Trial Outcomes & Findings for Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older (NCT NCT01165177)

NCT ID: NCT01165177

Last Updated: 2021-02-10

Results Overview

Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

16165 participants

Primary outcome timeframe

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

Results posted on

2021-02-10

Participant Flow

Out of all the subjects enrolled into this study, only 15405 received vaccination and were hence considered to start the study.

Participant milestones

Participant milestones
Measure	GSK1437173A Group Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.	Placebo Group Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Study STARTED	7695	7710
Overall Study COMPLETED	6773	6808
Overall Study NOT COMPLETED	922	902

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A Group Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.	Placebo Group Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Study Serious Adverse Event	227	235
Overall Study Withdrawal by Subject	368	354
Overall Study Protocol Violation	19	21
Overall Study Non-serious adverse event	30	18
Overall Study Other unspecified reasons	47	35
Overall Study Suspected HZ episode	0	2
Overall Study Lost to Follow-up	183	194
Overall Study Migrated/ moved from study area	48	43

Baseline Characteristics

Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A Group n=7695 Participants Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.	Placebo Group n=7710 Participants Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Total n=15405 Participants Total of all reporting groups
Age, Continuous	62.4 Years STANDARD_DEVIATION 9.0 • n=5 Participants	62.3 Years STANDARD_DEVIATION 9.0 • n=7 Participants	62.35 Years STANDARD_DEVIATION 9.0 • n=5 Participants
Age, Customized 50 - 59 YOA	3644 Participants n=5 Participants	3642 Participants n=7 Participants	7286 Participants n=5 Participants
Age, Customized 60 - 69 YOA	2243 Participants n=5 Participants	2245 Participants n=7 Participants	4488 Participants n=5 Participants
Age, Customized >= 70 YOA	1808 Participants n=5 Participants	1823 Participants n=7 Participants	3631 Participants n=5 Participants
Sex: Female, Male Female	4709 Participants n=5 Participants	4711 Participants n=7 Participants	9420 Participants n=5 Participants
Sex: Female, Male Male	2986 Participants n=5 Participants	2999 Participants n=7 Participants	5985 Participants n=5 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 were assessed in the Modified Total Vaccinated Cohort (mTVc)

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=3492 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=2141 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=1711 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=7344 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=3525 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=2166 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=1724 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=7415 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases	3 Participants	2 Participants	1 Participants	6 Participants	87 Participants	75 Participants	48 Participants	210 Participants

SECONDARY outcome

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

The incidence of PHN was calculated using the modified total vaccinated chort.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=3491 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=2140 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=1709 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=7430 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=3523 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=2166 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=1724 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=7413 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)	0 Participants	0 Participants	0 Participants	0 Participants	8 Participants	2 Participants	8 Participants	18 Participants

SECONDARY outcome

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

Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=3 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=2 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=9 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=103 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=90 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=61 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=254 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain	4 Participants	1 Participants	2 Participants	7 Participants	91 Participants	74 Participants	56 Participants	221 Participants

SECONDARY outcome

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

The analysis focused on the number of subjects who died due to HZ

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=3491 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=2140 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=1709 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=7340 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=3523 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=2166 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=1724 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=7413 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Confirmed HZ Episode Related Mortality	0 Participants	0 Participants	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)

The analysis focused on the incidence of HZ complications in subjects with confirmed HZ

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=3 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=2 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=9 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=103 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=90 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=61 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=254 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With HZ Related Complications	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants	6 Participants

SECONDARY outcome

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

The analysis focused on confirmed HZ episode related hospitalizations.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=3491 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=2140 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=1709 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=7340 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=3523 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=2166 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=1724 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=7413 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Confirmed HZ Episode Related Hospitalizations	0 Participants	0 Participants	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)

The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=3 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=2 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=9 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=103 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=90 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=61 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=254 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ	3 Participants	2 Participants	1 Participants	6 Participants	82 Participants	63 Participants	45 Participants	190 Participants

SECONDARY outcome

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

The analysis focused on subjects taking pain medication due to HZ

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=3 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=2 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=9 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=103 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=90 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=61 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=254 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ	3 Participants	2 Participants	1 Participants	6 Participants	82 Participants	63 Participants	45 Participants	190 Participants

SECONDARY outcome

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

Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=1 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=2 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=7 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=91 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=74 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=56 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=221 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Days With Severe 'Worst' HZ-associated Pain.	12.0 Days Standard Deviation 11.8	78.0 Days Standard Deviation 0.0	9.0 Days Standard Deviation 4.2	20.6 Days Standard Deviation 26.8	28.7 Days Standard Deviation 48.4	21.6 Days Standard Deviation 29.3	44.0 Days Standard Deviation 74.4	30.2 Days Standard Deviation 51.9

SECONDARY outcome

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

The analysis focused on confirmed HZ episode related hospitalizations and deaths.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=3491 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=2140 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=1709 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=7340 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=3523 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=2166 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=1724 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=7413 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations Mortality	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations Hospitalization	0 Participants	0 Participants	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	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)

Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=3 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=2 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=9 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=103 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=90 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=61 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=254 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With HZ Related Complications, by Complication Type At least one complication	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants	6 Participants
Number of Subjects With HZ Related Complications, by Complication Type HZ vasculitis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With HZ Related Complications, by Complication Type Disseminated Disease	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	4 Participants
Number of Subjects With HZ Related Complications, by Complication Type Ophtalmic Disease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With HZ Related Complications, by Complication Type Neurologic Disease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With HZ Related Complications, by Complication Type Visceral Disease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With HZ Related Complications, by Complication Type Stroke	0 Participants	0 Participants	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)

The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=3 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=2 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=9 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=103 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=90 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=61 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=254 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Distribution of Pain Medication Associated With HZ At least one pain medication	3 Participants	2 Participants	1 Participants	6 Participants	82 Participants	63 Participants	45 Participants	190 Participants
Distribution of Pain Medication Associated With HZ 1 pain medication only	1 Participants	1 Participants	0 Participants	2 Participants	30 Participants	23 Participants	14 Participants	67 Participants
Distribution of Pain Medication Associated With HZ 2 pain medications only	1 Participants	1 Participants	0 Participants	2 Participants	26 Participants	19 Participants	9 Participants	54 Participants
Distribution of Pain Medication Associated With HZ 3 pain medications or more	1 Participants	0 Participants	1 Participants	2 Participants	26 Participants	21 Participants	22 Participants	69 Participants

SECONDARY outcome

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

The analysis was performed on subjects with a confirmed HZ episode

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=3 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=2 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group n=1 Participants Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group n=6 Participants Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group n=82 Participants Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group n=63 Participants Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group n=45 Participants Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group n=190 Participants Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Days of Pain Medication Associated With HZ	17.3 Days Standard Deviation 14.5	20.5 Days Standard Deviation 16.3	63.0 Days Standard Deviation 0.0	26.0 Days Standard Deviation 21.6	49.2 Days Standard Deviation 121.5	74.3 Days Standard Deviation 166.3	127.7 Days Standard Deviation 266.9	76.1 Days Standard Deviation 181.5

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

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

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4379 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=4375 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	3120 Participants	352 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	159 Participants	6 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	1225 Participants	40 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	82 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	810 Participants	31 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	28 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	2807 Participants	258 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	185 Participants	10 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	1151 Participants	24 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	56 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	762 Participants	17 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	18 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Overall	3463 Participants	490 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Overall	293 Participants	16 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Overall	1665 Participants	59 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Overall	121 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Overall	1153 Participants	46 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Overall	43 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) post-vaccination period

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4372 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=4376 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Overall	813 Participants	78 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	1456 Participants	379 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	157 Participants	18 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fatigue, Dose 2	1270 Participants	279 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any GI symptoms, Dose 2	495 Participants	183 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 GI symptoms, Dose 2	33 Participants	14 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related GI symptoms, Dose 2	392 Participants	91 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	1249 Participants	340 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	105 Participants	13 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	1107 Participants	219 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	1474 Participants	274 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	160 Participants	13 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	1314 Participants	197 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	947 Participants	128 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	139 Participants	9 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	838 Participants	88 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	645 Participants	72 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	8 Participants	5 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	571 Participants	40 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Overall	2006 Participants	728 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Overall	241 Participants	46 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fatigue, Overall	1724 Participants	522 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any GI symptoms, Overall	787 Participants	386 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 GI symptoms, Overall	61 Participants	25 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related GI symptoms, Overall	591 Participants	206 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Overall	1714 Participants	700 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Overall	157 Participants	30 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Overall	1470 Participants	469 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Overall	2023 Participants	529 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Overall	236 Participants	31 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Overall	1791 Participants	390 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Overall	1232 Participants	259 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Overall	192 Participants	11 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Overall	1082 Participants	177 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Overall	940 Participants	132 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Overall	14 Participants	6 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	1395 Participants	531 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	109 Participants	29 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fatigue, Dose 1	1153 Participants	355 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any GI symptoms, Dose 1	465 Participants	263 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 GI symptoms, Dose 1	30 Participants	12 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related GI symptoms, Dose 1	317 Participants	141 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	1112 Participants	511 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	67 Participants	20 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	891 Participants	341 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	1446 Participants	377 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	104 Participants	21 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	1231 Participants	265 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	632 Participants	166 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	69 Participants	3 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	539 Participants	104 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	500 Participants	65 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	7 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	420 Participants	38 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) post-vaccination period

Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=4457 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=4464 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) Any solicited or unsolicited symptoms	3766 Participants	1691 Participants	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited) Grade 3 solicited or unsolicited symptoms	759 Participants	145 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) in all subjects

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=7695 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=7710 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Any pIMDs	87 Participants	105 Participants	—	—	—	—	—	—
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Related pIMDs	8 Participants	12 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 (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=7695 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=7710 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With AEs With Any and Related Medically Attended Visit Any medically attended visits	2952 Participants	3072 Participants	—	—	—	—	—	—
Number of Subjects With AEs With Any and Related Medically Attended Visit Related medically attended visits	142 Participants	60 Participants	—	—	—	—	—	—

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=7695 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=7710 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Unsolicited Adverse Events (AEs) Any unsolicited AEs	3534 Participants	2426 Participants	—	—	—	—	—	—
Number of Subjects With Unsolicited Adverse Events (AEs) Grade 3 unsolicited AEs	609 Participants	298 Participants	—	—	—	—	—	—
Number of Subjects With Unsolicited Adverse Events (AEs) Related unsolicited AEs	2199 Participants	439 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)

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

Occurrence and relationship to vaccination of all SAEs in all subjects. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=7695 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=7710 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Serious Adverse Events (SAEs) Any SAEs (up to Day 30)	88 Participants	97 Participants	—	—	—	—	—	—
Number of Subjects With Serious Adverse Events (SAEs) Related SAEs (up to Day 30)	1 Participants	3 Participants	—	—	—	—	—	—
Number of Subjects With Serious Adverse Events (SAEs) Any SAEs (up to Month 14)	594 Participants	590 Participants	—	—	—	—	—	—
Number of Subjects With Serious Adverse Events (SAEs) Related SAEs (up to Month 14)	3 Participants	6 Participants	—	—	—	—	—	—
Number of Subjects With Serious Adverse Events (SAEs) Any SAEs (up to study end)	727 Participants	731 Participants	—	—	—	—	—	—
Number of Subjects With Serious Adverse Events (SAEs) Related SAEs (up to study end)	3 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 TVC, which included all subjects with at least one dose of the study vaccine or place administered.

The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=7695 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=7710 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine	43 Participants	25 Participants	—	—	—	—	—	—

SECONDARY outcome

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

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

Number of subjects with fatal SAEs during the entire study period were tabulated

Outcome measures

Outcome measures
Measure	GSK1437173A 50-59 YOA Group n=7695 Participants Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A 60-69 YOA Group n=7710 Participants Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	GSK1437173A Overall Ages Group Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.	Placebo 50-59 YOA Group Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo 60-69 YOA Group Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Over 70 YOA Group Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.	Placebo Overall Ages Group Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Number of Subjects With Fatal SAEs	208 Participants	221 Participants	—	—	—	—	—	—

Adverse Events

GSK1437173A Group

Serious events: 727 serious events

Other events: 5586 other events

Deaths: 11 deaths

Placebo Group

Serious events: 731 serious events

Other events: 1893 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1437173A Group n=7695 participants at risk Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.	Placebo Group n=7710 participants at risk Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Gastrointestinal disorders Gastrointestinal disorder	10.3% 792/7695 • Number of events 967 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	5.0% 389/7710 • Number of events 449 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
General disorders Chills	19.0% 1464/7695 • Number of events 1860 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	3.6% 276/7710 • Number of events 314 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
General disorders Fatigue	28.7% 2211/7695 • Number of events 3111 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	10.0% 770/7710 • Number of events 961 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
General disorders Injection site erythema	6.4% 493/7695 • Number of events 636 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	0.13% 10/7710 • Number of events 11 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
General disorders Injection site pain	18.1% 1390/7695 • Number of events 2090 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	1.3% 104/7710 • Number of events 118 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
General disorders Injection site swelling	5.2% 401/7695 • Number of events 515 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	0.08% 6/7710 • Number of events 6 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
General disorders Pain	46.5% 3575/7695 • Number of events 6064 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	6.5% 505/7710 • Number of events 627 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
General disorders Pyrexia	19.5% 1498/7695 • Number of events 1839 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	2.2% 168/7710 • Number of events 176 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
General disorders Swelling	15.0% 1154/7695 • Number of events 1573 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	0.60% 46/7710 • Number of events 48 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
Musculoskeletal and connective tissue disorders Myalgia	29.6% 2277/7695 • Number of events 3234 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	7.4% 571/7710 • Number of events 704 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
Nervous system disorders Headache	28.2% 2167/7695 • Number of events 3044 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	12.0% 929/7710 • Number of events 1198 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
Skin and subcutaneous tissue disorders Erythema	22.0% 1690/7695 • Number of events 2408 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)	0.89% 69/7710 • Number of events 75 • Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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