 4 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Abn. Day 390 | 10 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Abn. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Nor. Day 390 | 39 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Nor. Day 390 | 49 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Abn. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Nor. Day 390 | 47 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Abn. Day 390 | 0 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Abn. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Abn. Day 390 | 0 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Nor. Day 390 | 50 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Nor. Day 390 | 50 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Abn. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Nor. Day 390 | 49 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Nor. Day 390 | 47 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Abn. Day 390 | 2 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Nor. Day 390 | 50 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Nor. Day 390 | 2 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 360 - Nor. Day 390 | 3 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Abn. Day 390 | 5 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 360 - Abn. Day 390 | 2 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 360 - Nor. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 360 - Abn. Day 390 | 2 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Nor. Day 390 | 3 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 360 - Abn. Day 390 | 2 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 360 - Abn. Day 390 | 5 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 360 - Nor. Day 390 | 53 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 360 - Nor. Day 390 | 46 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 360 - Nor. Day 390 | 53 Participants |
| Engerix-B Group | Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 360 - Nor. Day 390 | 46 Participants |
Secondary
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase
Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Days 360 and 390.
Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Nor. Day 390 | 53 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Abn. Day 390 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Abn. Day 390 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Nor. Day 390 | 52 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Nor. Day 390 | 55 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Nor. Day 390 | 58 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Nor. Day 390 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Nor. Day 390 | 55 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Nor. Day 390 | 52 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Abn. Day 390 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Nor. Day 390 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Abn. Day 390 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Nor. Day 390 | 54 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Nor. Day 390 | 55 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Nor. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Nor. Day 390 | 54 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Nor. Day 390 | 53 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Nor. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Nor. Day 390 | 55 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Nor. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Nor. Day 390 | 56 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Nor. Day 390 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Abn. Day 390 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Nor. Day 390 | 48 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Nor. Day 390 | 53 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Nor. Day 390 | 5 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Nor. Day 390 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Nor. Day 390 | 50 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Nor. Day 390 | 47 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Nor. Day 390 | 53 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Nor. Day 390 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Abn. Day 390 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Nor. Day 390 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Nor. Day 390 | 53 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Abn. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Nor. Day 390 | 51 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Nor. Day 390 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Abn. Day 390 | 6 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Nor. Day 390 | 46 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Abn. Day 390 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Nor. Day 390 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Abn. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Nor. Day 390 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Abn. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Abn. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Abn. Day 390 | 0 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Abn. Day 390 | 0 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Abn. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Nor. Day 390 | 0 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Nor. Day 390 | 48 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Nor. Day 390 | 45 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Nor. Day 390 | 52 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Nor. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Abn. Day 390 | 5 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Abn. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Nor. Day 390 | 48 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Abn. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Nor. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Nor. Day 390 | 2 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Nor. Day 390 | 50 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Abn. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Abn. Day 390 | 0 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Nor. Day 390 | 48 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Abn. Day 390 | 4 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Nor. Day 390 | 51 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Nor. Day 390 | 50 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Abn. Day 390 | 3 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Nor. Day 390 | 0 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Nor. Day 390 | 4 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Abn. Day 390 | 4 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Nor. Day 390 | 48 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Abn. Day 390 | 4 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Abn. Day 390 | 2 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Abn. Day 390 | 2 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Nor. Day 390 | 51 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 360 - Nor. Day 390 | 47 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 360 - Nor. Day 390 | 47 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Abn. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Nor. Day 390 | 49 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Abn. Day 390 | 4 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Nor. Day 390 | 50 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 360 - Nor. Day 390 | 3 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 360 - Nor. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 360 - Nor. Day 390 | 51 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Nor. Day 390 | 50 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 360 - Abn. Day 390 | 3 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 360 - Nor. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 360 - Abn. Day 390 | 0 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 360 - Nor. Day 390 | 1 Participants |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 360 - Abn. Day 390 | 3 Participants |
Secondary
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.
Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.
Time frame: Post vaccination (up to Day 360)
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. | 12 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. | 12 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. | 19 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. | 119 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. | 20 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. | 35 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. | 124 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. | 103 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. | 118 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. | 14 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. | 13 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. | 126 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. | 126 Subjects |
| GSK223192A 1 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. | 125 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. | 120 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. | 20 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. | 115 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. | 22 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. | 127 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. | 118 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. | 10 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. | 13 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. | 18 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. | 18 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. | 130 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. | 25 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. | 122 Subjects |
| GSK223192A 2 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. | 122 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. | 111 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. | 13 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. | 118 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. | 36 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. | 95 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. | 20 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. | 19 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. | 112 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. | 13 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. | 118 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. | 24 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. | 107 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. | 25 Subjects |
| GSK223192A 3 Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. | 106 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. | 114 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. | 14 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. | 19 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. | 119 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. | 95 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. | 11 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. | 16 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. | 38 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. | 117 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. | 122 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. | 119 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. | 22 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. | 14 Subjects |
| Fendrix Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. | 111 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. | 25 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. | 115 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. | 9 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. | 10 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. | 110 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. | 12 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. | 120 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. | 126 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. | 98 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. | 123 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. | 125 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. | 20 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. | 15 Subjects |
| Engerix-B Group | Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. | 37 Subjects |
Secondary
Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs)
AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Any AESI(s) | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) | Related AESI(s) | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens
Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any AE(s) | 12 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any grade 3 AE(s) | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with related AE(s) | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with Grade 3 and related AE(s) | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any AE(s) | 8 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with Grade 3 and related AE(s) | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any grade 3 AE(s) | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with related AE(s) | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with Grade 3 and related AE(s) | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any grade 3 AE(s) | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with related AE(s) | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any AE(s) | 9 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any AE(s) | 14 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any grade 3 AE(s) | 4 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with Grade 3 and related AE(s) | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with related AE(s) | 2 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with Grade 3 and related AE(s) | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with related AE(s) | 2 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any grade 3 AE(s) | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination | Subjects with any AE(s) | 10 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine.
Time frame: Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with any AE(s) | 80 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 AE(s) | 17 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with related AE(s) | 32 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 and related AE(s) | 7 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with any AE(s) | 73 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 and related AE(s) | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 AE(s) | 11 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with related AE(s) | 19 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 and related AE(s) | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 AE(s) | 12 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with related AE(s) | 27 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with any AE(s) | 76 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with any AE(s) | 67 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 AE(s) | 19 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 and related AE(s) | 1 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with related AE(s) | 21 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 and related AE(s) | 2 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with related AE(s) | 19 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with Grade 3 AE(s) | 15 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination | Subjects with any AE(s) | 71 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination.
Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (\>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (\>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens
Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fever | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Malaise | 6 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Gastr. | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Malaise | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Gastr. | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fever | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Malaise | 6 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fever | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Headache | 15 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Headache | 13 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Myalgia | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Gastr. | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Myalgia | 4 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fatigue | 15 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Myalgia | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fatigue | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fatigue | 15 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Headache | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Myalgia | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Malaise | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Malaise | 4 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Myalgia | 3 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fatigue | 12 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fever | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fatigue | 14 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fever | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Gastr. | 5 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fever | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Gastr. | 5 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Headache | 7 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Myalgia | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Gastr. | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Headache | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Headache | 5 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fatigue | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Malaise | 5 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fatigue | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Myalgia | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fever | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Malaise | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Malaise | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Headache | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fatigue | 5 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Myalgia | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fatigue | 7 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Gastr. | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fever | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Malaise | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fever | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Headache | 7 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Myalgia | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Gastr. | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Headache | 6 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Gastr. | 4 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Myalgia | 5 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fatigue | 15 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fatigue | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fatigue | 13 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fever | 3 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fever | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fever | 2 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Gastr. | 3 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Headache | 1 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Headache | 7 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Malaise | 4 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Malaise | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Malaise | 4 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Myalgia | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Myalgia | 5 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Gastr. | 2 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Gastr. | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Headache | 8 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fatigue | 10 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Myalgia | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Headache | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Gastr. | 5 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Fever | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Gastr. | 3 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Myalgia | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fever | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fever | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Fatigue | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Fatigue | 12 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Gastr. | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Headache | 14 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Malaise | 4 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Myalgia | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Grade 3 Malaise | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Any Malaise | 4 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. | Related Headache | 9 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination.
Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (\>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (\>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity.
Time frame: Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Gastr. | 2 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Gastr. | 30 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fever | 42 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fever | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fatigue | 83 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fever | 45 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Myalgia | 10 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Myalgia | 85 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Malaise | 53 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fatigue | 5 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Myalgia | 79 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Malaise | 9 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Malaise | 60 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Headache | 74 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fatigue | 91 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Headache | 8 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Headache | 90 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Gastr. | 21 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fever | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fever | 23 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fatigue | 76 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fatigue | 5 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fatigue | 67 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fever | 17 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Gastr. | 27 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Gastr. | 5 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Gastr. | 13 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Headache | 67 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Headache | 6 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Headache | 52 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Malaise | 44 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Malaise | 5 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Malaise | 36 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Myalgia | 57 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Myalgia | 4 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Myalgia | 49 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fever | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Myalgia | 47 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Gastr. | 5 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Headache | 46 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fever | 17 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Malaise | 30 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fever | 24 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Malaise | 4 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Malaise | 39 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fatigue | 5 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Gastr. | 29 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Headache | 66 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fatigue | 67 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Myalgia | 55 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fatigue | 57 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Myalgia | 3 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Headache | 8 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Gastr. | 19 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Malaise | 35 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Gastr. | 4 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Gastr. | 20 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fatigue | 55 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Myalgia | 50 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Headache | 62 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Headache | 3 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Myalgia | 2 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Headache | 41 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fatigue | 4 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fever | 6 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Malaise | 4 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Malaise | 27 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fatigue | 70 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fever | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fever | 12 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Myalgia | 58 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Gastr. | 36 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Headache | 35 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Gastr. | 7 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Malaise | 16 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Gastr. | 35 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fatigue | 3 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Headache | 5 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fatigue | 42 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Fever | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fever | 17 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Headache | 59 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Malaise | 28 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Myalgia | 34 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Gastr. | 19 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Myalgia | 2 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Fever | 5 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Grade 3 Malaise | 2 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Any Fatigue | 62 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. | Related Myalgia | 22 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination.
Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (\>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens
Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Grade 3 Pain | 0 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Pain | 19 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Redness | 6 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Redness > 50 mm | 1 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Swelling | 3 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Swelling > 50 mm | 1 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Swelling > 50 mm | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Swelling | 4 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Pain | 19 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Redness | 3 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Redness > 50 mm | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Grade 3 Pain | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Redness > 50 mm | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Swelling | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Redness | 8 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Grade 3 Pain | 1 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Pain | 13 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Swelling > 50 mm | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Pain | 16 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Grade 3 Pain | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Redness | 6 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Redness > 50 mm | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Swelling > 50 mm | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Swelling | 5 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Swelling | 1 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Grade 3 Pain | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Swelling > 50 mm | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Redness > 50 mm | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Redness | 2 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. | Any Pain | 10 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination.
Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (\>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination.
Time frame: Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Pain | 134 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Grade 3 Pain | 9 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Redness | 71 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Redness > 50 mm | 11 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Swelling | 46 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Swelling > 50 mm | 9 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Swelling | 36 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Swelling > 50 mm | 3 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Pain | 129 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Redness | 39 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Redness > 50 mm | 2 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Grade 3 Pain | 5 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Redness > 50 mm | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Swelling | 34 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Pain | 123 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Redness | 35 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Grade 3 Pain | 2 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Swelling > 50 mm | 2 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Redness > 50 mm | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Grade 3 Pain | 6 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Redness | 53 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Swelling > 50 mm | 2 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Swelling | 43 Participants |
| Fendrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Pain | 128 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Swelling | 16 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Redness | 23 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Grade 3 Pain | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Swelling > 50 mm | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Redness > 50 mm | 0 Participants |
| Engerix-B Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. | Any Pain | 70 Participants |
Secondary
Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination
A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination.
Time frame: During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Any SAE(s) | 7 Participants |
| GSK223192A 1 Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Related SAE(s) | 0 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Any SAE(s) | 4 Participants |
| GSK223192A 2 Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Related SAE(s) | 0 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Any SAE(s) | 10 Participants |
| GSK223192A 3 Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Related SAE(s) | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Related SAE(s) | 0 Participants |
| Fendrix Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Any SAE(s) | 7 Participants |
| Engerix-B Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Any SAE(s) | 7 Participants |
| Engerix-B Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination | Related SAE(s) | 0 Participants |
Secondary
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH
Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.
Time frame: post vaccination (up to Day 360).
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Nor. | 127 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Nor. | 127 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Nor. | 127 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Abn. | 10 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Abn. | 11 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Nor. | 114 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Abn. | 24 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Nor. | 123 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Nor. | 127 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Abn. | 11 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Nor. | 128 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Abn. | 11 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Abn. | 11 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Abn. | 15 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Nor. | 112 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Abn. | 26 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Abn. | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Abn. | 20 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Nor. | 126 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Abn. | 11 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Nor. | 120 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Abn. | 5 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Nor. | 135 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Abn. | 13 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Abn. | 14 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Nor. | 127 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Abn. | 14 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Nor. | 126 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Nor. | 123 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Nor. | 129 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Abn. | 17 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Nor. | 131 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Abn. | 10 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Abn. | 9 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Nor. | 119 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Abn. | 18 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Nor. | 113 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Nor. | 121 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Abn. | 16 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Abn. | 12 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Nor. | 115 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Abn. | 19 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Nor. | 124 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Nor. | 119 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Nor. | 112 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Abn. | 12 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Nor. | 122 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Abn. | 7 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Nor. | 128 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Abn. | 23 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Nor. | 110 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Abn. | 17 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Abn. | 5 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Nor. | 116 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Abn. | 4 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Nor. | 129 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Abn. | 13 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Nor. | 120 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Abn. | 7 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Nor. | 126 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Abn. | 9 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Nor. | 124 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Abn. | 17 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Nor. | 116 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Abn. | 18 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Abn. | 10 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Nor. | 124 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | LDH Abn. | 11 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Abn. | 17 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | S-CREA Nor. | 117 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Nor. | 120 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | HGB Abn. | 15 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Nor. | 126 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Nor. | 127 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | UREA Abn. | 8 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | AST Abn. | 9 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Nor. | 123 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | RBC Abn. | 12 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | PLA Nor. | 125 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH | ALT Nor. | 118 Participants |
Secondary
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase
Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60).
Time frame: At Day 0 and up to Day 60.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Nor. Day 60 | 122 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Abn. Day 60 | 12 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Abn. Day 60 | 11 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Nor. Day 60 | 119 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Nor. Day 60 | 113 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Abn. Day 60 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Nor. Day 60 | 128 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Abn. Day 60 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Nor. Day 60 | 117 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Abn. Day 60 | 12 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Nor. Day 60 | 125 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Abn. Day 60 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Abn. Day 60 | 15 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Nor. Day 60 | 127 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Abn. Day 60 | 15 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Nor. Day 60 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Nor. Day 60 | 112 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Abn. Day 60 | 18 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Abn. Day 60 | 12 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Abn. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Abn. Day 60 | 11 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Abn. Day 60 | 11 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Nor. Day 60 | 113 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Nor. Day 60 | 136 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Nor. Day 60 | 123 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Abn. Day 60 | 13 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Abn. Day 60 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Nor. Day 60 | 122 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Nor. Day 60 | 127 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Nor. Day 60 | 116 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Nor. Day 60 | 127 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Nor. Day 60 | 122 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Nor. Day 60 | 6 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Nor. Day 60 | 115 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Nor. Day 60 | 128 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Abn. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Nor. Day 60 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Abn. Day 60 | 11 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Nor. Day 60 | 115 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Nor. Day 60 | 126 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Nor. Day 60 | 122 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Abn. Day 60 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Nor. Day 60 | 6 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Abn. Day 60 | 17 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Nor. Day 60 | 113 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Abn. Day 60 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Nor. Day 60 | 124 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Abn. Day 60 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Nor. Day 60 | 5 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Abn. Day 60 | 16 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Nor. Day 60 | 113 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Abn. Day 60 | 8 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Nor. Day 60 | 122 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Nor. Day 60 | 119 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Abn. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Abn. Day 60 | 9 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Nor. Day 60 | 4 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Nor. Day 60 | 7 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Abn. Day 60 | 14 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Abn. Day 60 | 11 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Nor. Day 60 | 121 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Nor. Day 60 | 116 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Abn. Day 60 | 6 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Abn. Day 60 | 8 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Abn. Day 60 | 14 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Abn. Day 60 | 1 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Abn. Day 60 | 12 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Nor. Day 60 | 120 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Abn. Day 60 | 6 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Nor. Day 60 | 122 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Nor. Day 60 | 129 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Abn. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Nor. Day 60 | 124 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Abn. Day 60 | 8 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Abn. Day 60 | 9 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Abn. Day 60 | 8 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Nor. Day 60 | 6 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Abn. Day 60 | 8 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Nor. Day 60 | 121 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Nor. Day 60 | 125 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Nor. Day 60 | 126 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Nor. Day 60 | 110 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Abn. Day 60 | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Nor. Day 0 - Abn. Day 60 | 8 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Abn. Day 60 | 4 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Nor. Day 0 - Abn. Day 60 | 16 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Abn. Day 60 | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | UREA Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Abn. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Abn. Day 0 - Nor. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Nor. Day 60 | 4 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Nor. Day 60 | 113 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Abn. Day 0 - Abn. Day 60 | 7 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | HGB Abn. Day 0 - Abn. Day 60 | 9 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Nor. Day 0 - Abn. Day 60 | 9 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Abn. Day 60 | 12 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Nor. Day 0 - Nor. Day 60 | 119 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | RBC Nor. Day 0 - Nor. Day 60 | 124 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Nor. Day 60 | 128 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | PLA Nor. Day 0 - Abn. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Nor. Day 0 - Abn. Day 60 | 9 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | S-CREA Abn. Day 0 - Abn. Day 60 | 12 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | ALT Abn. Day 0 - Nor. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | AST Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase | LDH Abn. Day 0 - Abn. Day 60 | 8 Participants |
Secondary
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.
Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.
Time frame: At Day 0 and up to Day 60.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Abn. Day 60 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Nor. Day 60 | 59 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Nor. Day 60 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Abn. Day 60 | 14 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Nor. Day 60 | 42 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Nor. Day 60 | 51 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Nor. Day 60 | 51 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Nor. Day 60 | 50 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Abn. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Nor. Day 60 | 56 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Nor. Day 60 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Nor. Day 60 | 54 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Nor. Day 60 | 2 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Nor. Day 60 | 54 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Nor. Day 60 | 6 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Abn. Day 60 | 11 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Abn. Day 60 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Nor. Day 60 | 49 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Abn. Day 60 | 12 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Nor. Day 60 | 46 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Nor. Day 60 | 51 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Abn. Day 60 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Abn. Day 60 | 4 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Nor. Day 60 | 54 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Nor. Day 60 | 42 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Abn. Day 60 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Nor. Day 60 | 50 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Nor. Day 60 | 56 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Nor. Day 60 | 46 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Abn. Day 60 | 17 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Nor. Day 60 | 38 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Nor. Day 60 | 42 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Nor. Day 60 | 45 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Nor. Day 60 | 52 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Nor. Day 60 | 49 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Abn. Day 60 | 13 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Nor. Day 60 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Nor. Day 60 | 45 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Nor. Day 60 | 53 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Abn. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Nor. Day 60 | 60 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Abn. Day 60 | 12 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Nor. Day 60 | 6 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Abn. Day 60 | 4 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Nor. Day 60 | 50 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Nor. Day 60 | 58 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Nor. Day 60 | 58 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Abn. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Nor. Day 60 | 48 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Abn. Day 60 | 13 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Abn. Day 60 | 4 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Abn. Day 60 | 4 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Nor. Day 60 | 45 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Nor. Day 60 | 62 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Nor. Day 60 | 51 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Abn. Day 60 | 8 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Abn. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Abn. Day 60 | 10 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Abn. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Abn. Day 60 | 11 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Abn. Day 60 | 4 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Nor. Day 60 | 50 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Abn. Day 60 | 14 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Abn. Day 60 | 12 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Abn. Day 60 | 9 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Nor. Day 60 | 5 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Nor. Day 60 | 5 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Abn. Day 60 | 12 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Nor. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Nor. Day 0 - Nor. Day 60 | 43 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Nor. Day 60 | 4 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Abn. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Nor. Day 60 | 37 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Abn. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Abn. Day 60 | 2 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Nor. Day 60 | 50 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Nor. Day 60 | 60 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Nor. Day 0 - Abn. Day 60 | 12 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Nor. Day 0 - Nor. Day 60 | 53 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | LYM Abn. Day 0 - Abn. Day 60 | 7 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Abn. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Abn. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Abn. Day 60 | 8 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | MON Nor. Day 0 - Nor. Day 60 | 57 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Nor. Day 0 - Nor. Day 60 | 51 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | BAS Nor. Day 0 - Abn. Day 60 | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | EOS Nor. Day 0 - Nor. Day 60 | 51 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | NEU Abn. Day 0 - Abn. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | WBC Abn. Day 0 - Abn. Day 60 | 8 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CRP Abn. Day 0 - Nor. Day 60 | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. | CPK Abn. Day 0 - Abn. Day 60 | 11 Participants |
Secondary
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.
Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.
Time frame: At Day 0 and up to Day 60.
Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Nor. Day 60 | 39 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Nor. Day 60 | 42 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Nor. Day 60 | 36 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Nor. Day 60 | 61 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Nor. Day 60 | 35 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Abn. Day 60] | 3 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Abn. Day 60 | 11 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Abn. Day 60 | 29 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Abn. Day 60 | 30 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Nor. Day 60 | 45 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Abn. Day 60 | 1 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Nor. Day 60 | 58 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Nor. Day 60 | 16 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Abn. Day 60 | 12 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Abn. Day 60 | 30 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Abn. Day 60 | 32 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Abn. Day 60 | 13 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Abn. Day 60 | 21 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 1 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Abn. Day 60 | 56 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Abn. Day 60 | 15 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Nor. Day 60 | 54 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Abn. Day 60 | 29 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Nor. Day 60 | 39 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Abn. Day 60 | 11 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Abn. Day 60 | 26 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Nor. Day 60 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Nor. Day 60 | 54 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Abn. Day 60 | 8 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Abn. Day 60 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Abn. Day 60 | 10 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Nor. Day 60 | 44 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Nor. Day 60 | 62 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Nor. Day 60 | 42 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Abn. Day 60 | 27 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Abn. Day 60 | 33 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Nor. Day 60 | 33 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Abn. Day 60] | 6 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Nor. Day 60 | 59 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Abn. Day 60 | 2 Participants |
| GSK223192A 2 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Nor. Day 60 | 65 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Nor. Day 60 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Abn. Day 60 | 6 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Abn. Day 60 | 22 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Abn. Day 60 | 18 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Abn. Day 60 | 4 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Nor. Day 60 | 48 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Abn. Day 60 | 13 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Nor. Day 60 | 0 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Nor. Day 60 | 51 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Abn. Day 60 | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Abn. Day 60] | 3 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Abn. Day 60 | 12 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Nor. Day 60 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Nor. Day 60 | 53 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Abn. Day 60 | 2 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Abn. Day 60 | 19 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Abn. Day 60 | 9 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Nor. Day 60 | 56 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Abn. Day 60 | 5 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Abn. Day 60 | 7 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Nor. Day 60 | 62 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Nor. Day 60 | 46 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Nor. Day 60 | 1 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Abn. Day 60 | 19 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Nor. Day 60 | 44 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Abn. Day 60 | 16 Participants |
| GSK223192A 3 Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Nor. Day 60 | 0 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Nor. Day 60 | 0 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Nor. Day 60 | 62 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Abn. Day 60 | 12 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Abn. Day 60 | 20 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Nor. Day 60 | 40 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Abn. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Abn. Day 60 | 5 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Nor. Day 60 | 64 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Abn. Day 60 | 4 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Nor. Day 60 | 0 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Abn. Day 60 | 14 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Nor. Day 60 | 56 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Abn. Day 60] | 7 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Nor. Day 60 | 60 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Abn. Day 60 | 6 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Abn. Day 60 | 11 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Nor. Day 60 | 56 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Abn. Day 60 | 4 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Abn. Day 60 | 8 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Abn. Day 60 | 3 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Abn. Day 60 | 13 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Nor. Day 60 | 57 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Abn. Day 60 | 2 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Abn. Day 60 | 19 Participants |
| Fendrix Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Nor. Day 60 | 52 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Abn. Day 0 - Abn. Day 60 | 5 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Nor. Day 60 | 65 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Nor. Day 0 - Abn. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Abn. Day 60 | 14 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Nor. Day 60 | 62 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Nor. Day 60 | 0 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Nor. Day 0 - Abn. Day 60 | 8 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CRP Abn. Day 0 - Abn. Day 60 | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Abn. Day 0 - Abn. Day 60 | 0 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Abn. Day 60 | 8 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Abn. Day 60 | 7 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Nor. Day 60 | 0 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Nor. Day 60 | 69 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | NEU Nor. Day 0 - Nor. Day 60 | 67 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Abn. Day 0 - Abn. Day 60 | 4 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Nor. Day 60 | 51 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Nor. Day 0 - Abn. Day 60 | 14 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | EOS Abn. Day 0 - Abn. Day 60] | 3 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Abn. Day 60 | 6 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Abn. Day 0 - Nor. Day 60 | 1 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Abn. Day 60 | 8 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | CPK Abn. Day 0 - Nor. Day 60 | 2 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | BAS Nor. Day 0 - Nor. Day 60 | 64 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Nor. Day 60 | 0 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Abn. Day 0 - Abn. Day 60 | 0 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Nor. Day 60 | 59 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | LYM Nor. Day 0 - Abn. Day 60 | 10 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | WBC Nor. Day 0 - Nor. Day 60 | 54 Participants |
| Engerix-B Group | Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. | MON Nor. Day 0 - Abn. Day 60 | 6 Participants |