Herpes Zoster
Conditions
Brief summary
The purpose of this study was to evaluate the long-term immune responses to the Herpes Zoster subunit (HZ/su) vaccine as well as safety up to 7 years after the 2-dose primary vaccination course from study ZOSTER-041 (NCT02058589). This study also assessed immune responses as well as safety after revaccination with 2 additional doses of the HZ/su administered at 6 to 8 years after the 2-dose primary vaccination course.
Interventions
BIOLOGICALHZ/su vaccine (GSK1437173A)
2 intramuscular (IM) revaccination doses of the HZ/su vaccine administered - first dose at Month 24 and second dose at Month 25.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria for enrolment * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and subjects' Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * Written informed consent obtained from the subject/LAR(s) of the subject prior to performance of any study-specific procedure. * Subjects who previously participated in study ZOSTER-041 and completed the full 2 dose HZ/su primary vaccination course. * Inclusion criteria for revaccination * Subjects receiving maintenance CIS therapy for the prevention of allograft rejection for a minimum of one month prior to the first revaccination. * Subjects without an episode of allograft rejection within 90 days prior to the first revaccination visit. * Female subjects of non-childbearing potential may be revaccinated. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * Female subjects of childbearing potential may be revaccinated, if the subject: * has practiced adequate contraception for 30 days prior to revaccination, and * has a negative pregnancy test on the day of revaccination, and * has agreed to continue adequate contraception up to 2 months after completion of the revaccination series.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study | At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study | 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). |
| Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | 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 | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | From Month 13 (last visit) in ZOSTER-041 study until Day 1 (first visit) in the current ZOSTER-073 study | 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. |
| Number of Participants With Confirmed HZ Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | From Day 1 until Month 24 in the current ZOSTER-073 study | A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. |
| Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | From Month 13 (last visit) in ZOSTER-041 study until Day 1 (first visit) in the current ZOSTER-073 study | 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). |
| Number of Participants With Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | From Day 1 until Month 24 in the current ZOSTER-073 study | Biopsy-proven allograft rejection is defined as an adverse event of specific interest (AESI). |
| Number of Participants With Allograft Dysfunction Related to Allograft Rejection Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study | 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). |
| Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study | 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). |
| Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | 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 | 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. |
| Anti-gE Antibody Concentrations, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study | At Month 37 (12 months post-revaccination Dose 2) and Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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. |
| Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study | At Month 37 (12 months post-revaccination Dose 2) and Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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. |
| 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 | 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 | 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. |
| Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | 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 | 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. |
| Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study | 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 \[CD4(2+) T-cells/million cells\]. |
| Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | 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 | 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. |
| 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 | Within 30 days (across revaccination doses) post-revaccination period in the current ZOSTER-073 study | 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. |
| 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 | From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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. |
| Number of Participants With Related SAEs and Related-fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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. |
| 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 | From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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. |
| 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 | From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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. |
| Number of Participants With Confirmed HZ Cases, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study | From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study | A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. |
| Number of Participants With Allograft Dysfunction Following Revaccination, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study | From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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). |
| 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 | From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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). |
| 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 | From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study | 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). |
| 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 | 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 | Assessed solicited systemic events included fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[temperature higher than or equal (\>=) to 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F)\]. 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 higher (\>) than 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. |
| 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 | From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study | 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. |
Countries
Belgium, Canada, Finland, Panama, South Korea, Spain, Taiwan
Participant flow
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 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.
Participants by arm
| Arm | Count |
|---|---|
| HZ/su Group 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. | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event Requiring Expedited Reporting | 7 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Migrated / Moved From The Study Area | 1 |
| Overall Study | Unspecified reason | 4 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | HZ/su Group |
|---|---|
| Age, Continuous | 58.5 Years STANDARD_DEVIATION 12.3 |
| Race/Ethnicity, Customized ASIAN | 14 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 3 Participants |
| Race/Ethnicity, Customized OTHER - UNSPECIFIED | 5 Participants |
| Race/Ethnicity, Customized WHITE | 46 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 68 |
| other Total, other adverse events | 43 / 47 |
| serious Total, serious adverse events | 23 / 68 |
Outcome results
Primary
Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HZ/su Group | Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | At Month 24 | 2828.5 mIU/mL |
| HZ/su Group | Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | At Month 25 | 27655.5 mIU/mL |
| HZ/su Group | Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | At Month 26 | 31517.0 mIU/mL |
Primary
Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study
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).
Time frame: At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HZ/su Group | Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study | At Day 1 | 3729.8 mIU/mL |
| HZ/su Group | Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study | At Month 12 | 3440.2 mIU/mL |
| HZ/su Group | Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study | At Month 24 | 3075.8 mIU/mL |
Secondary
Anti-gE Antibody Concentrations, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
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.
Time frame: At Month 37 (12 months post-revaccination Dose 2) and Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HZ/su Group | Anti-gE Antibody Concentrations, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study | At Month 37 | 23989.4 mIU/mL |
| HZ/su Group | Anti-gE Antibody Concentrations, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study | At Month 49 | 9985.8 mIU/mL |
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
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HZ/su Group | Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Erythema, after revaccination Dose 1 | 4.0 Days |
| HZ/su Group | Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Pain, after revaccination Dose 1 | 3.0 Days |
| HZ/su Group | Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Swelling, after revaccination Dose 1 | 3.0 Days |
| HZ/su Group | Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Pain, after revaccination Dose 2 | 2.0 Days |
| HZ/su Group | Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Swelling, after revaccination Dose 2 | 2.5 Days |
| HZ/su Group | Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Erythema, after revaccination Dose 2 | 3.0 Days |
Secondary
Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Fatigue, after revaccination Dose 1 | 3.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Gastrointestinal symptoms, after revaccination Dose 1 | 2.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Headache, after revaccination Dose 1 | 2.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Myalgia, after revaccination Dose 1 | 2.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Shivering, after revaccination Dose 1 | 1.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Fatigue, after revaccination Dose 2 | 2.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Gastrointestinal symptoms, after revaccination Dose 2 | 1.5 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Headache, after revaccination Dose 2 | 2.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Myalgia, after revaccination Dose 2 | 2.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Shivering, after revaccination Dose 2 | 2.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Fever, after revaccination Dose 2 | 1.0 Days |
| HZ/su Group | Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Fever, after revaccination Dose 1 | 1.5 Days |
Secondary
Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HZ/su Group | Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | At Month 24 | 793.5 CD4(2+) T-cells/million cells |
| HZ/su Group | Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | At Month 25 | 4476.2 CD4(2+) T-cells/million cells |
| HZ/su Group | Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | At Month 26 | 3747.3 CD4(2+) T-cells/million cells |
Secondary
Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study
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.
Time frame: At Month 37 (12 months post-revaccination Dose 2) and Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HZ/su Group | Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study | At Month 37 | 1777.4 CD4(2+) T-cells/million cells |
| HZ/su Group | Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study | At Month 49 | 1144.9 CD4(2+) T-cells/million cells |
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
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 \[CD4(2+) T-cells/million cells\].
Time frame: At Day 1, Month 12 and Month 24 (pre-revaccination) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HZ/su Group | Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | At Day 1 | 608.9 CD4(2+) T-cells/million cells |
| HZ/su Group | Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | At Month 12 | 299.4 CD4(2+) T-cells/million cells |
| HZ/su Group | Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | At Month 24 | 711.0 CD4(2+) T-cells/million cells |
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
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).
Time frame: From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | Number of Participants With Allograft Dysfunction Following Revaccination, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study | 4 Participants |
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
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).
Time frame: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | 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 | 0 Participants |
Secondary
Number of Participants With Allograft Dysfunction Related to Allograft Rejection Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
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).
Time frame: From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | Number of Participants With Allograft Dysfunction Related to Allograft Rejection Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | 0 Participants |
Secondary
Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
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).
Time frame: From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | 0 Participants |
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
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).
Time frame: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | 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 | 0 Participants |
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
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | 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 | Any Erythema, after revaccination Dose 1 | 9 Participants |
| HZ/su Group | 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 | Grade 3 Erythema, after revaccination Dose 1 | 0 Participants |
| HZ/su Group | 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 | Any Erythema, after revaccination Dose 2 | 6 Participants |
| HZ/su Group | 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 | Grade 3 Erythema, after revaccination Dose 2 | 0 Participants |
| HZ/su Group | 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 | Any Pain, after revaccination Dose 1 | 37 Participants |
| HZ/su Group | 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 | Grade 3 Pain, after revaccination Dose 1 | 7 Participants |
| HZ/su Group | 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 | Any Pain, after revaccination Dose 2 | 31 Participants |
| HZ/su Group | 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 | Grade 3 Pain, after revaccination Dose 2 | 2 Participants |
| HZ/su Group | 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 | Any Swelling, after revaccination Dose 1 | 7 Participants |
| HZ/su Group | 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 | Grade 3 Swelling, after revaccination Dose 1 | 0 Participants |
| HZ/su Group | 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 | Any Swelling, after revaccination Dose 2 | 4 Participants |
| HZ/su Group | 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 | Grade 3 Swelling, after revaccination Dose 2 | 0 Participants |
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
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.
Time frame: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | 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 | Any biopsy-proven allograft rejection | 1 Participants |
| HZ/su Group | 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 | Related biopsy-proven allograft rejection | 0 Participants |
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
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.
Time frame: From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | 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 | Any pIMD(s) | 1 Participants |
| HZ/su Group | 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 | Related pIMD(s) | 0 Participants |
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
Assessed solicited systemic events included fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[temperature higher than or equal (\>=) to 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F)\]. 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 higher (\>) than 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | 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 | Any Fatigue, after revaccination Dose 1 | 26 Participants |
| HZ/su Group | 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 | Grade 3 Fatigue, after revaccination Dose 1 | 2 Participants |
| HZ/su Group | 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 | Related Fatigue, after revaccination Dose 1 | 22 Participants |
| HZ/su Group | 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 | Any Fatigue, after revaccination Dose 2 | 23 Participants |
| HZ/su Group | 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 | Grade 3 Fatigue, after revaccination Dose 2 | 2 Participants |
| HZ/su Group | 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 | Related Fatigue, after revaccination Dose 2 | 21 Participants |
| HZ/su Group | 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 | Any Gastrointestinal symptoms, after revaccination Dose 1 | 11 Participants |
| HZ/su Group | 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 | Grade 3 Gastrointestinal symptoms, after revaccination Dose 1 | 0 Participants |
| HZ/su Group | 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 | Related Gastrointestinal symptoms, after revaccination Dose 1 | 10 Participants |
| HZ/su Group | 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 | Any Gastrointestinal symptoms, after revaccination Dose 2 | 10 Participants |
| HZ/su Group | 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 | Grade 3 Gastrointestinal symptoms, after revaccination Dose 2 | 1 Participants |
| HZ/su Group | 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 | Related Gastrointestinal symptoms, after revaccination Dose 2 | 9 Participants |
| HZ/su Group | 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 | Any Headache, after revaccination Dose 1 | 22 Participants |
| HZ/su Group | 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 | Grade 3 Headache, after revaccination Dose 1 | 3 Participants |
| HZ/su Group | 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 | Related Headache, after revaccination Dose 1 | 19 Participants |
| HZ/su Group | 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 | Any Headache, after revaccination Dose 2 | 16 Participants |
| HZ/su Group | 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 | Grade 3 Headache, after revaccination Dose 2 | 0 Participants |
| HZ/su Group | 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 | Related Headache, after revaccination Dose 2 | 16 Participants |
| HZ/su Group | 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 | Any Myalgia, after revaccination Dose 1 | 21 Participants |
| HZ/su Group | 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 | Grade 3 Myalgia, after revaccination Dose 1 | 1 Participants |
| HZ/su Group | 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 | Related Myalgia, after revaccination Dose 1 | 17 Participants |
| HZ/su Group | 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 | Any Myalgia, after revaccination Dose 2 | 19 Participants |
| HZ/su Group | 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 | Grade 3 Myalgia, after revaccination Dose 2 | 1 Participants |
| HZ/su Group | 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 | Related Myalgia, after revaccination Dose 2 | 16 Participants |
| HZ/su Group | 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 | Any Shivering, after revaccination Dose 1 | 15 Participants |
| HZ/su Group | 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 | Grade 3 Shivering, after revaccination Dose 1 | 3 Participants |
| HZ/su Group | 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 | Related Shivering, after revaccination Dose 1 | 13 Participants |
| HZ/su Group | 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 | Any Shivering, after revaccination Dose 2 | 10 Participants |
| HZ/su Group | 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 | Grade 3 Shivering, after revaccination Dose 2 | 1 Participants |
| HZ/su Group | 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 | Related Shivering, after revaccination Dose 2 | 9 Participants |
| HZ/su Group | 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 | Any Fever, after revaccination Dose 1 | 4 Participants |
| HZ/su Group | 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 | Grade 3 Fever, after revaccination Dose 1 | 1 Participants |
| HZ/su Group | 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 | Related Fever, after revaccination Dose 1 | 4 Participants |
| HZ/su Group | 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 | Any Fever, after revaccination Dose 2 | 4 Participants |
| HZ/su Group | 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 | Grade 3 Fever, after revaccination Dose 2 | 1 Participants |
| HZ/su Group | 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 | Related Fever, after revaccination Dose 2 | 4 Participants |
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
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.
Time frame: Within 30 days (across revaccination doses) post-revaccination period in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | 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 | Related unsolicited AE(s) | 2 Participants |
| HZ/su Group | 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 | Any unsolicited AE(s) | 12 Participants |
| HZ/su Group | 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 | Grade 3 unsolicited AE(s) | 3 Participants |
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
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.
Time frame: From Month 24 (pre-revaccination) until Month 37 (12 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | 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 | Any SAE(s) | 9 Participants |
| HZ/su Group | 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 | Fatal SAE(s) | 1 Participants |
Secondary
Number of Participants With Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
Biopsy-proven allograft rejection is defined as an adverse event of specific interest (AESI).
Time frame: From Day 1 until Month 24 in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | Number of Participants With Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | 2 Participants |
Secondary
Number of Participants With Confirmed HZ Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination.
Time frame: From Day 1 until Month 24 in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | Number of Participants With Confirmed HZ Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | 3 Participants |
Secondary
Number of Participants With Confirmed HZ Cases, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study
A confirmed HZ case was diagnosed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination.
Time frame: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | Number of Participants With Confirmed HZ Cases, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study | 0 Participants |
Secondary
Number of Participants With Related SAEs and Related-fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study
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.
Time frame: From Month 24 (pre-revaccination) until Month 49 (24 months post-revaccination Dose 2) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | Number of Participants With Related SAEs and Related-fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Related SAE(s) | 0 Participants |
| HZ/su Group | Number of Participants With Related SAEs and Related-fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study | Related-fatal SAE(s) | 0 Participants |
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
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.
Time frame: From Month 13 (last visit) in ZOSTER-041 study until Month 24 in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HZ/su Group | 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 | 0 Participants |
Secondary
Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
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).
Time frame: From Month 13 (last visit) in ZOSTER-041 study until Day 1 (first visit) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | Biopsy-proven allograft rejection | 0 Participants |
| HZ/su Group | Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | Biopsy for clinical indication (suspected) or surveillance protocol | 5 Participants |
Secondary
Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study
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.
Time frame: From Month 13 (last visit) in ZOSTER-041 study until Day 1 (first visit) in the current ZOSTER-073 study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HZ/su Group | Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | Confirmed HZ case | 0 Participants |
| HZ/su Group | Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study | Suspected HZ case | 3 Participants |