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Clinical Trial Results:
A phase IIIb, open-label, multi-country, multi-centre, long-term follow-up study (ZOE-LTFU) of studies 110390 and 113077 (ZOSTER-006/022) to assess the prophylactic efficacy, safety, and immunogenicity persistence of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine and assessment of 1 or 2 additional doses on a 0 or 0, 2-month schedule in two subgroups of older adults

Summary
EudraCT number	2015-001778-17
Trial protocol	FI EE CZ GB DE ES IT
Global end of trial date	28 Jun 2023

Results information
Results version number	v1
This version publication date	14 Jul 2024
First version publication date	14 Jul 2024
Other versions	v2

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

201190

ISRCTN number

US NCT number

NCT02723773

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

22 Dec 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

28 Jun 2023

Was the trial ended prematurely?

Main objective of the trial

To assess the vaccine efficacy (VE) in the prevention of Herpes Zoster (HZ) over the total duration of the ZOSTER-049 study as measured by the reduction in HZ risk in subjects >= 50 years of age (YOA) overall at the time of first vaccination in the ZOSTER-006/022 studies.

Protection of trial subjects

Administration of the study vaccination was to be preceded by a review of the participants’ medical history (especially with regards to previous vaccination and possible occurrence of undesirable events) and a clinical examination. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of an anaphylactic event following the administration of the vaccine.

Background therapy

Evidence for comparator

Actual start date of recruitment

18 Apr 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 63

Country: Number of subjects enrolled

Brazil: 309

Country: Number of subjects enrolled

Canada: 407

Country: Number of subjects enrolled

Czechia: 420

Country: Number of subjects enrolled

Germany: 616

Country: Number of subjects enrolled

Estonia: 824

Country: Number of subjects enrolled

Spain: 565

Country: Number of subjects enrolled

Finland: 1131

Country: Number of subjects enrolled

France: 259

Country: Number of subjects enrolled

Hong Kong: 188

Country: Number of subjects enrolled

Italy: 70

Country: Number of subjects enrolled

Japan: 235

Country: Number of subjects enrolled

Korea, Republic of: 213

Country: Number of subjects enrolled

Mexico: 211

Country: Number of subjects enrolled

Sweden: 639

Country: Number of subjects enrolled

Taiwan: 717

Country: Number of subjects enrolled

United Kingdom: 315

Country: Number of subjects enrolled

United States: 352

Worldwide total number of subjects

7534

EEA total number of subjects

4524

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

2047

From 65 to 84 years

4818

85 years and over

669

Subject disposition

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Recruitment details

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.

Screening details

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.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

LTFU Group

Arm description

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.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

1-Additional Dose Group

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Herpes Zoster subunit (HZ/su) vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants were administered 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study.

Revaccination Group

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Herpes Zoster subunit (HZ/su) vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants were administered 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and 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

Arm description

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).

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 1 ^[1]	LTFU Group	1-Additional Dose Group	Revaccination Group	Control Group
Started	7289	61	60	119
Completed	5570	52	51	97
Not completed	1719	9	9	22
Consent withdrawn by subject	360	5	6	10
Adverse event, non-fatal	934	3	1	9
Migrated/moved from study area	37	-	-	1
Unspecified	189	1	2	2
Lost to follow-up	198	-	-	-
Protocol deviation	1	-	-	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 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.

Baseline characteristics

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Reporting group title

LTFU Group

Reporting group description

Reporting group title

1-Additional Dose Group

Reporting group description

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.

Reporting group title

Revaccination Group

Reporting group description

Reporting group title

Control Group

Reporting group description

Reporting group values	LTFU Group	1-Additional Dose Group	Revaccination Group	Control Group	Total
Number of subjects	7289	61	60	119	7529
Age categorical
Units: Participants
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0
Adults (18-64 years)	1962	21	21	40	2044
From 65-84 years	4669	36	35	76	4816
85 years and over	658	4	4	3	669
Age Continuous
Units: Years
arithmetic mean (standard deviation)	72.6 ( 9.4 )	70.4 ( 9.2 )	70.2 ( 9.4 )	70.2 ( 8.6 )	-
Sex: Female, Male
Units: Participants
Female	4432	30	36	69	4567
Male	2857	31	24	50	2962
Race/Ethnicity, Customized
Units: Subjects
African Heritage / African American	66	0	0	0	66
Asian - East Asian Heritage	1115	0	0	0	1115
Asian - Japanese Heritage	265	0	0	0	265
Other, Deidentified	5843	61	60	119	6083

End points

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Reporting group title

LTFU Group

Reporting group description

Reporting group title

1-Additional Dose Group

Reporting group description

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.

Reporting group title

Revaccination Group

Reporting group description

Reporting group title

Control Group

Reporting group description

Subject analysis set title

LTFU+Control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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.

Subject analysis set title

Historical Control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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).

Subject analysis set title

LTFU+Control 50-59 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 50 and 59 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.

Subject analysis set title

LTFU+Control 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 60 and 69 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.

Subject analysis set title

LTFU+Control >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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.

Subject analysis set title

LTFU+Control >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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.

Subject analysis set title

Historical Control 50-59 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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).

Subject analysis set title

Historical Control 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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).

Subject analysis set title

Historical Control >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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).

Subject analysis set title

Historical Control >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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).

Subject analysis set title

HZ/su >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=50 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. '999' is a placeholder value for '13881', which is the actual number of participants included in this sub-group for the specified analysis.

Subject analysis set title

HZ/su 50-59 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start.

Subject analysis set title

HZ/su 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start.

Subject analysis set title

HZ/su >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. '999' is a placeholder value for '10390', which is the actual number of participants included in this sub-group for the specified analysis.

Subject analysis set title

HZ/su >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. '999' is a placeholder value for '8250', which is the actual number of participants included in this sub-group for the specified analysis.

Subject analysis set title

Placebo/Historical control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=50 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. '999' is a placeholder value for '14035', which is the actual number of participants included in this sub-group for the specified analysis.

Subject analysis set title

Placebo/Historical control 50-59 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 50 and 59 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.

Subject analysis set title

Placebo/Historical control 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 60 and 69 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.

Subject analysis set title

Placebo/Historical control >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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. '999' is a placeholder value for '10512', which is the actual number of participants included in this sub-group for the specified analysis.

Subject analysis set title

Placebo/Historical control >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

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. '999' is a placeholder value for '8346', which is the actual number of participants included in this sub-group for the specified analysis.

Subject analysis set title

LTFU+Control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=50 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.

Subject analysis set title

LTFU+Control 50-59 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU+Control 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU+Control >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU+Control >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Historical Control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Historical Control 50-59 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Historical Control 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Historical Control >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Historical Control >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Placebo/Historical control >= 60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between >=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. '999' is a placeholder value for '10512', which is the actual number of participants included in this sub-group for the specified analysis.

Subject analysis set title

LTFU+Control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU+Control >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU+Control >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Historical Control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Historical Control >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Historical Control >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

HZ/su 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 60 to 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4.

Subject analysis set title

LTFU >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=50 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) 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.

Subject analysis set title

LTFU 50-59 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) 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.

Subject analysis set title

LTFU 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) 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.

Subject analysis set title

LTFU >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) 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.

Subject analysis set title

LTFU >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) 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.

Subject analysis set title

LTFU >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU 50-59 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU 60-69 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU >=60 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU >=70 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

LTFU+Control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants >=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.

Subject analysis set title

LTFU+Control >=50 YOA Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Primary: Number of participants having at least one confirmed Herpes Zoster (HZ) case during the total duration of ZOSTER-049:EXT 006-022 study, overall

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End point title

Number of participants having at least one confirmed Herpes Zoster (HZ) case during the total duration of ZOSTER-049:EXT 006-022 study, overall

End point description

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.

End point type

Primary

End point timeframe

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

End point values	LTFU+Control >=50 YOA Group	Historical Control >=50 YOA Group
Number of subjects analysed	7258	7258
Units: Participants	69	341

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control >=50 YOA Group and Historical Control >=50 YOA Group.

Comparison groups

LTFU+Control >=50 YOA Group v Historical Control >=50 YOA Group

Number of subjects included in analysis

14516

Analysis specification

Pre-specified

Analysis type

other ^[1]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

79.77

Confidence interval

level

95%

sides

2-sided

lower limit

73.72

upper limit

84.61

Notes
[1] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - the relative risk (RR). RR = the ratio of the incidence rates of LTFU+Control >=50 YOA Group over Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Secondary: Number of participants having at least one confirmed HZ case during the total duration of ZOSTER-049:EXT 006-022 study, by age ranges

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End point title

Number of participants having at least one confirmed HZ case during the total duration of ZOSTER-049:EXT 006-022 study, by age ranges

End point description

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: 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. 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.

End point type

Secondary

End point timeframe

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

End point values	LTFU+Control 50-59 YOA Group	LTFU+Control 60-69 YOA Group	LTFU+Control >=60 YOA Group	LTFU+Control >=70 YOA Group	Historical Control 50-59 YOA Group	Historical Control 60-69 YOA Group	Historical Control >=60 YOA Group	Historical Control >=70 YOA Group
Number of subjects analysed	2043	1242	5215	3973	2043	1242	5215	3973
Units: Participants	12	9	57	48	90	70	249	179

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.

Comparison groups

LTFU+Control 50-59 YOA Group v Historical Control 50-59 YOA Group

Number of subjects included in analysis

4086

Analysis specification

Pre-specified

Analysis type

other ^[2]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

86.67

Confidence interval

level

95%

sides

2-sided

lower limit

75.55

upper limit

93.36

Notes
[2] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.

Comparison groups

LTFU+Control 60-69 YOA Group v Historical Control 60-69 YOA Group

Number of subjects included in analysis

2484

Analysis specification

Pre-specified

Analysis type

other ^[3]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

87.14

Confidence interval

level

95%

sides

2-sided

lower limit

74.17

upper limit

94.35

Notes
[3] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control >=60 YOA Group and Historical Control >=60 YOA Group.

Comparison groups

LTFU+Control >=60 YOA Group v Historical Control >=60 YOA Group

Number of subjects included in analysis

10430

Analysis specification

Pre-specified

Analysis type

other ^[4]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

77.11

Confidence interval

level

95%

sides

2-sided

lower limit

69.37

upper limit

83.14

Notes
[4] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control >=60 YOA Group over Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control >=70 YOA Group and Historical Control >=70 YOA Group.

Comparison groups

LTFU+Control >=70 YOA Group v Historical Control >=70 YOA Group

Number of subjects included in analysis

7946

Analysis specification

Pre-specified

Analysis type

other ^[5]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

73.18

Confidence interval

level

95%

sides

2-sided

lower limit

62.94

upper limit

80.92

Notes
[5] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control >=70 YOA Group over Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Secondary: 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

Top of page

End point title

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

End point description

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. The analysis was performed on the mTVC pooled.

End point type

Secondary

End point 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

End point values	HZ/su >=50 YOA Group	HZ/su 50-59 YOA Group	HZ/su 60-69 YOA Group	HZ/su >=60 YOA Group	HZ/su >=70 YOA Group	Placebo/Historical control >=50 YOA Group	Placebo/Historical control 50-59 YOA Group	Placebo/Historical control 60-69 YOA Group	Placebo/Historical control >=60 YOA Group	Placebo/Historical control >=70 YOA Group
Number of subjects analysed	13881 ^[6]	3491	2140	10390 ^[7]	8250 ^[8]	14035 ^[9]	3523	2166	10512 ^[10]	8346 ^[11]
Units: Participants	101	16	12	85	73	818	193	160	623	463

Notes
[6] - '999' is a placeholder value for '13881', which is the actual number of participants analyzed.
[7] - '999' is a placeholder value for '10390', which is the actual number of participants analyzed.
[8] - '999' is a placeholder value for '8250', which is the actual number of participants analyzed.
[9] - '999' is a placeholder value for '14035', which is the actual number of participants analyzed.
[10] - '999' is a placeholder value for '10512', which is the actual number of participants analyzed.
[11] - '999' is a placeholder value for '8346', which is the actual number of participants analyzed.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[12]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

86.45

Confidence interval

level

95%

sides

2-sided

lower limit

82.98

upper limit

89.33

Notes
[12] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[13]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

87.73

Confidence interval

level

95%

sides

2-sided

lower limit

84.89

upper limit

90.12

Notes
[13] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[14]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

84.33

Confidence interval

level

95%

sides

2-sided

lower limit

79.91

upper limit

87.93

Notes
[14] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[15]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.57

Confidence interval

level

95%

sides

2-sided

lower limit

86.66

upper limit

96.24

Notes
[15] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[16]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

91.74

Confidence interval

level

95%

sides

2-sided

lower limit

86.25

upper limit

95.37

Notes
[16] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Secondary: 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

Top of page

End point title

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

End point description

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. The analysis was performed on the mTVC pooled.

End point type

Secondary

End point 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)

End point values	HZ/su >=50 YOA Group	HZ/su 50-59 YOA Group	HZ/su 60-69 YOA Group	HZ/su >=60 YOA Group	HZ/su >=70 YOA Group	Placebo/Historical control >=50 YOA Group	Placebo/Historical control 50-59 YOA Group	Placebo/Historical control 60-69 YOA Group	Placebo/Historical control >=60 YOA Group	Placebo/Historical control >=70 YOA Group
Number of subjects analysed	13881 ^[17]	3491	2140	10390 ^[18]	8250 ^[19]	14035 ^[20]	3523	2166	10512 ^[21]	8346 ^[22]
Units: Participants
Year 1	3	1	0	2	2	130	31	16	99	83
Year 2	10	2	1	8	7	136	27	22	109	87
Year 3	9	0	0	9	9	116	29	29	87	58
Year 4	10	1	2	9	7	95	16	23	79	56
Year 6	10	2	1	8	7	62	16	13	47	35
Year 7	10	1	2	9	7	61	15	13	46	33
Year 8	10	2	2	8	6	58	15	13	43	31
Year 9	15	5	3	10	7	57	15	11	42	29
Year 10	15	0	1	15	14	53	15	10	38	27
Year 11	9	2	0	7	7	50	15	10	34	25

Notes
[17] - '999' is a placeholder value for '13881', which is the actual number of participants analyzed.
[18] - '999' is a placeholder value for '10390', which is the actual number of participants analyzed.
[19] - '999' is a placeholder value for '8250', which is the actual number of participants analyzed.
[20] - '999' is a placeholder value for '14035', which is the actual number of participants analyzed.
[21] - '999' is a placeholder value for '10512', which is the actual number of participants analyzed.
[22] - '999' is a placeholder value for '8346', which is the actual number of participants analyzed.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 1.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[23]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

97.57

Confidence interval

level

95%

sides

2-sided

lower limit

90.96

upper limit

99.71

Notes
[23] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 1.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[24]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

97.97

Confidence interval

level

95%

sides

2-sided

lower limit

92.46

upper limit

99.76

Notes
[24] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 1.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[25]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

79.32

upper limit

100

Notes
[25] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 1.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[26]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

96.76

Confidence interval

level

95%

sides

2-sided

lower limit

80.57

upper limit

99.92

Notes
[26] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 1.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[27]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

97.68

Confidence interval

level

95%

sides

2-sided

lower limit

93.07

upper limit

99.53

Notes
[27] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 2.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[28]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.69

Confidence interval

level

95%

sides

2-sided

lower limit

86.15

upper limit

96.57

Notes
[28] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 3.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[29]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.36

Confidence interval

level

95%

sides

2-sided

lower limit

84.98

upper limit

96.59

Notes
[29] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 2.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[30]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.01

Confidence interval

level

95%

sides

2-sided

lower limit

82.82

upper limit

96.88

Notes
[30] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 2.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[31]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.71

Confidence interval

level

95%

sides

2-sided

lower limit

85.13

upper limit

96.93

Notes
[31] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 2.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[32]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

95.49

Confidence interval

level

95%

sides

2-sided

lower limit

72.11

upper limit

99.89

Notes
[32] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 2.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[33]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.66

Confidence interval

level

95%

sides

2-sided

lower limit

70.78

upper limit

99.15

Notes
[33] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 3.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[34]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

89.2

upper limit

100

Notes
[34] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 3.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[35]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

89.39

upper limit

100

Notes
[35] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 3.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[36]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

89.84

Confidence interval

level

95%

sides

2-sided

lower limit

79.81

upper limit

95.51

Notes
[36] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 3.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[37]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

84.74

Confidence interval

level

95%

sides

2-sided

lower limit

68.99

upper limit

93.35

Notes
[37] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 Group over Year 4.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[38]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

89.75

Confidence interval

level

95%

sides

2-sided

lower limit

80.31

upper limit

95.24

Notes
[38] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 4.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[39]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

93.88

Confidence interval

level

95%

sides

2-sided

lower limit

60.62

upper limit

99.85

Notes
[39] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 4.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[40]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

91.62

Confidence interval

level

95%

sides

2-sided

lower limit

66.1

upper limit

99.04

Notes
[40] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 6.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[41]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

82.98

Confidence interval

level

95%

sides

2-sided

lower limit

63.64

upper limit

93.05

Notes
[41] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 4.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[42]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

87.86

Confidence interval

level

95%

sides

2-sided

lower limit

73.3

upper limit

95.33

Notes
[42] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 6.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[43]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

83.87

Confidence interval

level

95%

sides

2-sided

lower limit

68.31

upper limit

92.63

Notes
[43] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 6.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[44]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

87.5

Confidence interval

level

95%

sides

2-sided

lower limit

46.83

upper limit

98.61

Notes
[44] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 6.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[45]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.31

Confidence interval

level

95%

sides

2-sided

lower limit

48.79

upper limit

99.82

Notes
[45] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 4.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[46]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

88.96

Confidence interval

level

95%

sides

2-sided

lower limit

77.96

upper limit

95.13

Notes
[46] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 6.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[47]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

54.3

upper limit

92.5

Notes
[47] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 8.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[48]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

81.4

Confidence interval

level

95%

sides

2-sided

lower limit

59.97

upper limit

92.45

Notes
[48] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 8.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[49]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

84.62

Confidence interval

level

95%

sides

2-sided

lower limit

32.04

upper limit

98.31

Notes
[49] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 8.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[50]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

86.67

Confidence interval

level

95%

sides

2-sided

lower limit

42.67

upper limit

98.52

Notes
[50] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 8.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[51]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

82.76

Confidence interval

level

95%

sides

2-sided

lower limit

65.98

upper limit

92.14

Notes
[51] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 7.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[52]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

78.79

Confidence interval

level

95%

sides

2-sided

lower limit

51.24

upper limit

92.08

Notes
[52] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 7.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[53]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

80.43

Confidence interval

level

95%

sides

2-sided

lower limit

59.54

upper limit

91.58

Notes
[53] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 7.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

^[54]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

84.62

Confidence interval

level

95%

sides

2-sided

lower limit

32.04

upper limit

98.31

Notes
[54] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 7.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[55]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

93.33

Confidence interval

level

95%

sides

2-sided

lower limit

56.67

upper limit

99.84

Notes
[55] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 7.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[56]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

83.61

Confidence interval

level

95%

sides

2-sided

lower limit

67.76

upper limit

92.51

Notes
[56] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 8.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

^[57]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

80.65

Confidence interval

level

95%

sides

2-sided

lower limit

52.91

upper limit

93.4

Notes
[57] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 9.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[58]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

73.68

Confidence interval

level

95%

sides

2-sided

lower limit

52.89

upper limit

86.16

Notes
[58] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 10.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[59]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

71.7

Confidence interval

level

95%

sides

2-sided

lower limit

49.03

upper limit

85.18

Notes
[59] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 10.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

^[60]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

77.89

upper limit

100

Notes
[60] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 10.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[61]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

29.71

upper limit

99.77

Notes
[61] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 10.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[62]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

60.53

Confidence interval

level

95%

sides

2-sided

lower limit

26.55

upper limit

79.83

Notes
[62] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 9.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[63]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

75.86

Confidence interval

level

95%

sides

2-sided

lower limit

43.69

upper limit

91.07

Notes
[63] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 9.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[64]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

66.67

Confidence interval

level

95%

sides

2-sided

lower limit

3.52

upper limit

90.52

Notes
[64] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 9.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[65]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

72.73

Confidence interval

level

95%

sides

2-sided

lower limit

-3.24

upper limit

95.11

Notes
[65] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 9.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[66]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

76.19

Confidence interval

level

95%

sides

2-sided

lower limit

51.78

upper limit

89.35

Notes
[66] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group over Year 11.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[67]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

79.41

Confidence interval

level

95%

sides

2-sided

lower limit

52.82

upper limit

92.3

Notes
[67] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 10.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[68]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

48.15

Confidence interval

level

95%

sides

2-sided

lower limit

-2.41

upper limit

74.87

Notes
[68] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group over Year 11.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[69]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

63.03

upper limit

92.22

Notes
[69] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 11.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[70]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

86.67

Confidence interval

level

95%

sides

2-sided

lower limit

42.67

upper limit

98.52

Notes
[70] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 11.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[71]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

65.07

upper limit

100

Notes
[71] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group over Year 11.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[72]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

33.41

upper limit

89.77

Notes
[72] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.

Secondary: 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

Top of page

End point title

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

End point description

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. The analysis was performed on the mTVC – LTFU+Control group.

End point type

Secondary

End point timeframe

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

End point values	LTFU+Control >=50 YOA Group	LTFU+Control 50-59 YOA Group	LTFU+Control 60-69 YOA Group	LTFU+Control >=60 YOA Group	LTFU+Control >=70 YOA Group	Historical Control >=50 YOA Group	Historical Control 50-59 YOA Group	Historical Control 60-69 YOA Group	Historical Control >=60 YOA Group	Historical Control >=70 YOA Group
Number of subjects analysed	7271	2046	1243	5225	3982	7271	2046	1243	5225	3982
Units: Participants	4	0	1	4	3	32	7	2	25	23

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.

Comparison groups

LTFU+Control 60-69 YOA Group v Historical Control 60-69 YOA Group

Number of subjects included in analysis

2486

Analysis specification

Pre-specified

Analysis type

other ^[73]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-860.45

upper limit

99.15

Notes
[73] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy in prevention of PHN between LTFU+Control >=60 YOA Group and Historical Control >=60 YOA Group.

Comparison groups

LTFU+Control >=60 YOA Group v Historical Control >=60 YOA Group

Number of subjects included in analysis

10450

Analysis specification

Pre-specified

Analysis type

other ^[74]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

53.66

upper limit

95.95

Notes
[74] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control >=60 YOA Group over Historical Control >=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.

Comparison groups

LTFU+Control 50-59 YOA Group v Historical Control 50-59 YOA Group

Number of subjects included in analysis

4092

Analysis specification

Pre-specified

Analysis type

other ^[75]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

46.59

upper limit

100

Notes
[75] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control >=50 YOA Group and Historical Control >=50 YOA Group.

Comparison groups

LTFU+Control >=50 YOA Group v Historical Control >=50 YOA Group

Number of subjects included in analysis

14542

Analysis specification

Pre-specified

Analysis type

other ^[76]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

87.5

Confidence interval

level

95%

sides

2-sided

lower limit

64.75

upper limit

96.79

Notes
[76] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control >=50 YOA Group over Historical Control >=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy in prevention of PHN between LTFU+Control >=70 YOA Group and Historical Control >=70 YOA Group.

Comparison groups

LTFU+Control >=70 YOA Group v Historical Control >=70 YOA Group

Number of subjects included in analysis

7964

Analysis specification

Pre-specified

Analysis type

other ^[77]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

86.96

Confidence interval

level

95%

sides

2-sided

lower limit

56.83

upper limit

97.49

Notes
[77] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control >=70 YOA Group over Historical Control >=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Secondary: 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

Top of page

End point title

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

End point description

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 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. 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.

End point type

Secondary

End point 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

End point values	HZ/su >=50 YOA Group	HZ/su 50-59 YOA Group	HZ/su 60-69 YOA Group	HZ/su >=60 YOA Group	HZ/su >=70 YOA Group	Placebo/Historical control >=50 YOA Group	Placebo/Historical control 50-59 YOA Group	Placebo/Historical control 60-69 YOA Group	Placebo/Historical control >=60 YOA Group	Placebo/Historical control >=70 YOA Group
Number of subjects analysed	13881 ^[78]	3491	2140	10390 ^[79]	8250 ^[80]	14035 ^[81]	3523	2166	10512 ^[82]	8346 ^[83]
Units: Participants	8	0	1	8	7	78	15	4	63	59

Notes
[78] - '999' is a placeholder value for '13881, which is the actual number of participants analyzed.
[79] - '999' is a placeholder value for '10390', which is the actual number of participants analyzed.
[80] - '999' is a placeholder value for '8250', which is the actual number of participants analyzed.
[81] - '999' is a placeholder value for '14035', which is the actual number of participants analyzed.
[82] - '999' is a placeholder value for '10512', which is the actual number of participants analyzed.
[83] - '999' is a placeholder value for '8346', which is the actual number of participants analyzed.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[84]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

89.69

Confidence interval

level

95%

sides

2-sided

lower limit

78.67

upper limit

95.7

Notes
[84] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

^[85]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

88.08

Confidence interval

level

95%

sides

2-sided

lower limit

73.87

upper limit

95.41

Notes
[85] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

^[86]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

87.24

Confidence interval

level

95%

sides

2-sided

lower limit

73.29

upper limit

94.72

Notes
[86] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[87]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

77.79

upper limit

100

Notes
[87] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[88]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

74.75

Confidence interval

level

95%

sides

2-sided

lower limit

-155.17

upper limit

99.49

Notes
[88] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.

Secondary: 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

Top of page

End point title

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

End point description

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. 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.

End point type

Secondary

End point timeframe

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

End point values	LTFU+Control 50-59 YOA Group	LTFU+Control 60-69 YOA Group	Historical Control 50-59 YOA Group	Historical Control 60-69 YOA Group	LTFU+Control >=50 YOA Group	LTFU+Control >=60 YOA Group	LTFU+Control >=70 YOA Group	Historical Control >=50 YOA Group	Historical Control >=60 YOA Group	Historical Control >=70 YOA Group
Number of subjects analysed	2046	1243	2046	1243	7273	5227	3984	7273	5227	3984
Units: Participants	0	0	0	2	1	1	1	12	11	9

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control >=50 YOA Group and Historical Control >=50 YOA Group.

Comparison groups

LTFU+Control >=50 YOA Group v Historical Control >=50 YOA Group

Number of subjects included in analysis

14546

Analysis specification

Pre-specified

Analysis type

other ^[89]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

91.67

Confidence interval

level

95%

sides

2-sided

lower limit

43.68

upper limit

99.81

Notes
[89] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control >=50 YOA Group over Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control >=70 YOA Group and Historical Control >=70 YOA Group.

Comparison groups

LTFU+Control >=70 YOA Group v Historical Control >=70 YOA Group

Number of subjects included in analysis

7968

Analysis specification

Pre-specified

Analysis type

other ^[90]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

88.89

Confidence interval

level

95%

sides

2-sided

lower limit

19.81

upper limit

99.75

Notes
[90] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control >=70 YOA Group over Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control >=60 YOA Group and Historical Control >=60 YOA Group.

Comparison groups

LTFU+Control >=60 YOA Group v Historical Control >=60 YOA Group

Number of subjects included in analysis

10454

Analysis specification

Pre-specified

Analysis type

other ^[91]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

90.91

Confidence interval

level

95%

sides

2-sided

lower limit

37.45

upper limit

99.79

Notes
[91] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control >=60 YOA Group over Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.

Comparison groups

LTFU+Control 60-69 YOA Group v Historical Control 60-69 YOA Group

Number of subjects included in analysis

2486

Analysis specification

Pre-specified

Analysis type

other ^[92]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

-247.21

upper limit

100

Notes
[92] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Secondary: 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

Top of page

End point title

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

End point description

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. 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.

End point type

Secondary

End point 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

End point values	HZ/su >=50 YOA Group	HZ/su 50-59 YOA Group	HZ/su 60-69 YOA Group	HZ/su >=60 YOA Group	HZ/su >=70 YOA Group	Placebo/Historical control >=50 YOA Group	Placebo/Historical control 50-59 YOA Group	Placebo/Historical control 60-69 YOA Group	Placebo/Historical control >=60 YOA Group	Placebo/Historical control >=70 YOA Group
Number of subjects analysed	13881 ^[93]	3491	2140	10390 ^[94]	8250 ^[95]	14035 ^[96]	3523	2166	10512 ^[97]	8346 ^[98]
Units: Participants	2	0	0	2	2	28	1	5	26	21

Notes
[93] - '999' is a placeholder value for '13881', which is the actual number of participants analyzed.
[94] - '999' is a placeholder value for '10390', which is the actual number of participants analyzed.
[95] - '999' is a placeholder value for '8250', which is the actual number of participants analyzed.
[96] - '999' is a placeholder value for '14035', which is the actual number of participants analyzed.
[97] - '999' is a placeholder value for '10512', which is the actual number of participants analyzed.
[98] - '999' is a placeholder value for '8346', which is the actual number of participants analyzed.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su >=50 YOA Group and Placebo/Historical Control >=50 YOA Group.

Comparison groups

HZ/su >=50 YOA Group v Placebo/Historical control >=50 YOA Group

Number of subjects included in analysis

27916

Analysis specification

Pre-specified

Analysis type

other ^[99]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.83

Confidence interval

level

95%

sides

2-sided

lower limit

71.57

upper limit

99.17

Notes
[99] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=50 YOA Group over Placebo/Historical Control >=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.

Comparison groups

HZ/su 50-59 YOA Group v Placebo/Historical control 50-59 YOA Group

Number of subjects included in analysis

7014

Analysis specification

Pre-specified

Analysis type

other ^[100]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

-1830.98

upper limit

100

Notes
[100] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.

Comparison groups

HZ/su 60-69 YOA Group v Placebo/Historical control 60-69 YOA Group

Number of subjects included in analysis

4306

Analysis specification

Pre-specified

Analysis type

other ^[101]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

100

Confidence interval

level

95%

sides

2-sided

lower limit

17.55

upper limit

100

Notes
[101] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su >=60 YOA Group and Placebo/Historical Control >=60 YOA Group.

Comparison groups

HZ/su >=60 YOA Group v Placebo/Historical control >=60 YOA Group

Number of subjects included in analysis

20902

Analysis specification

Pre-specified

Analysis type

other ^[102]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

92.28

Confidence interval

level

95%

sides

2-sided

lower limit

69.17

upper limit

99.11

Notes
[102] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=60 YOA Group over Placebo/Historical Control >=60 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Vaccine efficacy

Statistical analysis description

Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su >=70 YOA Group and Placebo/Historical Control >=70 YOA Group.

Comparison groups

HZ/su >=70 YOA Group v Placebo/Historical control >=70 YOA Group

Number of subjects included in analysis

16596

Analysis specification

Pre-specified

Analysis type

other ^[103]

Method

Poisson regression method

Parameter type

Vaccine efficacy

Point estimate

90.45

Confidence interval

level

95%

sides

2-sided

lower limit

60.93

upper limit

98.91

Notes
[103] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study. VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su >=70 YOA Group over Placebo/Historical Control >=70 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.

Secondary: 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

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End point title

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

End point description

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. 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 ZOSTER-006/022 studies, continued participation in this study and had humoral persistence results available at the specified time points.

End point type

Secondary

End point timeframe

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

End point values	LTFU >=50 YOA Group	LTFU 50-59 YOA Group	LTFU 60-69 YOA Group	LTFU >=60 YOA Group	LTFU >=70 YOA Group
Number of subjects analysed	786	219	230	567	337
Units: mIU/mL
geometric mean (confidence interval 95%)
Year 5 (N=214,51,35,163,128)	8043.5 (7224.9 to 8954.7)	8044.2 (6106.6 to 10596.6)	8715.1 (6807.0 to 11158.1)	8043.2 (7180.7 to 9009.3)	7868.7 (6915.4 to 8953.5)
Year 6 (N=786,219,230,567,337)	8536.6 (8113.5 to 8981.7)	8584.3 (7739.9 to 9520.7)	8913.4 (8155.1 to 9742.3)	8518.3 (8036.5 to 9028.9)	8258.7 (7646.0 to 8920.4)
Year 7 (N=757,215,222,542,320)	8375.1 (7941.0 to 8833.0)	8325.6 (7483.0 to 9263.1)	8869.6 (8084.4 to 9731.1)	8394.8 (7895.3 to 8925.8)	8080.4 (7446.1 to 8768.7)
Year 8 (N=732,215,219,517,298)	8231.2 (7778.2 to 8710.6)	8318.0 (7412.7 to 9333.9)	8680.0 (7901.2 to 9535.5)	8195.4 (7683.4 to 8741.5)	7856.6 (7193.3 to 8581.0)
Year 9 (N=641,199,195,442,247)	7219.4 (6803.4 to 7660.9)	7097.6 (6341.6 to 7943.7)	7706.7 (6994.6 to 8491.4)	7275.0 (6784.2 to 7801.3)	6951.3 (6295.8 to 7674.9)
Year 10 (N=606,197,187,409,222)	6861.5 (6433.2 to 7318.3)	7007.0 (6228.4 to 7882.9)	7060.8 (6304.2 to 7908.3)	6792.5 (6288.2 to 7337.3)	6574.4 (5913.8 to 7308.8)
Year 11 (N=612,196,192,416,224)	7039.3 (6589.0 to 7520.5)	7146.9 (6294.9 to 8114.3)	7159.8 (6406.3 to 8001.9)	6989.2 (6470.8 to 7549.2)	6846.3 (6148.5 to 7623.3)
Year 12 (N=435,151,161,284,123)	6844.3 (6335.2 to 7394.3)	6737.1 (5900.9 to 7691.7)	6943.4 (6071.3 to 7940.7)	6902.0 (6272.0 to 7595.3)	6848.2 (5976.0 to 7847.6)

No statistical analyses for this end point

Secondary: 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

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End point title

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

End point description

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. 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. '99999' was entered as a placeholder value in those instances where mean/standard deviation could not be calculated as there were 0 or only 1 participant with frequency of antigen-specific CD4 (2+) T-cells data available at the specified time point.

End point type

Secondary

End point timeframe

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

End point values	LTFU >=50 YOA Group	LTFU 50-59 YOA Group	LTFU 60-69 YOA Group	LTFU >=60 YOA Group	LTFU >=70 YOA Group
Number of subjects analysed	100	39	38	61	24
Units: CD4 (2+) T-cells/million cells
arithmetic mean (standard deviation)
Year 5 (N= 3,2,0,1,1)	698.00 ( 531.11 )	858.92 ( 639.37 )	99999 ( 99999 )	376.16 ( 99999 )	376.16 ( 99999 )
Year 6 (N=100,39,38,61,23)	886.15 ( 869.09 )	1174.70 ( 1103.76 )	839.31 ( 644.97 )	701.66 ( 621.26 )	474.23 ( 515.96 )
Year 7 (N=100,39,37,61,24)	859.46 ( 881.80 )	1141.00 ( 1074.96 )	745.36 ( 572.57 )	679.46 ( 683.15 )	577.87 ( 828.60 )
Year 8 (N=97,37,38,60,22)	896.26 ( 925.58 )	1217.84 ( 1155.53 )	737.78 ( 602.91 )	697.96 ( 688.76 )	629.18 ( 827.35 )
Year 9 (N=84,34,35,50,15)	1099.20 ( 1151.15 )	1403.78 ( 1435.49 )	930.89 ( 796.20 )	892.09 ( 865.29 )	801.54 ( 1033.67 )
Year 10 (N=80,35,31,45,14)	1016.13 ( 992.38 )	1210.28 ( 1216.92 )	952.86 ( 763.05 )	865.13 ( 755.35 )	670.87 ( 726.96 )
Year 11 (N=83,36,33,47,14)	909.95 ( 1025.40 )	1113.90 ( 1317.91 )	884.65 ( 712.45 )	753.74 ( 703.75 )	445.15 ( 597.48 )
Year 12 (N=73,32,29,41,12)	853.77 ( 815.20 )	1030.37 ( 971.86 )	828.62 ( 666.18 )	715.95 ( 647.90 )	443.65 ( 531.44 )

No statistical analyses for this end point

Secondary: 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

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End point title

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

End point description

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

End point type

Secondary

End point timeframe

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

End point values	LTFU+Control >=50 YOA Group
Number of subjects analysed	62
Units: mIU/mL
geometric mean (confidence interval 95%)
Year 5 (N=6)	12455.1 (8549.9 to 18144.1)
Year 6 (N=22)	8138.7 (5770.6 to 11478.7)
Year 7 (N=30)	6888.0 (4919.2 to 9644.7)
Year 8 (N=39)	5831.9 (4435.1 to 7668.6)
Year 9 (N=38)	7706.8 (5941.6 to 9996.5)
Year 10 (N=48)	6800.1 (5048.6 to 9159.2)
Year 11 (N=62)	6214.7 (4807.3 to 8034.2)
Year 12 (N=30)	4770.7 (3523.6 to 6459.2)

No statistical analyses for this end point

Secondary: 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

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End point title

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

End point description

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. 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. '99999' was entered as a placeholder value in those instances where standard deviation could not be calculated as there was only 1 participant with frequency of antigen-specific CD4 (2+) T-cells data available at the specified time point.

End point type

Secondary

End point timeframe

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

End point values	LTFU+Control >=50 YOA Group
Number of subjects analysed	2
Units: CD4 (2+) T-cells/million cells
arithmetic mean (standard deviation)
Year 5 (N=1)	683.76 ( 99999 )
Year 6 (N=2)	398.70 ( 164.34 )
Year 7 (N=2)	347.43 ( 138.41 )
Year 8 (N=1)	509.67 ( 99999 )
Year 10 (N=1)	749.75 ( 99999 )

No statistical analyses for this end point

Secondary: Anti-gE antibody concentrations for 1-Additional Dose, Revaccination and Control groups at Month 1 in the current ZOSTER-049:EXT 006-022 study

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End point title

Anti-gE antibody concentrations for 1-Additional Dose, Revaccination and Control groups at Month 1 in the current ZOSTER-049:EXT 006-022 study ^[104]

End point description

Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. The analysis was performed on Adapted ATP cohort for immunogenicity, which 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.

End point type

Secondary

End point timeframe

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

Notes
[104] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose, Revaccination and Control groups.

End point values	1-Additional Dose Group	Revaccination Group	Control Group
Number of subjects analysed	58	55	117
Units: mIU/mL
geometric mean (confidence interval 95%)	73834.4 (60603.6 to 89953.7)	79419.8 (65089.6 to 96904.9)	9655.2 (8316.9 to 11208.8)

No statistical analyses for this end point

Secondary: 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

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End point title

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 ^[105]

End point description

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. The analysis was performed on Adapted ATP cohort for immunogenicity, which 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.

End point type

Secondary

End point timeframe

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

Notes
[105] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose, Revaccination and Control groups.

End point values	1-Additional Dose Group	Revaccination Group	Control Group
Number of subjects analysed	52	46	104
Units: CD4 (2+) T-cells/million cells
arithmetic mean (standard deviation)	3899.69 ( 3243.16 )	2803.96 ( 1544.14 )	716.01 ( 635.32 )

No statistical analyses for this end point

Secondary: Anti-gE antibody concentrations for Revaccination and Control groups at Month 3 in the current ZOSTER-049:EXT 006-022 study

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End point title

Anti-gE antibody concentrations for Revaccination and Control groups at Month 3 in the current ZOSTER-049:EXT 006-022 study ^[106]

End point description

End point type

Secondary

End point timeframe

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

Notes
[106] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the Revaccination and Control groups.

End point values	Revaccination Group	Control Group
Number of subjects analysed	55	117
Units: mIU/mL
geometric mean (confidence interval 95%)	64603.0 (54008.4 to 77275.9)	9428.1 (8154.4 to 10900.8)

No statistical analyses for this end point

Secondary: 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

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End point title

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 ^[107]

End point description

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. The analysis was performed on Adapted ATP cohort for immunogenicity, which 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.

End point type

Secondary

End point timeframe

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

Notes
[107] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the Revaccination and Control groups.

End point values	Revaccination Group	Control Group
Number of subjects analysed	51	107
Units: CD4 (2+) T-cells/million cells
arithmetic mean (standard deviation)	2443.17 ( 3896.14 )	739.07 ( 659.78 )

No statistical analyses for this end point

Secondary: 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

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End point title

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 ^[108]

End point description

Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. The analysis was performed on Adapted ATP cohort for immunogenicity, which 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.

End point type

Secondary

End point timeframe

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

Notes
[108] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose, Revaccination and Control groups.

End point values	1-Additional Dose Group	Revaccination Group	Control Group
Number of subjects analysed	60	55	117
Units: mIU/mL
geometric mean (confidence interval 95%)
Month 0 (N=58,55,117)	10149.5 (8640.2 to 11922.4)	11548.5 (9386.8 to 14208.0)	10232.0 (8836.7 to 11847.5)
Year 1 (N=60,52,115)	24663.6 (20790.2 to 29258.7)	26167.5 (21755.6 to 31474.2)	8825.4 (7616.3 to 10226.5)
Year 2 (N=59,51,112)	19417.9 (16460.7 to 22906.4)	19973.2 (16538.1 to 24121.8)	8643.3 (7450.5 to 10027.0)
Year 3 (N=57,51,108)	16335.6 (13890.4 to 19211.3)	16264.7 (13417.7 to 19715.7)	8314.9 (7080.3 to 9764.7)
Year 4 (N=48,44,94)	18676.4 (15562.0 to 22414.2)	16363.2 (13219.3 to 20254.9)	8581.7 (7195.2 to 10235.3)
Year 5 (N=52,47,99)	14797.3 (12340.7 to 17742.9)	14595.7 (11767.0 to 18104.4)	7238.7 (6004.3 to 8727.0)
Year 6 (N=50,46,91)	12868.4 (11048.3 to 14988.2)	13534.0 (11107.7 to 16490.2)	6858.8 (5698.0 to 8256.3)

No statistical analyses for this end point

Secondary: 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

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End point title

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 ^[109]

End point description

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. The analysis was performed on Adapted ATP cohort for immunogenicity, which 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.

End point type

Secondary

End point timeframe

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

Notes
[109] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose, Revaccination and Control groups.

End point values	1-Additional Dose Group	Revaccination Group	Control Group
Number of subjects analysed	58	54	109
Units: CD4(2+) T-cells/million cells
arithmetic mean (standard deviation)
Month 0 (N=55,54,109)	843.55 ( 792.93 )	876.23 ( 784.84 )	817.97 ( 809.77 )
Year 1 (N=53,50,97)	1798.39 ( 2119.46 )	1155.04 ( 714.97 )	665.50 ( 603.93 )
Year 2 (N=58,46,109)	1634.47 ( 1900.93 )	1154.97 ( 818.16 )	712.02 ( 715.32 )
Year 3 (N=51,45,95)	2112.90 ( 2564.29 )	1219.13 ( 889.76 )	836.62 ( 921.57 )
Year 4 (N=45,43,83)	2047.92 ( 2477.92 )	1083.64 ( 669.54 )	901.57 ( 917.41 )
Year 5 (N=48,47,93)	1649.03 ( 2407.72 )	917.93 ( 648.92 )	720.32 ( 726.20 )
Year 6 (N=48,41,82)	1682.94 ( 2694.90 )	844.81 ( 651.28 )	736.01 ( 724.10 )

No statistical analyses for this end point

Secondary: Number of participants with any and Grade 3 solicited local symptoms

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End point title

Number of participants with any and Grade 3 solicited local symptoms ^[110]

End point description

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. 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 and who have documented solicited symptoms (i.e., diary card for solicited AEs completed and returned) after each vaccination. '99999" was entered as a placeholder value in those instances where no data are available post-Dose 2, since the participants in the 1-Additional Dose group only received Dose 1 of HZ/su vaccine.

End point type

Secondary

End point 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

Notes
[110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose and Revaccination groups.

End point values	1-Additional Dose Group	Revaccination Group
Number of subjects analysed	61	60
Units: Participants
Any pain, post-Dose 1 (N=61,60)	42	52
Grade 3 pain, post-Dose 1 (N=61,60)	1	3
Any redness, post-Dose 1 (N=61,60)	13	20
Grade 3 redness, post-Dose 1 (N=61,60)	4	1
Any swelling, post-Dose 1 (N=61,60)	7	12
Grade 3 swelling, post-Dose 1 (N=61,60)	1	0
Any pain, post-Dose 2 (N=0,55)	99999	37
Grade 3 pain, post-Dose 2 (N=0,55)	99999	2
Any redness, post-Dose 2 (N=0,55)	99999	20
Grade 3 redness, post-Dose 2 (N=0,55)	99999	3
Any swelling, post-Dose 2 (N=0,55)	99999	13
Grade 3 swelling, post-Dose 2 (N=0,55)	99999	1

No statistical analyses for this end point

Secondary: Duration in days of solicited local symptoms

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End point title

Duration in days of solicited local symptoms ^[111]

End point description

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. 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, with diary data available after each vaccination and who experienced the specified solicited local symptom within 7 days following the respective vaccine dose. '99999' was entered as a placeholder value in those instances where no data are available post-Dose 2, since the participants in the 1-Additional Dose group only received Dose 1 of HZ/su vaccine.

End point type

Secondary

End point 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

Notes
[111] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose and Revaccination groups.

End point values	1-Additional Dose Group	Revaccination Group
Number of subjects analysed	61	60
Units: Days
median (inter-quartile range (Q1-Q3))
Pain, post-Dose 1 (N=61,60)	3.0 (2.0 to 3.0)	3.0 (2.0 to 3.5)
Pain, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	2.0 (2.0 to 3.0)
Redness, post-Dose 1 (N=61,60)	3.0 (2.0 to 4.0)	3.0 (2.0 to 4.0)
Redness, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	2.5 (1.0 to 4.5)
Swelling, post-Dose 1 (N=61,60)	2.0 (2.0 to 3.0)	3.0 (1.0 to 5.0)
Swelling, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	2.0 (1.0 to 3.0)

No statistical analyses for this end point

Secondary: Number of participants with any, Grade 3 and related solicited general symptoms

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End point title

Number of participants with any, Grade 3 and related solicited general symptoms ^[112]

End point description

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. 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 and who have documented solicited symptoms (i.e., diary card for solicited AEs completed and returned) after each vaccination. '99999' was entered as a placeholder value in those instances where no data are available post-Dose 2, since the participants in the 1-Additional Dose group only received Dose 1 of HZ/su vaccine.

End point type

Secondary

End point 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

Notes
[112] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose and Revaccination groups.

End point values	1-Additional Dose Group	Revaccination Group
Number of subjects analysed	61	60
Units: Participants
Any fatigue, post-Dose 1(N=61,60)	32	24
Grade 3 fatigue, post-Dose 1 (N=61,60)	0	2
Related fatigue, post-Dose 1 (N=61,60)	32	23
Any fever, post-Dose 1(N=61,60)	18	13
Grade 3 fever, post-Dose 1 (N=61,60)	0	0
Related fever, post-Dose 1,(N=61,60)	18	13
Any gastrointestinal, post-Dose1 (N=61,60)	9	9
Grade 3 gastrointestinal, post-Dose 1 (N=61,60)	0	2
Related gastrointestinal, post-Dose1 (N=61,60)	9	8
Any headache, post-Dose 1 (N=61,60)	23	17
Grade 3 headache, post-Dose 1 (N=61,60)	0	2
Related headache, post-Dose 1 (N=61,60)	23	17
Any myalgia, post-Dose 1 (N=61,60)	27	22
Grade 3 myalgia, post-Dose 1 (N=61,60)	0	2
Related myalgia, post-Dose 1 (N=61,60)	27	21
Any shivering, post-Dose 1 (N=61,60)	25	15
Grade 3 shivering, post-Dose 1, N=61,60	2	4
Related shivering, post-Dose 1 (N=61,60)	25	15
Any fatigue, post-Dose 2 (N=0,55)	99999	22
Grade 3 fatigue, post-Dose 2 (N=0,55)	99999	3
Related fatigue, post-Dose 2 (N=0,55)	99999	21
Any fever, post-Dose 2 (N=0,55)	99999	7
Grade 3 fever, post-Dose 2 (N=0,55)	99999	0
Related fever, post-Dose 2 (N=0,55)	99999	4
Any gastrointestinal, post-Dose 2 (N=0,55)	99999	4
Grade 3 gastrointestinal, post-Dose 2 (N=0,55)	99999	0
Related gastrointestinal, post-Dose 2 (N=0,55)	99999	4
Any headache, post-Dose 2,N=0,55	99999	15
Grade 3 headache, post-Dose 2 (N=0,55)	99999	1
Related headache, post-Dose 2 (N=0,55)	99999	14
Any myalgia, post-Dose 2 (N=0,55)	99999	12
Grade 3 myalgia, post-Dose 2 (N=0,55)	99999	1
Related myalgia, post-Dose 2 (N=0,55)	99999	11
Any shivering, post-Dose 2 (N=0,55)	99999	7
Grade 3 shivering, post-Dose 2 (N=0,55)	99999	0
Related shivering, post-Dose 2 (N=0,55)	99999	7

No statistical analyses for this end point

Secondary: Duration in days of solicited general symptoms

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End point title

Duration in days of solicited general symptoms ^[113]

End point description

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. 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, with diary data available after each vaccination and who experienced the specified solicited general symptom within 7 days following the respective vaccine dose. '99999' was entered as a placeholder value in those instances where no data are available post-Dose 2, since the participants in the 1-Additional Dose group only received Dose 1 of HZ/su vaccine.

End point type

Secondary

End point 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

Notes
[113] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose and Revaccination groups.

End point values	1-Additional Dose Group	Revaccination Group
Number of subjects analysed	61	60
Units: Days
median (inter-quartile range (Q1-Q3))
Fatigue, post-Dose 1 (N=61,60)	2.0 (1.0 to 3.0)	2.0 (1.0 to 2.0)
Fatigue, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	2.0 (1.0 to 3.0)
Fever, post-Dose 1 (N=61,60)	1.0 (1.0 to 1.0)	1.0 (1.0 to 2.0)
Fever, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	1.0 (1.0 to 2.0)
Gastrointestinal symptoms, post-Dose 1 (N=61,60)	1.0 (1.0 to 2.0)	1.0 (1.0 to 3.0)
Gastrointestinal symptoms, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	1.5 (1.0 to 2.0)
Headache, post-Dose 1 (N=61,60)	1.0 (1.0 to 2.0)	2.0 (1.0 to 3.0)
Headache, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	2.0 (1.0 to 3.0)
Myalgia, post-Dose 1 (N=61,60)	2.0 (1.0 to 2.0)	1.0 (1.0 to 3.0)
Myalgia, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	1.5 (1.0 to 2.5)
Shivering, post-Dose 1 (N=61,60)	1.0 (1.0 to 2.0)	1.0 (1.0 to 2.0)
Shivering, post-Dose 2 (N=0,55)	99999 (99999 to 99999)	1.0 (1.0 to 2.0)

No statistical analyses for this end point

Secondary: Number of participants with any unsolicited adverse events (AEs)

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End point title

Number of participants with any unsolicited adverse events (AEs) ^[114]

End point description

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. 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.

End point type

Secondary

End point 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

Notes
[114] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose and Revaccination groups.

End point values	1-Additional Dose Group	Revaccination Group
Number of subjects analysed	61	60
Units: Participants	13	15

No statistical analyses for this end point

Secondary: Number of participants with any and related serious adverse events (SAEs)

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End point title

Number of participants with any and related serious adverse events (SAEs) ^[115]

End point description

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. 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 (1-Additional Dose and Revaccination groups) and all participants who came for Month 0 visit (Control group).

End point type

Secondary

End point 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)

Notes
[115] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose, Revaccination and Control groups.

End point values	1-Additional Dose Group	Revaccination Group	Control Group
Number of subjects analysed	61	60	119
Units: Participants
Any SAEs	4	4	11
Related SAEs	0	0	0

No statistical analyses for this end point

Secondary: Number of participants with SAEs related to investigational vaccine, related to study participation or to GSK concomitant medication/vaccine

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End point title

Number of participants with SAEs related to investigational vaccine, related to study participation or to GSK concomitant medication/vaccine

End point description

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. 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 (1-Additional Dose and Revaccination groups) and all participants who came for Month 0 visit (LTFU and Control groups).

End point type

Secondary

End point timeframe

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

End point values	LTFU Group	1-Additional Dose Group	Revaccination Group	Control Group
Number of subjects analysed	7289	61	60	119
Units: Participants	0	0	0	0

No statistical analyses for this end point

Secondary: Number of participants with any and related potential immune-mediated diseases (pIMDs)

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End point title

Number of participants with any and related potential immune-mediated diseases (pIMDs) ^[116]

End point description

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. 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 (1-Additional Dose and Revaccination groups) and all participants who came for Month 0 visit (Control group).

End point type

Secondary

End point 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)

Notes
[116] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting values for the participants in the 1-Additional Dose, Revaccination and Control groups.

End point values	1-Additional Dose Group	Revaccination Group	Control Group
Number of subjects analysed	61	60	119
Units: Participants	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited AEs: within 7 days & Unsolicited AEs: within 30 days across HZ/su doses. SAEs: Month (M) 0 to M72 (only related SAEs for LTFU group), M0 to M12 (1-Additional Dose & Control groups) & M0 until 12 months post-last HZ/su dose (Revaccination group).

Adverse event reporting additional description

As pre-specified in protocol, data in the Non-Serious Adverse Events module was only collected for the revaccinated participants in ZOSTER-049:EXT 006-022 study (1-Additional Dose and Revaccination groups). As per the amended information in protocol, for the LTFU group, AEs/SAEs that were not considered related were not analyzed.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

LTFU Group

Reporting group description

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 study were followed up for long-term vaccine efficacy and safety.

Reporting group title

Revaccination Group

Reporting group description

Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and got revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049 study.

Reporting group title

Control Group

Reporting group description

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 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).

Reporting group title

1-Additional Dose Group

Reporting group description

Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049 study.

Serious adverse events	LTFU Group	Revaccination Group	Control Group	1-Additional Dose Group
Total subjects affected by serious adverse events
subjects affected / exposed	62 / 7289 (0.85%)	4 / 60 (6.67%)	11 / 119 (9.24%)	4 / 61 (6.56%)
number of deaths (all causes)	56	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cancer stage IV
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Mantle cell lymphoma
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metastases to peritoneum
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Neurofibrosarcoma
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Arteriosclerosis
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed	5 / 7289 (0.07%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	2 / 7289 (0.03%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Extradural haematoma
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiac failure
subjects affected / exposed	14 / 7289 (0.19%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 14	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	3 / 7289 (0.04%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disoder
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	1 / 7289 (0.01%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac hypertrophy
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	5 / 7289 (0.07%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Adams-stokes syndrome
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Headache
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dementia
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	2 / 7289 (0.03%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	2 / 7289 (0.03%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebellar stroke
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	2 / 119 (1.68%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Pancreatitis necrotising
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngo-oesophageal diverticulum
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Sepsis
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	5 / 7289 (0.07%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Labyrinthitis
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Septic shock
subjects affected / exposed	1 / 7289 (0.01%)	0 / 60 (0.00%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pertussis
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	1 / 119 (0.84%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	LTFU Group	Revaccination Group	Control Group	1-Additional Dose Group
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 7289 (0.00%)	58 / 60 (96.67%)	0 / 119 (0.00%)	54 / 61 (88.52%)
Investigations
Prostatic specific antigen increased
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
Nervous system disorders
Headache
subjects affected / exposed	0 / 7289 (0.00%)	23 / 60 (38.33%)	0 / 119 (0.00%)	24 / 61 (39.34%)
occurrences all number	0	33	0	25
Hypoaesthesia
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
General disorders and administration site conditions
Chills
subjects affected / exposed	0 / 7289 (0.00%)	19 / 60 (31.67%)	0 / 119 (0.00%)	26 / 61 (42.62%)
occurrences all number	0	22	0	26
Chest pain
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	1	0	1
Swelling
subjects affected / exposed	0 / 7289 (0.00%)	16 / 60 (26.67%)	0 / 119 (0.00%)	7 / 61 (11.48%)
occurrences all number	0	25	0	7
Pyrexia
subjects affected / exposed	0 / 7289 (0.00%)	17 / 60 (28.33%)	0 / 119 (0.00%)	18 / 61 (29.51%)
occurrences all number	0	20	0	18
Pain
subjects affected / exposed	0 / 7289 (0.00%)	53 / 60 (88.33%)	0 / 119 (0.00%)	42 / 61 (68.85%)
occurrences all number	0	89	0	42
Injection site pruritus
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
Fatigue
subjects affected / exposed	0 / 7289 (0.00%)	33 / 60 (55.00%)	0 / 119 (0.00%)	32 / 61 (52.46%)
occurrences all number	0	46	0	32
Eye disorders
Vitreous floaters
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
Macular degeneration
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Gastrointestinal disorders
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Gastrointestinal disorder
subjects affected / exposed	0 / 7289 (0.00%)	10 / 60 (16.67%)	0 / 119 (0.00%)	9 / 61 (14.75%)
occurrences all number	0	13	0	9
Gastritis
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
Aphonia
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Blister
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Papule
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
Erythema
subjects affected / exposed	0 / 7289 (0.00%)	28 / 60 (46.67%)	0 / 119 (0.00%)	13 / 61 (21.31%)
occurrences all number	0	42	0	13
Ecchymosis
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	2
Psychiatric disorders
Nightmare
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 7289 (0.00%)	2 / 60 (3.33%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	2	0	0
Myalgia
subjects affected / exposed	0 / 7289 (0.00%)	26 / 60 (43.33%)	0 / 119 (0.00%)	27 / 61 (44.26%)
occurrences all number	0	34	0	27
Osteoarthritis
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Osteoporosis
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	2	0	1
Oral herpes
subjects affected / exposed	0 / 7289 (0.00%)	2 / 60 (3.33%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	2	0	0
Nail infection
subjects affected / exposed	0 / 7289 (0.00%)	0 / 60 (0.00%)	0 / 119 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	0	1
Pneumonia
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0
Metabolism and nutrition disorders
Iron deficiency
subjects affected / exposed	0 / 7289 (0.00%)	1 / 60 (1.67%)	0 / 119 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

19 Feb 2016

This amendment was done for countries that recruited subjects in the 1-Additional Dose, Revaccination and Control groups. Administrative changes were done for Germany and Japan. The additional inclusion and exclusion criteria for the 1-Additional Dose and Revaccination groups were also made applicable to the Control group to allow non-biased randomisation of subjects into the 3 groups and an additional exclusion criterion has been added for 1-Additional Dose, Revaccination and Control groups. The reference to “GSK Japan” has been changed to “Japan Vaccine Co., Ltd.” The study period indicated was also corrected as per local request in the requirements for Japan. Typographical errors were corrected in addition to the term “ZOSTER-056” that was corrected to “ZOSTER-049” in the requirements for Germany.

19 Jan 2017

This protocol was amended after study start, because this being a long-term follow-up study and considering the age of the study population and the study duration (6 years), the current safety data collection requirement of the protocol would lead to collection of safety data that is not relevant for assessing the safety profile of the vaccine. This amendment was done to qualify that for the recording of AEs/SAEs leading to withdrawal which are not related to: investigational vaccine, study participation, GSK concomitant medication/vaccine, HZ complications. Only the name (diagnosis/description) of the event was recorded in the eCRF. No other details about these types of AEs/SAEs were recorded during the entire study (for the LTFU group), after 12 months from Visit Month 0 (for the Control and 1-Additional Dose groups) and after 12 months from last HZ/su vaccination (for the Revaccination group). The footnote was added to Synopsis Table 1 and Tables 1 and 16 for clarity that all subjects entering the study would have a humoral immunogenicity (HI) blood sample at Visit Month 0 and for subjects in the LTFU group, who did not belong to any subset, these samples would be stored and tested for HI only if the subject develops HZ during the ZOSTER-049 study or if there are other reasons requiring the HI testing of these samples. Although no confirmed signals related to hypersensitivity reactions (including anaphylaxis) have been identified during the HZ/su clinical program, a mitigation strategy for the potential risk has been added to the Risk Assessment Section. The CMI Vaccine Response Rate (VRR) for gE was defined to align with the Statistical Analysis Plan (SAP).

16 Mar 2018

The protocol was amended following a request by the European Medicines Agency (EMA). Vaccine efficacy (VE) in prevention of Herpes Zoster (HZ) related complications (other than Postherpetic Neuralgia [PHN]) in the overall study population and VE in the prevention of PHN over each year of follow-up from one month post dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-049 study would be assessed. The corresponding objectives and endpoints were added. In addition, as per EMA’s request, a sensitivity analysis would be performed to assess the impact on VE of HZ episodes occurring during the interval between the end of the ZOSTER-006/022 studies and beginning of the ZOSTER-049. Evaluation of memory B cell responses would be performed. The corresponding tertiary objectives and endpoints were added. Description of the Enzyme-linked ImmunoSpot (ELISPOT) assay and descriptive statistics were also added. Since the HZ/su vaccine was first approved in Canada and the United States in October 2017, the Trademarks were updated to include the trade name Shingrix.

23 Oct 2018

This amendment was related to the time frame of completing the Zoster Brief Pain Inventory (ZBPI) questionnaire. This change would ensure thorough reporting of postherpetic neuralgia cases. Subjects with suspected herpes zoster (HZ) were required to complete the questionnaire until a 4-week pain-free period was documented and beyond Day HZ-91, if applicable. This amendment removed the stipulation “or until Day HZ-91” and therefore, if pain developed after Day HZ-91 to capture of cases of postherpetic neuralgia according to the protocol definition. Reporting of cytotoxic chemotherapy as a concomitant medication was clarified. Other minor changes included correcting and updating text regarding country approvals of Shingrix, and correcting minor typographical errors.

11 May 2020

This amendment outlined measures that may have been applicable during special circumstances (e.g., during COVID-19 pandemic). The purpose of the amendment was to introduce measures that may have allowed protection of subject’s welfare and safety, as well as maintaining the integrity of the study. The classification of HZ cases by HZAC has been clarified with the addition of “not able to decide” to be classified as “not HZ” for confirmation of suspected HZ by the HZAC. The timelines concerning data entry into the eCRF for France have been updated to align with the timelines presented in the data management plan.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of participants having at least one confirmed Herpes Zoster (HZ) case during the total duration of ZOSTER-049:EXT 006-022 study, overall

Primary: Number of participants having at least one confirmed Herpes Zoster (HZ) case during the total duration of ZOSTER-049:EXT 006-022 study, overall

Secondary: Number of participants having at least one confirmed HZ case during the total duration of ZOSTER-049:EXT 006-022 study, by age ranges

Secondary: Number of participants having at least one confirmed HZ case during the total duration of ZOSTER-049:EXT 006-022 study, by age ranges

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: Anti-gE antibody concentrations for 1-Additional Dose, Revaccination and Control groups at Month 1 in the current ZOSTER-049:EXT 006-022 study

Secondary: Anti-gE antibody concentrations for 1-Additional Dose, Revaccination and Control groups at Month 1 in the current ZOSTER-049:EXT 006-022 study

Secondary: 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

Secondary: 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

Secondary: Anti-gE antibody concentrations for Revaccination and Control groups at Month 3 in the current ZOSTER-049:EXT 006-022 study

Secondary: Anti-gE antibody concentrations for Revaccination and Control groups at Month 3 in the current ZOSTER-049:EXT 006-022 study

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: 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

Secondary: Number of participants with any and Grade 3 solicited local symptoms

Secondary: Number of participants with any and Grade 3 solicited local symptoms

Secondary: Duration in days of solicited local symptoms

Secondary: Duration in days of solicited local symptoms

Secondary: Number of participants with any, Grade 3 and related solicited general symptoms

Secondary: Number of participants with any, Grade 3 and related solicited general symptoms

Secondary: Duration in days of solicited general symptoms

Secondary: Duration in days of solicited general symptoms

Secondary: Number of participants with any unsolicited adverse events (AEs)

Secondary: Number of participants with any unsolicited adverse events (AEs)

Secondary: Number of participants with any and related serious adverse events (SAEs)

Secondary: Number of participants with any and related serious adverse events (SAEs)

Secondary: Number of participants with SAEs related to investigational vaccine, related to study participation or to GSK concomitant medication/vaccine

Secondary: Number of participants with SAEs related to investigational vaccine, related to study participation or to GSK concomitant medication/vaccine

Secondary: Number of participants with any and related potential immune-mediated diseases (pIMDs)

Secondary: Number of participants with any and related potential immune-mediated diseases (pIMDs)

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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