Herpes Zoster, Herpes Zoster Vaccine
Conditions
Keywords
Immunogenicity, Subjects 70 years and older, Efficacy, Herpes Zoster, Safety, Adults, Vaccine
Brief summary
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.
Detailed description
This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.
Interventions
BIOLOGICALHerpes Zoster Vaccine GSK1437173A
Intramuscular injection
BIOLOGICALPlacebo
Intramuscular injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * A male or female aged 70 years or older at the time of the first vaccination.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy History of HZ. * Previous vaccination against varicella or HZ. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. * Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period. * Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine. * Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. * Acute disease and/or fever at the time of enrolment. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Episodes of Herpes Zoster (HZ) | During the entire study period (3 to 5 year period following Day 0) | Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc). |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) | During the entire study period (3 to 5 year period following Day 0) | Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA). |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ | During the entire study period (3 to 5 year period following Day 0) | Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Overall Mortality and HZ-related Mortality | During the entire study period (3 to 5 year period following Day 0) | The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported. |
| Number of Subjects With Confirmed HZ Episode Related Hospitalizations | During the entire study period (3 to 5 year period following Day 0) | Incidence of overall and HZ-related hospitalizations during the study. |
| Number of Subjects With HZ Related Complications | During the entire study period (3 to 5 year period following Day 0) | Incidence of HZ complications during the study in subjects with confirmed HZ. |
| Number of Subjects Receiving Pain Medication Associated With HZ | During the entire study period (3 to 5 year period following Day 0) | Incidence of use of pain medications throughout the study |
| Number of Days With Pain Medication Associated With HZ | During the entire study period (3 to 5 year period following Day 0) | Incidence of reduction of duration of pain medication associated with HZ throughout the study. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within the 30 days (Days 0-29) after each vaccination | Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, 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 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. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | From Month 0 to Month 14 | 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. |
| Number of Subjects With Fatal Serious Adverse Events (SAEs) | During the entire study period (3 to 5 year period following Day 0) | 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. |
| Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication | During the entire study period (3 to 5 year period following day 0) | The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated |
| Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | During the entire study period (3 to 5 year period following Day 0) | Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects |
| Number of Subjects With Post-herpetic Neuralgia (PHN) | During the entire study period (3 to 5 year period following Day 0) | PHN cases in the mTVc. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | During the entire study period (3 to 5 year period following Day 0) | Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | During the entire study period (3 to 5 year period following Day 0) | Occurrence of PHN during the entire study period in all subjects with confirmed HZ. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | During the entire study period (3 to 5 year period following Day 0) | The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ . |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | During the entire study period (3 to 5 year period following Day 0) | Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. 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. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = Temperature\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA | Within 30 days (Days 0 - 29) after each vaccination | Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.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. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs | From Month 0 to Month 14 | Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs | During the entire study period (3 to 5 year period following Day 0) | Fatal SAEs during the entire study period in subjects ≥ 70 YOA. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs | During the entire study period (3 to 5 year period following Day 0) | Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA. |
| Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits | From Month 0 to Month 8 post-vaccination | Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA. |
| Number of Subjects With Any and Related Medically Attended Visits | From Month 0 to Month 8 post-vaccination | Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination. |
| Number of Days With Severe 'Worst' HZ-associated Pain | During the entire study period (3 to 5 year period following Day 0) | Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ. |
| Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | During the entire study period (3 to 5 year period following Day 0) | The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated. |
Countries
Australia, Brazil, Canada, Czechia, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Mexico, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
Only 13900 subjects from the total enrolled number were vaccinated and included in the Total Vaccinated Cohort. In the placebo group,1 subject had an unknown withdrawal status before the study site closure. This was not identified during database freeze, leading to 1190 subjects in place of 1189 that actually completed the placebo group
Participants by arm
| Arm | Count |
|---|---|
| Zoster-022 GSK1437173A Group Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule. | 6,950 |
| Zoster-022 Placebo Group Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule. | 6,950 |
| Total | 13,900 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 123 | 133 |
| Overall Study | Migrated/moved from study area | 51 | 46 |
| Overall Study | Non-Serious Adverse Event | 47 | 15 |
| Overall Study | No reason from the subject | 108 | 102 |
| Overall Study | Protocol Violation | 6 | 8 |
| Overall Study | Serious Adverse Event | 456 | 487 |
| Overall Study | Suspected HZ Episode | 2 | 2 |
| Overall Study | Unknown completion status | 0 | 1 |
| Overall Study | Withdrawal by Subject | 387 | 396 |
Baseline characteristics
| Characteristic | Zoster-022 Placebo Group | Total | Zoster-022 GSK1437173A Group |
|---|---|---|---|
| Age, Continuous | 75.6 Years STANDARD_DEVIATION 4.7 | 75.6 Years STANDARD_DEVIATION 4.7 | 75.6 Years STANDARD_DEVIATION 4.7 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage / African American | 67 Participants | 146 Participants | 79 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan Native | 8 Participants | 9 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian Heritage | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian Heritage | 908 Participants | 1815 Participants | 907 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Japanese Heritage | 300 Participants | 598 Participants | 298 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian Heritage | 4 Participants | 12 Participants | 8 Participants |
| Race/Ethnicity, Customized Geographic ancestry Native Hawaiian or Other Pacific Islander | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other | 306 Participants | 610 Participants | 304 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic / North African Heritage | 47 Participants | 87 Participants | 40 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian / European Heritage | 5301 Participants | 10608 Participants | 5307 Participants |
| Sex: Female, Male Female | 3836 Participants | 7625 Participants | 3789 Participants |
| Sex: Female, Male Male | 3114 Participants | 6275 Participants | 3161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 426 / 6,950 | 459 / 6,950 |
| other Total, other adverse events | 3,067 / 6,950 | 610 / 6,950 |
| serious Total, serious adverse events | 1,153 / 6,950 | 1,214 / 6,950 |
Outcome results
Primary
Number of Subjects With Any Episodes of Herpes Zoster (HZ)
Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any Episodes of Herpes Zoster (HZ) | 17 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any Episodes of Herpes Zoster (HZ) | 6 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With Any Episodes of Herpes Zoster (HZ) | 23 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With Any Episodes of Herpes Zoster (HZ) | 169 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With Any Episodes of Herpes Zoster (HZ) | 54 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With Any Episodes of Herpes Zoster (HZ) | 223 Participants |
Comparison: Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.p-value: <0.000195% CI: [83.54, 94.32]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo Zoster-022 Placebo \>=80YOA Groupp-value: <0.000195% CI: [74.65, 96.16]Poisson exact method
Comparison: Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Groupp-value: <0.000195% CI: [84.29, 93.66]Poisson exact test
Primary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ | 19 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ | 6 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ | 25 Participants |
| Zoster-022 Placebo 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ | 216 Participants |
| Zoster-022 Placebo >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ | 68 Participants |
| Zoster-022 Placebo >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ | 284 Participants |
Comparison: Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Groupp-value: <0.000195% CI: [86.04, 94.85]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Groupp-value: <0.000195% CI: [80.22, 96.94]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Groupp-value: <0.000195% CI: [86.88, 94.46]Poisson exact test
Primary
Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)
Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) | 2 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) | 4 Participants |
| Zoster-022 Placebo 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) | 29 Participants |
| Zoster-022 Placebo >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) | 7 Participants |
| Zoster-022 Placebo >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) | 36 Participants |
Comparison: Comparison of vaccine efficacy in prevention of Post-Herpetic Neuralgia (PHN) between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Groupp-value: <0.000195% CI: [72.47, 99.19]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Groupp-value: 0.184495% CI: [-51.51, 97.08]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=70YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Groupp-value: <0.000195% CI: [68.7, 97.1]Poisson exact test
Secondary
Number of Days With Pain Medication Associated With HZ
Incidence of reduction of duration of pain medication associated with HZ throughout the study.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Days With Pain Medication Associated With HZ | 38.7 Days | Standard Deviation 56.44 |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Days With Pain Medication Associated With HZ | 274.7 Days | Standard Deviation 337 |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Days With Pain Medication Associated With HZ | 109.5 Days | Standard Deviation 200.88 |
| Zoster-022 Placebo 70-79YOA Group | Number of Days With Pain Medication Associated With HZ | 218.6 Days | Standard Deviation 593.8 |
| Zoster-022 Placebo >=80YOA Group | Number of Days With Pain Medication Associated With HZ | 135.0 Days | Standard Deviation 207.31 |
| Zoster-022 Placebo >=70YOA Group | Number of Days With Pain Medication Associated With HZ | 199.3 Days | Standard Deviation 530.6 |
Comparison: Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Groupp-value: 0.023295% CI: [11.45, 80.96]Poisson exact test
Comparison: Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Groupp-value: 0.832495% CI: [-303.3, 67.46]Poisson exact test
Comparison: Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Groupp-value: 0.040495% CI: [2.92, 73.47]Poisson exact test
Secondary
Number of Days With Severe 'Worst' HZ-associated Pain
Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain | 21.8 Days | Standard Deviation 31.41 |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain | 98.7 Days | Standard Deviation 57.73 |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain | 34.6 Days | Standard Deviation 45.54 |
| Zoster-022 Placebo 70-79YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain | 47.9 Days | Standard Deviation 100.08 |
| Zoster-022 Placebo >=80YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain | 50.4 Days | Standard Deviation 106.51 |
| Zoster-022 Placebo >=70YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain | 48.5 Days | Standard Deviation 101.4 |
Comparison: Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Groupp-value: 0.374995% CI: [-34.4, 54.39]Poisson exact test
Comparison: Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo\>=80YOA Groupp-value: 0.246695% CI: [-65.55, 85.95]Poisson exact test
Comparison: Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo\>=70YOA Groupp-value: 0.187795% CI: [-17.69, 56.44]Poisson exact test
Secondary
Number of Subjects Receiving Pain Medication Associated With HZ
Incidence of use of pain medications throughout the study
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 1 pain medication only | 5 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 3 pain medications or more | 2 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | At least 1 pain medication | 7 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 2 pain medications only | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | At least 1 pain medication | 3 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 1 pain medication only | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 3 pain medications or more | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 2 pain medications only | 1 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 1 pain medication only | 5 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | At least 1 pain medication | 10 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 2 pain medications only | 1 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 3 pain medications or more | 4 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | At least 1 pain medication | 123 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 3 pain medications or more | 50 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 2 pain medications only | 30 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 1 pain medication only | 43 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | At least 1 pain medication | 37 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 3 pain medications or more | 16 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 2 pain medications only | 4 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 1 pain medication only | 17 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 3 pain medications or more | 66 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 2 pain medications only | 34 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | At least 1 pain medication | 160 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects Receiving Pain Medication Associated With HZ | 1 pain medication only | 60 Participants |
Comparison: Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Groupp-value: 0.011295% CI: [10.77, 70.53]Poisson exact test
Comparison: Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Groupp-value: 0.390395% CI: [-26.43, 73.2]Poisson exact test
Comparison: Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=70YOA group and Zoster-022 Placebo \>=70YOA Groupp-value: 0.008395% CI: [10.79, 64.75]Poisson exact test
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the total vaccinated cohort - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 68 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 7 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 347 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 22 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 198 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 20 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 114 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 8 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 297 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 12 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 143 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 9 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 85 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 282 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 12 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 137 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 15 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 43 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 3 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 1 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 23 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 5 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 3 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 26 Participants |
Secondary
Number of Subjects With Any and Related Medically Attended Visits
Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.
Time frame: From Month 0 to Month 8 post-vaccination
Population: This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Related Medically Attended Visits | Any medically attended visits | 2882 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Related Medically Attended Visits | Related medically attended visits | 165 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Related Medically Attended Visits | Any medically attended visits | 2911 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Related Medically Attended Visits | Related medically attended visits | 66 Participants |
Secondary
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Related pIMDs | 8 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Any pIMD | 92 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Related pIMDs | 6 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Any pIMD | 97 Participants |
Secondary
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 to Month 14
Population: This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 891 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 12 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 939 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 7 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the total vaccinated cohort - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across Doses | 104 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across Doses | 137 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across Doses | 6 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 104 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 8 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 85 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 25 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 3 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 16 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 72 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 2 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 58 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 5 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 106 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 47 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 6 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 38 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 91 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 38 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 32 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 39 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across Doses | 12 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 35 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across Doses | 75 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across Doses | 166 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across Doses | 64 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across Doses | 62 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across Doses | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across Doses | 16 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across Doses | 54 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across Doses | 140 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 4 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 63 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 113 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 7 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 94 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across Doses | 55 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across Doses | 5 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across Doses | 38 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across Doses | 124 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across Doses | 5 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across Doses | 157 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 59 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 31 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 122 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 9 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 105 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 37 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 3 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 26 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 76 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across Doses | 77 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across Doses | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across Doses | 16 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across Doses | 13 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across Doses | 21 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 56 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across Doses | 55 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 34 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across Doses | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 28 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 39 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across Doses | 6 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 14 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across Doses | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 42 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across Doses | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 26 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across Doses | 37 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 27 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 27 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 19 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 20 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 9 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 18 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 6 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 11 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 16 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 17 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 13 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 16 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 12 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across Doses | 52 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 9 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across Doses | 41 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across Doses | 40 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across Doses | 29 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 30 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across Doses | 22 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across Doses | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across Doses | 2 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within the 30 days (Days 0-29) after each vaccination
Population: This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AE(s) | 3859 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AE(s) | 485 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AE(s) | 2853 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AE(s) | 2263 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AE(s) | 265 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AE(s) | 529 Participants |
Secondary
Number of Subjects With Confirmed HZ Episode Related Hospitalizations
Incidence of overall and HZ-related hospitalizations during the study.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 3 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 2 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 5 Participants |
Comparison: Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Groupp-value: 0.253395% CI: [-144.13, 100]Poisson exact test
Comparison: Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Groupp-value: 0.502495% CI: [-435.14, 100]Poisson exact test
Comparison: Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Groupp-value: 0.063695% CI: [-9.92, 100]Poisson exact test
Secondary
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 3 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 3 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 2 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 2 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 5 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 5 Participants |
Secondary
Number of Subjects With Fatal Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Fatal Serious Adverse Events (SAEs) | 426 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Fatal Serious Adverse Events (SAEs) | 459 Participants |
Secondary
Number of Subjects With HZ Related Complications
Incidence of HZ complications during the study in subjects with confirmed HZ.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With HZ Related Complications | HZ vasculitis | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With HZ Related Complications | Neurologic Disease | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With HZ Related Complications | Visceral Disease | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With HZ Related Complications | At least one complication | 1 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With HZ Related Complications | Disseminated Disease | 0 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With HZ Related Complications | Ophthalmic Disease | 1 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With HZ Related Complications | Stroke | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With HZ Related Complications | Ophthalmic Disease | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With HZ Related Complications | Neurologic Disease | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With HZ Related Complications | Stroke | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With HZ Related Complications | At least one complication | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With HZ Related Complications | HZ vasculitis | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With HZ Related Complications | Visceral Disease | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With HZ Related Complications | Disseminated Disease | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With HZ Related Complications | At least one complication | 1 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With HZ Related Complications | Disseminated Disease | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With HZ Related Complications | Ophthalmic Disease | 1 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With HZ Related Complications | HZ vasculitis | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With HZ Related Complications | Neurologic Disease | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With HZ Related Complications | Stroke | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With HZ Related Complications | Visceral Disease | 0 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With HZ Related Complications | HZ vasculitis | 0 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With HZ Related Complications | At least one complication | 6 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With HZ Related Complications | Disseminated Disease | 0 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With HZ Related Complications | Ophthalmic Disease | 4 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With HZ Related Complications | Neurologic Disease | 3 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With HZ Related Complications | Visceral Disease | 0 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With HZ Related Complications | Stroke | 0 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With HZ Related Complications | Visceral Disease | 0 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With HZ Related Complications | Disseminated Disease | 2 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With HZ Related Complications | Neurologic Disease | 0 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With HZ Related Complications | At least one complication | 4 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With HZ Related Complications | HZ vasculitis | 0 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With HZ Related Complications | Ophthalmic Disease | 2 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With HZ Related Complications | Stroke | 0 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With HZ Related Complications | Disseminated Disease | 2 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With HZ Related Complications | Neurologic Disease | 3 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With HZ Related Complications | HZ vasculitis | 0 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With HZ Related Complications | Visceral Disease | 0 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With HZ Related Complications | At least one complication | 10 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With HZ Related Complications | Ophthalmic Disease | 6 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With HZ Related Complications | Stroke | 0 Participants |
Comparison: Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Groupp-value: 0.494795% CI: [-827.06, 73.62]Poisson exact test
Comparison: Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Groupp-value: 195% CI: [-558.05, 100]Poisson exact test
Comparison: Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Groupp-value: 195% CI: [-433.32, 83.16]Poisson exact test
Secondary
Number of Subjects With Overall Mortality and HZ-related Mortality
The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Overall Mortality and HZ-related Mortality | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Overall Mortality and HZ-related Mortality | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With Overall Mortality and HZ-related Mortality | 0 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With Overall Mortality and HZ-related Mortality | 0 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With Overall Mortality and HZ-related Mortality | 0 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With Overall Mortality and HZ-related Mortality | 0 Participants |
Secondary
Number of Subjects With Post-herpetic Neuralgia (PHN)
PHN cases in the mTVc.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With Post-herpetic Neuralgia (PHN) | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With Post-herpetic Neuralgia (PHN) | 2 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Number of Subjects With Post-herpetic Neuralgia (PHN) | 4 Participants |
| Zoster-022 Placebo 70-79YOA Group | Number of Subjects With Post-herpetic Neuralgia (PHN) | 22 Participants |
| Zoster-022 Placebo >=80YOA Group | Number of Subjects With Post-herpetic Neuralgia (PHN) | 6 Participants |
| Zoster-022 Placebo >=70YOA Group | Number of Subjects With Post-herpetic Neuralgia (PHN) | 28 Participants |
Comparison: Comparison of of Vaccine Efficacy (VE) in prevention of PHN between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 placebo 70-79YOA Groupp-value: <0.000195% CI: [62.57, 98.95]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Groupp-value: 0.307295% CI: [-91.58, 96.62]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Groupp-value: <0.000195% CI: [58.52, 96.3]Poisson exact test
Secondary
Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication
The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated
Time frame: During the entire study period (3 to 5 year period following day 0)
Population: The analysis was based on the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication | 57 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication | 84 Participants |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.
Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 20.3 Days | Standard Deviation 29.71 |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 98.7 Days | Standard Deviation 57.73 |
| Zoster-022 GSK1437173A >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 32.1 Days | Standard Deviation 43.8 |
| Zoster-022 Placebo 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 48.3 Days | Standard Deviation 96.34 |
| Zoster-022 Placebo >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 45.2 Days | Standard Deviation 95.58 |
| Zoster-022 Placebo >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 47.5 Days | Standard Deviation 95.98 |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the total vaccinated cohort - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 1336 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 42 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 606 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 43 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 355 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 17 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 1241 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 60 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 582 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 39 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 344 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 15 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 1562 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 90 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 851 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 70 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 519 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 30 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 128 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 17 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 10 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 27 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 17 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 25 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 107 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 199 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 3 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 14 Participants |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits
Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA.
Time frame: From Month 0 to Month 8 post-vaccination
Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits | Any medically attended visits | 3593 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits | Related medically attended visits | 180 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits | Any medically attended visits | 3648 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits | Related medically attended visits | 80 Participants |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs
Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs | Any pIMD(s) | 110 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs | Related pIMD(s) | 8 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs | Any pIMD(s) | 118 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs | Related pIMD(s) | 8 Participants |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs
Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.
Time frame: From Month 0 to Month 14
Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs | Any SAE(s) | 1117 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs | Related SAE(s) | 12 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs | Any SAE(s) | 1171 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs | Related SAE(s) | 7 Participants |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = Temperature\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the total vaccinated cohort - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 386 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 15 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 560 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 380 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 42 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 173 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 484 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across Doses | 62 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 334 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 142 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 36 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 7 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 292 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 1 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 224 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 170 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 2 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 111 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 189 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 293 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across Doses | 825 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 579 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across Doses | 79 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 530 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across Doses | 699 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 53 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across Doses | 304 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 31 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal,Across Doses | 26 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 495 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal,Across Doses | 210 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 26 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across Doses | 653 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 188 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across Doses | 34 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 15 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across Doses | 547 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 14 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across Doses | 790 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 445 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 101 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across Doses | 689 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 142 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across Doses | 439 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 545 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across Doses | 49 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 455 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across Doses | 380 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 206 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across Doses | 323 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 30 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across Doses | 3 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 441 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across Doses | 265 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across Doses | 10 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 132 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across Doses | 30 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 231 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 13 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 147 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 123 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 6 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 67 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 189 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 8 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 159 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 7 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 101 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 73 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 3 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 50 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 34 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 16 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 169 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 116 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 75 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 5 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 35 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 133 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 86 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 112 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 75 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 55 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 4 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 34 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 30 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 3 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 14 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across Doses | 326 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across Doses | 17 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across Doses | 220 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across Doses | 172 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal,Across Doses | 10 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal,Across Doses | 91 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across Doses | 268 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across Doses | 10 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across Doses | 185 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across Doses | 225 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across Doses | 157 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across Doses | 110 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across Doses | 6 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across Doses | 75 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across Doses | 61 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across Doses | 3 Participants |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA
Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within 30 days (Days 0 - 29) after each vaccination
Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA | Any unsolicited AE(s) | 4366 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA | Grade 3 unsolicited AE(s) | 553 Participants |
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA | Related unsolicited AE(s) | 2961 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA | Any unsolicited AE(s) | 2732 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA | Grade 3 unsolicited AE(s) | 335 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA | Related unsolicited AE(s) | 578 Participants |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ
Occurrence of PHN during the entire study period in all subjects with confirmed HZ.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 2 Participants |
| Zoster-022 Placebo 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 2 Participants |
| Zoster-022 Placebo >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 4 Participants |
| Zoster-022 Placebo >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 8 Participants |
| Zoster-022/006 Pooled Placebo 60-69 YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 2 Participants |
| Zoster-022/006 Pooled Placebo 70-79 YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 29 Participants |
| Zoster-022/006 Pooled Placebo >=80 YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 7 Participants |
| Zoster-022/006 Pooled Placebo >=50 YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ | 46 Participants |
Comparison: Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group versus Zoster-022/006 Pooled Placebo 50-59 YOA Groupp-value: 195% CI: [-649.86, 100]Poisson exact test
Comparison: Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group versus Zoster-022/006 Pooled Placebo 60-69 YOA Groupp-value: 195% CI: [-3938.7, 100]Poisson exact test
Comparison: Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group versus Zoster-022/006 Pooled Placebo 70-79 YOA Groupp-value: 195% CI: [-149.41, 78.91]Poisson exact test
Comparison: Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=80 YOA Group versus Zoster-022/006 Pooled Placebo\>=80 YOA Groupp-value: 0.152895% CI: [-883.05, 18.84]Poisson exact test
Comparison: Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=50 YOA Group versus Zoster-022/006 Pooled Placebo \>=50 YOA Groupp-value: 0.541795% CI: [-161.53, 65.57]Poisson exact test
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.
The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ .
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 17 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 3 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 20 Participants |
| Zoster-022 Placebo 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 193 Participants |
| Zoster-022 Placebo >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 61 Participants |
| Zoster-022 Placebo >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. | 254 Participants |
Comparison: Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A 70-79YOA Group and Zoster-022/006 pooled Placebo 70-79YOA Groupp-value: 0.288595% CI: [-25.8, 53.78]Poisson exact test
Comparison: Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=80 YOA Group and Zoster-022/006 pooled Placebo \>=80 YOA Groupp-value: 0.19495% CI: [-50.03, 86.46]Poisson exact test
Comparison: Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 pooled Placebo\>=70 YOA Groupp-value: 0.124395% CI: [-10.52, 56.27]Poisson exact test
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs
Fatal SAEs during the entire study period in subjects ≥ 70 YOA.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs | 128 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs | 144 Participants |
Secondary
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA
Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoster-022 GSK1437173A 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 0 Participants |
| Zoster-022 GSK1437173A >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 0 Participants |
| Zoster-022 GSK1437173A >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 2 Participants |
| Zoster-022 Placebo 70-79YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 2 Participants |
| Zoster-022 Placebo >=80YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 4 Participants |
| Zoster-022 Placebo >=70YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 8 Participants |
| Zoster-022/006 Pooled Placebo 60-69 YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 2 Participants |
| Zoster-022/006 Pooled Placebo 70-79 YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 29 Participants |
| Zoster-022/006 Pooled Placebo >=80 YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 7 Participants |
| Zoster-022/006 Pooled Placebo >=50 YOA Group | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA | 46 Participants |
Comparison: Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 50-59YOA Group and Zoster-022/006 Pooled Placebo 50-59YOA Group.Comparison of vaccine efficacy for groups 70-79 and above 80 YOA are presented in outcome measure 2.p-value: 0.008195% CI: [40.88, 100]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 60-69YOA Group and Zoster-022/006 Pooled Placebo 60-69YOA Groupp-value: 0.509795% CI: [-442.83, 100]Poisson exact test