Herpes Zoster
Conditions
Keywords
subjects 50 years and older, vaccine, immunogenicity, efficacy, Herpes Zoster, safety
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 ≥ 50 years. Two studies \[ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)\] are being 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. The protocol posting of study ZOSTER-022 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 and the analyses of the objectives in 2 steps. Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA, and other pre-specified endpoints will be analyzed.
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, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 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 50 years or older at the time of the first vaccination; * Female subjects of non-childbearing potential may be enrolled in the study; For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;
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 enrollment; * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Pregnant or lactating female; * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | During the entire study period (3 to 5 year period following Day 0) | Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | During the entire study period (3 to 5 year period following Day 0) | Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the 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 ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study. |
| Number of Subjects With Confirmed HZ Episode Related Mortality | During the entire study period (3 to 5 year period following Day 0) | The analysis focused on the number of subjects who died due to HZ |
| Number of Subjects With HZ Related Complications | During the entire study period (3 to 5 year period following Day 0) | The analysis focused on the incidence of HZ complications in subjects with confirmed HZ |
| Number of Subjects With Confirmed HZ Episode Related Hospitalizations | During the entire study period (3 to 5 year period following Day 0) | The analysis focused on confirmed HZ episode related hospitalizations. |
| Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | During the entire study period (3 to 5 year period following Day 0) | The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ. |
| Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | During the entire study period (3 to 5 year period following Day 0) | The analysis focused on subjects taking pain medication due to HZ |
| Number of Days With Severe 'Worst' HZ-associated Pain. | During the entire study period (3 to 5 year period following Day 0) | Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study. |
| 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 analysis focused on confirmed HZ episode related hospitalizations and deaths. |
| Number of Subjects With HZ Related Complications, by Complication Type | During the entire study period (3 to 5 year period following Day 0) | Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ. |
| Distribution of Pain Medication Associated With HZ | During the entire study period (3 to 5 year period following Day 0) | The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ. |
| Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | During the entire study period (3 to 5 year period following Day 0) | The incidence of PHN was calculated using the modified total vaccinated chort. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period | 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 normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 7-day (Days 0-6) post-vaccination period | Assessed solicited general symptoms were fatigue, GI (gastrointestinal) symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), fever \[defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. 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. |
| Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) | Within the 7-day (Days 0-6) post-vaccination period | Number of subjects with any and grade 3 solicited and unsolicited symptoms 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) in all subjects |
| Number of Subjects With AEs With Any and Related Medically Attended Visit | 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 in all subjects. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within 30 days (Days 0 - 29) after each vaccination | Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any 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 Serious Adverse Events (SAEs) | Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0) | Occurrence and relationship to vaccination of all SAEs in all subjects. 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 to a Concurrent GSK Medication/Vaccine | During the entire study period (3 to 5 year period following Day 0) | The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated |
| Number of Subjects With Fatal SAEs | During the entire study period (3 to 5 years following day 0) | Number of subjects with fatal SAEs during the entire study period were tabulated |
| Number of Days of Pain Medication Associated With HZ | During the entire study period (3 to 5 year period following Day 0) | The analysis was performed on subjects with a confirmed HZ episode |
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
Out of all the subjects enrolled into this study, only 15405 received vaccination and were hence considered to start the study.
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Group Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule. | 7,695 |
| Placebo Group Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule. | 7,710 |
| Total | 15,405 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 183 | 194 |
| Overall Study | Migrated/ moved from study area | 48 | 43 |
| Overall Study | Non-serious adverse event | 30 | 18 |
| Overall Study | Other unspecified reasons | 47 | 35 |
| Overall Study | Protocol Violation | 19 | 21 |
| Overall Study | Serious Adverse Event | 227 | 235 |
| Overall Study | Suspected HZ episode | 0 | 2 |
| Overall Study | Withdrawal by Subject | 368 | 354 |
Baseline characteristics
| Characteristic | GSK1437173A Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 62.4 Years STANDARD_DEVIATION 9 | 62.3 Years STANDARD_DEVIATION 9 | 62.35 Years STANDARD_DEVIATION 9 |
| Age, Customized 50 - 59 YOA | 3644 Participants | 3642 Participants | 7286 Participants |
| Age, Customized 60 - 69 YOA | 2243 Participants | 2245 Participants | 4488 Participants |
| Age, Customized >= 70 YOA | 1808 Participants | 1823 Participants | 3631 Participants |
| Sex: Female, Male Female | 4709 Participants | 4711 Participants | 9420 Participants |
| Sex: Female, Male Male | 2986 Participants | 2999 Participants | 5985 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 7,695 | 15 / 7,710 |
| other Total, other adverse events | 5,586 / 7,695 | 1,893 / 7,710 |
| serious Total, serious adverse events | 727 / 7,695 | 731 / 7,710 |
Outcome results
Primary
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
Confirmed HZ cases during the study were assessed 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) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | 3 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | 2 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | 1 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | 6 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | 87 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | 75 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | 48 Participants |
| Placebo Overall Ages Group | Number of Subjects With Confirmed Herpes Zoster (HZ) Cases | 210 Participants |
Comparison: Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA groupp-value: <0.000195% CI: [89.6, 99.3]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 60-69 YOA group and placebo over 60-69 YOA groupp-value: <0.000195% CI: [90.1, 99.7]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 70 YOA group and placebo over 70 YOA groupp-value: 0.000195% CI: [87.9, 100]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of HZ between GSK1437173A overall ages group and placebo overall ages groupp-value: <0.000195% CI: [93.7, 99]Poisson exact test
Secondary
Distribution of Pain Medication Associated With HZ
The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants 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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Distribution of Pain Medication Associated With HZ | At least one pain medication | 3 Participants |
| GSK1437173A 50-59 YOA Group | Distribution of Pain Medication Associated With HZ | 1 pain medication only | 1 Participants |
| GSK1437173A 50-59 YOA Group | Distribution of Pain Medication Associated With HZ | 2 pain medications only | 1 Participants |
| GSK1437173A 50-59 YOA Group | Distribution of Pain Medication Associated With HZ | 3 pain medications or more | 1 Participants |
| GSK1437173A 60-69 YOA Group | Distribution of Pain Medication Associated With HZ | 3 pain medications or more | 0 Participants |
| GSK1437173A 60-69 YOA Group | Distribution of Pain Medication Associated With HZ | 1 pain medication only | 1 Participants |
| GSK1437173A 60-69 YOA Group | Distribution of Pain Medication Associated With HZ | At least one pain medication | 2 Participants |
| GSK1437173A 60-69 YOA Group | Distribution of Pain Medication Associated With HZ | 2 pain medications only | 1 Participants |
| GSK1437173A Over 70 YOA Group | Distribution of Pain Medication Associated With HZ | At least one pain medication | 1 Participants |
| GSK1437173A Over 70 YOA Group | Distribution of Pain Medication Associated With HZ | 3 pain medications or more | 1 Participants |
| GSK1437173A Over 70 YOA Group | Distribution of Pain Medication Associated With HZ | 1 pain medication only | 0 Participants |
| GSK1437173A Over 70 YOA Group | Distribution of Pain Medication Associated With HZ | 2 pain medications only | 0 Participants |
| GSK1437173A Overall Ages Group | Distribution of Pain Medication Associated With HZ | At least one pain medication | 6 Participants |
| GSK1437173A Overall Ages Group | Distribution of Pain Medication Associated With HZ | 1 pain medication only | 2 Participants |
| GSK1437173A Overall Ages Group | Distribution of Pain Medication Associated With HZ | 2 pain medications only | 2 Participants |
| GSK1437173A Overall Ages Group | Distribution of Pain Medication Associated With HZ | 3 pain medications or more | 2 Participants |
| Placebo 50-59 YOA Group | Distribution of Pain Medication Associated With HZ | 3 pain medications or more | 26 Participants |
| Placebo 50-59 YOA Group | Distribution of Pain Medication Associated With HZ | 2 pain medications only | 26 Participants |
| Placebo 50-59 YOA Group | Distribution of Pain Medication Associated With HZ | 1 pain medication only | 30 Participants |
| Placebo 50-59 YOA Group | Distribution of Pain Medication Associated With HZ | At least one pain medication | 82 Participants |
| Placebo 60-69 YOA Group | Distribution of Pain Medication Associated With HZ | 3 pain medications or more | 21 Participants |
| Placebo 60-69 YOA Group | Distribution of Pain Medication Associated With HZ | 2 pain medications only | 19 Participants |
| Placebo 60-69 YOA Group | Distribution of Pain Medication Associated With HZ | 1 pain medication only | 23 Participants |
| Placebo 60-69 YOA Group | Distribution of Pain Medication Associated With HZ | At least one pain medication | 63 Participants |
| Placebo Over 70 YOA Group | Distribution of Pain Medication Associated With HZ | 3 pain medications or more | 22 Participants |
| Placebo Over 70 YOA Group | Distribution of Pain Medication Associated With HZ | At least one pain medication | 45 Participants |
| Placebo Over 70 YOA Group | Distribution of Pain Medication Associated With HZ | 2 pain medications only | 9 Participants |
| Placebo Over 70 YOA Group | Distribution of Pain Medication Associated With HZ | 1 pain medication only | 14 Participants |
| Placebo Overall Ages Group | Distribution of Pain Medication Associated With HZ | 1 pain medication only | 67 Participants |
| Placebo Overall Ages Group | Distribution of Pain Medication Associated With HZ | 2 pain medications only | 54 Participants |
| Placebo Overall Ages Group | Distribution of Pain Medication Associated With HZ | 3 pain medications or more | 69 Participants |
| Placebo Overall Ages Group | Distribution of Pain Medication Associated With HZ | At least one pain medication | 190 Participants |
Secondary
Number of Days of Pain Medication Associated With HZ
The analysis was performed on subjects with a confirmed HZ episode
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 |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Days of Pain Medication Associated With HZ | 17.3 Days | Standard Deviation 14.5 |
| GSK1437173A 60-69 YOA Group | Number of Days of Pain Medication Associated With HZ | 20.5 Days | Standard Deviation 16.3 |
| GSK1437173A Over 70 YOA Group | Number of Days of Pain Medication Associated With HZ | 63.0 Days | Standard Deviation 0 |
| GSK1437173A Overall Ages Group | Number of Days of Pain Medication Associated With HZ | 26.0 Days | Standard Deviation 21.6 |
| Placebo 50-59 YOA Group | Number of Days of Pain Medication Associated With HZ | 49.2 Days | Standard Deviation 121.5 |
| Placebo 60-69 YOA Group | Number of Days of Pain Medication Associated With HZ | 74.3 Days | Standard Deviation 166.3 |
| Placebo Over 70 YOA Group | Number of Days of Pain Medication Associated With HZ | 127.7 Days | Standard Deviation 266.9 |
| Placebo Overall Ages Group | Number of Days of Pain Medication Associated With HZ | 76.1 Days | Standard Deviation 181.5 |
Secondary
Number of Days With Severe 'Worst' HZ-associated Pain.
Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time 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 (MEAN) | Dispersion |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain. | 12.0 Days | Standard Deviation 11.8 |
| GSK1437173A 60-69 YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain. | 78.0 Days | Standard Deviation 0 |
| GSK1437173A Over 70 YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain. | 9.0 Days | Standard Deviation 4.2 |
| GSK1437173A Overall Ages Group | Number of Days With Severe 'Worst' HZ-associated Pain. | 20.6 Days | Standard Deviation 26.8 |
| Placebo 50-59 YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain. | 28.7 Days | Standard Deviation 48.4 |
| Placebo 60-69 YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain. | 21.6 Days | Standard Deviation 29.3 |
| Placebo Over 70 YOA Group | Number of Days With Severe 'Worst' HZ-associated Pain. | 44.0 Days | Standard Deviation 74.4 |
| Placebo Overall Ages Group | Number of Days With Severe 'Worst' HZ-associated Pain. | 30.2 Days | Standard Deviation 51.9 |
Secondary
Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ
The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ 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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | 3 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | 2 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | 1 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | 6 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | 82 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | 63 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | 45 Participants |
| Placebo Overall Ages Group | Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ | 190 Participants |
Secondary
Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ
The analysis focused on subjects taking pain medication due to 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) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | 3 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | 2 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | 1 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | 6 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | 82 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | 63 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | 45 Participants |
| Placebo Overall Ages Group | Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ | 190 Participants |
Secondary
Number of Subjects With AEs With Any and Related Medically Attended Visit
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 in all subjects.
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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With AEs With Any and Related Medically Attended Visit | Any medically attended visits | 2952 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With AEs With Any and Related Medically Attended Visit | Related medically attended visits | 142 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With AEs With Any and Related Medically Attended Visit | Any medically attended visits | 3072 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With AEs With Any and Related Medically Attended Visit | Related medically attended visits | 60 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
Time frame: During the 7-day (Days 0-6) post-vaccination period
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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 810 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 56 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 1225 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 762 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 28 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 18 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 159 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Overall | 3463 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 2807 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 82 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Overall | 1665 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 185 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Overall | 121 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 3120 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Overall | 1153 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1151 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Overall | 43 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Overall | 293 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Overall | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 352 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 6 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 40 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 31 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 258 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 10 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 24 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 17 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Overall | 490 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Overall | 16 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Overall | 59 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Overall | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Overall | 46 Participants |
Secondary
Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)
Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated
Time frame: Within the 7-day (Days 0-6) post-vaccination period
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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) | Any solicited or unsolicited symptoms | 3766 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) | Grade 3 solicited or unsolicited symptoms | 759 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) | Any solicited or unsolicited symptoms | 1691 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) | Grade 3 solicited or unsolicited symptoms | 145 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) 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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Any pIMDs | 87 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Related pIMDs | 8 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Any pIMDs | 105 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Related pIMDs | 12 Participants |
Secondary
Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)
The incidence of PHN was calculated using the modified total vaccinated chort.
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) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | 8 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | 2 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | 8 Participants |
| Placebo Overall Ages Group | Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN) | 18 Participants |
Comparison: Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 50-59 YOA group and placebo 50-59 YOA groupp-value: 0.008195% CI: [40.9, 100]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 60-69 YOA group and placebo 60-69 YOA groupp-value: 0.509795% CI: [-442.8, 100]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of PHN between GSK1437173A over 70 YOA group and placebo over 70 YOA groupp-value: 0.007895% CI: [41.4, 100]Poisson exact test
Comparison: Comparison of vaccine efficacy in prevention of PHN between GSK1437173A overall ages group and placebo overall ages groupp-value: <0.000195% CI: [77.1, 100]Poisson exact test
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, GI (gastrointestinal) symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), fever \[defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. 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
Population: The analysis was performed on the TVc - Diary Card, which was a subset of subjects from the TVc, 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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 1474 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 539 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 160 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 GI symptoms, Dose 1 | 30 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 1314 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 500 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 947 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 891 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 139 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 7 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 838 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 109 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 645 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 420 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 8 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 1446 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 571 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 1456 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Overall | 2006 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose 1 | 317 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Overall | 241 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 157 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue, Overall | 1724 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 104 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Overall | 787 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue, Dose 2 | 1270 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 GI symptoms, Overall | 61 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose 1 | 465 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Overall | 591 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose 2 | 495 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Overall | 1714 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 1231 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Overall | 157 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 GI symptoms, Dose 2 | 33 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Overall | 1470 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 1112 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Overall | 2023 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose 2 | 392 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Overall | 236 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 632 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Overall | 1791 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 1249 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Overall | 1232 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue, Dose 1 | 1153 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Overall | 192 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 105 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Overall | 1082 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 69 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Overall | 940 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 1107 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Overall | 14 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 67 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Overall | 813 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 1395 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Overall | 78 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 531 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 29 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue, Dose 1 | 355 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose 1 | 263 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 GI symptoms, Dose 1 | 12 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose 1 | 141 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 511 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 20 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 341 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 377 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 21 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 265 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 166 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 3 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 104 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 65 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 1 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 38 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 379 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 18 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue, Dose 2 | 279 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Dose 2 | 183 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 GI symptoms, Dose 2 | 14 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Dose 2 | 91 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 340 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 13 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 219 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 274 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 13 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 197 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 128 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 9 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 88 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 72 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 5 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 40 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Overall | 728 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Overall | 46 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue, Overall | 522 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any GI symptoms, Overall | 386 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 GI symptoms, Overall | 25 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related GI symptoms, Overall | 206 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Overall | 700 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Overall | 30 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Overall | 469 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Overall | 529 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Overall | 31 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Overall | 390 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Overall | 259 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Overall | 11 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Overall | 177 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Overall | 132 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Overall | 6 Participants |
Secondary
Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain
Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the 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 ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time 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) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | 4 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | 1 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | 2 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | 7 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | 91 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | 74 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | 56 Participants |
| Placebo Overall Ages Group | Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain | 221 Participants |
Secondary
Number of Subjects With Confirmed HZ Episode Related Hospitalizations
The analysis focused on confirmed HZ episode related hospitalizations.
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) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Hospitalizations | 0 Participants |
Secondary
Number of Subjects With Confirmed HZ Episode Related Mortality
The analysis focused on the number of subjects who died due to 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) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Mortality | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Mortality | 0 Participants |
Secondary
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
The analysis focused on confirmed HZ episode related hospitalizations and deaths.
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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Hospitalization | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations | Mortality or hospitalization | 0 Participants |
Secondary
Number of Subjects With Fatal SAEs
Number of subjects with fatal SAEs during the entire study period were tabulated
Time frame: During the entire study period (3 to 5 years 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) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Fatal SAEs | 208 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Fatal SAEs | 221 Participants |
Secondary
Number of Subjects With HZ Related Complications
The analysis focused on the incidence of HZ complications 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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With HZ Related Complications | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With HZ Related Complications | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With HZ Related Complications | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With HZ Related Complications | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With HZ Related Complications | 1 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With HZ Related Complications | 3 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With HZ Related Complications | 2 Participants |
| Placebo Overall Ages Group | Number of Subjects With HZ Related Complications | 6 Participants |
Secondary
Number of Subjects With HZ Related Complications, by Complication Type
Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants 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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Neurologic Disease | 0 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Visceral Disease | 0 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Disseminated Disease | 0 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | At least one complication | 0 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | HZ vasculitis | 0 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Ophtalmic Disease | 0 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Stroke | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Stroke | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Neurologic Disease | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | HZ vasculitis | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Disseminated Disease | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Ophtalmic Disease | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | At least one complication | 0 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Visceral Disease | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Neurologic Disease | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Stroke | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Ophtalmic Disease | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | HZ vasculitis | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | At least one complication | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Visceral Disease | 0 Participants |
| GSK1437173A Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Disseminated Disease | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Ophtalmic Disease | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Stroke | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | HZ vasculitis | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Visceral Disease | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Disseminated Disease | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | At least one complication | 0 Participants |
| GSK1437173A Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Neurologic Disease | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Ophtalmic Disease | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | At least one complication | 1 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | HZ vasculitis | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Disseminated Disease | 1 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Neurologic Disease | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Visceral Disease | 0 Participants |
| Placebo 50-59 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Stroke | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Ophtalmic Disease | 1 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Stroke | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Neurologic Disease | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Disseminated Disease | 1 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Visceral Disease | 0 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | HZ vasculitis | 1 Participants |
| Placebo 60-69 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | At least one complication | 3 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | HZ vasculitis | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | At least one complication | 2 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Visceral Disease | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Neurologic Disease | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Stroke | 0 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Disseminated Disease | 2 Participants |
| Placebo Over 70 YOA Group | Number of Subjects With HZ Related Complications, by Complication Type | Ophtalmic Disease | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Stroke | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Ophtalmic Disease | 1 Participants |
| Placebo Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Visceral Disease | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | At least one complication | 6 Participants |
| Placebo Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Disseminated Disease | 4 Participants |
| Placebo Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | Neurologic Disease | 0 Participants |
| Placebo Overall Ages Group | Number of Subjects With HZ Related Complications, by Complication Type | HZ vasculitis | 1 Participants |
Secondary
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated
Time frame: During the entire study period (3 to 5 year period following Day 0)
Population: The analysis was based on TVC, which included all subjects with at least one dose of the study vaccine or place administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine | 43 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine | 25 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Occurrence and relationship to vaccination of all SAEs in all subjects. 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: Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs (up to Day 30) | 88 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs (up to Day 30) | 1 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs (up to Month 14) | 594 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs (up to Month 14) | 3 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs (up to study end) | 727 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs (up to study end) | 3 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs (up to study end) | 731 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs (up to Day 30) | 97 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs (up to Month 14) | 6 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs (up to Day 30) | 3 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs (up to study end) | 7 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs (up to Month 14) | 590 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any 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: 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) |
|---|---|---|---|
| GSK1437173A 50-59 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 3534 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 609 Participants |
| GSK1437173A 50-59 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 2199 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 2426 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 298 Participants |
| GSK1437173A 60-69 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 439 Participants |