| Primary | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations | Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL). | The analysis for persistence at month 108 was performed on the According-to-protocol (ATP) cohort analysis of immunogenicity at Year 9, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| | | Title | Measurements |
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| - OG0009122.9(7775.2 to 10704.1)
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| Primary | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations | Anti-gE Ab concentrations were determined by ELISA, presented as GMCs and expressed in mIU/mL. | The analysis for persistence at month 120 was performed on the ATP cohort analysis of immunogenicity at Year 10, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Primary | Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells. | gE specific CD4 (2+) T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L, were determined by means of Intracellular Cytokine Staining (ICS) and expressed in T-cells/million cells. | The analysis for persistence at month 108 was performed on the ATP cohort analysis of immunogenicity at Year 9, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered. | Posted | | Median | Inter-Quartile Range | CD4 T-cells/million cells | | At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Primary | Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells. | gE specific CD4 (2+)T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L were determined by means of ICS and expressed in T-cells/million cells. | The analysis for persistence at month 120 was performed on the ATP cohort analysis of immunogenicity at Year 10, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered. | Posted | | Median | Inter-Quartile Range | CD4 T-cells/million cells | | At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Secondary | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category | Anti-gE Ab concentrations as determined by ELISA by each age category (60-69 years of age [YOA] and ≥70 YOA at the time of initial vaccination).Antibody concentrations were presented as GMCs and expressed in mIU/mL. | The analysis for persistence at month 108 and 120 was performed on the ATP cohort analysis of immunogenicity at Years 9 and 10, which included subjects who complied with the protocol criteria and had immunogenicity results available at the time points considered. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine 60-69 YOA Sub-group | Subjects of 60-69 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study. | | OG001 | GSK1437173A Vaccine ≥ 70 YOA Sub-group | Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study. |
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| Secondary | Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category | Antigen specific CD4 (2+) T-cells as determined by means of ICS and expressed in T-cells/million cells, by each age category (60-69 YOA and ≥ 70 YOA at the time of initial vaccination). | The analysis for persistence at month 108 and 120 was performed on the ATP cohort analysis of immunogenicity at Years 9 and 10, which included subjects who complied with the protocol criteria and had immunogenicity results available at the timepoints considered. | Posted | | Median | Inter-Quartile Range | CD4 T-cells/million cells | | At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine 60-69 YOA Sub-group | Subjects of 60-69 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study. | | OG001 | GSK1437173A Vaccine ≥ 70 YOA Sub-group | Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study. |
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| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study). | 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 enrolled cohort which included all subjects enrolled into the current study [ZOSTER-060 (NCT02735915)]. | Posted | | Count of Participants | | Participants | | Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Secondary | Anti-gE Specific Antibody (Ab) Concentrations | Anti-gE antibody concentrations were determined by ELISA in all subjects, presented as GMCs and expressed in mIU/mL. | The analysis was performed on the ATP cohort analysis of immunogenicity after re-vaccination, which included subjects who complied with the protocol criteria, have received at least one dose from the re-vaccination schedule and had immunogenicity results available at the timepoints considered. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Secondary | Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course. | Antigen specific CD4 (2+)T cells were determined by means of ICS and expressed in T-cells/million cells. | The analysis was performed on the ATP cohort analysis of immunogenicity after re-vaccination, which included subjects who complied with the protocol criteria, have received at least one dose from the re-vaccination schedule and had immunogenicity results available at the timepoints considered. | Posted | | Median | Inter-Quartile Range | CD4 T-cells/million cells | | At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms included: pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = symptoms spreading beyond a surface of (>) 100 millimeters (mm). | The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study, who had their symptom sheets filled in. | Posted | | Count of Participants | | Participants | | Within 7 days (Days 0-6) after each vaccination and across doses, in the current study. | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms included: fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, shivering and temperature [higher than or equal to (≥) 37.5 degrees Celsius (°C) for axillary, oral or tympanic route] and ≥38.0°C for rectal route. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = symptoms that prevented normal activity. Grade 3 temperature = defined as fever higher than (>) 39.0°C, regardless of the route used. | The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study, who had their symptom sheets filled in. | Posted | | Count of Participants | | Participants | | Within 7 days (Days 0-6) after each vaccination and across doses, in the current study. | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects. | 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 is 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 for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study. | Posted | | Count of Participants | | Participants | | Within 30 days (Days 0-29) after each vaccination in the current study. | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Secondary | Number of Subjects With Any, Related and Fatal SAEs. | SAEs assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. | The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study. | Posted | | Count of Participants | | Participants | | From Dose 1 of re-vaccination (Month 120) until study end (Month 134). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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| Secondary | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs). | pIMDs assessed includes AEs that were autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as related to the vaccination. | The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study. | Posted | | Count of Participants | | Participants | | From Dose 1 of re-vaccination (Month 120) until study end (Month 134). | | | | ID | Title | Description |
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| OG000 | GSK1437173A Vaccine Group | Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study |
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