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Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

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ClinicalTrials.gov Identifier: NCT01165229
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : November 20, 2017
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Herpes Zoster
Interventions Biological: Herpes Zoster Vaccine GSK1437173A
Biological: Placebo
Enrollment 14819
Recruitment Details  
Pre-assignment Details Out of the 14819 subjects originally enrolled in the study, only 13900 subjects have been vaccinated and included in the Total Vaccinated Cohort.
Arm/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Hide Arm/Group Description Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule. Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Period Title: Overall Study
Started 6950 6950
Completed 5770 5761
Not Completed 1180 1189
Reason Not Completed
Unknown completion status             0             1
Serious Adverse Event             459             487
Non-Serious Adverse Event             47             15
Protocol Violation             10             12
Withdrawal by Subject             396             403
Migrated/moved from study area             51             46
Lost to Follow-up             124             138
Suspected HZ Episode             0             2
No reason from the subject             0             1
Page entered in error             0             1
Patient not eligible             0             1
Health issues             61             56
Site closure             18             20
Personal reason             10             4
Investigator decision             0             2
Sponsor study termination             1             0
Missed visit             1             0
Lack of time             1             0
Screening criteria unmet             1             0
Arm/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group Total
Hide Arm/Group Description Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule. Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 6950 6950 13900
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6950 participants 6950 participants 13900 participants
75.6  (4.7) 75.6  (4.7) 75.6  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6950 participants 6950 participants 13900 participants
Female
3789
  54.5%
3836
  55.2%
7625
  54.9%
Male
3161
  45.5%
3114
  44.8%
6275
  45.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 6950 participants 6950 participants 13900 participants
African Heritage / African American
79
   1.1%
67
   1.0%
146
   1.1%
American Indian or Alaskan Native
1
   0.0%
8
   0.1%
9
   0.1%
Asian - Central/South Asian Heritage
3
   0.0%
6
   0.1%
9
   0.1%
Asian - East Asian Heritage
907
  13.1%
908
  13.1%
1815
  13.1%
Asian - Japanese Heritage
298
   4.3%
300
   4.3%
598
   4.3%
Asian - South East Asian Heritage
8
   0.1%
4
   0.1%
12
   0.1%
Native Hawaiian or Other Pacific Islander
3
   0.0%
3
   0.0%
6
   0.0%
White - Arabic / North African Heritage
40
   0.6%
47
   0.7%
87
   0.6%
White - Caucasian / European Heritage
5307
  76.4%
5301
  76.3%
10608
  76.3%
Other
304
   4.4%
306
   4.4%
610
   4.4%
1.Primary Outcome
Title Number of Subjects With Any Episodes of Herpes Zoster (HZ)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 5114 1427 6541 5189 1433 6622
Measure Type: Count of Participants
Unit of Measure: Participants
17
   0.3%
6
   0.4%
23
   0.4%
169
   3.3%
54
   3.8%
223
   3.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 90.02
Confidence Interval (2-Sided) 95%
83.54 to 94.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 89.08
Confidence Interval (2-Sided) 95%
74.65 to 96.16
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 89.79
Confidence Interval (2-Sided) 95%
84.29 to 93.66
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022/006 Pooled GSK1437173A 70-79YOA Group Zoster-022/006 Pooled GSK1437173A >=80YOA Group Zoster-022/006 Pooled GSK1437173A >=70YOA Group Zoster-022/006 Pooled Placebo 70-79YOA Group Zoster-022/006 Pooled Placebo >=80YOA Group Zoster-022/006 Pooled Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 6468 1782 8250 6554 1792 8346
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.0%
2
   0.1%
4
   0.0%
29
   0.4%
7
   0.4%
36
   0.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoster-022/006 Pooled GSK1437173A 70-79YOA Group, Zoster-022/006 Pooled Placebo 70-79YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 93.04
Confidence Interval (2-Sided) 95%
72.47 to 99.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoster-022/006 Pooled GSK1437173A >=80YOA Group, Zoster-022/006 Pooled Placebo >=80YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1844
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 71.16
Confidence Interval (2-Sided) 95%
-51.51 to 97.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zoster-022/006 Pooled GSK1437173A >=70YOA Group, Zoster-022/006 Pooled Placebo >=70YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 88.78
Confidence Interval (2-Sided) 95%
68.70 to 97.10
Estimation Comments [Not Specified]
3.Primary Outcome
Title Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022/006 Pooled GSK1437173A 70-79YOA Group Zoster-022/006 Pooled GSK1437173A >=80YOA Group Zoster-022/006 Pooled GSK1437173A >=70YOA Group Zoster-022/006 Pooled Placebo 70-79YOA Group Zoster-022/006 Pooled Placebo >=80YOA Group Zoster-022/006 Pooled Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 6468 1782 8250 6554 1792 8346
Measure Type: Count of Participants
Unit of Measure: Participants
19
   0.3%
6
   0.3%
25
   0.3%
216
   3.3%
68
   3.8%
284
   3.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoster-022/006 Pooled GSK1437173A 70-79YOA Group, Zoster-022/006 Pooled Placebo 70-79YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 91.27
Confidence Interval (2-Sided) 95%
86.04 to 94.85
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoster-022/006 Pooled GSK1437173A >=80YOA Group, Zoster-022/006 Pooled Placebo >=80YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 91.37
Confidence Interval (2-Sided) 95%
80.22 to 96.94
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zoster-022/006 Pooled GSK1437173A >=70YOA Group, Zoster-022/006 Pooled Placebo >=70YOA Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-RR
Estimated Value 91.30
Confidence Interval (2-Sided) 95%
86.88 to 94.46
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Subjects With Post-herpetic Neuralgia (PHN)
Hide Description PHN cases in the mTVc.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 5114 1427 6541 5189 1433 6622
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.0%
2
   0.1%
4
   0.1%
22
   0.4%
6
   0.4%
28
   0.4%
5.Secondary Outcome
Title Number of Days With Severe ‘Worst’ HZ-associated Pain
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 15 3 18 150 48 198
Mean (Standard Deviation)
Unit of Measure: Days
21.8  (31.41) 98.7  (57.73) 34.6  (45.54) 47.9  (100.08) 50.4  (106.51) 48.5  (101.40)
6.Secondary Outcome
Title Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
Hide Description [Not Specified]
Time Frame During the entire study period (3 to 5 year period following Day 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 5114 1427 6541 5189 1433 6622
Measure Type: Count of Participants
Unit of Measure: Participants
Mortality
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hospitalization
0
   0.0%
0
   0.0%
0
   0.0%
3
   0.1%
2
   0.1%
5
   0.1%
Mortality or hospitalization
0
   0.0%
0
   0.0%
0
   0.0%
3
   0.1%
2
   0.1%
5
   0.1%
7.Secondary Outcome
Title Number of Subjects With Overall Mortality and HZ-related Mortality
Hide Description Incidence of overall and HZ-related mortality during the study.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 5114 1427 6541 5189 1433 6622
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Subjects With Confirmed HZ Episode Related Hospitalizations
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 5114 1427 6541 5189 1433 6622
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
3
   0.1%
2
   0.1%
5
   0.1%
9.Secondary Outcome
Title Number of Subjects With HZ Related Complications
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 17 6 23 169 54 223
Measure Type: Count of Participants
Unit of Measure: Participants
At least one complication
1
   5.9%
0
   0.0%
1
   4.3%
6
   3.6%
4
   7.4%
10
   4.5%
HZ vasculitis
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Disseminated Disease
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.7%
2
   0.9%
Ophthalmic Disease
1
   5.9%
0
   0.0%
1
   4.3%
4
   2.4%
2
   3.7%
6
   2.7%
Neurologic Disease
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.8%
0
   0.0%
3
   1.3%
Visceral Disease
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Stroke
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Subjects Receiving Pain Medication Associated With HZ
Hide Description [Not Specified]
Time Frame During the entire study period (3 to 5 year period following Day 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 17 6 23 169 54 223
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 pain medication
7
  41.2%
3
  50.0%
10
  43.5%
123
  72.8%
37
  68.5%
160
  71.7%
1 pain medication only
5
  29.4%
0
   0.0%
5
  21.7%
43
  25.4%
17
  31.5%
60
  26.9%
2 pain medications only
0
   0.0%
1
  16.7%
1
   4.3%
30
  17.8%
4
   7.4%
34
  15.2%
3 pain medications or more
2
  11.8%
2
  33.3%
4
  17.4%
50
  29.6%
16
  29.6%
66
  29.6%
11.Secondary Outcome
Title Number of Days With Pain Medication Associated With HZ
Hide Description [Not Specified]
Time Frame During the entire study period (3 to 5 year period following Day 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 7 3 10 123 37 160
Mean (Standard Deviation)
Unit of Measure: Days
38.7  (56.44) 274.7  (337.00) 109.5  (200.88) 218.6  (593.80) 135.0  (207.31) 199.3  (530.60)
12.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description 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 = 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 505 505
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 502 participants 504 participants
297
  59.2%
26
   5.2%
Grade 3 Pain, Dose 1 Number Analyzed 502 participants 504 participants
12
   2.4%
1
   0.2%
Any Redness, Dose 1 Number Analyzed 502 participants 504 participants
143
  28.5%
3
   0.6%
Grade 3 Redness, Dose 1 Number Analyzed 502 participants 504 participants
9
   1.8%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 502 participants 504 participants
85
  16.9%
2
   0.4%
Grade 3 Swelling, Dose 1 Number Analyzed 502 participants 504 participants
2
   0.4%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 492 participants 491 participants
282
  57.3%
23
   4.7%
Grade 3 Pain, Dose 2 Number Analyzed 492 participants 491 participants
12
   2.4%
0
   0.0%
Any Redness, Dose 2 Number Analyzed 492 participants 491 participants
137
  27.8%
3
   0.6%
Grade 3 Redness, Dose 2 Number Analyzed 492 participants 491 participants
15
   3.0%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 492 participants 491 participants
68
  13.8%
0
   0.0%
Grade 3 Swelling, Dose 2 Number Analyzed 492 participants 491 participants
7
   1.4%
0
   0.0%
Any Pain, Across Doses Number Analyzed 505 participants 505 participants
347
  68.7%
43
   8.5%
Grade 3 Pain, Across Doses Number Analyzed 505 participants 505 participants
22
   4.4%
1
   0.2%
Any Redness, Across Doses Number Analyzed 505 participants 505 participants
198
  39.2%
5
   1.0%
Grade 3 Redness, Across Doses Number Analyzed 505 participants 505 participants
20
   4.0%
0
   0.0%
Any Swelling, Across Doses Number Analyzed 505 participants 505 participants
114
  22.6%
2
   0.4%
Grade 3 Swelling, Across Doses Number Analyzed 505 participants 505 participants
8
   1.6%
0
   0.0%
13.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description 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 = 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 504 505
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 501 participants 503 participants
104
  20.8%
56
  11.1%
Grade 3 Fatigue, Dose 1 Number Analyzed 501 participants 503 participants
8
   1.6%
4
   0.8%
Related Fatigue, Dose 1 Number Analyzed 501 participants 503 participants
85
  17.0%
34
   6.8%
Any Gastrointestinal, Dose 1 Number Analyzed 501 participants 503 participants
25
   5.0%
28
   5.6%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 501 participants 503 participants
3
   0.6%
2
   0.4%
Related Gastrointestinal, Dose 1 Number Analyzed 501 participants 503 participants
16
   3.2%
14
   2.8%
Any Headache, Dose 1 Number Analyzed 501 participants 503 participants
72
  14.4%
42
   8.3%
Grade 3 Headache, Dose 1 Number Analyzed 501 participants 503 participants
2
   0.4%
4
   0.8%
Related Headache, Dose 1 Number Analyzed 501 participants 503 participants
58
  11.6%
27
   5.4%
Any Myalgia, Dose 1 Number Analyzed 501 participants 503 participants
106
  21.2%
27
   5.4%
Grade 3 Myalgia, Dose 1 Number Analyzed 501 participants 503 participants
6
   1.2%
2
   0.4%
Related Myalgia, Dose 1 Number Analyzed 501 participants 503 participants
91
  18.2%
16
   3.2%
Any Shivering, Dose 1 Number Analyzed 501 participants 503 participants
38
   7.6%
17
   3.4%
Grade 3 Shivering, Dose 1 Number Analyzed 501 participants 503 participants
1
   0.2%
1
   0.2%
Related Shivering, Dose 1 Number Analyzed 501 participants 503 participants
32
   6.4%
12
   2.4%
Any Temperature, Dose 1 Number Analyzed 501 participants 503 participants
39
   7.8%
9
   1.8%
Grade 3 Temperature, Dose 1 Number Analyzed 501 participants 503 participants
0
   0.0%
2
   0.4%
Related Temperature, Dose 1 Number Analyzed 501 participants 503 participants
31
   6.2%
4
   0.8%
Any Fatigue, Dose 2 Number Analyzed 492 participants 489 participants
122
  24.8%
39
   8.0%
Grade 3 Fatigue, Dose 2 Number Analyzed 492 participants 489 participants
9
   1.8%
0
   0.0%
Related Fatigue, Dose 2 Number Analyzed 492 participants 489 participants
105
  21.3%
30
   6.1%
Any Gastrointestinal, Dose 2 Number Analyzed 492 participants 489 participants
37
   7.5%
19
   3.9%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 492 participants 489 participants
3
   0.6%
1
   0.2%
Related Gastrointestinal, Dose 2 Number Analyzed 492 participants 489 participants
26
   5.3%
13
   2.7%
Any Headache, Dose 2 Number Analyzed 492 participants 489 participants
76
  15.4%
26
   5.3%
Grade 3 Headache, Dose 2 Number Analyzed 492 participants 489 participants
4
   0.8%
0
   0.0%
Related Headache, Dose 2 Number Analyzed 492 participants 489 participants
63
  12.8%
20
   4.1%
Any Myalgia, Dose 2 Number Analyzed 492 participants 489 participants
113
  23.0%
18
   3.7%
Grade 3 Myalgia, Dose 2 Number Analyzed 492 participants 489 participants
7
   1.4%
0
   0.0%
Related Myalgia, Dose 2 Number Analyzed 492 participants 489 participants
94
  19.1%
16
   3.3%
Any Shivering, Dose 2 Number Analyzed 492 participants 489 participants
59
  12.0%
11
   2.2%
Grade 3 Shivering, Dose 2 Number Analyzed 492 participants 489 participants
5
   1.0%
1
   0.2%
Related Shivering, Dose 2 Number Analyzed 492 participants 489 participants
47
   9.6%
9
   1.8%
Any Temperature, Dose 2 Number Analyzed 492 participants 489 participants
38
   7.7%
6
   1.2%
Grade 3 Temperature, Dose 2 Number Analyzed 492 participants 489 participants
0
   0.0%
2
   0.4%
Related Temperature, Dose 2 Number Analyzed 492 participants 489 participants
35
   7.1%
2
   0.4%
Any Fatigue, Across Doses Number Analyzed 504 participants 505 participants
166
  32.9%
77
  15.2%
Grade 3 Fatigue, Across Doses Number Analyzed 504 participants 505 participants
16
   3.2%
4
   0.8%
Related Fatigue, Across Doses Number Analyzed 504 participants 505 participants
140
  27.8%
52
  10.3%
Any Gastrointestinal, Across Doses Number Analyzed 504 participants 505 participants
55
  10.9%
40
   7.9%
Grade 3 Gastrointestinal, Across Doses Number Analyzed 504 participants 505 participants
5
   1.0%
2
   0.4%
Related Gastrointestinal, Across Doses Number Analyzed 504 participants 505 participants
38
   7.5%
21
   4.2%
Any Headache, Across Doses Number Analyzed 504 participants 505 participants
124
  24.6%
55
  10.9%
Grade 3 Headache, Across Doses Number Analyzed 504 participants 505 participants
5
   1.0%
4
   0.8%
Related Headache, Across Doses Number Analyzed 504 participants 505 participants
104
  20.6%
37
   7.3%
Any Myalgia, Across Doses Number Analyzed 504 participants 505 participants
157
  31.2%
41
   8.1%
Grade 3 Myalgia, Across Doses Number Analyzed 504 participants 505 participants
12
   2.4%
2
   0.4%
Related Myalgia, Across Doses Number Analyzed 504 participants 505 participants
137
  27.2%
29
   5.7%
Any Shivering, Across Doses Number Analyzed 504 participants 505 participants
75
  14.9%
22
   4.4%
Grade 3 Shivering, Across Doses Number Analyzed 504 participants 505 participants
6
   1.2%
2
   0.4%
Related Shivering, Across Doses Number Analyzed 504 participants 505 participants
64
  12.7%
16
   3.2%
Any Temperature, Across Doses Number Analyzed 504 participants 505 participants
62
  12.3%
13
   2.6%
Grade 3 Temperature, Across Doses Number Analyzed 504 participants 505 participants
0
   0.0%
2
   0.4%
Related Temperature, Across Doses Number Analyzed 504 participants 505 participants
54
  10.7%
6
   1.2%
14.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 6950 6950
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
3859
  55.5%
2263
  32.6%
Grade 3 AE(s)
485
   7.0%
265
   3.8%
Related AE(s)
2853
  41.1%
529
   7.6%
15.Secondary Outcome
Title Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)
Hide Description 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 and until study end (3 to 5 year period following Day 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 6950 6695
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s) up to Month 14
891
  12.8%
939
  14.0%
Related SAE(s) up to Month 14
12
   0.2%
7
   0.1%
Fatal SAE(s) up to Month 14
101
   1.5%
110
   1.6%
Any SAE(s) up to study end
1153
  16.6%
1214
  18.1%
Related SAE(s) up to study end
12
   0.2%
8
   0.1%
Fatal SAE(s) up to study end
426
   6.1%
459
   6.9%
16.Secondary Outcome
Title Number of Subjects With Potential Immune Mediated Diseases (pIMDs)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 6950 6950
Measure Type: Count of Participants
Unit of Measure: Participants
92
   1.3%
97
   1.4%
17.Secondary Outcome
Title Number of Subjects With Medically Attended Events (MAEs)
Hide Description Occurrence and relationship to vaccination of medically attended visitsother than routine health care visits, from Month 0 to Month 8 in all subjects. MAEs 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 MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time Frame From Month 0 to Month 8 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 6950 6950
Measure Type: Count of Participants
Unit of Measure: Participants
Any MAE(s)
2882
  41.5%
2911
  41.9%
Related MAE(s)
165
   2.4%
66
   0.9%
18.Secondary Outcome
Title 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
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group Zoster-022/006 Pooled GSK1437173A >=80 YOA Group Zoster-022/006 Pooled GSK1437173A >=50 YOA Group Zoster-022/006 Pooled Placebo 50-59 YOA Group Zoster-022/006 Pooled Placebo 60-69 YOA Group Zoster-022/006 Pooled Placebo 70-79 YOA Group Zoster-022/006 Pooled Placebo >=80 YOA Group Zoster-022/006 Pooled Placebo >=50 YOA Group
Hide Arm/Group Description:
Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 50 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 50 and 59 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 3491 2140 6468 1782 13881 3523 2166 6554 1792 14035
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2
   0.0%
2
   0.1%
4
   0.0%
8
   0.2%
2
   0.1%
29
   0.4%
7
   0.4%
46
   0.3%
19.Secondary Outcome
Title 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
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group Zoster-022/006 Pooled GSK1437173A >=80 YOA Group Zoster-022/006 Pooled GSK1437173A >=50 YOA Group Zoster-022/006 Pooled Placebo 50-59 YOA Group Zoster-022/006 Pooled Placebo 60-69 YOA Group Zoster-022/006 Pooled Placebo 70-79 YOA Group Zoster-022/006 Pooled Placebo >=80 YOA Group Zoster-022/006 Pooled Placebo >=50 YOA Group
Hide Arm/Group Description:
Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 50 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 50 and 59 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4 3 19 6 32 103 90 216 68 477
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2
  10.5%
2
  33.3%
4
  12.5%
8
   7.8%
2
   2.2%
29
  13.4%
7
  10.3%
46
   9.6%
20.Secondary Outcome
Title 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.
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group Zoster-022/006 Pooled GSK1437173A >=80 YOA Group Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo 70-79 YOA Group Zoster-022/006 Pooled Placebo >=80 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 19 6 25 216 68 284
Measure Type: Count of Participants
Unit of Measure: Participants
17
  89.5%
3
  50.0%
20
  80.0%
193
  89.4%
61
  89.7%
254
  89.4%
21.Secondary Outcome
Title 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.
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group Zoster-022/006 Pooled GSK1437173A >=80 YOA Group Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo 70-79 YOA Group Zoster-022/006 Pooled Placebo >=80 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
Hide Arm/Group Description:
Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 17 3 20 193 61 254
Mean (Standard Deviation)
Unit of Measure: Days
20.3  (29.71) 98.7  (57.73) 32.1  (43.80) 48.3  (96.34) 45.2  (95.58) 47.5  (95.98)
22.Secondary Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022/006 Pooled GSK1437173A Group Zoster-022/006 Pooled Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 2258 2263
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 2246 participants 2255 participants
1336
  59.5%
128
   5.7%
Grade 3 Pain, Dose 1 Number Analyzed 2246 participants 2255 participants
42
   1.9%
1
   0.0%
Any Redness, Dose 1 Number Analyzed 2246 participants 2255 participants
606
  27.0%
17
   0.8%
Grade 3 Redness, Dose 1 Number Analyzed 2246 participants 2255 participants
43
   1.9%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 2246 participants 2255 participants
355
  15.8%
17
   0.8%
Grade 3 Swelling, Dose 1 Number Analyzed 2246 participants 2255 participants
17
   0.8%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 2160 participants 2169 participants
1241
  57.5%
107
   4.9%
Grade 3 Pain, Dose 2 Number Analyzed 2160 participants 2169 participants
60
   2.8%
3
   0.1%
Any Redness, Dose 2 Number Analyzed 2160 participants 2169 participants
582
  26.9%
14
   0.6%
Grade 3 Redness, Dose 2 Number Analyzed 2160 participants 2169 participants
39
   1.8%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 2160 participants 2169 participants
344
  15.9%
10
   0.5%
Grade 3 Swelling, Dose 2 Number Analyzed 2160 participants 2169 participants
15
   0.7%
0
   0.0%
Any Pain, Across Doses Number Analyzed 2258 participants 2263 participants
1562
  69.2%
199
   8.8%
Grade 3 Pain, Across Doses Number Analyzed 2258 participants 2263 participants
90
   4.0%
4
   0.2%
Any Redness, Across Doses Number Analyzed 2258 participants 2263 participants
851
  37.7%
27
   1.2%
Grade 3 Redness, Across Doses Number Analyzed 2258 participants 2263 participants
70
   3.1%
0
   0.0%
Any Swelling, Across Doses Number Analyzed 2258 participants 2263 participants
519
  23.0%
25
   1.1%
Grade 3 Swelling, Across Doses Number Analyzed 2258 participants 2263 participants
30
   1.3%
0
   0.0%
23.Secondary Outcome
Title 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
Hide Description 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 = 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Zoster-022/006 Pooled GSK1437173A Group Zoster-022/006 Pooled Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 2252 2264
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 2237 participants 2256 participants
545
  24.4%
231
  10.2%
Grade 3 Fatigue, Dose 1 Number Analyzed 2237 participants 2256 participants
31
   1.4%
13
   0.6%
Related Fatigue, Dose 1 Number Analyzed 2237 participants 2256 participants
441
  19.7%
147
   6.5%
Any Gastrointestinal, Dose 1 Number Analyzed 2237 participants 2256 participants
170
   7.6%
123
   5.5%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 2237 participants 2256 participants
15
   0.7%
6
   0.3%
Related Gastrointestinal, Dose 1 Number Analyzed 2237 participants 2256 participants
101
   4.5%
67
   3.0%
Any Headache, Dose 1 Number Analyzed 2237 participants 2256 participants
380
  17.0%
189
   8.4%
Grade 3 Headache, Dose 1 Number Analyzed 2237 participants 2256 participants
7
   0.3%
8
   0.4%
Related Headache, Dose 1 Number Analyzed 2237 participants 2256 participants
293
  13.1%
132
   5.9%
Any Myalgia, Dose 1 Number Analyzed 2237 participants 2256 participants
530
  23.7%
159
   7.0%
Grade 3 Myalgia, Dose 1 Number Analyzed 2237 participants 2256 participants
26
   1.2%
7
   0.3%
Related Myalgia, Dose 1 Number Analyzed 2237 participants 2256 participants
445
  19.9%
101
   4.5%
Any Shivering, Dose 1 Number Analyzed 2237 participants 2256 participants
206
   9.2%
73
   3.2%
Grade 3 Shivering, Dose 1 Number Analyzed 2237 participants 2256 participants
15
   0.7%
3
   0.1%
Related Shivering, Dose 1 Number Analyzed 2237 participants 2256 participants
173
   7.7%
50
   2.2%
Any Temperature, Dose 1 Number Analyzed 2237 participants 2256 participants
142
   6.3%
34
   1.5%
Grade 3 Temperature, Dose 1 Number Analyzed 2237 participants 2256 participants
1
   0.0%
2
   0.1%
Related Temperature, Dose 1 Number Analyzed 2237 participants 2256 participants
111
   5.0%
16
   0.7%
Any Fatigue, Dose 2 Number Analyzed 2159 participants 2166 participants
579
  26.8%
169
   7.8%
Grade 3 Fatigue, Dose 2 Number Analyzed 2159 participants 2166 participants
53
   2.5%
4
   0.2%
Related Fatigue, Dose 2 Number Analyzed 2159 participants 2166 participants
495
  22.9%
116
   5.4%
Any Gastrointestinal, Dose 2 Number Analyzed 2159 participants 2166 participants
188
   8.7%
75
   3.5%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 2159 participants 2166 participants
14
   0.6%
5
   0.2%
Related Gastrointestinal, Dose 2 Number Analyzed 2159 participants 2166 participants
142
   6.6%
35
   1.6%
Any Headache, Dose 2 Number Analyzed 2159 participants 2166 participants
455
  21.1%
133
   6.1%
Grade 3 Headache, Dose 2 Number Analyzed 2159 participants 2166 participants
30
   1.4%
2
   0.1%
Related Headache, Dose 2 Number Analyzed 2159 participants 2166 participants
386
  17.9%
86
   4.0%
Any Myalgia, Dose 2 Number Analyzed 2159 participants 2166 participants
560
  25.9%
112
   5.2%
Grade 3 Myalgia, Dose 2 Number Analyzed 2159 participants 2166 participants
42
   1.9%
4
   0.2%
Related Myalgia, Dose 2 Number Analyzed 2159 participants 2166 participants
484
  22.4%
75
   3.5%
Any Shivering, Dose 2 Number Analyzed 2159 participants 2166 participants
334
  15.5%
55
   2.5%
Grade 3 Shivering, Dose 2 Number Analyzed 2159 participants 2166 participants
36
   1.7%
4
   0.2%
Related Shivering, Dose 2 Number Analyzed 2159 participants 2166 participants
292
  13.5%
34
   1.6%
Any Temperature, Dose 2 Number Analyzed 2159 participants 2166 participants
224
  10.4%
30
   1.4%
Grade 3 Temperature, Dose 2 Number Analyzed 2159 participants 2166 participants
2
   0.1%
3
   0.1%
Related Temperature, Dose 2 Number Analyzed 2159 participants 2166 participants
189
   8.8%
14
   0.6%
Any Fatigue, Across Doses Number Analyzed 2252 participants 2264 participants
825
  36.6%
326
  14.4%
Grade 3 Fatigue, Across Doses Number Analyzed 2252 participants 2264 participants
79
   3.5%
17
   0.8%
Related Fatigue, Across Doses Number Analyzed 2252 participants 2264 participants
699
  31.0%
220
   9.7%
Any Gastrointestinal, Across Doses Number Analyzed 2252 participants 2264 participants
304
  13.5%
172
   7.6%
Grade 3 Gastrointestinal,Across Doses Number Analyzed 2252 participants 2264 participants
26
   1.2%
10
   0.4%
Related Gastrointestinal,Across Doses Number Analyzed 2252 participants 2264 participants
210
   9.3%
91
   4.0%
Any Headache, Across Doses Number Analyzed 2252 participants 2264 participants
653
  29.0%
268
  11.8%
Grade 3 Headache, Across Doses Number Analyzed 2252 participants 2264 participants
34
   1.5%
10
   0.4%
Related Headache, Across Doses Number Analyzed 2252 participants 2264 participants
547
  24.3%
185
   8.2%
Any Myalgia, Across Doses Number Analyzed 2252 participants 2264 participants
790
  35.1%
225
   9.9%
Grade 3 Myalgia, Across Doses Number Analyzed 2252 participants 2264 participants
62
   2.8%
10
   0.4%
Related Myalgia, Across Doses Number Analyzed 2252 participants 2264 participants
689
  30.6%
157
   6.9%
Any Shivering, Across Doses Number Analyzed 2252 participants 2264 participants
439
  19.5%
110
   4.9%
Grade 3 Shivering, Across Doses Number Analyzed 2252 participants 2264 participants
49
   2.2%
6
   0.3%
Related Shivering, Across Doses Number Analyzed 2252 participants 2264 participants
380
  16.9%
75
   3.3%
Any Temperature, Across Doses Number Analyzed 2252 participants 2264 participants
323
  14.3%
61
   2.7%
Grade 3 Temperature, Across Doses Number Analyzed 2252 participants 2264 participants
3
   0.1%
3
   0.1%
Related Temperature, Across Doses Number Analyzed 2252 participants 2264 participants
265
  11.8%
30
   1.3%
24.Secondary Outcome
Title Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Unsolicited AEs in Subjects ≥ 70 YOA
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
Arm/Group Title Zoster-022/006 Pooled GSK1437173A Group Zoster-022/006 Pooled Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 8758 8773
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
4366
  49.9%
2732
  31.1%
Grade 3 AE(s)
553
   6.3%
335
   3.8%
Related AE(s)
2961
  33.8%
578
   6.6%
25.Secondary Outcome
Title Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Related and Fatal SAEs
Hide Description Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA.
Time Frame From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
Arm/Group Title Zoster-022/006 Pooled GSK1437173A Group Zoster-022/006 Pooled Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 8758 8773
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
1117
  12.8%
1171
  13.3%
Related SAE(s)
12
   0.1%
7
   0.1%
Fatal SAE(s)
128
   1.5%
144
   1.6%
26.Secondary Outcome
Title Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any pIMDs
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
Arm/Group Title Zoster-022/006 Pooled GSK1437173A Group Zoster-022/006 Pooled Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 8758 8773
Measure Type: Count of Participants
Unit of Measure: Participants
Any pIMD(s)
110
   1.3%
118
   1.3%
Related pIMD(s)
8
   0.1%
8
   0.1%
27.Secondary Outcome
Title Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Medically Attended Events (MAEs)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.
Arm/Group Title Zoster-022/006 Pooled GSK1437173A Group Zoster-022/006 Pooled Placebo Group
Hide Arm/Group Description:
Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 8758 8773
Measure Type: Count of Participants
Unit of Measure: Participants
Any MAE(s)
3593
  41.0%
3648
  41.6%
Related MAE(s)
180
   2.1%
80
   0.9%
<
Time Frame Solicited symptoms: within 7 days (Days 0-6) after vaccination; Unsolicited adverse events: within 30 days (Days 0-29) after vaccination; Serious Adverse Events (SAEs): during the entire study period (3 to 5 year period following Day 0).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Hide Arm/Group Description Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule. Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
All-Cause Mortality
Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   426/6950 (6.13%)      459/6950 (6.60%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1153/6950 (16.59%)      1214/6950 (17.47%)    
Blood and lymphatic system disorders     
Anaemia  1  6/6950 (0.09%)  6 13/6950 (0.19%)  15
Anaemia vitamin b12 deficiency  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Coagulopathy  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Disseminated intravascular coagulation  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Haemorrhagic anaemia  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Hypersplenism  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Immune thrombocytopenic purpura  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Iron deficiency anaemia  1  5/6950 (0.07%)  5 4/6950 (0.06%)  4
Lymphadenitis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Lymphadenopathy  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Microcytic anaemia  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Nephrogenic anaemia  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Normochromic normocytic anaemia  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Pancytopenia  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Pernicious anaemia  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Thrombocytopenia  1  0/6950 (0.00%)  0 3/6950 (0.04%)  3
Cardiac disorders     
Acute coronary syndrome  1  3/6950 (0.04%)  3 4/6950 (0.06%)  6
Acute left ventricular failure  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Acute myocardial infarction  1  21/6950 (0.30%)  22 28/6950 (0.40%)  29
Angina pectoris  1  13/6950 (0.19%)  13 6/6950 (0.09%)  6
Angina unstable  1  7/6950 (0.10%)  7 7/6950 (0.10%)  7
Aortic valve disease  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Aortic valve incompetence  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Aortic valve stenosis  1  1/6950 (0.01%)  1 3/6950 (0.04%)  3
Arrhythmia  1  5/6950 (0.07%)  5 9/6950 (0.13%)  9
Arrhythmia supraventricular  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Arteriosclerosis coronary artery  1  1/6950 (0.01%)  1 3/6950 (0.04%)  3
Atrial fibrillation  1  40/6950 (0.58%)  45 54/6950 (0.78%)  56
Atrial flutter  1  6/6950 (0.09%)  6 5/6950 (0.07%)  5
Atrioventricular block  1  0/6950 (0.00%)  0 4/6950 (0.06%)  4
Atrioventricular block complete  1  4/6950 (0.06%)  4 2/6950 (0.03%)  2
Atrioventricular block first degree  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Atrioventricular block second degree  1  1/6950 (0.01%)  1 3/6950 (0.04%)  3
Bradyarrhythmia  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Bradycardia  1  4/6950 (0.06%)  4 8/6950 (0.12%)  8
Cardiac arrest  1  23/6950 (0.33%)  23 17/6950 (0.24%)  17
Cardiac disorder  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Cardiac failure  1  51/6950 (0.73%)  52 57/6950 (0.82%)  62
Cardiac failure acute  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Cardiac failure chronic  1  3/6950 (0.04%)  3 6/6950 (0.09%)  6
Cardiac failure congestive  1  23/6950 (0.33%)  23 33/6950 (0.47%)  37
Cardiac tamponade  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Cardiac valve disease  1  2/6950 (0.03%)  2 1/6950 (0.01%)  1
Cardio-respiratory arrest  1  3/6950 (0.04%)  3 5/6950 (0.07%)  5
Cardiogenic shock  1  6/6950 (0.09%)  6 2/6950 (0.03%)  2
Cardiomegaly  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Cardiomyopathy  1  1/6950 (0.01%)  1 2/6950 (0.03%)  2
Cardiopulmonary failure  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Chronotropic incompetence  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Congestive cardiomyopathy  1  2/6950 (0.03%)  2 1/6950 (0.01%)  1
Cor pulmonale  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Coronary artery disease  1  28/6950 (0.40%)  29 25/6950 (0.36%)  25
Coronary artery insufficiency  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Coronary artery occlusion  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Coronary artery stenosis  1  3/6950 (0.04%)  3 6/6950 (0.09%)  6
Diastolic dysfunction  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Extrasystoles  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Heart valve incompetence  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Hypertensive heart disease  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Ischaemic cardiomyopathy  1  0/6950 (0.00%)  0 4/6950 (0.06%)  4
Left ventricular failure  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Left ventricular hypertrophy  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Mitral valve incompetence  1  2/6950 (0.03%)  2 3/6950 (0.04%)  3
Myocardial infarction  1  41/6950 (0.59%)  43 45/6950 (0.65%)  45
Myocardial ischaemia  1  5/6950 (0.07%)  6 16/6950 (0.23%)  16
Palpitations  1  1/6950 (0.01%)  1 3/6950 (0.04%)  3
Pericarditis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Right ventricular failure  1  2/6950 (0.03%)  2 1/6950 (0.01%)  1
Sinus arrest  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Sinus node dysfunction  1  5/6950 (0.07%)  5 6/6950 (0.09%)  6
Sinus tachycardia  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Supraventricular tachycardia  1  3/6950 (0.04%)  3 0/6950 (0.00%)  0
Tachyarrhythmia  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Tachycardia  1  3/6950 (0.04%)  3 2/6950 (0.03%)  2
Tricuspid valve incompetence  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Ventricular arrhythmia  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Ventricular extrasystoles  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Ventricular fibrillation  1  2/6950 (0.03%)  2 3/6950 (0.04%)  3
Ventricular tachycardia  1  2/6950 (0.03%)  2 6/6950 (0.09%)  8
Congenital, familial and genetic disorders     
Congenital cystic kidney disease  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Hypertrophic cardiomyopathy  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Pyloric stenosis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Renal dysplasia  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Ear and labyrinth disorders     
Sudden hearing loss  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Vertigo  1  3/6950 (0.04%)  3 4/6950 (0.06%)  4
Vertigo positional  1  2/6950 (0.03%)  2 1/6950 (0.01%)  1
Vestibular disorder  1  0/6950 (0.00%)  0 3/6950 (0.04%)  3
Endocrine disorders     
Autoimmune thyroiditis  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Cushingoid  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Goitre  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Hyperparathyroidism primary  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Hyperthyroidism  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Hypothyroidism  1  0/6950 (0.00%)  0 3/6950 (0.04%)  3
Eye disorders     
Age-related macular degeneration  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Amaurosis fugax  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Cataract  1  7/6950 (0.10%)  7 7/6950 (0.10%)  7
Choroidal effusion  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Diplopia  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Glaucoma  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Iridocele  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Iritis  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Ocular hypertension  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Ocular vascular disorder  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Optic ischaemic neuropathy  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Retinal degeneration  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Retinal detachment  1  0/6950 (0.00%)  0 4/6950 (0.06%)  4
Retinal haemorrhage  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Gastrointestinal disorders     
Abdominal adhesions  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Abdominal discomfort  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Abdominal hernia  1  2/6950 (0.03%)  2 2/6950 (0.03%)  2
Abdominal pain  1  1/6950 (0.01%)  1 7/6950 (0.10%)  7
Abdominal pain upper  1  2/6950 (0.03%)  2 2/6950 (0.03%)  2
Abdominal strangulated hernia  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Anal prolapse  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Ascites  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Autoimmune pancreatitis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Barrett's oesophagus  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Chronic gastritis  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Colitis  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Colitis ischaemic  1  3/6950 (0.04%)  3 1/6950 (0.01%)  1
Colitis ulcerative  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Constipation  1  3/6950 (0.04%)  3 2/6950 (0.03%)  2
Crohn's disease  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Diaphragmatic hernia  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Diaphragmatic hernia, obstructive  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Diarrhoea  1  0/6950 (0.00%)  0 4/6950 (0.06%)  4
Diverticulum  1  3/6950 (0.04%)  3 3/6950 (0.04%)  3
Diverticulum intestinal  1  1/6950 (0.01%)  1 2/6950 (0.03%)  2
Diverticulum intestinal haemorrhagic  1  0/6950 (0.00%)  0 1/6950 (0.01%)  2
Duodenal ulcer  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Duodenal ulcer haemorrhage  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Duodenal ulcer perforation  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Enteritis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Enterovesical fistula  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Faecal incontinence  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Gastric haemorrhage  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Gastric perforation  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Gastric ulcer  1  4/6950 (0.06%)  4 6/6950 (0.09%)  6
Gastric ulcer haemorrhage  1  2/6950 (0.03%)  2 4/6950 (0.06%)  4
Gastric ulcer perforation  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Gastritis  1  3/6950 (0.04%)  3 6/6950 (0.09%)  6
Gastritis haemorrhagic  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Gastrointestinal angiodysplasia  1  0/6950 (0.00%)  0 1/6950 (0.01%)  2
Gastrointestinal haemorrhage  1  3/6950 (0.04%)  3 4/6950 (0.06%)  5
Gastrooesophageal reflux disease  1  3/6950 (0.04%)  3 2/6950 (0.03%)  2
Haematochezia  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Haemorrhoids  1  2/6950 (0.03%)  2 1/6950 (0.01%)  1
Hiatus hernia  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Ileus  1  6/6950 (0.09%)  6 7/6950 (0.10%)  7
Incarcerated inguinal hernia  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Incarcerated umbilical hernia  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Inguinal hernia  1  5/6950 (0.07%)  5 10/6950 (0.14%)  10
Inguinal hernia strangulated  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Intestinal haemorrhage  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Intestinal infarction  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Intestinal ischaemia  1  2/6950 (0.03%)  2 2/6950 (0.03%)  2
Intestinal obstruction  1  6/6950 (0.09%)  6 6/6950 (0.09%)  6
Intestinal perforation  1  1/6950 (0.01%)  1 2/6950 (0.03%)  2
Large intestinal obstruction  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Large intestine perforation  1  3/6950 (0.04%)  3 2/6950 (0.03%)  2
Large intestine polyp  1  3/6950 (0.04%)  3 4/6950 (0.06%)  4
Mallory-weiss syndrome  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Melaena  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Mesenteric artery embolism  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Mesenteric artery thrombosis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Mesenteritis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Mouth ulceration  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Nausea  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Oesophageal haemorrhage  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Oesophageal spasm  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Oesophageal ulcer  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Oesophageal ulcer haemorrhage  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Oesophagitis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Pancreatic disorder  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Pancreatitis  1  3/6950 (0.04%)  3 8/6950 (0.12%)  8
Pancreatitis acute  1  5/6950 (0.07%)  5 4/6950 (0.06%)  5
Peptic ulcer haemorrhage  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Pharyngo-oesophageal diverticulum  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Proctitis  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Rectal haemorrhage  1  2/6950 (0.03%)  2 3/6950 (0.04%)  3
Rectal perforation  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Rectal polyp  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Rectal prolapse  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Retroperitoneal haemorrhage  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Salivary gland calculus  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Small intestinal obstruction  1  2/6950 (0.03%)  2 4/6950 (0.06%)  4
Subileus  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Thrombosis mesenteric vessel  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Umbilical hernia  1  2/6950 (0.03%)  2 2/6950 (0.03%)  2
Upper gastrointestinal haemorrhage  1  2/6950 (0.03%)  2 2/6950 (0.03%)  2
Vomiting  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
General disorders     
Accidental death  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Administration site erythema  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Administration site pain  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Adverse drug reaction  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Asthenia  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Cardiac death  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Chest discomfort  1  0/6950 (0.00%)  0 3/6950 (0.04%)  4
Chest pain  1  20/6950 (0.29%)  20 19/6950 (0.27%)  20
Chills  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Cyst  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Death  1  17/6950 (0.24%)  17 29/6950 (0.42%)  29
Device battery issue  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Device deposit issue  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Device dislocation  1  1/6950 (0.01%)  1 2/6950 (0.03%)  2
Device leakage  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Device occlusion  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Drowning  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Fatigue  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
General physical health deterioration  1  1/6950 (0.01%)  1 2/6950 (0.03%)  2
Generalised oedema  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Ill-defined disorder  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Incarcerated hernia  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Inflammation  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Malaise  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Multi-organ failure  1  9/6950 (0.13%)  9 12/6950 (0.17%)  12
Non-cardiac chest pain  1  0/6950 (0.00%)  0 4/6950 (0.06%)  4
Oedema peripheral  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Organ failure  1  2/6950 (0.03%)  2 1/6950 (0.01%)  1
Peripheral swelling  1  1/6950 (0.01%)  1 2/6950 (0.03%)  2
Pyrexia  1  2/6950 (0.03%)  2 1/6950 (0.01%)  1
Sudden cardiac death  1  2/6950 (0.03%)  2 3/6950 (0.04%)  3
Sudden death  1  13/6950 (0.19%)  13 4/6950 (0.06%)  4
Systemic inflammatory response syndrome  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Thrombosis in device  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Hepatobiliary disorders     
Acute hepatic failure  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Bile duct obstruction  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Bile duct stone  1  3/6950 (0.04%)  3 3/6950 (0.04%)  3
Biliary colic  1  1/6950 (0.01%)  1 1/6950 (0.01%)  1
Biliary dilatation  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Cholangitis  1  5/6950 (0.07%)  5 5/6950 (0.07%)  5
Cholangitis acute  1  0/6950 (0.00%)  0 2/6950 (0.03%)  2
Cholecystitis  1  7/6950 (0.10%)  8 15/6950 (0.22%)  17
Cholecystitis acute  1  7/6950 (0.10%)  7 4/6950 (0.06%)  4
Cholecystitis chronic  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Cholelithiasis  1  14/6950 (0.20%)  14 14/6950 (0.20%)  14
Cholestasis  1  1/6950 (0.01%)  1 0/6950 (0.00%)  0
Chronic hepatic failure  1  0/6950 (0.00%)  0 1/6950 (0.01%)  1
Cirrhosis alcoholic  1  2/6950 (0.03%)  2 0/6950 (0.00%)  0
Drug-induced liver injury  1  0/6950 (0.00%)