Trial Outcomes & Findings for Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older (NCT NCT01165229)

NCT ID: NCT01165229

Last Updated: 2020-04-27

Results Overview

Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

14819 participants

Primary outcome timeframe

During the entire study period (3 to 5 year period following Day 0)

Results posted on

2020-04-27

Participant Flow

Only 13900 subjects from the total enrolled number were vaccinated and included in the Total Vaccinated Cohort. In the placebo group,1 subject had an unknown withdrawal status before the study site closure. This was not identified during database freeze, leading to 1190 subjects in place of 1189 that actually completed the placebo group

Participant milestones

Participant milestones
Measure	Zoster-022 GSK1437173A Group Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo Group Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Study STARTED	6950	6950
Overall Study COMPLETED	5770	5760
Overall Study NOT COMPLETED	1180	1190

Reasons for withdrawal

Reasons for withdrawal
Measure	Zoster-022 GSK1437173A Group Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo Group Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Study Serious Adverse Event	456	487
Overall Study Non-Serious Adverse Event	47	15
Overall Study Protocol Violation	6	8
Overall Study Withdrawal by Subject	387	396
Overall Study Migrated/moved from study area	51	46
Overall Study Lost to Follow-up	123	133
Overall Study Suspected HZ Episode	2	2
Overall Study No reason from the subject	108	102
Overall Study Unknown completion status	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoster-022 GSK1437173A Group n=6950 Participants Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo Group n=6950 Participants Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Total n=13900 Participants Total of all reporting groups
Age, Continuous	75.6 Years STANDARD_DEVIATION 4.7 • n=93 Participants	75.6 Years STANDARD_DEVIATION 4.7 • n=4 Participants	75.6 Years STANDARD_DEVIATION 4.7 • n=27 Participants
Sex: Female, Male Female	3789 Participants n=93 Participants	3836 Participants n=4 Participants	7625 Participants n=27 Participants
Sex: Female, Male Male	3161 Participants n=93 Participants	3114 Participants n=4 Participants	6275 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage / African American	79 Participants n=93 Participants	67 Participants n=4 Participants	146 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan Native	1 Participants n=93 Participants	8 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian Heritage	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian Heritage	907 Participants n=93 Participants	908 Participants n=4 Participants	1815 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese Heritage	298 Participants n=93 Participants	300 Participants n=4 Participants	598 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian Heritage	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or Other Pacific Islander	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic / North African Heritage	40 Participants n=93 Participants	47 Participants n=4 Participants	87 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian / European Heritage	5307 Participants n=93 Participants	5301 Participants n=4 Participants	10608 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	304 Participants n=93 Participants	306 Participants n=4 Participants	610 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=5114 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=1427 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=6541 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=5189 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=1433 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=6622 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Any Episodes of Herpes Zoster (HZ)	17 Participants	6 Participants	23 Participants	169 Participants	54 Participants	223 Participants	—	—	—	—

PRIMARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=6468 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=1782 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=8250 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=6554 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=1792 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=8346 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)	2 Participants	2 Participants	4 Participants	29 Participants	7 Participants	36 Participants	—	—	—	—

PRIMARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=6468 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=1782 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=8250 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=6554 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=1792 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=8346 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ	19 Participants	6 Participants	25 Participants	216 Participants	68 Participants	284 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

PHN cases in the mTVc.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=5114 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=1427 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=6541 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=5189 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=1433 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=6622 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Post-herpetic Neuralgia (PHN)	2 Participants	2 Participants	4 Participants	22 Participants	6 Participants	28 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=15 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=3 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=18 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=150 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=48 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=198 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Days With Severe 'Worst' HZ-associated Pain	21.8 Days Standard Deviation 31.41	98.7 Days Standard Deviation 57.73	34.6 Days Standard Deviation 45.54	47.9 Days Standard Deviation 100.08	50.4 Days Standard Deviation 106.51	48.5 Days Standard Deviation 101.40	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=5114 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=1427 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=6541 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=5189 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=1433 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=6622 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations Hospitalization	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	5 Participants	—	—	—	—
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations Mortality	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations Mortality or hospitalization	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	5 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=5114 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=1427 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=6541 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=5189 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=1433 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=6622 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Overall Mortality and HZ-related Mortality	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Incidence of overall and HZ-related hospitalizations during the study.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=5114 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=1427 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=6541 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=5189 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=1433 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=6622 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Confirmed HZ Episode Related Hospitalizations	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	5 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Incidence of HZ complications during the study in subjects with confirmed HZ.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=17 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=23 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=169 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=54 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=223 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With HZ Related Complications Neurologic Disease	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	3 Participants	—	—	—	—
Number of Subjects With HZ Related Complications Visceral Disease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Number of Subjects With HZ Related Complications At least one complication	1 Participants	0 Participants	1 Participants	6 Participants	4 Participants	10 Participants	—	—	—	—
Number of Subjects With HZ Related Complications HZ vasculitis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Number of Subjects With HZ Related Complications Disseminated Disease	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	—	—	—	—
Number of Subjects With HZ Related Complications Ophthalmic Disease	1 Participants	0 Participants	1 Participants	4 Participants	2 Participants	6 Participants	—	—	—	—
Number of Subjects With HZ Related Complications Stroke	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Incidence of use of pain medications throughout the study

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=17 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=23 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=169 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=54 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=223 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects Receiving Pain Medication Associated With HZ At least 1 pain medication	7 Participants	3 Participants	10 Participants	123 Participants	37 Participants	160 Participants	—	—	—	—
Number of Subjects Receiving Pain Medication Associated With HZ 1 pain medication only	5 Participants	0 Participants	5 Participants	43 Participants	17 Participants	60 Participants	—	—	—	—
Number of Subjects Receiving Pain Medication Associated With HZ 2 pain medications only	0 Participants	1 Participants	1 Participants	30 Participants	4 Participants	34 Participants	—	—	—	—
Number of Subjects Receiving Pain Medication Associated With HZ 3 pain medications or more	2 Participants	2 Participants	4 Participants	50 Participants	16 Participants	66 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Incidence of reduction of duration of pain medication associated with HZ throughout the study.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=7 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=3 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=10 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=123 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=37 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=160 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Days With Pain Medication Associated With HZ	38.7 Days Standard Deviation 56.44	274.7 Days Standard Deviation 337.00	109.5 Days Standard Deviation 200.88	218.6 Days Standard Deviation 593.80	135.0 Days Standard Deviation 207.31	199.3 Days Standard Deviation 530.60	—	—	—	—

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the total vaccinated cohort - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period

Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=505 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=505 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	297 Participants	26 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	12 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	143 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	9 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	85 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	282 Participants	23 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	12 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	137 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	15 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	68 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	7 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across Doses	347 Participants	43 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across Doses	22 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across Doses	198 Participants	5 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across Doses	20 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across Doses	114 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across Doses	8 Participants	0 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=504 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=505 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Across Doses	38 Participants	21 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across Doses	124 Participants	55 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across Doses	5 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across Doses	104 Participants	37 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	104 Participants	56 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	8 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	85 Participants	34 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 1	25 Participants	28 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	16 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	72 Participants	42 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	2 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	58 Participants	27 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	106 Participants	27 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	6 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	91 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	38 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	32 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	39 Participants	9 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	31 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	122 Participants	39 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	9 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	105 Participants	30 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 2	37 Participants	19 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	26 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	76 Participants	26 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	63 Participants	20 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	113 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	7 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	94 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	59 Participants	11 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	5 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	47 Participants	9 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	38 Participants	6 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	35 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across Doses	166 Participants	77 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across Doses	16 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across Doses	140 Participants	52 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Across Doses	55 Participants	40 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Across Doses	5 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across Doses	157 Participants	41 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across Doses	12 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across Doses	137 Participants	29 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across Doses	75 Participants	22 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across Doses	6 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across Doses	64 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across Doses	62 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across Doses	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across Doses	54 Participants	6 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within the 30 days (Days 0-29) after each vaccination

Population: This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

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.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=6950 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6950 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related unsolicited AE(s)	2853 Participants	529 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any unsolicited AE(s)	3859 Participants	2263 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 unsolicited AE(s)	485 Participants	265 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Month 0 to Month 14

Population: This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

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.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=6950 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6950 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Any SAE(s)	891 Participants	939 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Related SAE(s)	12 Participants	7 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=6950 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6950 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Fatal Serious Adverse Events (SAEs)	426 Participants	459 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following day 0)

Population: The analysis was based on the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered

The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=6950 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6950 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication	57 Participants	84 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=6950 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6950 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Any pIMD	92 Participants	97 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Related pIMDs	8 Participants	6 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=6950 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6950 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Number of Subjects With Any and Related Medically Attended Visits Any medically attended visits	2882 Participants	2911 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any and Related Medically Attended Visits Related medically attended visits	165 Participants	66 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=3491 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=2140 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=6468 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=1782 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=13881 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=3523 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group n=2166 Participants Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group n=6554 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group n=1792 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group n=14035 Participants Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA	0 Participants	0 Participants	2 Participants	2 Participants	4 Participants	8 Participants	2 Participants	29 Participants	7 Participants	46 Participants

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Occurrence of PHN during the entire study period in all subjects with confirmed HZ.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=4 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=3 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=19 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=6 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=32 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=103 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group n=90 Participants Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group n=216 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group n=68 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group n=477 Participants Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ	0 Participants	0 Participants	2 Participants	2 Participants	4 Participants	8 Participants	2 Participants	29 Participants	7 Participants	46 Participants

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ .

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=19 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=6 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=25 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=216 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=68 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=284 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.	17 Participants	3 Participants	20 Participants	193 Participants	61 Participants	254 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=17 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=3 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group n=20 Participants Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group n=193 Participants Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group n=61 Participants Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group n=254 Participants Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.	20.3 Days Standard Deviation 29.71	98.7 Days Standard Deviation 57.73	32.1 Days Standard Deviation 43.80	48.3 Days Standard Deviation 96.34	45.2 Days Standard Deviation 95.58	47.5 Days Standard Deviation 95.98	—	—	—	—

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=2258 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=2263 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	17 Participants	0 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across Doses	90 Participants	4 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across Doses	70 Participants	0 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	1336 Participants	128 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	42 Participants	1 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	606 Participants	17 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	43 Participants	0 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	355 Participants	17 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	1241 Participants	107 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	60 Participants	3 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	582 Participants	14 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	39 Participants	0 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	344 Participants	10 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	15 Participants	0 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across Doses	1562 Participants	199 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across Doses	851 Participants	27 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across Doses	519 Participants	25 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across Doses	30 Participants	0 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = Temperature\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=2252 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=2264 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	445 Participants	101 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	53 Participants	4 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	292 Participants	34 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	2 Participants	3 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	189 Participants	14 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across Doses	825 Participants	326 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across Doses	79 Participants	17 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across Doses	699 Participants	220 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Across Doses	304 Participants	172 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across Doses	34 Participants	10 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across Doses	547 Participants	185 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across Doses	790 Participants	225 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across Doses	62 Participants	10 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across Doses	689 Participants	157 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across Doses	439 Participants	110 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across Doses	49 Participants	6 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across Doses	380 Participants	75 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across Doses	323 Participants	61 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across Doses	3 Participants	3 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across Doses	265 Participants	30 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	545 Participants	231 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	31 Participants	13 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	441 Participants	147 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 1	170 Participants	123 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	15 Participants	6 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	101 Participants	67 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	380 Participants	189 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	7 Participants	8 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	26 Participants	7 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	293 Participants	132 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	530 Participants	159 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	206 Participants	73 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	15 Participants	3 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	173 Participants	50 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	142 Participants	34 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	1 Participants	2 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	111 Participants	16 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	579 Participants	169 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	495 Participants	116 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 2	188 Participants	75 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	14 Participants	5 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	142 Participants	35 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	455 Participants	133 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	30 Participants	2 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	386 Participants	86 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	560 Participants	112 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	42 Participants	4 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	484 Participants	75 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	334 Participants	55 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	36 Participants	4 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	224 Participants	30 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal,Across Doses	26 Participants	10 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal,Across Doses	210 Participants	91 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across Doses	653 Participants	268 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 30 days (Days 0 - 29) after each vaccination

Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=8758 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=8773 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA Any unsolicited AE(s)	4366 Participants	2732 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA Grade 3 unsolicited AE(s)	553 Participants	335 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA Related unsolicited AE(s)	2961 Participants	578 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Month 0 to Month 14

Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=8758 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=8773 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs Any SAE(s)	1117 Participants	1171 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs Related SAE(s)	12 Participants	7 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Fatal SAEs during the entire study period in subjects ≥ 70 YOA.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=8758 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=8773 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs	128 Participants	144 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=8758 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=8773 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs Any pIMD(s)	110 Participants	118 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs Related pIMD(s)	8 Participants	8 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Month 0 to Month 8 post-vaccination

Population: The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

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.

Outcome measures

Outcome measures
Measure	Zoster-022 GSK1437173A 70-79YOA Group n=8758 Participants Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=80YOA Group n=8773 Participants Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 GSK1437173A >=70YOA Group Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo 70-79YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=80YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022 Placebo >=70YOA Group Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 60-69 YOA Group Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo 70-79 YOA Group Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=80 YOA Group Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Zoster-022/006 Pooled Placebo >=50 YOA Group Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits Any medically attended visits	3593 Participants	3648 Participants	—	—	—	—	—	—	—	—
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits Related medically attended visits	180 Participants	80 Participants	—	—	—	—	—	—	—	—

Adverse Events

Zoster-022 GSK1437173A Group

Serious events: 1153 serious events

Other events: 3067 other events

Deaths: 426 deaths

Zoster-022 Placebo Group

Serious events: 1214 serious events

Other events: 610 other events

Deaths: 459 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Zoster-022 GSK1437173A Group n=6950 participants at risk Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Zoster-022 Placebo Group n=6950 participants at risk Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
General disorders Chills	5.1% 353/6950 • Number of events 415 • 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).	0.56% 39/6950 • Number of events 46 • 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).
General disorders Fatigue	6.8% 474/6950 • Number of events 592 • 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).	2.4% 169/6950 • Number of events 192 • 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).
Nervous system disorders Headache	8.4% 586/6950 • Number of events 717 • 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).	3.5% 243/6950 • Number of events 307 • 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).
General disorders Injection site erythema	12.4% 864/6950 • Number of events 1150 • 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).	0.39% 27/6950 • Number of events 29 • 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).
General disorders Injection site pain	28.4% 1975/6950 • Number of events 2762 • 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).	2.1% 148/6950 • Number of events 165 • 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).
General disorders Injection site swelling	8.8% 613/6950 • Number of events 773 • 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).	0.23% 16/6950 • Number of events 18 • 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).
Musculoskeletal and connective tissue disorders Myalgia	5.4% 378/6950 • Number of events 472 • 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).	1.4% 99/6950 • Number of events 113 • 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).
General disorders Pain	6.2% 428/6950 • Number of events 669 • 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).	0.86% 60/6950 • Number of events 67 • 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).
General disorders Pyrexia	7.7% 535/6950 • Number of events 633 • 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).	0.75% 52/6950 • Number of events 56 • 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).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER