Herpes Zoster
Conditions
Keywords
Cytokine, Vaccine, Herpes Zoster (HZ), Cell mediated immunity (CMI), Antibody response, Varicella Zoster Virus (VZV), Shingles
Brief summary
The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.
Interventions
BIOLOGICALHerpes zoster vaccine GSK1437173A
2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)
BIOLOGICALPlacebo
2 vaccinations at Months 0 and 2 with placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female 50 years of age or above at the time of the first vaccination; * Written informed consent obtained from the subject; * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in 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
* 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; * Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination; * Previous vaccination against HZ; * Previous vaccination against varicella; * History of HZ; * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine; * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy; * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period; * Acute disease at the time of enrolment. * Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study; * History of or current drug and/or alcohol abuse; * Pregnant or lactating female; * Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers | One month after the second vaccination (Month 3) | The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS). |
| Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | One month after the second vaccination (Month 3) | The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS). |
| Anti-glycoprotein E (gE) Antibody Concentrations | One month after the second vaccination (Month 3) | Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). |
| Anti-VZV Antibody Concentrations | One month after the second vaccination (Month 3) | Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period after each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6)post-vaccination period after each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within the 30-day (Days 0-29) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | At Month 0 and at Month 2 | The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS). |
| Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | From Month 0 until Month 8 | Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases. |
| Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | From Month 0 until Month 8 | A suspected case of HZ was defined as a rash consistent with HZ. |
| Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | At Month 0 | Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC). |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 up to Month 8 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | At Month 0 and at Month 2 | The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS). |
| Anti-gE Antibody Concentrations | At Month 0 and at Month 2 | Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). |
| Anti-VZV Antibody Concentrations | At Month 0 and at Month 2 | Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). |
Countries
Czechia, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule. | 38 |
| GSK1437173A Formulation 3 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule. | 73 |
| GSK1437173A Formulation 2 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule. | 149 |
| GSK1437173A Formulation 1 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule. | 150 |
| Total | 410 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Month 0 - Month 8 | Adverse Event | 0 | 1 | 1 | 2 |
| Month 0 - Month 8 | Lost to Follow-up | 0 | 1 | 2 | 2 |
| Month 0 - Month 8 | Other | 0 | 0 | 1 | 0 |
| Month 0 - Month 8 | Protocol Violation | 0 | 0 | 1 | 0 |
| Month 0 - Month 8 | Withdrawal by Subject | 0 | 1 | 2 | 5 |
| Month 8 - Month 14 | Adverse Event | 0 | 1 | 0 | 0 |
| Month 8 - Month 14 | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Month 8 - Month 14 | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo Group | GSK1437173A Formulation 3 Group | GSK1437173A Formulation 2 Group | GSK1437173A Formulation 1 Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.0 Years STANDARD_DEVIATION 9 | 65.1 Years STANDARD_DEVIATION 8.7 | 65.1 Years STANDARD_DEVIATION 9.9 | 65.0 Years STANDARD_DEVIATION 8.9 | 65.0 Years STANDARD_DEVIATION 9.2 |
| Race/Ethnicity, Customized Race/Ethnicity African Heritage / African American | 0 Participants | 1 Participants | 2 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White - Arabic / North African Heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White - Caucasian / European Heritage | 38 Participants | 72 Participants | 145 Participants | 141 Participants | 396 Participants |
| Sex: Female, Male Female | 22 Participants | 40 Participants | 89 Participants | 81 Participants | 232 Participants |
| Sex: Female, Male Male | 16 Participants | 33 Participants | 60 Participants | 69 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 2 / 73 | 0 / 149 | 1 / 150 |
| other Total, other adverse events | 9 / 38 | 31 / 73 | 114 / 149 | 131 / 150 |
| serious Total, serious adverse events | 3 / 38 | 8 / 73 | 6 / 149 | 10 / 150 |
Outcome results
Primary
Anti-glycoprotein E (gE) Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: One month after the second vaccination (Month 3)
Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo Group | Anti-glycoprotein E (gE) Antibody Concentrations | 1987.0 mIU/mL |
| GSK1437173A Formulation 3 Group | Anti-glycoprotein E (gE) Antibody Concentrations | 14627.6 mIU/mL |
| GSK1437173A Formulation 2 Group | Anti-glycoprotein E (gE) Antibody Concentrations | 49531.5 mIU/mL |
| GSK1437173A Formulation 1 Group | Anti-glycoprotein E (gE) Antibody Concentrations | 68798.2 mIU/mL |
Comparison: Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.95% CI: [3.81, 5.85]
Comparison: Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.95% CI: [2.72, 4.17]
Comparison: Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.95% CI: [1.17, 1.68]
Primary
Anti-VZV Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: One month after the second vaccination (Month 3)
Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo Group | Anti-VZV Antibody Concentrations | 1423.2 mIU/mL |
| GSK1437173A Formulation 3 Group | Anti-VZV Antibody Concentrations | 2786.4 mIU/mL |
| GSK1437173A Formulation 2 Group | Anti-VZV Antibody Concentrations | 4565.4 mIU/mL |
| GSK1437173A Formulation 1 Group | Anti-VZV Antibody Concentrations | 4972.8 mIU/mL |
Comparison: Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.36% CI: [2.64, 3.9]
Comparison: Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.95% CI: [2.02, 2.97]
Comparison: Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.95% CI: [1.12, 1.54]
Primary
Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Time frame: One month after the second vaccination (Month 3)
Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers | 231.82 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 411.84 |
| GSK1437173A Formulation 3 Group | Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers | 570.36 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 610.1 |
| GSK1437173A Formulation 2 Group | Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers | 2172.37 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 1805.51 |
| GSK1437173A Formulation 1 Group | Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers | 2582.80 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 2154.92 |
Comparison: Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.95% CI: [3.89, 6.98]
Comparison: Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.95% CI: [3, 5.4]
Comparison: Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.95% CI: [1.07, 1.58]
Primary
Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Time frame: One month after the second vaccination (Month 3)
Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | 457.43 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 275.25 |
| GSK1437173A Formulation 3 Group | Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | 523.12 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 396.01 |
| GSK1437173A Formulation 2 Group | Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | 1093.08 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 927.18 |
| GSK1437173A Formulation 1 Group | Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | 1270.79 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 1106.45 |
Comparison: Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.95% CI: [1.67, 2.69]
Comparison: Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.95% CI: [1.28, 2.07]
Comparison: Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.95% CI: [1.09, 1.56]
Secondary
Anti-gE Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Month 0 and at Month 2
Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo Group | Anti-gE Antibody Concentrations | Month 0 | 1907.7 mIU/mL |
| Placebo Group | Anti-gE Antibody Concentrations | Month 2 | 2022.3 mIU/mL |
| GSK1437173A Formulation 3 Group | Anti-gE Antibody Concentrations | Month 2 | 10022.8 mIU/mL |
| GSK1437173A Formulation 3 Group | Anti-gE Antibody Concentrations | Month 0 | 1640.3 mIU/mL |
| GSK1437173A Formulation 2 Group | Anti-gE Antibody Concentrations | Month 0 | 1526.7 mIU/mL |
| GSK1437173A Formulation 2 Group | Anti-gE Antibody Concentrations | Month 2 | 19962.3 mIU/mL |
| GSK1437173A Formulation 1 Group | Anti-gE Antibody Concentrations | Month 0 | 1398.3 mIU/mL |
| GSK1437173A Formulation 1 Group | Anti-gE Antibody Concentrations | Month 2 | 23942.4 mIU/mL |
Secondary
Anti-VZV Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Month 0 and at Month 2
Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo Group | Anti-VZV Antibody Concentrations | Month 0 | 1505.5 mIU/mL |
| Placebo Group | Anti-VZV Antibody Concentrations | Month 2 | 1365.5 mIU/mL |
| GSK1437173A Formulation 3 Group | Anti-VZV Antibody Concentrations | Month 0 | 1289.6 mIU/mL |
| GSK1437173A Formulation 3 Group | Anti-VZV Antibody Concentrations | Month 2 | 2392.8 mIU/mL |
| GSK1437173A Formulation 2 Group | Anti-VZV Antibody Concentrations | Month 0 | 1215.9 mIU/mL |
| GSK1437173A Formulation 2 Group | Anti-VZV Antibody Concentrations | Month 2 | 3125.6 mIU/mL |
| GSK1437173A Formulation 1 Group | Anti-VZV Antibody Concentrations | Month 0 | 1175.8 mIU/mL |
| GSK1437173A Formulation 1 Group | Anti-VZV Antibody Concentrations | Month 2 | 3355.1 mIU/mL |
Secondary
Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Time frame: At Month 0 and at Month 2
Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 0 | 210.18 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 363.37 |
| Placebo Group | Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 2 | 185.59 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 310.06 |
| GSK1437173A Formulation 3 Group | Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 2 | 189.46 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 188.8 |
| GSK1437173A Formulation 3 Group | Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 0 | 130.98 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 115.9 |
| GSK1437173A Formulation 2 Group | Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 0 | 196.52 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 217.94 |
| GSK1437173A Formulation 2 Group | Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 2 | 463.79 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 386.94 |
| GSK1437173A Formulation 1 Group | Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 0 | 173.48 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 203.54 |
| GSK1437173A Formulation 1 Group | Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 2 | 430.50 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 323.88 |
Secondary
Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Time frame: At Month 0 and at Month 2
Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 0 | 533.97 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 422.46 |
| Placebo Group | Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 2 | 491.12 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 330.34 |
| GSK1437173A Formulation 3 Group | Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 2 | 410.69 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 356.65 |
| GSK1437173A Formulation 3 Group | Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 0 | 352.71 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 283.42 |
| GSK1437173A Formulation 2 Group | Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 0 | 457.28 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 402.04 |
| GSK1437173A Formulation 2 Group | Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 2 | 595.10 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 588.51 |
| GSK1437173A Formulation 1 Group | Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 0 | 482.63 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 512.05 |
| GSK1437173A Formulation 1 Group | Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers | Month 2 | 574.54 VZV-specific CD4+ T-cells/million T-cell | Standard Deviation 586.85 |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 3 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 9 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 14 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 20 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 15 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 25 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 104 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 89 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 26 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 82 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 9 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 19 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 8 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 37 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 6 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 26 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 112 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 106 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 44 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 6 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 125 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 18 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 23 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6)post-vaccination period after each dose and across doses
Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across Doses | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across Doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across Doses | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Across Doses | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Across Doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Across Doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across Doses | 4 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across Doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across Doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across Doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across Doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across Doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Across Doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Across Doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Across Doses | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 10 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Across Doses | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 10 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Across Doses | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Across Doses | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across Doses | 14 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across Doses | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across Doses | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across Doses | 16 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Across Doses | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 2 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Across Doses | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across Doses | 11 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 2 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 9 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across Doses | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Dose 2 | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across Doses | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Dose 2 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 1 | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Dose 1 | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 9 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Dose 2 | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 6 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Across Doses | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across Doses | 10 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across Doses | 12 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across Doses | 37 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 29 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 1 | 7 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Across Doses | 13 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 1 | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across Doses | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 41 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 34 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Dose 2 | 12 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across Doses | 29 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Dose 2 | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Dose 2 | 8 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Across Doses | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 25 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across Doses | 49 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 20 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 33 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 26 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across Doses | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 2 | 14 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 2 | 11 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across Doses | 52 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across Doses | 41 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across Doses | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across Doses | 45 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Across Doses | 18 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 32 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 28 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Across Doses | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Dose 1 | 10 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Dose 1 | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Across Doses | 18 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Dose 1 | 7 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 22 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Across Doses | 12 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 14 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 36 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Across Doses | 17 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 38 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 42 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 42 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Across Doses | 15 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Dose 2 | 9 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across Doses | 53 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 1 | 8 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 39 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 40 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Dose 2 | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 29 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Dose 1 | 8 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Across Doses | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastr. sympt., Dose 2 | 12 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Across Doses | 25 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastr. sympt., Dose 1 | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 56 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastr. sympt., Dose 1 | 7 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 7 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Across Doses | 23 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across Doses | 7 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across Doses | 5 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 2 | 20 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 2 | 21 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 48 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 42 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across Doses | 72 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 32 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 6 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 1 | 11 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across Doses | 9 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across Doses | 62 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Temperature, Across Doses | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 58 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across Doses | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 49 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across Doses | 62 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across Doses | 56 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within the 30-day (Days 0-29) post-vaccination period
Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 18 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 37 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 15 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 46 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 24 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 5 Participants |
Secondary
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Time frame: From Month 0 until Month 8
Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Group | Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | 0 Participants |
Secondary
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)
Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Time frame: During the period after Month 8 up to the end of the study at Month 14
Population: The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Group | Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) | 0 Participants |
Secondary
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time frame: At Month 2
Population: The analyses were performed on the Month 2 Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and who completed the Month 2 study visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 34 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 3 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 34 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 3 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 38 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 136 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 136 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 12 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 130 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 124 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 129 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 139 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 142 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 10 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 9 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 137 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 6 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 126 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 12 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 143 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 138 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 131 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 134 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 137 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 133 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 132 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 12 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 139 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 125 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 137 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 140 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 144 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 139 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 138 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 6 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 140 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 142 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 136 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 7 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 6 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 12 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 129 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 138 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 126 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 7 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 131 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 6 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 134 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 144 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 139 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 139 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 11 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 9 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 133 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 138 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 129 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 11 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 135 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 132 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 8 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 10 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 131 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 59 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 67 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 9 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 68 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 65 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 67 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 5 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 62 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 7 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 67 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 64 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 66 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 8 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 70 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 68 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 67 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 67 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 67 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 72 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 68 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 6 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 66 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 64 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 4 Participants |
Secondary
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time frame: At Month 0
Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 3 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 34 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 3 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 37 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 141 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 135 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 18 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 146 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 7 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 10 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 145 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 142 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 140 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 12 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 6 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 148 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 142 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 135 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 11 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 144 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 149 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 6 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 148 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 141 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 135 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 144 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 7 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 150 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 6 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 149 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 127 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 146 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 132 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 148 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 12 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 135 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 137 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 126 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 18 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 9 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 8 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 135 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 7 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 137 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 149 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 142 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 145 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 145 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 144 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 146 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 140 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 137 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 142 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 7 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 146 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 8 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 143 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 148 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 144 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 142 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 7 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 73 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 8 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 73 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 70 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 73 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 70 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 73 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 70 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 69 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 65 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 16 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 68 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 72 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 67 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 70 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 70 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 56 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 1 Participants |
Secondary
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time frame: At Month 3
Population: The analyses were performed on the Month 3 Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and who completed the Month 3 study visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 4 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 34 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 35 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 1 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 2 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 36 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 38 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 0 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 37 Participants |
| Placebo Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 131 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 131 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 9 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 136 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 142 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 135 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 133 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 139 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 8 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 132 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 12 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 9 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 130 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 126 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 7 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 131 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 139 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 10 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 3 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 135 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 127 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 2 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 131 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 6 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 5 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 7 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 7 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 138 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 140 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 141 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 131 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 7 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 125 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 13 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 122 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 137 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 133 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 10 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 126 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 5 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 133 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 8 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 142 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 131 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 136 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 137 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 13 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 126 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 138 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 137 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 142 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 136 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 6 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 139 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 140 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 2 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 134 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 139 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 1 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 138 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 134 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 8 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Normal | 64 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Below | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Unknown | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Below | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Normal | 70 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Unknown | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LDH | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Below | 11 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | ALT | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Unknown | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Normal | 71 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Normal | 65 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Below | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HGB | Unknown | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Above | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Normal | 70 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | AST | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Above | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Unknown | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Normal | 61 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Below | 6 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Normal | 68 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CREA | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Below | 8 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | HCT | Unknown | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Normal | 61 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Unknown | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MON | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Above | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Above | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Normal | 69 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Unknown | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Normal | 63 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Below | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PLAT | Normal | 66 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Unknown | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | MCV | Unknown | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | EOS | Normal | 57 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Normal | 65 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | WBC | Below | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | BAS | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | NEU | Above | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Above | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Above | 7 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | RBC | Normal | 64 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Normal | 68 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Unknown | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Below | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | CAL | Unknown | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Below | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PT | Normal | 68 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Normal | 68 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | TP | Normal | 72 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | LYM | Unknown | 3 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | FIBR | Normal | 61 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges | PTT | Above | 2 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 up to Month 8
Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | Up to Month 3 | 2 Participants |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | After Month 3 up to Month 8 | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Serious Adverse Events (SAEs) | After Month 3 up to Month 8 | 4 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Serious Adverse Events (SAEs) | Up to Month 3 | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | Up to Month 3 | 4 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | After Month 3 up to Month 8 | 2 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | Up to Month 3 | 4 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | After Month 3 up to Month 8 | 2 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the period after Month 8 up to the end of the study at Month 14
Population: The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
Secondary
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
A suspected case of HZ is defined as a rash consistent with HZ.
Time frame: During the period after Month 8 up to the end of the study at Month 14
Population: The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Group | Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | 0 Participants |
Secondary
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)
A suspected case of HZ was defined as a rash consistent with HZ.
Time frame: From Month 0 until Month 8
Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Group | Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | 0 Participants |
| GSK1437173A Formulation 3 Group | Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | 0 Participants |
| GSK1437173A Formulation 2 Group | Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | 0 Participants |
| GSK1437173A Formulation 1 Group | Number of Subjects With Suspected Cases of Herpes Zoster (HZ) | 0 Participants |