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    Clinical Trial Results:
    A phase IIIB, open label, long term follow-up study to assess persistence of immune responses to GSK’s HZ/su vaccine 4-7 years after primary vaccination; and immunogenicity and safety assessment of revaccination with 2 additional doses of HZ/su vaccine, administered 1-2 months apart, 6-8 years after primary vaccination of adults with renal transplant from study ZOSTER-041

    Summary
    EudraCT number
    		 2019-001815-21
    Trial protocol
    		 BE   FI  
    Global end of trial date
    27 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2025
    First version publication date
    13 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    212340
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04176939
    WHO universal trial number (UTN)
    		 -
    Sponsors
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Oct 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Long term follow-up (LTFU) phase - Immunogenicity assessment: • To evaluate persistence of humoral immunity after primary vaccination course. Revaccination active phase - Immunogenicity assessment: • To evaluate humoral immunity of HZ/su vaccine post-revaccination Doses 1 & 2.
    Protection of trial subjects
    An internal Safety Review Team oversaw the safety and wellbeing of the study participants. All participants were supervised/observed for 30 mins after vaccine administration with appropriate medical treatment readily available in case if serious allergic reaction to vaccination. Study procedures including vaccine administration and blood sampling were performed by qualified/trained personnel. Study vaccine was administered only to eligible participants that had no contraindications to any components of the vaccine. Participants were followed up for 2 years in the LTFU phase of the current extension ZOSTER-073 study, representing up to 6-8 years after the vaccination in the primary ZOSTER-041 study. Also, participants were followed up for 24 months after the second revaccination dose received in the current ZOSTER-073 study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Dec 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Regulatory reason
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Panama: 3
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    Taiwan: 3
    Worldwide total number of subjects
    68
    EEA total number of subjects
    45
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    47
    From 65 to 84 years
    20
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants from the Herpes Zoster (HZ/su) treatment group of ZOSTER-041 (NCT02058589) study who had a complete primary vaccination course (2 doses of HZ/su vaccine) were offered enrollment in the current ZOSTER-073 study (NCT04176939). A total of 68 participants met the eligibility criteria and consented to participate in this study.

    Pre-assignment
    Screening details
    		 Out of the 68 participants originally enrolled in the current ZOSTER-073 study (Enrolled Set), 21 participants did not receive any revaccination doses, hence only 47 participants were vaccinated with at least one revaccination dose and included in the Exposed Set for revaccination phase in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is an open-label study with one treatment group.

    Arms
    Arm title
    		 HZ/su Group
    Arm description
    		 Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) study. 47 of these participants further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of the current ZOSTER-073 (NCT04176939) study, first dose at Month 24 and second dose at Month 25.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HZ/su vaccine
    Investigational medicinal product code
    Other name
    GSK1437173A
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 additional doses of the HZ/su vaccine were administered intramuscularly at Month 24 and at Month 25 in the revaccination phase of the study.

    Number of subjects in period 1
    		HZ/su Group
    Started
    68
    Revaccinated
    47 [1]
    Completed
    49
    Not completed
    19
         Adverse Event Requiring Expedited Reporting
    7
         Consent withdrawn by subject
    5
         Migrated / Moved From The Study Area
    1
         Unspecified reason
    4
         Lost to follow-up
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Out of the 68 participants originally enrolled in the current ZOSTER-073 study (Enrolled Set), only 47 participants were vaccinated with at least one revaccination dose and included in the Exposed Set for revaccination phase in this study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HZ/su Group
    Reporting group description
    		 Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) study. 47 of these participants further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of the current ZOSTER-073 (NCT04176939) study, first dose at Month 24 and second dose at Month 25.

    Reporting group values
    		 HZ/su Group Total
    Number of subjects
    		 68 68
    Age categorical
    Units: Participants
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 47 47
        From 65-84 years
    		 20 20
        85 years and over
    		 1 1
    Age Continuous
    Descriptive summaries of Age at the time of enrollment in the current ZOSTER-073 study are presented for the participants enrolled in this study (Enrolled Set).
    Units: Years
        arithmetic mean (standard deviation)
    		 58.5 ( 12.3 ) -
    Sex: Female, Male
    Descriptive summaries of Sex at the time of enrollment in the current ZOSTER-073 study are presented for the participants enrolled in this study (Enrolled Set).
    Units: Participants
        Female
    		 22 22
        Male
    		 46 46
    Race/Ethnicity, Customized
    Descriptive summaries of Race/Ethnicity at the time of enrollment in the current ZOSTER-073 study are presented for the participants enrolled in this study (Enrolled Set).
    Units: Subjects
        ASIAN
    		 14 14
        BLACK OR AFRICAN AMERICAN
    		 3 3
        WHITE
    		 46 46
        OTHER - UNSPECIFIED
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    HZ/su Group
    Reporting group description
    		 Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) study. 47 of these participants further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of the current ZOSTER-073 (NCT04176939) study, first dose at Month 24 and second dose at Month 25.

    Primary: Anti-glycoprotein E (anti-gE) antibody concentrations, as assessed in the Long term follow-up (LTFU) phase of the current ZOSTER-073 study

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    End point title
    		 Anti-glycoprotein E (anti-gE) antibody concentrations, as assessed in the Long term follow-up (LTFU) phase of the current ZOSTER-073 study [1]
    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). Analysis was performed on the Per Protocol Set for analysis of persistence (LTFU phase), which included evaluable participants from the Enrolled Set with a complete vaccination course (2 doses of HZ/su vaccine) in the ZOSTER-041 study, who met the eligibility criteria and signed informed consent in the current study and for whom persistence immunogenicity results after primary vaccination course were available at the specified time points in the current study, regardless of revaccination status.
    End point type
    Primary
    End point timeframe
    At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HZ/su Group
    Number of subjects analysed
    60
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        At Day 1 (N=56)
    3729.8 (2736.2 to 5084.0)
        At Month 12 (N=60)
    3440.2 (2499.0 to 4735.7)
        At Month 24 (N=49)
    3075.8 (2091.8 to 4522.8)
    No statistical analyses for this end point

    Primary: Anti-gE antibody concentrations, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Anti-gE antibody concentrations, as assessed in the Revaccination active phase of the current ZOSTER-073 study [2]
    End point description
    Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. Analysis was performed on the Per Protocol Set for Immunogenicity after revaccination course (Revaccination active phase), which included evaluable participants who were administered 1 or 2 doses of revaccination as per the revaccination schedule and who had immunogenicity data available for the specified analysis at the specified time points in the current study.
    End point type
    Primary
    End point timeframe
    At Month 24 (pre-revaccination), Month 25 (1 month post-revaccination Dose 1) and Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HZ/su Group
    Number of subjects analysed
    45
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        At Month 24 (N=45)
    2828.5 (1886.6 to 4240.5)
        At Month 25 (N=44)
    27655.5 (17882.7 to 42769.1)
        At Month 26 (N=44)
    31517.0 (21581.1 to 46027.3)
    No statistical analyses for this end point

    Secondary: Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as assessed in the LTFU phase of the current ZOSTER-073 study

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    End point title
    		 Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as assessed in the LTFU phase of the current ZOSTER-073 study
    End point description
    Frequency of gE-specific CD4 (2+) T-cells expressing two or more activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and CD40 Ligand [CD40L]) was determined by intracellular cytokine staining (ICS) as measured by cytokine flow cytometry (CFC) and expressed in CD4(2+) T-cells per million cells [CD4(2+) T-cells/million cells]. Analysis was performed on a sub-cohort of participants from the Per Protocol Set for analysis of persistence (LTFU phase), for whom an additional blood sample for cell-mediated immunity (CMI) analysis was collected and who had CMI results available for the specified analysis at the specified time points in the current study.
    End point type
    Secondary
    End point timeframe
    At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    28
    Units: CD4(2+) T-cells/million cells
    median (inter-quartile range (Q1-Q3))
        At Day 1 (N=28)
    608.9 (167.2 to 993.6)
        At Month 12 (N=18)
    299.4 (105.3 to 1068.4)
        At Month 24 (N=19)
    711.0 (309.9 to 1211.0)
    No statistical analyses for this end point

    Secondary: Number of participants with serious adverse events (SAEs) related to primary vaccination in ZOSTER-041 study, as assessed in the LTFU phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with serious adverse events (SAEs) related to primary vaccination in ZOSTER-041 study, as assessed in the LTFU phase of the current ZOSTER-073 study
    End point description
    SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. SAEs related to primary vaccination in ZOSTER-041 study were assessed by the investigator. Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current study.
    End point type
    Secondary
    End point timeframe
    From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    68
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: Number of participants with suspected or confirmed Herpes Zoster (HZ) cases, as assessed in the LTFU phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with suspected or confirmed Herpes Zoster (HZ) cases, as assessed in the LTFU phase of the current ZOSTER-073 study
    End point description
    A suspected HZ case was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) without alternative diagnosis. A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current study.
    End point type
    Secondary
    End point timeframe
    From Month 13 (last visit) in ZOSTER-041 study until Day 1 (first visit) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    68
    Units: Participants
        Confirmed HZ case (N=68)
    0
        Suspected HZ case (N=68)
    3
    No statistical analyses for this end point

    Secondary: Number of participants with confirmed HZ cases, as assessed in the LTFU phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with confirmed HZ cases, as assessed in the LTFU phase of the current ZOSTER-073 study
    End point description
    A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 primary study who met the eligibility criteria and signed informed consent in the current study.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Month 24 in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    68
    Units: Participants
    3
    No statistical analyses for this end point

    Secondary: Number of participants with suspected or biopsy-proven allograft rejections, as assessed in the LTFU phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with suspected or biopsy-proven allograft rejections, as assessed in the LTFU phase of the current ZOSTER-073 study
    End point description
    The number of participants with biopsy for clinical indication (suspected) or surveillance protocol that was not biopsy-proven rejection and with biopsy-proven allograft rejections are reported. Biopsy-proven allograft rejections are defined as adverse events of specific interest (AESIs). Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current study.
    End point type
    Secondary
    End point timeframe
    From Month 13 (last visit) in ZOSTER-041 study until Day 1 (first visit) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    68
    Units: Participants
        Biopsy-proven allograft rejection (N=68)
    0
        Biopsy for clinical indication/surveillance (N=68)
    5
    No statistical analyses for this end point

    Secondary: Number of participants with biopsy-proven allograft rejections, as assessed in the LTFU phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with biopsy-proven allograft rejections, as assessed in the LTFU phase of the current ZOSTER-073 study
    End point description
    Biopsy-proven allograft rejection is defined as an adverse event of specific interest (AESI). Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current study.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Month 24 in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    68
    Units: Participants
    2
    No statistical analyses for this end point

    Secondary: Number of participants with allograft dysfunction related to allograft rejection episodes, as assessed in the LTFU phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with allograft dysfunction related to allograft rejection episodes, as assessed in the LTFU phase of the current ZOSTER-073 study
    End point description
    Declining allograft function (allograft dysfunction) was assessed through all clinically obtained serum creatinine values from 2 months prior to an episode of biopsy-proven rejection and up to 2 months after rejection resolution and cessation of therapeutic immunosuppressive therapy. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (2 months prior to an episode of biopsy-proven rejection). Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 primary study who met the eligibility criteria and signed informed consent in the current study.
    End point type
    Secondary
    End point timeframe
    From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    68
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: Number of participants with allograft dysfunction related to HZ episodes, as assessed in the LTFU phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with allograft dysfunction related to HZ episodes, as assessed in the LTFU phase of the current ZOSTER-073 study
    End point description
    Declining allograft function was assessed through all clinically obtained serum creatinine values from 2 months prior to an episode of HZ and up to 2 months after HZ rash resolution. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (2 months prior to an episode of HZ). Analysis was performed on the Enrolled Set, which included all participants with a complete vaccination course (2 doses of HZ/su vaccine) in ZOSTER-041 study who met the eligibility criteria and signed informed consent in the current study.
    End point type
    Secondary
    End point timeframe
    From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    68
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: Frequency of gE-specific CD4(2+) T-cells, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Frequency of gE-specific CD4(2+) T-cells, as assessed in the Revaccination active phase of the current ZOSTER-073 study
    End point description
    Frequency of gE-specific CD4 (2+) T-cells expressing two or more activation markers (from among IFN-γ, IL-2, TNF-α and CD40L) was determined by ICS as measured by CFC and expressed in CD4(2+) T-cells/million cells. Analysis was performed on a sub-cohort of participants from the Per Protocol Set for Immunogenicity after revaccination course (Revaccination active phase), for whom an additional blood sample for CMI analysis was collected and who had CMI results available for the specified analysis at the specified time points in the current study.
    End point type
    Secondary
    End point timeframe
    At Month 24 (pre-revaccination), Month 25 (1 month post-revaccination Dose 1) and Month 26 (1 month post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    23
    Units: CD4(2+) T-cells/million cells
    median (inter-quartile range (Q1-Q3))
        At Month 24 (N=23)
    793.5 (309.9 to 1235.8)
        At Month 25 (N=20)
    4476.2 (3136.7 to 7704.6)
        At Month 26 (N=18)
    3747.3 (2758.1 to 8906.2)
    No statistical analyses for this end point

    Secondary: Anti-gE antibody concentrations, as assessed in the Revaccination follow-up phase of the current ZOSTER-073 study

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    End point title
    		 Anti-gE antibody concentrations, as assessed in the Revaccination follow-up phase of the current ZOSTER-073 study
    End point description
    Persistence of humoral immunity after the revaccination course was evaluated in terms of anti-gE antibody concentrations. Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. Analysis was performed on the Per Protocol Set for persistence after revaccination course (Revaccination follow-up phase), which included evaluable participants who received 2 doses of revaccination in the current ZOSTER-073 study and for whom immunogenicity persistence results after revaccination were available for the specified analysis at the specified time points in the current study.
    End point type
    Secondary
    End point timeframe
    At Month 37 (12 months post-revaccination Dose 2) and Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    44
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        At Month 37 (N=44)
    23989.4 (17539.6 to 32811.0)
        At Month 49 (N=36)
    9985.8 (5917.8 to 16850.0)
    No statistical analyses for this end point

    Secondary: Frequency of gE-specific CD4(2+) T-cells, as assessed in the Revaccination follow-up phase of the current ZOSTER-073 study

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    End point title
    		 Frequency of gE-specific CD4(2+) T-cells, as assessed in the Revaccination follow-up phase of the current ZOSTER-073 study
    End point description
    Frequency of gE-specific CD4 (2+) T-cells expressing two or more activation markers (from among IFN-γ, IL-2, TNF-α and CD40L) was determined by ICS as measured by CFC and expressed in CD4(2+) T-cells/million cells. Analysis was performed on a sub-cohort of participants from the Per Protocol Set for persistence after revaccination course (Revaccination follow-up phase), for whom an additional blood sample for CMI analysis was collected and who had CMI results available for the specified analysis at the specified time points in the current study.
    End point type
    Secondary
    End point timeframe
    At Month 37 (12 months post-revaccination Dose 2) and Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    20
    Units: CD4(2+) T-cells/million cells
    median (inter-quartile range (Q1-Q3))
        At Month 37 (N=20)
    1777.4 (1297.7 to 2505.4)
        At Month 49 (N=16)
    1144.9 (818.1 to 2724.1)
    No statistical analyses for this end point

    Secondary: Number of participants with any and Grade 3 solicited administration site events after each revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with any and Grade 3 solicited administration site events after each revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study
    End point description
    Assessed solicited administration site events included erythema, pain and swelling at injection site. Any = occurrence of the event regardless of intensity grade. Any erythema/swelling at injection site = erythema/swelling at injection site with a diameter larger than (>) 20 millimeters (mm). Grade 3 pain = significant pain at rest, which prevented normal, everyday activities. Grade 3 erythema/swelling at injection site = erythema/swelling at injection site with a diameter >100 mm. Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and with the solicited administration site events diary card data available after the corresponding revaccination, for the specified duration.
    End point type
    Secondary
    End point timeframe
    Within 7 days after each revaccination dose (administered at Month 24 [Dose 1] and at Month 25 [Dose 2]) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    45
    Units: Participants
        Any Erythema, after revacc. Dose 1 (N=45)
    9
        Grade 3 Erythema, after revacc. Dose 1 (N=45)
    0
        Any Erythema, after revacc. Dose 2 (N=45)
    6
        Grade 3 Erythema, after revacc. Dose 2 (N=45)
    0
        Any Pain, after revacc. Dose 1 (N=45)
    37
        Grade 3 Pain, after revacc. Dose 1 (N=45)
    7
        Any Pain, after revacc. Dose 2 (N=45)
    31
        Grade 3 Pain, after revacc. Dose 2 (N=45)
    2
        Any Swelling, after revacc. Dose 1 (N=45)
    7
        Grade 3 Swelling, after revacc. Dose 1 (N=45)
    0
        Any Swelling, after revacc. Dose 2 (N=45)
    4
        Grade 3 Swelling, after revacc. Dose 2 (N=45)
    0
    No statistical analyses for this end point

    Secondary: Duration in days of solicited administration site events after each revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Duration in days of solicited administration site events after each revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study
    End point description
    Duration is the number of days in which a participant experienced the solicited administration site event within the 7-day solicited follow-up period. Assessed solicited administration site events included erythema, pain and swelling at injection site. Analysis was performed on the Exposed Set for revaccination phase, which included participants with at least one HZ/su revaccination dose administered in the current study, with solicited diary data available after the corresponding revaccination, who experienced the specified solicited administration site event within 7 days following the respective revaccination dose and with the duration documented.
    End point type
    Secondary
    End point timeframe
    Within 7 days after each revaccination dose (administered at Month 24 [Dose 1] and at Month 25 [Dose 2]) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    37
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Erythema, after revacc. Dose 1 (N=9)
    4.0 (1.0 to 5.0)
        Pain, after revacc. Dose 1 (N=37)
    3.0 (2.0 to 4.0)
        Swelling, after revacc. Dose 1 (N=6)
    3.0 (2.0 to 3.0)
        Erythema, after revacc. Dose 2 (N=6)
    3.0 (2.0 to 3.0)
        Pain, after revacc. Dose 2 (N=31)
    2.0 (2.0 to 3.0)
        Swelling, after revacc. Dose 2 (N=4)
    2.5 (1.5 to 3.5)
    No statistical analyses for this end point

    Secondary: Number of participants with any, Grade 3 and related solicited systemic events after each revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with any, Grade 3 and related solicited systemic events after each revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study
    End point description
    Assessed solicited systemic events included fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever (temperature >=38.0°C/100.4°F). Any AE = occurrence of the event regardless of intensity grade. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = event that prevented normal, everyday activities. Grade 3 fever = temperature >39°C/102.2°F. Related fatigue, gastrointestinal symptoms, headache, myalgia, shivering, fever = event assessed by the investigator as related to the revaccination. The preferred route for measuring temperature in this study was oral. Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and with the solicited systemic events diary card data available after the corresponding revaccination, for the specified duration.
    End point type
    Secondary
    End point timeframe
    Within 7 days after each revaccination dose (administered at Month 24 [Dose 1] and at Month 25 [Dose 2]) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    46
    Units: Participants
        Any Fatigue, after revacc. Dose 1 (N=46)
    26
        Grade 3 Fatigue, after revacc. Dose 1 (N=46)
    2
        Related Fatigue, after revacc. Dose 1 (N=46)
    22
        Any Fatigue, after revacc. Dose 2 (N=45)
    23
        Grade 3 Fatigue, after revacc. Dose 2 (N=45)
    2
        Related Fatigue, after revacc. Dose 2 (N=45)
    21
        Any Gastrointest., after revacc. Dose 1 (N=46)
    11
        Grade 3 Gastrointest., after revacc. Dose 1 (N=46)
    0
        Related Gastrointest., after revacc. Dose 1 (N=46)
    10
        Any Gastrointest., after revacc. Dose 2 (N=45)
    10
        Grade 3 Gastrointest., after revacc. Dose 2 (N=45)
    1
        Related Gastrointest., after revacc. Dose 2 (N=45)
    9
        Any Headache, after revacc. Dose 1 (N=46)
    22
        Grade 3 Headache, after revacc. Dose 1 (N=46)
    3
        Related Headache, after revacc. Dose 1 (N=46)
    19
        Any Headache, after revacc. Dose 2 (N=45)
    16
        Grade 3 Headache, after revacc. Dose 2 (N=45)
    0
        Related Headache, after revacc. Dose 2 (N=45)
    16
        Any Myalgia, after revacc. Dose 1 (N=46)
    21
        Grade 3 Myalgia, after revacc. Dose 1 (N=46)
    1
        Related Myalgia, after revacc. Dose 1 (N=46)
    17
        Any Myalgia, after revacc. Dose 2 (N=45)
    19
        Grade 3 Myalgia, after revacc. Dose 2 (N=45)
    1
        Related Myalgia, after revacc. Dose 2 (N=45)
    16
        Any Shivering, after revacc. Dose 1 (N=46)
    15
        Grade 3 Shivering, after revacc. Dose 1 (N=46)
    3
        Related Shivering, after revacc. Dose 1 (N=46)
    13
        Any Shivering, after revacc. Dose 2 (N=45)
    10
        Grade 3 Shivering, after revacc. Dose 2 (N=45)
    1
        Related Shivering, after revacc. Dose 2 (N=45)
    9
        Any Fever, after revacc. Dose 1 (N=46)
    4
        Grade 3 Fever, after revacc. Dose 1 (N=46)
    1
        Related Fever, after revacc. Dose 1 (N=46)
    4
        Any Fever, after revacc. Dose 2 (N=45)
    4
        Grade 3 Fever, after revacc. Dose 2 (N=45)
    1
        Related Fever, after revacc. Dose 2 (N=45)
    4
    No statistical analyses for this end point

    Secondary: Duration in days of solicited systemic events after each revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Duration in days of solicited systemic events after each revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study
    End point description
    Duration is the number of days in which a participant experienced the solicited systemic event within the 7-day solicited follow-up period. Assessed solicited systemic events included fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever. Analysis was performed on the Exposed Set for revaccination phase, which included participants with at least one HZ/su revaccination dose administered in the current study, with solicited diary data available after the corresponding revaccination, who experienced the specified solicited systemic event within 7 days following the respective revaccination dose and with the duration documented.
    End point type
    Secondary
    End point timeframe
    Within 7 days after each revaccination dose (administered at Month 24 [Dose 1] and at Month 25 [Dose 2]) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    26
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Fatigue, after revacc. Dose 1 (N=26)
    3.0 (2.0 to 3.0)
        Gastrointest., after revacc. Dose 1 (N=11)
    2.0 (1.0 to 2.0)
        Headache, after revacc. Dose 1 (N=22)
    2.0 (1.0 to 3.0)
        Myalgia, after revacc. Dose 1 (N=21)
    2.0 (2.0 to 4.0)
        Shivering, after revacc. Dose 1 (N=15)
    1.0 (1.0 to 2.0)
        Fever, after revacc. Dose 1 (N=4)
    1.5 (1.0 to 2.0)
        Fatigue, after revacc. Dose 2 (N=23)
    2.0 (2.0 to 4.0)
        Gastrointest., after revacc. Dose 2 (N=10)
    1.5 (1.0 to 2.0)
        Headache, after revacc. Dose 2 (N=16)
    2.0 (1.0 to 3.0)
        Myalgia, after revacc. Dose 2 (N=19)
    2.0 (1.0 to 4.0)
        Shivering, after revacc. Dose 2 (N=10)
    2.0 (1.0 to 2.0)
        Fever, after revacc. Dose 2 (N=4)
    1.0 (1.0 to 1.0)
    No statistical analyses for this end point

    Secondary: Number of participants with any, Grade 3 and related unsolicited adverse events (AEs) post-revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with any, Grade 3 and related unsolicited adverse events (AEs) post-revaccination, as assessed in the Revaccination active phase of the current ZOSTER-073 study
    End point description
    An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade or relation to revaccination. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as related to revaccination. Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom unsolicited AEs data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    Within 30 days (across revaccination doses) post-revaccination period in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    47
    Units: Participants
        Any unsolicited AE(s) (N=47)
    12
        Grade 3 unsolicited AE(s) (N=47)
    3
        Related unsolicited AE(s) (N=47)
    2
    No statistical analyses for this end point

    Secondary: Number of participants with any serious adverse events (SAEs) and fatal SAEs, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with any serious adverse events (SAEs) and fatal SAEs, as assessed in the Revaccination active phase of the current ZOSTER-073 study
    End point description
    SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to revaccination. Fatal = SAE resulting in the death of the participant. Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom SAEs data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    47
    Units: Participants
        Any SAE(s) (N=47)
    9
        Fatal SAE(s) (N=47)
    1
    No statistical analyses for this end point

    Secondary: Number of participants with related SAEs and related-fatal SAEs, as assessed in the Revaccination active phase of the current ZOSTER-073 study

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    End point title
    		 Number of participants with related SAEs and related-fatal SAEs, as assessed in the Revaccination active phase of the current ZOSTER-073 study
    End point description
    SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Related = SAE assessed by the investigator as related to revaccination. Related-fatal = SAE resulting in the death of the participant assessed by the investigator as related to revaccination. Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom SAEs data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    47
    Units: Participants
        Related SAE(s) (N=47)
    0
        Related-fatal SAE(s) (N=47)
    0
    No statistical analyses for this end point

    Secondary: Number of participants with any and related biopsy-proven allograft rejections, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study

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    End point title
    		 Number of participants with any and related biopsy-proven allograft rejections, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study
    End point description
    Biopsy-proven allograft rejection is defined as an adverse event of special interest (AESI) and is recorded in serious adverse event (SAE) screens, irrespective of the seriousness of the event. Related biopsy proven allograft rejections = biopsy-proven allograft rejections assessed by the investigator as related to revaccination. Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom biopsy-proven allograft rejections data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    47
    Units: Participants
        Any biopsy-proven allograft rejection (N=47)
    1
        Related biopsy-proven allograft rejection (N=47)
    0
    No statistical analyses for this end point

    Secondary: Number of participants with any and related potential immune-mediated diseases (pIMDs), as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study

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    End point title
    		 Number of participants with any and related potential immune-mediated diseases (pIMDs), as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study
    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 etiology. Any = occurrence of the pIMD regardless of intensity grade or relation to revaccination. Related = pIMDs assessed by the investigator as related to revaccination. Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom pIMDs data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    47
    Units: Participants
        Any pIMD(s) (N=47)
    1
        Related pIMD(s) (N=47)
    0
    No statistical analyses for this end point

    Secondary: Number of participants with confirmed HZ cases, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study

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    End point title
    		 Number of participants with confirmed HZ cases, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study
    End point description
    A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom HZ cases data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    47
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: Number of participants with allograft dysfunction related to allograft rejection, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study

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    End point title
    		 Number of participants with allograft dysfunction related to allograft rejection, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study
    End point description
    Declining allograft function was assessed through all clinically obtained serum creatinine values from 2 months prior to an episode of biopsy-proven rejection and up to 2 months after rejection resolution and cessation of therapeutic immunosuppressive therapy. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (2 months prior to an episode of biopsy-proven rejection). Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom allograft dysfunction related to allograft rejection data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    47
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: Number of participants with allograft dysfunction following revaccination, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study

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    End point title
    		 Number of participants with allograft dysfunction following revaccination, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study
    End point description
    Declining allograft function was assessed through all clinically obtained serum creatinine values from 3 months before the first revaccination dose until 3 months after the last revaccination dose. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (3 months prior to revaccination). Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom allograft dysfunction following revaccination data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    33
    Units: Participants
    4
    No statistical analyses for this end point

    Secondary: Number of participants with allograft dysfunction related to HZ episodes, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study

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    End point title
    		 Number of participants with allograft dysfunction related to HZ episodes, as assessed in the Revaccination active and follow-up phases of the current ZOSTER-073 study
    End point description
    Declining allograft function was assessed through all clinically obtained serum creatinine values from 2 months prior to an episode of HZ and up to 2 months after HZ resolution. Allograft dysfunction is defined as having a fold increase in serum creatinine of 1.2 greater from the reference timepoint (2 months prior to an episode of HZ). Analysis was performed on the Exposed Set for revaccination phase, which included all participants with at least one HZ/su revaccination dose administered in the current study and for whom allograft dysfunction related to HZ episodes data were available for the specified duration.
    End point type
    Secondary
    End point timeframe
    From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
    End point values
    		 HZ/su Group
    Number of subjects analysed
    47
    Units: Participants
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: Within 7 days & Unsolicited AEs: Within 30 days, after any revaccination; SAEs & pIMDs: from Month 24 until Month 37; Deaths, Related SAEs and biopsy-proven allograft rejections: from Day 1 until Month 49, in the current ZOSTER-073 study.
    Adverse event reporting additional description
    As pre-specified in Protocol, deaths and events presented in the SAEs module were assessed in both non-revaccinated and revaccinated participants from the Enrolled Set. In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    HZ/su Group
    Reporting group description
    		 Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) study. 47 of these participants further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of the current ZOSTER-073 (NCT04176939) study, first dose at Month 24 and second dose at Month 25.

    Serious adverse events
    		 HZ/su Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 68 (33.82%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Liposarcoma
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin squamous cell carcinoma metastatic
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal neoplasm
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung carcinoma cell type unspecified recurrent
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Syncope
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Bronchiectasis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Klebsiella urinary tract infection
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Staphylococcal bacteriaemia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HZ/su Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 68 (63.24%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed [1]
    1 / 47 (2.13%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed [2]
    27 / 47 (57.45%)
         occurrences all number
    39
    General disorders and administration site conditions
    Chills
         subjects affected / exposed [3]
    19 / 47 (40.43%)
         occurrences all number
    25
    Fatigue
         subjects affected / exposed [4]
    31 / 47 (65.96%)
         occurrences all number
    50
    Administration site pain
         subjects affected / exposed [5]
    40 / 47 (85.11%)
         occurrences all number
    68
    Administration site swelling
         subjects affected / exposed [6]
    16 / 47 (34.04%)
         occurrences all number
    25
    Administration site erythema
         subjects affected / exposed [7]
    14 / 47 (29.79%)
         occurrences all number
    22
    Pyrexia
         subjects affected / exposed [8]
    6 / 47 (12.77%)
         occurrences all number
    9
    Peripheral swelling
         subjects affected / exposed [9]
    1 / 47 (2.13%)
         occurrences all number
    1
    Injection site pruritus
         subjects affected / exposed [10]
    1 / 47 (2.13%)
         occurrences all number
    1
    Eye disorders
    Blindness
         subjects affected / exposed [11]
    1 / 47 (2.13%)
         occurrences all number
    1
    Visual impairment
         subjects affected / exposed [12]
    1 / 47 (2.13%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed [13]
    1 / 47 (2.13%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed [14]
    16 / 47 (34.04%)
         occurrences all number
    21
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed [15]
    1 / 47 (2.13%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed [16]
    26 / 47 (55.32%)
         occurrences all number
    41
    Infections and infestations
    COVID-19
         subjects affected / exposed [17]
    3 / 47 (6.38%)
         occurrences all number
    3
    Onychomycosis
         subjects affected / exposed [18]
    1 / 47 (2.13%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed [19]
    1 / 47 (2.13%)
         occurrences all number
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: In this study, only revaccinated participants from the Exposed Set had their events in the Non-SAEs module assessed, and non-SAEs were not assessed in non-revaccinated participants.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2020
    The purpose of the amendment was to: • Outline measures to be applied during special circumstances (e.g., COVID-19 pandemic), to protect participant’s welfare and safety, and, as far as possible, to ensure the potential benefit to the participant and promote study integrity. • Define study procedures/assessments to allow participation of non-revaccinated participants in an extended long-term follow-up phase.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Mar 2020
    The trial was put on temporary global enrollment hold due to COVID-19 restrictions. Delayed enrollees were enrolled at Visit 2 and hence missed their Visit 1 blood draw.
    07 Oct 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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