Trial Outcomes & Findings for A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults (NCT NCT02723773)

Last Updated: 2025-12-12

Results Overview

A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) and/or by HZ Ascertainment Committee (HZAC) determination, as per the algorithm pre-specified in the protocol. As pre-specified in the protocol: * due to the high VE observed in ZOSTER-006/022 studies, recipients of placebo in both studies were offered cross-vaccination with HZ/su. Since there was no placebo group in this study, historic controls were used for VE assessment. Incidence rates estimations on Historical Control group were done by utilizing Poisson regression model using placebo data from ZOSTER-006/022 studies to obtain the coefficients by age ranges. * the participants in Control group were a subset of LTFU group that were randomized to serve as control for those who were vaccinated in this study, otherwise they were treated similarly as LTFU group, hence LTFU and Control groups were combined.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

7539 participants

Primary outcome timeframe

During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

Results posted on

2025-12-12

Participant Flow

Potentially eligible participants who participated and received at least one dose of the HZ/su vaccine in the ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies were contacted and considered for entry in the current ZOSTER-049:EXT 006-022 (NCT02723773) study.

Out of the 7534 participants enrolled in the current ZOSTER-049 EXT:006-022 study, 5 participants originally enrolled in the Long-term follow-up (LTFU) group were eliminated due to data modification post-investigator signature, and hence 7529 participants were included in the Total Vaccinated Cohort and started the study.

Participant milestones

Participant milestones
Measure	LTFU Group Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety.	1-Additional Dose Group Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study.	Revaccination Group Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study.	Control Group Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group).
Overall Study STARTED	7289	61	60	119
Overall Study COMPLETED	5570	52	51	97
Overall Study NOT COMPLETED	1719	9	9	22

Reasons for withdrawal

Reasons for withdrawal
Measure	LTFU Group Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety.	1-Additional Dose Group Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study.	Revaccination Group Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study.	Control Group Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group).
Overall Study Adverse Event	934	3	1	9
Overall Study Protocol Violation	1	0	0	0
Overall Study Withdrawal by Subject	360	5	6	10
Overall Study Migrated/moved from study area	37	0	0	1
Overall Study Lost to Follow-up	198	0	0	0
Overall Study Other	189	1	2	2

Baseline Characteristics

A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LTFU Group n=7289 Participants Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety.	1-Additional Dose Group n=61 Participants Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study.	Revaccination Group n=60 Participants Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study.	Control Group n=119 Participants Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group).	Total n=7529 Participants Total of all reporting groups
Age, Continuous	72.6 Years STANDARD_DEVIATION 9.4 • n=26 Participants	70.4 Years STANDARD_DEVIATION 9.2 • n=24 Participants	70.2 Years STANDARD_DEVIATION 9.4 • n=50 Participants	70.2 Years STANDARD_DEVIATION 8.6 • n=391 Participants	72.5 Years STANDARD_DEVIATION 9.4 • n=1175 Participants
Sex: Female, Male Female	4432 Participants n=26 Participants	30 Participants n=24 Participants	36 Participants n=50 Participants	69 Participants n=391 Participants	4567 Participants n=1175 Participants
Sex: Female, Male Male	2857 Participants n=26 Participants	31 Participants n=24 Participants	24 Participants n=50 Participants	50 Participants n=391 Participants	2962 Participants n=1175 Participants
Race/Ethnicity, Customized African Heritage / African American	66 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants	0 Participants n=391 Participants	66 Participants n=1175 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1115 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants	0 Participants n=391 Participants	1115 Participants n=1175 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	265 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants	0 Participants n=391 Participants	265 Participants n=1175 Participants
Race/Ethnicity, Customized Other, Deidentified	5843 Participants n=26 Participants	61 Participants n=24 Participants	60 Participants n=50 Participants	119 Participants n=391 Participants	6083 Participants n=1175 Participants

PRIMARY outcome

Timeframe: During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

Population: The analysis was performed on the Modified Total Vaccinated cohort (mTVC) - LTFU+Control group, which included all participants in the LTFU and Control groups combined, with efficacy data available for the specified analysis during the specified period, minus those participants who were not administered with the second vaccination during the ZOSTER-006/022 studies, or who developed a confirmed case of HZ prior to 1 month after the second vaccination in the ZOSTER-006/022 studies.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=7258 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=7258 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants Having at Least One Confirmed Herpes Zoster (HZ) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall	69 Participants	341 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

Population: The analysis was performed on the mTVC - LTFU+Control group, which included all participants in the LTFU and Control groups combined, with efficacy data available for the specified analysis and age ranges during the specified period, minus those participants who were not administered with the second vaccination during the ZOSTER-006/022 studies, or who developed a confirmed case of HZ prior to 1 month after the second vaccination in the ZOSTER-006/022 studies.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=2043 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=1242 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=5215 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=3973 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=2043 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group n=1242 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group n=5215 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group n=3973 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants Having at Least One Confirmed HZ Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, by Age Ranges	12 Participants	9 Participants	57 Participants	48 Participants	90 Participants	70 Participants	249 Participants	179 Participants	—	—

SECONDARY outcome

Timeframe: From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years

Population: The analysis was performed on the mTVC pooled, which included participants from the mTVC in ZOSTER-006/-022 studies and participants from the mTVC in ZOSTER-049:EXT 006-022 study with efficacy data available for the specified analysis and age ranges during the specified period.

A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR and/or by the HZAC determination, as per the algorithm pre-specified in the protocol. The age ranges assessed were: \>=50 YOA (overall), 50-59 YOA, 60-69 YOA, \>=60 YOA and \>=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. As pre-specified in the protocol: \- participants from the Placebo groups in the ZOSTER-006/022 studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined in the Placebo/Historical control group.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=13881 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=3491 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=2140 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=10390 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=8250 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group n=14035 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group n=3523 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group n=2166 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group n=10512 Participants Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group n=8346 Participants Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants Having at Least One Confirmed HZ Case From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges	101 Participants	16 Participants	12 Participants	85 Participants	73 Participants	818 Participants	193 Participants	160 Participants	623 Participants	463 Participants

SECONDARY outcome

Timeframe: Over the follow-up years (Year 1, Year 2, Year 3, Year 4, Year 6, Year 7, Year 8, Year 9, Year 10 and Year 11) from one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72)

A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR and/or by the HZAC determination, as per the algorithm pre-specified in the protocol. The age ranges assessed were: \>=50 YOA (overall), 50-59 YOA, 60-69 YOA, \>=60 YOA and \>=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. Confirmed HZ cases data was not collected for the participants included in the HZ/su and Placebo/Historical control groups during Year 5, as this was a gap year between end of ZOSTER-006/-022 studies and start of ZOSTER-049:EXT-006-022 study. Results from the ZOSTER-006/022 studies were pooled for each year after vaccination with methods used in these studies. For overlapping years between ZOSTER-006/022 studies and this study, all the data were pooled. For the non-overlapping years only the data from ZOSTER-049:EXT 006-022 study was used.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=13881 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=3491 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=2140 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=10390 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=8250 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group n=14035 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group n=3523 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group n=2166 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group n=10512 Participants Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group n=8346 Participants Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 3	9 Participants	0 Participants	0 Participants	9 Participants	9 Participants	116 Participants	29 Participants	29 Participants	87 Participants	58 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 9	15 Participants	5 Participants	3 Participants	10 Participants	7 Participants	57 Participants	15 Participants	11 Participants	42 Participants	29 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 10	15 Participants	0 Participants	1 Participants	15 Participants	14 Participants	53 Participants	15 Participants	10 Participants	38 Participants	27 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 1	3 Participants	1 Participants	0 Participants	2 Participants	2 Participants	130 Participants	31 Participants	16 Participants	99 Participants	83 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 2	10 Participants	2 Participants	1 Participants	8 Participants	7 Participants	136 Participants	27 Participants	22 Participants	109 Participants	87 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 4	10 Participants	1 Participants	2 Participants	9 Participants	7 Participants	95 Participants	16 Participants	23 Participants	79 Participants	56 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 6	10 Participants	2 Participants	1 Participants	8 Participants	7 Participants	62 Participants	16 Participants	13 Participants	47 Participants	35 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 7	10 Participants	1 Participants	2 Participants	9 Participants	7 Participants	61 Participants	15 Participants	13 Participants	46 Participants	33 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 8	10 Participants	2 Participants	2 Participants	8 Participants	6 Participants	58 Participants	15 Participants	13 Participants	43 Participants	31 Participants
Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges Year 11	9 Participants	2 Participants	0 Participants	7 Participants	7 Participants	50 Participants	15 Participants	10 Participants	34 Participants	25 Participants

SECONDARY outcome

Timeframe: During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

PHN is defined by the presence of HZ-associated severe worst pain persisting or appearing more than 90 days after onset of the HZ rash. Severe worst pain is defined as HZ-associated pain rated as 3 or greater on the worst pain question on the Zoster Brief Pain Inventory (ZBPI) questionnaire. The ZBPI questionnaire uses a 0 to 10 point numeric and visual intensity scale, in which 0 represents the minimum value and 10 the maximum value on the scale. The age ranges assessed were: \>=50 YOA (overall), 50-59 YOA, 60-69 YOA, \>=60 YOA and \>=70 YOA at time of primary vaccination in ZOSTER-006/022 studies.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=7271 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=2046 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=1243 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=5225 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=3982 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group n=7271 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group n=2046 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group n=1243 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group n=5225 Participants Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group n=3982 Participants Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants Having at Least One Post-herpetic Neuralgia (PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges	4 Participants	0 Participants	1 Participants	4 Participants	3 Participants	32 Participants	7 Participants	2 Participants	25 Participants	23 Participants

SECONDARY outcome

Timeframe: From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=13881 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=3491 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=2140 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=10390 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=8250 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group n=14035 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group n=3523 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group n=2166 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group n=10512 Participants Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group n=8346 Participants Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants Having at Least One PHN Case From One Month Post-Dose 2 in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges	8 Participants	0 Participants	1 Participants	8 Participants	7 Participants	78 Participants	15 Participants	4 Participants	63 Participants	59 Participants

SECONDARY outcome

Timeframe: During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

HZ complications include HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke. If a recorded complication was associated with a case of suspected HZ, and that case was finally not considered to be a confirmed case, the associated complication would not be considered as a complication of HZ. The age ranges assessed were: \>=50 YOA (overall), 50-59 YOA, 60-69 YOA, \>=60 YOA and \>=70 YOA at time of primary vaccination in ZOSTER-006/022 studies.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=7273 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=2046 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=1243 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=5227 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=3984 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group n=7273 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group n=2046 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group n=1243 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group n=5227 Participants Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group n=3984 Participants Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants Having at Least One HZ Related Complications (Other Than PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	12 Participants	0 Participants	2 Participants	11 Participants	9 Participants

SECONDARY outcome

Timeframe: From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=13881 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=3491 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=2140 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=10390 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=8250 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group n=14035 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group n=3523 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group n=2166 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group n=10512 Participants Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group n=8346 Participants Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants Having at Least One HZ Related Complications (Other Than PHN) Case From One Month Post-dose 2 (Month 3) in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges	2 Participants	0 Participants	0 Participants	2 Participants	2 Participants	28 Participants	1 Participants	5 Participants	26 Participants	21 Participants

SECONDARY outcome

Timeframe: At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies

Population: The analysis was performed on a subset of participants from the Adapted ATP cohort for humoral persistence - LTFU, who were included in the immunogenicity subset during the ZOSTER-006/022 studies, continued participation in this study and had humoral persistence results available at the specified time points.

Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). The age ranges assessed were: \>=50 YOA (overall), 50-59 YOA, 60-69 YOA, \>=60 YOA and \>=70 YOA at time of primary vaccination in ZOSTER-006/022 studies.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=786 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=219 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=230 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=567 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=337 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 5	8043.5 mIU/mL Interval 7224.9 to 8954.7	8044.2 mIU/mL Interval 6106.6 to 10596.6	8715.1 mIU/mL Interval 6807.0 to 11158.1	8043.2 mIU/mL Interval 7180.7 to 9009.3	7868.7 mIU/mL Interval 6915.4 to 8953.5	—	—	—	—	—
Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 6	8536.6 mIU/mL Interval 8113.5 to 8981.7	8584.3 mIU/mL Interval 7739.9 to 9520.7	8913.4 mIU/mL Interval 8155.1 to 9742.3	8518.3 mIU/mL Interval 8036.5 to 9028.9	8258.7 mIU/mL Interval 7646.0 to 8920.4	—	—	—	—	—
Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 7	8375.1 mIU/mL Interval 7941.0 to 8833.0	8325.6 mIU/mL Interval 7483.0 to 9263.1	8869.6 mIU/mL Interval 8084.4 to 9731.1	8394.8 mIU/mL Interval 7895.3 to 8925.8	8080.4 mIU/mL Interval 7446.1 to 8768.7	—	—	—	—	—
Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 9	7219.4 mIU/mL Interval 6803.4 to 7660.9	7097.6 mIU/mL Interval 6341.6 to 7943.7	7706.7 mIU/mL Interval 6994.6 to 8491.4	7275.0 mIU/mL Interval 6784.2 to 7801.3	6951.3 mIU/mL Interval 6295.8 to 7674.9	—	—	—	—	—
Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 11	7039.3 mIU/mL Interval 6589.0 to 7520.5	7146.9 mIU/mL Interval 6294.9 to 8114.3	7159.8 mIU/mL Interval 6406.3 to 8001.9	6989.2 mIU/mL Interval 6470.8 to 7549.2	6846.3 mIU/mL Interval 6148.5 to 7623.3	—	—	—	—	—
Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 12	6844.3 mIU/mL Interval 6335.2 to 7394.3	6737.1 mIU/mL Interval 5900.9 to 7691.7	6943.4 mIU/mL Interval 6071.3 to 7940.7	6902.0 mIU/mL Interval 6272.0 to 7595.3	6848.2 mIU/mL Interval 5976.0 to 7847.6	—	—	—	—	—
Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 8	8231.2 mIU/mL Interval 7778.2 to 8710.6	8318.0 mIU/mL Interval 7412.7 to 9333.9	8680.0 mIU/mL Interval 7901.2 to 9535.5	8195.4 mIU/mL Interval 7683.4 to 8741.5	7856.6 mIU/mL Interval 7193.3 to 8581.0	—	—	—	—	—
Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 10	6861.5 mIU/mL Interval 6433.2 to 7318.3	7007.0 mIU/mL Interval 6228.4 to 7882.9	7060.8 mIU/mL Interval 6304.2 to 7908.3	6792.5 mIU/mL Interval 6288.2 to 7337.3	6574.4 mIU/mL Interval 5913.8 to 7308.8	—	—	—	—	—

SECONDARY outcome

Timeframe: At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies

Population: The analysis was performed on a subset of participants from the Adapted ATP cohort for CMI persistence - LTFU, who were included in the CMI subset during ZOSTER-006/-022 studies, continued participation in this study and had CMI results available at the specified time points.

Frequency of CD4 (2+) T-cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to gE was determined by Intracellular Cytokine Staining (ICS) and expressed in CD4 (2+) T-cells/million cells. The age ranges assessed were: \>=50 YOA (overall), 50-59 YOA, 60-69 YOA, \>=60 YOA and \>=70 YOA at time of primary vaccination in ZOSTER-006/022 studies.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=100 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=39 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=38 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=61 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group n=24 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 7	859.46 CD4 (2+) T-cells/million cells Standard Deviation 881.80	1141.00 CD4 (2+) T-cells/million cells Standard Deviation 1074.96	745.36 CD4 (2+) T-cells/million cells Standard Deviation 572.57	679.46 CD4 (2+) T-cells/million cells Standard Deviation 683.15	577.87 CD4 (2+) T-cells/million cells Standard Deviation 828.60	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 8	896.26 CD4 (2+) T-cells/million cells Standard Deviation 925.58	1217.84 CD4 (2+) T-cells/million cells Standard Deviation 1155.53	737.78 CD4 (2+) T-cells/million cells Standard Deviation 602.91	697.96 CD4 (2+) T-cells/million cells Standard Deviation 688.76	629.18 CD4 (2+) T-cells/million cells Standard Deviation 827.35	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 9	1099.20 CD4 (2+) T-cells/million cells Standard Deviation 1151.15	1403.78 CD4 (2+) T-cells/million cells Standard Deviation 1435.49	930.89 CD4 (2+) T-cells/million cells Standard Deviation 796.20	892.09 CD4 (2+) T-cells/million cells Standard Deviation 865.29	801.54 CD4 (2+) T-cells/million cells Standard Deviation 1033.67	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 12	853.77 CD4 (2+) T-cells/million cells Standard Deviation 815.20	1030.37 CD4 (2+) T-cells/million cells Standard Deviation 971.86	828.62 CD4 (2+) T-cells/million cells Standard Deviation 666.18	715.95 CD4 (2+) T-cells/million cells Standard Deviation 647.90	443.65 CD4 (2+) T-cells/million cells Standard Deviation 531.44	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 5	698.00 CD4 (2+) T-cells/million cells Standard Deviation 531.11	858.92 CD4 (2+) T-cells/million cells Standard Deviation 639.37	—	376.16 CD4 (2+) T-cells/million cells Standard Deviation NA Standard deviation could not be calculated as there was only one participant with frequency of antigen-specific CD4 (2+) T-cells data available.	376.16 CD4 (2+) T-cells/million cells Standard Deviation NA Standard deviation could not be calculated as there was only one participant with frequency of antigen-specific CD4 (2+) T-cells data available.	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 6	886.15 CD4 (2+) T-cells/million cells Standard Deviation 869.09	1174.70 CD4 (2+) T-cells/million cells Standard Deviation 1103.76	839.31 CD4 (2+) T-cells/million cells Standard Deviation 644.97	701.66 CD4 (2+) T-cells/million cells Standard Deviation 621.26	474.23 CD4 (2+) T-cells/million cells Standard Deviation 515.96	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 10	1016.13 CD4 (2+) T-cells/million cells Standard Deviation 992.38	1210.28 CD4 (2+) T-cells/million cells Standard Deviation 1216.92	952.86 CD4 (2+) T-cells/million cells Standard Deviation 763.05	865.13 CD4 (2+) T-cells/million cells Standard Deviation 755.35	670.87 CD4 (2+) T-cells/million cells Standard Deviation 726.96	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group Year 11	909.95 CD4 (2+) T-cells/million cells Standard Deviation 1025.40	1113.90 CD4 (2+) T-cells/million cells Standard Deviation 1317.91	884.65 CD4 (2+) T-cells/million cells Standard Deviation 712.45	753.74 CD4 (2+) T-cells/million cells Standard Deviation 703.75	445.15 CD4 (2+) T-cells/million cells Standard Deviation 597.48	—	—	—	—	—

SECONDARY outcome

Timeframe: At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies

Population: The analysis was performed on a HZ subset for HI, which included participants who developed confirmed HZ during ZOSTER-006 or ZOSTER-022 studies, or who developed HZ during the interval between the end of the ZOSTER-006/022 studies and the beginning of the current ZOSTER-049:EXT 006-022 study, or who developed suspected HZ during the current ZOSTER-049:EXT 006-022 study and with immunogenicity results available for the specified analysis at the specified time points.

Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=62 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies Year 5	12455.1 mIU/mL Interval 8549.9 to 18144.1	—	—	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies Year 8	5831.9 mIU/mL Interval 4435.1 to 7668.6	—	—	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies Year 9	7706.8 mIU/mL Interval 5941.6 to 9996.5	—	—	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies Year 10	6800.1 mIU/mL Interval 5048.6 to 9159.2	—	—	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies Year 11	6214.7 mIU/mL Interval 4807.3 to 8034.2	—	—	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies Year 12	4770.7 mIU/mL Interval 3523.6 to 6459.2	—	—	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies Year 6	8138.7 mIU/mL Interval 5770.6 to 11478.7	—	—	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies Year 7	6888.0 mIU/mL Interval 4919.2 to 9644.7	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Years 5, 6, 7, 8, 9, and 10 after the primary vaccination in ZOSTER-006/022 studies

Population: The analysis was performed on a HZ subset for CMI, which included participants who developed confirmed HZ during ZOSTER-006 or ZOSTER-022 studies, or who developed HZ during the interval between the end of the ZOSTER-006/022 studies and the beginning of the current ZOSTER-049:EXT 006-022 study, or who developed suspected HZ during the current ZOSTER-049:EXT 006-022 study and with CMI results available for the specified analysis at the specified time points.

Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=2 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Frequency of Antigen-specific CD4 (2+) T-cells for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9 and 10 After the Primary Vaccination in ZOSTER-006/022 Studies Year 5	683.76 CD4 (2+) T-cells/million cells Standard Deviation NA Standard deviation could not be calculated as there was only one participant with frequency of antigen-specific CD4 (2+) T-cells data available.	—	—	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9 and 10 After the Primary Vaccination in ZOSTER-006/022 Studies Year 6	398.70 CD4 (2+) T-cells/million cells Standard Deviation 164.34	—	—	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9 and 10 After the Primary Vaccination in ZOSTER-006/022 Studies Year 7	347.43 CD4 (2+) T-cells/million cells Standard Deviation 138.41	—	—	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9 and 10 After the Primary Vaccination in ZOSTER-006/022 Studies Year 8	509.67 CD4 (2+) T-cells/million cells Standard Deviation NA Standard deviation could not be calculated as there was only one participant with frequency of antigen-specific CD4 (2+) T-cells data available.	—	—	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4 (2+) T-cells for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9 and 10 After the Primary Vaccination in ZOSTER-006/022 Studies Year 10	749.75 CD4 (2+) T-cells/million cells Standard Deviation NA Standard deviation could not be calculated as there was only one participant with frequency of antigen-specific CD4 (2+) T-cells data available.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 1 in the current ZOSTER-049:EXT 006-022 study

Population: Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment\*, for whom administration site of study vaccine was known\*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination\* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time point. \*only applicable for the participants revaccinated in the current study.

Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=58 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=55 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=117 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Anti-gE Antibody Concentrations for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study	73834.4 mIU/mL Interval 60603.6 to 89953.7	79419.8 mIU/mL Interval 65089.6 to 96904.9	9655.2 mIU/mL Interval 8316.9 to 11208.8	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 1 in the current ZOSTER-049:EXT 006-022 study

Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=52 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=46 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=104 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study	3899.69 CD4 (2+) T-cells/million cells Standard Deviation 3243.16	2803.96 CD4 (2+) T-cells/million cells Standard Deviation 1544.14	716.01 CD4 (2+) T-cells/million cells Standard Deviation 635.32	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 3 in the current ZOSTER-049:EXT 006-022 study

Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=55 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=117 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Anti-gE Antibody Concentrations for Revaccination and Control Groups at Month 3 in the Current ZOSTER-049:EXT 006-022 Study	64603.0 mIU/mL Interval 54008.4 to 77275.9	9428.1 mIU/mL Interval 8154.4 to 10900.8	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 3 in the current ZOSTER-049:EXT 006-022 study

Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=51 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=107 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Frequency of Antigen-specific CD4 (2+) T-cells for Revaccination and Control Groups at Month 3 in the Current ZOSTER-049:EXT 006-022 Study	2443.17 CD4 (2+) T-cells/million cells Standard Deviation 3896.14	739.07 CD4 (2+) T-cells/million cells Standard Deviation 659.78	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 0 and Years 1, 2, 3, 4, 5 and 6 in the current ZOSTER-049:EXT 006-022 study

Population: Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment\*, for whom administration site of study vaccine was known\*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination\* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time points. \*only applicable for the participants revaccinated in the current study.

Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=60 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=55 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=117 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 2	19417.9 mIU/mL Interval 16460.7 to 22906.4	19973.2 mIU/mL Interval 16538.1 to 24121.8	8643.3 mIU/mL Interval 7450.5 to 10027.0	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 3	16335.6 mIU/mL Interval 13890.4 to 19211.3	16264.7 mIU/mL Interval 13417.7 to 19715.7	8314.9 mIU/mL Interval 7080.3 to 9764.7	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 4	18676.4 mIU/mL Interval 15562.0 to 22414.2	16363.2 mIU/mL Interval 13219.3 to 20254.9	8581.7 mIU/mL Interval 7195.2 to 10235.3	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 5	14797.3 mIU/mL Interval 12340.7 to 17742.9	14595.7 mIU/mL Interval 11767.0 to 18104.4	7238.7 mIU/mL Interval 6004.3 to 8727.0	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 6	12868.4 mIU/mL Interval 11048.3 to 14988.2	13534.0 mIU/mL Interval 11107.7 to 16490.2	6858.8 mIU/mL Interval 5698.0 to 8256.3	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Month 0	10149.5 mIU/mL Interval 8640.2 to 11922.4	11548.5 mIU/mL Interval 9386.8 to 14208.0	10232.0 mIU/mL Interval 8836.7 to 11847.5	—	—	—	—	—	—	—
Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 1	24663.6 mIU/mL Interval 20790.2 to 29258.7	26167.5 mIU/mL Interval 21755.6 to 31474.2	8825.4 mIU/mL Interval 7616.3 to 10226.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 0 and Years 1, 2, 3, 4, 5 and 6 in the current ZOSTER-049:EXT 006-022 study

Population: Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment\*, for whom administration site of study vaccine was known\*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination\* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time points. \*only applicable for the participants revaccinated in the current study.

Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=58 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=54 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=109 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 4	2047.92 CD4(2+) T-cells/million cells Standard Deviation 2477.92	1083.64 CD4(2+) T-cells/million cells Standard Deviation 669.54	901.57 CD4(2+) T-cells/million cells Standard Deviation 917.41	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 3	2112.90 CD4(2+) T-cells/million cells Standard Deviation 2564.29	1219.13 CD4(2+) T-cells/million cells Standard Deviation 889.76	836.62 CD4(2+) T-cells/million cells Standard Deviation 921.57	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 6	1682.94 CD4(2+) T-cells/million cells Standard Deviation 2694.90	844.81 CD4(2+) T-cells/million cells Standard Deviation 651.28	736.01 CD4(2+) T-cells/million cells Standard Deviation 724.10	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Month 0	843.55 CD4(2+) T-cells/million cells Standard Deviation 792.93	876.23 CD4(2+) T-cells/million cells Standard Deviation 784.84	817.97 CD4(2+) T-cells/million cells Standard Deviation 809.77	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 1	1798.39 CD4(2+) T-cells/million cells Standard Deviation 2119.46	1155.04 CD4(2+) T-cells/million cells Standard Deviation 714.97	665.50 CD4(2+) T-cells/million cells Standard Deviation 603.93	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 2	1634.47 CD4(2+) T-cells/million cells Standard Deviation 1900.93	1154.97 CD4(2+) T-cells/million cells Standard Deviation 818.16	712.02 CD4(2+) T-cells/million cells Standard Deviation 715.32	—	—	—	—	—	—	—
Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study Year 5	1649.03 CD4(2+) T-cells/million cells Standard Deviation 2407.72	917.93 CD4(2+) T-cells/million cells Standard Deviation 648.92	720.32 CD4(2+) T-cells/million cells Standard Deviation 726.20	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study

Population: The analysis was performed on the Total Vaccinated Cohort (for 1-Additional Dose and Revaccination groups), which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study and who have documented solicited symptoms (i.e., diary card for solicited AEs completed and returned) after each vaccination. Here, 'number analyzed' = participants with available data for each specified category.

The assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. 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	LTFU+Control >=50YOA Group n=61 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=60 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants With Any and Grade 3 Solicited Local Symptoms Any swelling, post-Dose 2	—	13 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Grade 3 swelling, post-Dose 2	—	1 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Any pain, post-Dose 1	42 Participants	52 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Grade 3 redness, post-Dose 1	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Grade 3 pain, post-Dose 1	1 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Any redness, post-Dose 1	13 Participants	20 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Any swelling, post-Dose 1	7 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Grade 3 swelling, post-Dose 1	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Any pain, post-Dose 2	—	37 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Grade 3 pain, post-Dose 2	—	2 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Any redness, post-Dose 2	—	20 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any and Grade 3 Solicited Local Symptoms Grade 3 redness, post-Dose 2	—	3 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The analysis was performed on the Total Vaccinated Cohort (for 1-Additional Dose and Revaccination groups), which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study, with diary data available after each vaccination and who experienced the specified solicited local symptom within 7 days following the respective vaccine dose. Here, 'number analyzed' = participants with available data for each specified category.

Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. The assessed solicited local symptoms included pain, redness and swelling.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=61 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=60 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Duration in Days of Solicited Local Symptoms Pain, post-Dose 1	3.0 Days Interval 2.0 to 3.0	3.0 Days Interval 2.0 to 3.5	—	—	—	—	—	—	—	—
Duration in Days of Solicited Local Symptoms Pain, post-Dose 2	—	2.0 Days Interval 2.0 to 3.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited Local Symptoms Redness, post-Dose 1	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited Local Symptoms Swelling, post-Dose 1	2.0 Days Interval 2.0 to 3.0	3.0 Days Interval 1.0 to 5.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited Local Symptoms Swelling, post-Dose 2	—	2.0 Days Interval 1.0 to 3.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited Local Symptoms Redness, post-Dose 2	—	2.5 Days Interval 1.0 to 4.5	—	—	—	—	—	—	—	—

SECONDARY outcome

The assessed solicited general symptoms included fatigue, fever \[defined as oral temperature \>=37.5 degrees Celsius (°C)\], gastrointestinal symptoms, headache, myalgia, and shivering. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. 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	LTFU+Control >=50YOA Group n=61 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=60 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any fatigue, post-Dose 1	32 Participants	24 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 gastrointestinal symptoms, post-Dose 1	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related gastrointestinal symptoms, post-Dose 1	9 Participants	8 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any headache, post-Dose 1	23 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 shivering, post-Dose 1	2 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related shivering, post-Dose 1	25 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any fatigue, post-Dose 2	—	22 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache, post-Dose 2	—	1 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 myalgia, post-Dose 2	—	1 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue, post-Dose 1	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related fatigue, post-Dose 1	32 Participants	23 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any fever, post-Dose 1	18 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fever, post-Dose 1	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related fever, post-Dose 1	18 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any gastrointestinal symptoms, post-Dose 1	9 Participants	9 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache, post-Dose 1	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related headache, post-Dose 1	23 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any myalgia, post-Dose 1	27 Participants	22 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 myalgia, post-Dose 1	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related myalgia, post-Dose 1	27 Participants	21 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any shivering, post-Dose 1	25 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue, post-Dose 2	—	3 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related fatigue, post-Dose 2	—	21 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any fever, post-Dose 2	—	7 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fever, post-Dose 2	—	0 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related fever, post-Dose 2	—	4 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any gastrointestinal symptoms, post-Dose 2	—	4 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 gastrointestinal symptoms, post-Dose 2	—	0 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related gastrointestinal symptoms, post-dose 2	—	4 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any headache, post-Dose 2	—	15 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related headache, post-Dose 2	—	14 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any myalgia, post-Dose 2	—	12 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related myalgia, post-Dose 2	—	11 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Any shivering, post-Dose 2	—	7 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Grade 3 shivering, post-Dose 2	—	0 Participants	—	—	—	—	—	—	—	—
Number of Participants With Any, Grade 3 and Related Solicited General Symptoms Related shivering, post-Dose 2	—	7 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The analysis was performed on the Total Vaccinated Cohort (for 1-Additional Dose and Revaccination groups), which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study, with diary data available after each vaccination and who experienced the specified solicited general symptom within 7 days following the respective vaccine dose. Here, 'number analyzed' = participants with available data for each specified category.

Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. The assessed solicited general symptoms included fatigue, fever \[defined as oral temperature \>=37.5°C\], gastrointestinal symptoms, headache, myalgia, and shivering.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=61 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=60 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Duration in Days of Solicited General Symptoms Myalgia, post-Dose 1	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Myalgia, post-Dose 2	—	1.5 Days Interval 1.0 to 2.5	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Shivering, post-Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Shivering, post-Dose 2	—	1.0 Days Interval 1.0 to 2.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Fatigue, post-Dose 2	—	2.0 Days Interval 1.0 to 3.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Fever, post-Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Gastrointestinal symptoms, post-Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Headache, post-Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Fatigue, post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 2.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Fever, post-Dose 2	—	1.0 Days Interval 1.0 to 2.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Gastrointestinal symptoms, post-Dose 2	—	1.5 Days Interval 1.0 to 2.0	—	—	—	—	—	—	—	—
Duration in Days of Solicited General Symptoms Headache, post-Dose 2	—	2.0 Days Interval 1.0 to 3.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 30 days after any vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study

An unsolicited AE is defined as 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 = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=61 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=60 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants With Any Unsolicited Adverse Events (AEs)	13 Participants	15 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month 0 until 12 months after last HZ/su vaccination (Revaccination group)

Population: The analysis was performed on Total Vaccinated cohort, which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study (1-Additional Dose and Revaccination groups) and all participants who came for Month 0 visit (Control group).

An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of intensity or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to vaccination.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=61 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=60 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=119 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants With Any and Related Serious Adverse Events (SAEs) Any SAEs	4 Participants	4 Participants	11 Participants	—	—	—	—	—	—	—
Number of Participants With Any and Related Serious Adverse Events (SAEs) Related SAEs	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the total duration of ZOSTER-049:EXT 006-022 study (from Month 0 to Month 72)

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=7289 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=61 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=60 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group n=119 Participants Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month until 12 months after last HZ/su vaccination (Revaccination group)

pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any pIMDs = occurrence of a pIMD regardless of relation to vaccination. Related pIMD = a pIMD assessed by the investigator as related to the study vaccination.

Outcome measures

Outcome measures
Measure	LTFU+Control >=50YOA Group n=61 Participants Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study.	Historical Control >=50 YOA Group n=60 Participants Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	LTFU+Control >=60 YOA Group n=119 Participants Participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	LTFU+Control >=70 YOA Group Participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study.	Historical Control 50-59 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control 60-69 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=60 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Historical Control >=70 YOA Group Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies).	Placebo/Historical Control >= 60 YOA Group Participants \>=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.	Placebo/Historical Control >=70 YOA Group Participants \>=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group.
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs) Any pIMDs	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs) Related pIMDs	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

Adverse Events

LTFU Group

Serious events: 62 serious events

Other events: 0 other events

Deaths: 56 deaths

1-Additional Dose Group

Serious events: 4 serious events

Other events: 54 other events

Deaths: 0 deaths

Revaccination Group

Serious events: 4 serious events

Other events: 58 other events

Deaths: 0 deaths

Control Group

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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