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| ID | Type | Description | Link |
|---|---|---|---|
| 108516 | Other Identifier | GSK | |
| 108518 | Other Identifier | GSK | |
| 108520 | Other Identifier | GSK | |
| 2006-004863-69 | EudraCT Number |
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Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.
No new subjects will be enrolled during the extension phases of the study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1437173A _LD Group | Experimental | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm. |
|
| GSK1437173A _MD Group | Experimental | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
| GSK1437173A _HD Group | Experimental | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
| Placebo + GSK1437173A _HD Group | Placebo Comparator | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes Zoster vaccine GSK1437173A Low Dose | Biological | Single or two-dose intramuscular injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects aged 70 or higher (≥). | One month after the second vaccination (Month 3) |
| Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level. | One month after the second vaccination (Month 3) |
| Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. | One month after the second vaccination (Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects 60 to 69 years (60-69y) and ≥ 70 years (+70y) old. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hradec Králové | 500 01 | Czechia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24508036 | Background | Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JA, Richardus JH, Plassmann G, Schwarz TF, Ledent E, Heineman TC. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014 Mar 26;32(15):1745-53. doi: 10.1016/j.vaccine.2014.01.019. Epub 2014 Feb 6. | |
| 29461919 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 108494 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Out of 715 subjects enrolled, only 714 were vaccinated.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1437173A _LD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Months 0-3 |
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| GSK1437173A_MODIFIED GROUP | Active Comparator | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
| Herpes Zoster vaccine GSK1437173A Medium Dose | Biological | Single or two-dose intramuscular injection. |
|
| Herpes Zoster vaccine GSK1437173A High Dose | Biological | Single or two-dose intramuscular injection. |
|
| Herpes Zoster vaccine GSK1437173A Modified | Biological | Single or two-dose intramuscular injection. |
|
| Placebo | Biological | Single intramuscular injection |
|
| At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Anti-gE Specific Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA. | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | At Months 12, 24 and 36 |
| Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | At Months 12, 24 and 36 |
| Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | At Months 12, 24 and 36 |
| Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | At Month 12, 24 and 36 |
| Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | At Month 12, 24 and 36 |
| Anti-gE Specific Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | At Months 12, 24 and 36 |
| Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). | At Months 12, 24 and 36 |
| Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older. | At pre-vaccination (Day 0) and at Month 3 |
| Number of Subjects With Different Biochemical and Haematological Levels | Among biochemical and haematological parameters assessed were albumin [ALB], alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], calcium [CAL], eosinophils [EOS], fibrinogen [FIB], haematocrit [HEM], hemoglobin [Hgb], leucocytes [LEU], lymphocytes [LYM], lactate dehydrogenate [LDH], monocytes [MON], neutrophils [NEU], partial thromboplastin time [PTPT], platelets [PLA], pro thrombin time [PTT], red blood cells [RBC], serum creatinine [SCREA], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above. | At Day 0, Month 2 and Month 3 |
| Number of German Subjects With Different Biochemical and Haematological Levels | Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed. | At one week post-vaccination 1 (Month 0) |
| Number of German Subjects With Different Biochemical and Haematological Levels | Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed. | At one week post-vaccination 2 (Month 2) |
| 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. | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes | Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae. | From Month 0 to Month 3 |
| Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae. | From Month 3 up to Month 36 |
| 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. | During the 30-day (Days 0-29) post-vaccination period |
| 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. | From Month 0 to Month 3 |
| 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. | From Month 3 to Month 12 |
| Mannheim |
| Baden-Wurttemberg |
| 68161 |
| Germany |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51069 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45359 | Germany |
| GSK Investigational Site | Berlin | 13347 | Germany |
| GSK Investigational Site | Amsterdam | 1018 WT | Netherlands |
| GSK Investigational Site | Rotterdam | 3011 EN | Netherlands |
| GSK Investigational Site | Eskilstuna | SE-631 88 | Sweden |
| GSK Investigational Site | Uppsala | SE-751 85 | Sweden |
| Derived |
| Schwarz TF, Volpe S, Catteau G, Chlibek R, David MP, Richardus JH, Lal H, Oostvogels L, Pauksens K, Ravault S, Rombo L, Sonder G, Smetana J, Heineman T, Bastidas A. Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults. Hum Vaccin Immunother. 2018 Jun 3;14(6):1370-1377. doi: 10.1080/21645515.2018.1442162. Epub 2018 Mar 21. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 108494 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108494 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108494 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108494 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108494 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108494 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GSK1437173A _MD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| FG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| FG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| FG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| COMPLETED |
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| NOT COMPLETED |
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| Month 12 |
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| Month 24 |
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| Month 36 |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1437173A _LD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm. |
| BG001 | GSK1437173A _MD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| BG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| BG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| BG004 | GSK1437173A_MODIFIED GROUP | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects aged 70 or higher (≥). | The analysis was performed on the According-to-Protocol(ATP) cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T-cells/million cells | One month after the second vaccination (Month 3) |
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| Primary | Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level. | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | Fold Change | One month after the second vaccination (Month 3) |
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| Primary | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | One month after the second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects 60 to 69 years (60-69y) and ≥ 70 years (+70y) old. | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells//million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Mean | Standard Deviation | T-cells/million cells | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Anti-gE Specific Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA. | The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) |
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| Secondary | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively. | Posted | Mean | Standard Deviation | T-cells/million cells | At Months 12, 24 and 36 |
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| Secondary | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively. | Posted | Mean | Standard Deviation | T-cells/million cells | At Months 12, 24 and 36 |
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| Secondary | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively. | Posted | Mean | Standard Deviation | T-cells/million cells | At Months 12, 24 and 36 |
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| Secondary | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively. | Posted | Geometric Mean | Standard Deviation | T-cells/million cells | At Month 12, 24 and 36 |
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| Secondary | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively. | Posted | Mean | Standard Deviation | T-cells/million cells | At Month 12, 24 and 36 |
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| Secondary | Anti-gE Specific Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 12, 24 and 36 |
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| Secondary | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 12, 24 and 36 |
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| Secondary | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older. | The analysis was performed on the Total cohort for persistence at Month 12, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Month 12. | Posted | Mean | Standard Deviation | B-cells/million cells | At pre-vaccination (Day 0) and at Month 3 |
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| Secondary | Number of Subjects With Different Biochemical and Haematological Levels | Among biochemical and haematological parameters assessed were albumin [ALB], alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], calcium [CAL], eosinophils [EOS], fibrinogen [FIB], haematocrit [HEM], hemoglobin [Hgb], leucocytes [LEU], lymphocytes [LYM], lactate dehydrogenate [LDH], monocytes [MON], neutrophils [NEU], partial thromboplastin time [PTPT], platelets [PLA], pro thrombin time [PTT], red blood cells [RBC], serum creatinine [SCREA], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented. | Posted | Count of Participants | Participants | At Day 0, Month 2 and Month 3 |
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| Secondary | Number of German Subjects With Different Biochemical and Haematological Levels | Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented. | Posted | Count of Participants | Participants | At one week post-vaccination 1 (Month 0) |
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| Secondary | Number of German Subjects With Different Biochemical and Haematological Levels | Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented. | Posted | Count of Participants | Participants | At one week post-vaccination 2 (Month 2) |
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| 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented, who filled in their symptom sheets. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented, who filled in their symptom sheets. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
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| Secondary | Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes | Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented. | Posted | Count of Participants | Participants | From Month 0 to Month 3 |
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| Secondary | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae. | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36. | Posted | Count of Participants | Participants | From Month 3 up to Month 36 |
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| 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented. | Posted | Count of Participants | Participants | During the 30-day (Days 0-29) post-vaccination period |
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| 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented. | Posted | Count of Participants | Participants | From Month 0 to Month 3 |
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| 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. | The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36. | Posted | Count of Participants | Participants | From Month 3 to Month 12 |
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Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 36).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK1437173A _LD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm. | 2 | 164 | 53 | 164 | 134 | 164 |
| EG001 | GSK1437173A _MD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. | 3 | 166 | 57 | 166 | 142 | 166 |
| EG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. | 3 | 165 | 68 | 165 | 140 | 165 |
| EG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. | 5 | 165 | 67 | 165 | 124 | 165 |
| EG004 | Placebo Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. | 1 | 54 | 22 | 54 | 19 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Sinoatrial block | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gastrointestinal angiodysplasia | Congenital, familial and genetic disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Retinal vein thrombosis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Diabetic gastropathy | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Amyloidosis | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Gastroenteritis aeromonas | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Neuroborreliosis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pancreatic abscess | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Sinusitis aspergillus | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Asbestosis | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Back disorder | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bone cyst | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Haemangiopericytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Hypopharyngeal cancer stage iii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Melanoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Pleural mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Drop attacks | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Viith nerve paralysis | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 10.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| Male |
|
| Asian - Central/South Asian Heritage |
|
| White - Arabic/North African Heritage |
|
| White - Caucasian/European Heritage |
|
| Other |
|
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 |
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 |
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 |
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 |
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 |
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| GSK1437173A _HD Group |
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG002 | GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
|
|
Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
| OG003 | Placebo + GSK1437173A _HD Group | Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
| OG004 | GSK1437173A_MODIFIED Group | Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. |
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