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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001778-17 | EudraCT Number |
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The purpose of this study was a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses in two subgroups of older adults.
This is the long-term follow-up study (ZOE-LTFU) of studies 110390 and 113077 (ZOSTER-006/022) to assess the prophylactic efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses on a 0 or 0, 2-month schedule in two subgroups of older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTFU Group | No Intervention | Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety. | |
| 1-Additional Dose Group | Experimental | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study. |
|
| Revaccination Group | Experimental | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study. |
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| Control Group | No Intervention | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes Zoster Vaccine GSK1437173A | Biological | Intramuscular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Having at Least One Confirmed Herpes Zoster (HZ) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) and/or by HZ Ascertainment Committee (HZAC) determination, as per the algorithm pre-specified in the protocol. As pre-specified in the protocol:
| During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Having at Least One Confirmed HZ Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, by Age Ranges | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR and/or by the HZAC determination, as per the algorithm pre-specified in the protocol. The age ranges assessed were: 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. |
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Inclusion Criteria:
Additional inclusion criteria for the 1-Additional Dose Revaccination and Control groups, ONLY:
Female subjects of non-childbearing potential may be enrolled in this study.
Female subjects of childbearing potential may be enrolled in this study, if the subject:
Exclusion Criteria:
Additional exclusion criteria for the 1-Additional Dose Revaccination and Control groups, only:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 29651 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40630610 | Background | Strezova A, Diez Domingo J, Cunningham AL, Eto T, Andrews C, Arns C, Choo EJ, Hui DSC, Icardi G, McNeil SA, Poder A, Kosina P, Rombo L, Schwarz TF, Tinoco JC, Yu CJ, Wang J, Soni J, Tsang M, Leon R, Mwakingwe-Omari A; Zoster-049 Study Group. Final analysis of the ZOE-LTFU trial to 11 years post-vaccination: efficacy of the adjuvanted recombinant zoster vaccine against herpes zoster and related complications. EClinicalMedicine. 2025 May 9;83:103241. doi: 10.1016/j.eclinm.2025.103241. eCollection 2025 May. | |
| 42245229 |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Out of the 7534 participants enrolled in the current ZOSTER-049 EXT:006-022 study, 5 participants originally enrolled in the Long-term follow-up (LTFU) group were eliminated due to data modification post-investigator signature, and hence 7529 participants were included in the Total Vaccinated Cohort and started the study.
Potentially eligible participants who participated and received at least one dose of the HZ/su vaccine in the ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies were contacted and considered for entry in the current ZOSTER-049:EXT 006-022 (NCT02723773) study.
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| ID | Title | Description |
|---|---|---|
| FG000 | LTFU Group | Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety. |
| FG001 | 1-Additional Dose Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2020 | Aug 20, 2024 |
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| During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) |
| Number of Participants Having at Least One Confirmed HZ Case From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR and/or by the HZAC determination, as per the algorithm pre-specified in the protocol. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. As pre-specified in the protocol: - participants from the Placebo groups in the ZOSTER-006/022 studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined in the Placebo/Historical control group. | From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years |
| Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR and/or by the HZAC determination, as per the algorithm pre-specified in the protocol. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. Confirmed HZ cases data was not collected for the participants included in the HZ/su and Placebo/Historical control groups during Year 5, as this was a gap year between end of ZOSTER-006/-022 studies and start of ZOSTER-049:EXT-006-022 study. Results from the ZOSTER-006/022 studies were pooled for each year after vaccination with methods used in these studies. For overlapping years between ZOSTER-006/022 studies and this study, all the data were pooled. For the non-overlapping years only the data from ZOSTER-049:EXT 006-022 study was used. | Over the follow-up years (Year 1, Year 2, Year 3, Year 4, Year 6, Year 7, Year 8, Year 9, Year 10 and Year 11) from one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72) |
| Number of Participants Having at Least One Post-herpetic Neuralgia (PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | PHN is defined by the presence of HZ-associated severe worst pain persisting or appearing more than 90 days after onset of the HZ rash. Severe worst pain is defined as HZ-associated pain rated as 3 or greater on the worst pain question on the Zoster Brief Pain Inventory (ZBPI) questionnaire. The ZBPI questionnaire uses a 0 to 10 point numeric and visual intensity scale, in which 0 represents the minimum value and 10 the maximum value on the scale. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) |
| Number of Participants Having at Least One PHN Case From One Month Post-Dose 2 in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | PHN is defined by the presence of HZ-associated severe worst pain persisting or appearing more than 90 days after onset of the HZ rash. Severe worst pain is defined as HZ-associated pain rated as 3 or greater on the worst pain question on the Zoster Brief Pain Inventory (ZBPI) questionnaire. The ZBPI questionnaire uses a 0 to 10 point numeric and visual intensity scale, in which 0 represents the minimum value and 10 the maximum value on the scale. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years |
| Number of Participants Having at Least One HZ Related Complications (Other Than PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | HZ complications include HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke. If a recorded complication was associated with a case of suspected HZ, and that case was finally not considered to be a confirmed case, the associated complication would not be considered as a complication of HZ. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) |
| Number of Participants Having at Least One HZ Related Complications (Other Than PHN) Case From One Month Post-dose 2 (Month 3) in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | HZ complications include HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke. If a recorded complication was associated with a case of suspected HZ, and that case was finally not considered to be a confirmed case, the associated complication would not be considered as a complication of HZ. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years |
| Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group | Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies |
| Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group | Frequency of CD4 (2+) T-cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to gE was determined by Intracellular Cytokine Staining (ICS) and expressed in CD4 (2+) T-cells/million cells. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies |
| Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies |
| Frequency of Antigen-specific CD4 (2+) T-cells for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9 and 10 After the Primary Vaccination in ZOSTER-006/022 Studies | Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells. | At Years 5, 6, 7, 8, 9, and 10 after the primary vaccination in ZOSTER-006/022 studies |
| Anti-gE Antibody Concentrations for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | At Month 1 in the current ZOSTER-049:EXT 006-022 study |
| Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study | Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells. | At Month 1 in the current ZOSTER-049:EXT 006-022 study |
| Anti-gE Antibody Concentrations for Revaccination and Control Groups at Month 3 in the Current ZOSTER-049:EXT 006-022 Study | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | At Month 3 in the current ZOSTER-049:EXT 006-022 study |
| Frequency of Antigen-specific CD4 (2+) T-cells for Revaccination and Control Groups at Month 3 in the Current ZOSTER-049:EXT 006-022 Study | Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells. | At Month 3 in the current ZOSTER-049:EXT 006-022 study |
| Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | At Month 0 and Years 1, 2, 3, 4, 5 and 6 in the current ZOSTER-049:EXT 006-022 study |
| Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study | Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells. | At Month 0 and Years 1, 2, 3, 4, 5 and 6 in the current ZOSTER-049:EXT 006-022 study |
| Number of Participants With Any and Grade 3 Solicited Local Symptoms | The assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
| Duration in Days of Solicited Local Symptoms | Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. The assessed solicited local symptoms included pain, redness and swelling. | Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
| Number of Participants With Any, Grade 3 and Related Solicited General Symptoms | The assessed solicited general symptoms included fatigue, fever [defined as oral temperature >=37.5 degrees Celsius (°C)], gastrointestinal symptoms, headache, myalgia, and shivering. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever >39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
| Duration in Days of Solicited General Symptoms | Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. The assessed solicited general symptoms included fatigue, fever [defined as oral temperature >=37.5°C], gastrointestinal symptoms, headache, myalgia, and shivering. | Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
| Number of Participants With Any Unsolicited Adverse Events (AEs) | An unsolicited AE is defined as any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Within 30 days after any vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
| Number of Participants With Any and Related Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of intensity or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to vaccination. | From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month 0 until 12 months after last HZ/su vaccination (Revaccination group) |
| Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine | An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant. | During the total duration of ZOSTER-049:EXT 006-022 study (from Month 0 to Month 72) |
| Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs) | pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any pIMDs = occurrence of a pIMD regardless of relation to vaccination. Related pIMD = a pIMD assessed by the investigator as related to the study vaccination. | From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month until 12 months after last HZ/su vaccination (Revaccination group) |
| Phoenix |
| Arizona |
| 84123 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85018 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85020 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85306 | United States |
| GSK Investigational Site | Spring Valley | California | 91978 | United States |
| GSK Investigational Site | Hallandale | Florida | 85213 | United States |
| GSK Investigational Site | Boise | Idaho | 83712 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Columbia | Maryland | 21045 | United States |
| GSK Investigational Site | Elkridge | Maryland | 21075 | United States |
| GSK Investigational Site | Cary | North Carolina | 27518 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Hickory | North Carolina | 28601 | United States |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28412 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44122 | United States |
| GSK Investigational Site | Wadsworth | Ohio | 44281 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Uniontown | Pennsylvania | 15401 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Bristol | Tennessee | 37620 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Newport News | Virginia | 23606 | United States |
| GSK Investigational Site | Westmead | New South Wales | 2145 | Australia |
| GSK Investigational Site | Wollongong | New South Wales | 2522 | Australia |
| GSK Investigational Site | Geelong | Victoria | 3220 | Australia |
| GSK Investigational Site | Belo Horizonte | 30150-320 | Brazil |
| GSK Investigational Site | Curitiba | 80069-900 | Brazil |
| GSK Investigational Site | CuritibaPR | 80240-000 | Brazil |
| GSK Investigational Site | São Paulo | 04266-010 | Brazil |
| GSK Investigational Site | São Paulo | 04312903 | Brazil |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| GSK Investigational Site | Victoria | British Columbia | V8V 3M9 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 6R8 | Canada |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4S 1Y2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Woodstock | Ontario | N4V 0E1 | Canada |
| GSK Investigational Site | Gatineau | Quebec | J8Y1W2 | Canada |
| GSK Investigational Site | Montreal | Quebec | J7J 2K8 | Canada |
| GSK Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Québec | Quebec | G1E 7G9 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1J 2G2 | Canada |
| GSK Investigational Site | Brno | 612 00 | Czechia |
| GSK Investigational Site | České Budějovice | 370 05 | Czechia |
| GSK Investigational Site | Hradec Králové | 500 05 | Czechia |
| GSK Investigational Site | Tallinn | 13619 | Estonia |
| GSK Investigational Site | Tartu | 50106 | Estonia |
| GSK Investigational Site | Espoo | 02230 | Finland |
| GSK Investigational Site | Helsinki | 00100 | Finland |
| GSK Investigational Site | Helsinki | 00930 | Finland |
| GSK Investigational Site | Jarvenpaa | 04400 | Finland |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Oulu | 90220 | Finland |
| GSK Investigational Site | Pori | 28100 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Angers | 49000 | France |
| GSK Investigational Site | Angers | 49100 | France |
| GSK Investigational Site | Château-Gontier | 53200 | France |
| GSK Investigational Site | Clermont-Ferrand | 63003 | France |
| GSK Investigational Site | Laval | 53000 | France |
| GSK Investigational Site | Montrevault | 49110 | France |
| GSK Investigational Site | Muret | 31600 | France |
| GSK Investigational Site | Mûrs-Erigné | 49610 | France |
| GSK Investigational Site | Nantes | 44300 | France |
| GSK Investigational Site | Rosiers-d'Égletons | 19300 | France |
| GSK Investigational Site | Segré | 49500 | France |
| GSK Investigational Site | Tours | 37100 | France |
| GSK Investigational Site | Berlin | 10629 | Germany |
| GSK Investigational Site | Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | 13347 | Germany |
| GSK Investigational Site | Cologne | 51069 | Germany |
| GSK Investigational Site | Dachau | 85221 | Germany |
| GSK Investigational Site | Dresden | 01097 | Germany |
| GSK Investigational Site | Essen | 45355 | Germany |
| GSK Investigational Site | Essen | 45359 | Germany |
| GSK Investigational Site | Flörsheim | 65439 | Germany |
| GSK Investigational Site | Freiberg | 09599 | Germany |
| GSK Investigational Site | Goch | 47574 | Germany |
| GSK Investigational Site | Güglingen | 74363 | Germany |
| GSK Investigational Site | Hamburg | 20251 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | Hamburg | 22415 | Germany |
| GSK Investigational Site | Köthen | 06366 | Germany |
| GSK Investigational Site | Künzing | 94550 | Germany |
| GSK Investigational Site | Leipzig | 04315 | Germany |
| GSK Investigational Site | Lübeck | 23554 | Germany |
| GSK Investigational Site | Magdeburg | 39112 | Germany |
| GSK Investigational Site | Mainz | 55116 | Germany |
| GSK Investigational Site | Mannheim | 68161 | Germany |
| GSK Investigational Site | München | 80339 | Germany |
| GSK Investigational Site | Rednitzhembach | 91126 | Germany |
| GSK Investigational Site | Rhaunen | 55624 | Germany |
| GSK Investigational Site | Tübingen | 72074 | Germany |
| GSK Investigational Site | Wallerfing | 94574 | Germany |
| GSK Investigational Site | Wangen | 88239 | Germany |
| GSK Investigational Site | Weinheim | 69469 | Germany |
| GSK Investigational Site | Witten | 58455 | Germany |
| GSK Investigational Site | Würzburg | 97070 | Germany |
| GSK Investigational Site | Kwun Tong Kowloon | Hong Kong |
| GSK Investigational Site | Shatin | 000000 | Hong Kong |
| GSK Investigational Site | Chieti | 66013 | Italy |
| GSK Investigational Site | Genova | 16132 | Italy |
| GSK Investigational Site | Monza MB | 20900 | Italy |
| GSK Investigational Site | Roma | 00163 | Italy |
| GSK Investigational Site | Sassari | 07100 | Italy |
| GSK Investigational Site | Fukuoka | 810-0021 | Japan |
| GSK Investigational Site | Fukuoka | 812-0025 | Japan |
| GSK Investigational Site | Fukuoka | 813-8588 | Japan |
| GSK Investigational Site | Fukuoka | 816-0864 | Japan |
| GSK Investigational Site | Kanagawa | 224-8503 | Japan |
| GSK Investigational Site | Kanagawa | 247-8533 | Japan |
| GSK Investigational Site | Tokyo | 142-0054 | Japan |
| GSK Investigational Site | Tokyo | 142-8666 | Japan |
| GSK Investigational Site | Tokyo | 154-0024 | Japan |
| GSK Investigational Site | Durango | 34000 | Mexico |
| GSK Investigational Site | Zapopan Jalisco | 45190 | Mexico |
| GSK Investigational Site | Ansan | 425-707 | South Korea |
| GSK Investigational Site | Bucheon-si Kyunggi-do 14584 | 420-767 | South Korea |
| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Kangwon-do | 220-701 | South Korea |
| GSK Investigational Site | Seoul | 150-950 | South Korea |
| GSK Investigational Site | Seoul | 152-703 | South Korea |
| GSK Investigational Site | Alcover Tarragona | 43460 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08430 | Spain |
| GSK Investigational Site | Barcelona | 08540 | Spain |
| GSK Investigational Site | Barcelona | 28500 | Spain |
| GSK Investigational Site | Hostalets de Balenya Ba | 08550 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Madrid | 28222 | Spain |
| GSK Investigational Site | Peralada Girona | 17491 | Spain |
| GSK Investigational Site | Valencia | 46020 | Spain |
| GSK Investigational Site | Borås | SE-506 30 | Sweden |
| GSK Investigational Site | Eskilstuna | SE-631 88 | Sweden |
| GSK Investigational Site | Gothenburg | SE-413 45 | Sweden |
| GSK Investigational Site | Jönköping | SE-551 85 | Sweden |
| GSK Investigational Site | Karlskrona | SE-371 79 | Sweden |
| GSK Investigational Site | Linköping | SE-58758 | Sweden |
| GSK Investigational Site | Malmö | SE-211 52 | Sweden |
| GSK Investigational Site | Örebro | SE-703 62 | Sweden |
| GSK Investigational Site | Stockholm | 11446 | Sweden |
| GSK Investigational Site | Uppsala | SE-751 85 | Sweden |
| GSK Investigational Site | Vällingby | SE-194 61 | Sweden |
| GSK Investigational Site | Taichung | 40447 | Taiwan |
| GSK Investigational Site | Taipei | 10002 | Taiwan |
| GSK Investigational Site | Taipei | 112 | Taiwan |
| GSK Investigational Site | Tau-Yuan | 333 | Taiwan |
| GSK Investigational Site | Atherstone Warwickshire | CV9 1EU | United Kingdom |
| GSK Investigational Site | Belfast | BT7 2EB | United Kingdom |
| GSK Investigational Site | Bradford on Avon Wiltsh | BA15 1DQ | United Kingdom |
| GSK Investigational Site | Broughshane | BT42 4JP | United Kingdom |
| GSK Investigational Site | Chorley | PR7 7NA | United Kingdom |
| GSK Investigational Site | Liverpool | L22 0LG | United Kingdom |
| Derived |
| Leon R, Diez-Domingo J, Andrews C, Arns da Cunha C, Choo EJ, Hui DSC, Cunningham AL, Eto T, Icardi G, McNeil SA, Poder A, Kosina P, Rombo L, Schwarz TF, Tinoco JC, Yu CJ, Wang J, Soni J, Tsang M, Strezova A, Salaun B, Mwakingwe-Omari A. Safety and Immunogenicity of 1 or 2 Additional Doses of the Adjuvanted Recombinant Zoster Vaccine Administered 5-6 Years After Primary Vaccination in Adults >/=50 Years. Open Forum Infect Dis. 2026 May 4;13(6):ofag282. doi: 10.1093/ofid/ofag282. eCollection 2026 Jun. |
| 40399558 | Derived | Giannelos N, Curran D, Matthews S, Carrico J, Cunningham AL. The Potential Impact of Increased Recombinant Zoster Vaccine Uptake in Older Adults Worldwide. Infect Dis Ther. 2025 Jun;14(6):1327-1341. doi: 10.1007/s40121-025-01161-y. Epub 2025 May 21. |
| 34283213 | Derived | Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu CJ, Andrews C, Beytout J, Caso C, Cheng HS, Cheong HJ, Choo EJ, Curiac D, Di Paolo E, Dionne M, Eckermann T, Esen M, Ferguson M, Ghesquiere W, Hwang SJ, Avelino-Silva TJ, Kosina P, Liu CS, Markkula J, Moeckesch B, Murta de Oliveira C, Park DW, Pauksens K, Pirrotta P, Plassmann G, Pretswell C, Rombo L, Salaun B, Sanmartin Berglund J, Schenkenberger I, Schwarz T, Shi M, Ukkonen B, Zahaf T, Zerbini C, Schuind A, Cunningham AL; Zoster-049 Study Group. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70. Clin Infect Dis. 2022 Apr 28;74(8):1459-1467. doi: 10.1093/cid/ciab629. |
Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study. |
| FG002 | Revaccination Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study. |
| FG003 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LTFU Group | Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety. |
| BG001 | 1-Additional Dose Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study. |
| BG002 | Revaccination Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study. |
| BG003 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Having at Least One Confirmed Herpes Zoster (HZ) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) and/or by HZ Ascertainment Committee (HZAC) determination, as per the algorithm pre-specified in the protocol. As pre-specified in the protocol:
| The analysis was performed on the Modified Total Vaccinated cohort (mTVC) - LTFU+Control group, which included all participants in the LTFU and Control groups combined, with efficacy data available for the specified analysis during the specified period, minus those participants who were not administered with the second vaccination during the ZOSTER-006/022 studies, or who developed a confirmed case of HZ prior to 1 month after the second vaccination in the ZOSTER-006/022 studies. | Posted | Count of Participants | Participants | During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) |
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| Secondary | Number of Participants Having at Least One Confirmed HZ Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, by Age Ranges | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR and/or by the HZAC determination, as per the algorithm pre-specified in the protocol. The age ranges assessed were: 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | The analysis was performed on the mTVC - LTFU+Control group, which included all participants in the LTFU and Control groups combined, with efficacy data available for the specified analysis and age ranges during the specified period, minus those participants who were not administered with the second vaccination during the ZOSTER-006/022 studies, or who developed a confirmed case of HZ prior to 1 month after the second vaccination in the ZOSTER-006/022 studies. | Posted | Count of Participants | Participants | During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) |
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| Secondary | Number of Participants Having at Least One Confirmed HZ Case From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR and/or by the HZAC determination, as per the algorithm pre-specified in the protocol. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. As pre-specified in the protocol: - participants from the Placebo groups in the ZOSTER-006/022 studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined in the Placebo/Historical control group. | The analysis was performed on the mTVC pooled, which included participants from the mTVC in ZOSTER-006/-022 studies and participants from the mTVC in ZOSTER-049:EXT 006-022 study with efficacy data available for the specified analysis and age ranges during the specified period. | Posted | Count of Participants | Participants | From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years |
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| Secondary | Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR and/or by the HZAC determination, as per the algorithm pre-specified in the protocol. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. Confirmed HZ cases data was not collected for the participants included in the HZ/su and Placebo/Historical control groups during Year 5, as this was a gap year between end of ZOSTER-006/-022 studies and start of ZOSTER-049:EXT-006-022 study. Results from the ZOSTER-006/022 studies were pooled for each year after vaccination with methods used in these studies. For overlapping years between ZOSTER-006/022 studies and this study, all the data were pooled. For the non-overlapping years only the data from ZOSTER-049:EXT 006-022 study was used. | The analysis was performed on the mTVC pooled, which included participants from the mTVC in ZOSTER-006/-022 studies and participants from the mTVC in ZOSTER-049:EXT 006-022 study with efficacy data available for the specified analysis and age ranges during the specified time points. | Posted | Count of Participants | Participants | Over the follow-up years (Year 1, Year 2, Year 3, Year 4, Year 6, Year 7, Year 8, Year 9, Year 10 and Year 11) from one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72) |
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| Secondary | Number of Participants Having at Least One Post-herpetic Neuralgia (PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | PHN is defined by the presence of HZ-associated severe worst pain persisting or appearing more than 90 days after onset of the HZ rash. Severe worst pain is defined as HZ-associated pain rated as 3 or greater on the worst pain question on the Zoster Brief Pain Inventory (ZBPI) questionnaire. The ZBPI questionnaire uses a 0 to 10 point numeric and visual intensity scale, in which 0 represents the minimum value and 10 the maximum value on the scale. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | The analysis was performed on the mTVC - LTFU+Control group, which included all participants in the LTFU and Control groups combined, with efficacy data available for the specified analysis and age ranges during the specified period, minus those participants who were not administered with the second vaccination during the ZOSTER-006/022 studies, or who developed a confirmed case of HZ prior to 1 month after the second vaccination in the ZOSTER-006/022 studies. | Posted | Count of Participants | Participants | During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) |
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| Secondary | Number of Participants Having at Least One PHN Case From One Month Post-Dose 2 in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | PHN is defined by the presence of HZ-associated severe worst pain persisting or appearing more than 90 days after onset of the HZ rash. Severe worst pain is defined as HZ-associated pain rated as 3 or greater on the worst pain question on the Zoster Brief Pain Inventory (ZBPI) questionnaire. The ZBPI questionnaire uses a 0 to 10 point numeric and visual intensity scale, in which 0 represents the minimum value and 10 the maximum value on the scale. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | The analysis was performed on the mTVC pooled, which included participants from the mTVC in ZOSTER-006/-022 studies and participants from the mTVC in ZOSTER-049:EXT 006-022 study with efficacy data available for the specified analysis and age ranges during the specified period. | Posted | Count of Participants | Participants | From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years |
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| Secondary | Number of Participants Having at Least One HZ Related Complications (Other Than PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | HZ complications include HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke. If a recorded complication was associated with a case of suspected HZ, and that case was finally not considered to be a confirmed case, the associated complication would not be considered as a complication of HZ. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | The analysis was performed on the mTVC - LTFU+Control group, which included all participants in the LTFU and Control groups combined, with efficacy data available for the specified analysis and age ranges during the specified period, minus those participants who were not administered with the second vaccination during the ZOSTER-006/022 studies, or who developed a confirmed case of HZ prior to 1 month after the second vaccination in the ZOSTER-006/022 studies. | Posted | Count of Participants | Participants | During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) |
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| Secondary | Number of Participants Having at Least One HZ Related Complications (Other Than PHN) Case From One Month Post-dose 2 (Month 3) in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges | HZ complications include HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke. If a recorded complication was associated with a case of suspected HZ, and that case was finally not considered to be a confirmed case, the associated complication would not be considered as a complication of HZ. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | The analysis was performed on the mTVC pooled, which included participants from the mTVC in ZOSTER-006/-022 studies and participants from the mTVC in ZOSTER-049:EXT 006-022 study with efficacy data available for the specified analysis and age ranges during the specified period. | Posted | Count of Participants | Participants | From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years |
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| Secondary | Anti-glycoprotein (gE) Antibody Concentrations for Humoral Immunity (HI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group | Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | The analysis was performed on a subset of participants from the Adapted ATP cohort for humoral persistence - LTFU, who were included in the immunogenicity subset during the ZOSTER-006/022 studies, continued participation in this study and had humoral persistence results available at the specified time points. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies |
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| Secondary | Frequency of Antigen-specific CD4 (2+) T-cells for Cell Mediated Immunity (CMI) Subset at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies, Overall and by Age Ranges in the LTFU Group | Frequency of CD4 (2+) T-cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to gE was determined by Intracellular Cytokine Staining (ICS) and expressed in CD4 (2+) T-cells/million cells. The age ranges assessed were: >=50 YOA (overall), 50-59 YOA, 60-69 YOA, >=60 YOA and >=70 YOA at time of primary vaccination in ZOSTER-006/022 studies. | The analysis was performed on a subset of participants from the Adapted ATP cohort for CMI persistence - LTFU, who were included in the CMI subset during ZOSTER-006/-022 studies, continued participation in this study and had CMI results available at the specified time points. | Posted | Mean | Standard Deviation | CD4 (2+) T-cells/million cells | At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies |
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| Secondary | Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | The analysis was performed on a HZ subset for HI, which included participants who developed confirmed HZ during ZOSTER-006 or ZOSTER-022 studies, or who developed HZ during the interval between the end of the ZOSTER-006/022 studies and the beginning of the current ZOSTER-049:EXT 006-022 study, or who developed suspected HZ during the current ZOSTER-049:EXT 006-022 study and with immunogenicity results available for the specified analysis at the specified time points. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in ZOSTER-006/022 studies |
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| Secondary | Frequency of Antigen-specific CD4 (2+) T-cells for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9 and 10 After the Primary Vaccination in ZOSTER-006/022 Studies | Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells. | The analysis was performed on a HZ subset for CMI, which included participants who developed confirmed HZ during ZOSTER-006 or ZOSTER-022 studies, or who developed HZ during the interval between the end of the ZOSTER-006/022 studies and the beginning of the current ZOSTER-049:EXT 006-022 study, or who developed suspected HZ during the current ZOSTER-049:EXT 006-022 study and with CMI results available for the specified analysis at the specified time points. | Posted | Mean | Standard Deviation | CD4 (2+) T-cells/million cells | At Years 5, 6, 7, 8, 9, and 10 after the primary vaccination in ZOSTER-006/022 studies |
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| Secondary | Anti-gE Antibody Concentrations for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment*, for whom administration site of study vaccine was known*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time point. *only applicable for the participants revaccinated in the current study. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 1 in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study | Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells. | Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment*, for whom administration site of study vaccine was known*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time point. *only applicable for the participants revaccinated in the current study. | Posted | Mean | Standard Deviation | CD4 (2+) T-cells/million cells | At Month 1 in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Anti-gE Antibody Concentrations for Revaccination and Control Groups at Month 3 in the Current ZOSTER-049:EXT 006-022 Study | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment*, for whom administration site of study vaccine was known*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time point. *only applicable for the participants revaccinated in the current study. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 3 in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Frequency of Antigen-specific CD4 (2+) T-cells for Revaccination and Control Groups at Month 3 in the Current ZOSTER-049:EXT 006-022 Study | Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells. | Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment*, for whom administration site of study vaccine was known*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time point. *only applicable for the participants revaccinated in the current study. | Posted | Mean | Standard Deviation | CD4 (2+) T-cells/million cells | At Month 3 in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment*, for whom administration site of study vaccine was known*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time points. *only applicable for the participants revaccinated in the current study. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 0 and Years 1, 2, 3, 4, 5 and 6 in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Frequency of Antigen-specific CD4(2+) T-cells for 1-Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study | Frequency of CD4 (2+) T-cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression to gE was determined by ICS and expressed in CD4 (2+) T-cells/million cells. | Adapted ATP cohort for immunogenicity included all participants who met all eligibility criteria, received all doses as per assignment*, for whom administration site of study vaccine was known*, who did not receive any other vaccine, who complied with the procedures defined in protocol, vaccination* and blood sample schedule and with immunogenicity data available for the specified analysis at the specified time points. *only applicable for the participants revaccinated in the current study. | Posted | Mean | Standard Deviation | CD4(2+) T-cells/million cells | At Month 0 and Years 1, 2, 3, 4, 5 and 6 in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Number of Participants With Any and Grade 3 Solicited Local Symptoms | The assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated Cohort (for 1-Additional Dose and Revaccination groups), which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study and who have documented solicited symptoms (i.e., diary card for solicited AEs completed and returned) after each vaccination. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Duration in Days of Solicited Local Symptoms | Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. The assessed solicited local symptoms included pain, redness and swelling. | The analysis was performed on the Total Vaccinated Cohort (for 1-Additional Dose and Revaccination groups), which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study, with diary data available after each vaccination and who experienced the specified solicited local symptom within 7 days following the respective vaccine dose. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Median | Inter-Quartile Range | Days | Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Number of Participants With Any, Grade 3 and Related Solicited General Symptoms | The assessed solicited general symptoms included fatigue, fever [defined as oral temperature >=37.5 degrees Celsius (°C)], gastrointestinal symptoms, headache, myalgia, and shivering. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever >39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort (for 1-Additional Dose and Revaccination groups), which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study and who have documented solicited symptoms (i.e., diary card for solicited AEs completed and returned) after each vaccination. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration in Days of Solicited General Symptoms | Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. The assessed solicited general symptoms included fatigue, fever [defined as oral temperature >=37.5°C], gastrointestinal symptoms, headache, myalgia, and shivering. | The analysis was performed on the Total Vaccinated Cohort (for 1-Additional Dose and Revaccination groups), which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study, with diary data available after each vaccination and who experienced the specified solicited general symptom within 7 days following the respective vaccine dose. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Median | Inter-Quartile Range | Days | Within 7 days after each vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Number of Participants With Any Unsolicited Adverse Events (AEs) | An unsolicited AE is defined as any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort (for 1-Additional Dose and Revaccination groups), which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study. | Posted | Count of Participants | Participants | Within 30 days after any vaccination (vaccination occurring at Month 0 for 1-Additional Dose Group and at Months 0 and 2 for Revaccination Group) in the current ZOSTER-049:EXT 006-022 study |
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| Secondary | Number of Participants With Any and Related Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of intensity or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to vaccination. | The analysis was performed on Total Vaccinated cohort, which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study (1-Additional Dose and Revaccination groups) and all participants who came for Month 0 visit (Control group). | Posted | Count of Participants | Participants | From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month 0 until 12 months after last HZ/su vaccination (Revaccination group) |
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| Secondary | Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine | An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant. | The analysis was performed on Total Vaccinated cohort, which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study (1-Additional Dose and Revaccination groups) and all participants who came for Month 0 visit (LTFU and Control groups). | Posted | Count of Participants | Participants | During the total duration of ZOSTER-049:EXT 006-022 study (from Month 0 to Month 72) |
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| Secondary | Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs) | pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any pIMDs = occurrence of a pIMD regardless of relation to vaccination. Related pIMD = a pIMD assessed by the investigator as related to the study vaccination. | The analysis was performed on Total Vaccinated cohort, which included all participants who received at least 1 dose of the study treatment in ZOSTER-049:EXT 006-022 study (1-Additional Dose and Revaccination groups) and all participants who came for Month 0 visit (Control group). | Posted | Count of Participants | Participants | From Month 0 to Month 12 (1-Additional Dose and Control groups) and from Month until 12 months after last HZ/su vaccination (Revaccination group) |
|
Solicited AEs: Within 7 days after any vaccination & Unsolicited AEs: Within 30 days after any vaccination in this study. All-cause mortality & SAEs related to investigational vaccine/study participation/GSK concomitant medication/vaccine: during the entire study period (Month 0 to Month 72) (all study groups). All SAEs: Month 0 to Month 12 (1-Additional Dose & Control groups) and Month 0 until 12 months after last HZ/su vaccination (Revaccination group).
As pre-specified in protocol, data in the Other (Non-Serious) Adverse Events module was only collected for the revaccinated participants in ZOSTER-049:EXT 006-022 study (1-Additional Dose and Revaccination groups).
As per the change in AE reporting requirements from protocol amendment 2 onwards, only the related SAEs were recorded in the electronic case report form (eCRF) for LTFU group and reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LTFU Group | Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety. | 56 | 7,289 | 62 | 7,289 | 0 | 0 |
| EG001 | 1-Additional Dose Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study. | 0 | 61 | 4 | 61 | 54 | 61 |
| EG002 | Revaccination Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study. | 0 | 60 | 4 | 60 | 58 | 60 |
| EG003 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). | 0 | 119 | 11 | 119 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac disoder | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac hypertrophy | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Ovarian cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adams-stokes syndrome | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pharyngo-oesophageal diverticulum | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mantle cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Neurofibrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebellar stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular degeneration | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2023 | Jun 28, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| Male |
|
| Asian - East Asian Heritage |
|
| Asian - Japanese Heritage |
|
| Other, Deidentified |
|
Participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG002 | LTFU+Control >=60 YOA Group | Participants >=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG003 | LTFU+Control >=70 YOA Group | Participants >=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG004 | Historical Control 50-59 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG005 | Historical Control 60-69 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG006 | Historical Control >=60 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants >=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG007 | Historical Control >=70 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants >=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
|
|
|
| OG001 | HZ/su 50-59 YOA Group | Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG002 | HZ/su 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG003 | HZ/su >=60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG004 | HZ/su >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG005 | Placebo/Historical Control >=50 YOA Group | Participants >=50 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG006 | Placebo/Historical Control 50-59 YOA Group | Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG007 | Placebo/Historical Control 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG008 | Placebo/Historical Control >= 60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG009 | Placebo/Historical Control >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
|
|
|
Participants >=50 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG001 | HZ/su 50-59 YOA Group | Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG002 | HZ/su 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG003 | HZ/su >=60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG004 | HZ/su >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG005 | Placebo/Historical Control >=50 YOA Group | Participants >=50 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG006 | Placebo/Historical Control 50-59 YOA Group | Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG007 | Placebo/Historical Control 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG008 | Placebo/Historical Control >= 60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG009 | Placebo/Historical Control >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
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| OG001 | LTFU+Control 50-59 YOA Group | Participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG002 | LTFU+Control 60-69 YOA Group | Participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG003 | LTFU+Control >=60 YOA Group | Participants >=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG004 | LTFU+Control >=70 YOA Group | Participants >=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG005 | Historical Control >=50 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants >=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG006 | Historical Control 50-59 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG007 | Historical Control 60-69 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG008 | Historical Control >=60 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants >=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG009 | Historical Control >=70 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants >=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
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| OG001 | HZ/su 50-59 YOA Group | Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG002 | HZ/su 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG003 | HZ/su >=60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG004 | HZ/su >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG005 | Placebo/Historical Control >=50 YOA Group | Participants >=50 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG006 | Placebo/Historical Control 50-59 YOA Group | Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG007 | Placebo/Historical Control 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG008 | Placebo/Historical Control >= 60 YOA Group | Participants between >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG009 | Placebo/Historical Control >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
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| OG001 | LTFU+Control 50-59 YOA Group | Participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG002 | LTFU+Control 60-69 YOA Group | Participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG003 | LTFU+Control >=60 YOA Group | Participants >=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG004 | LTFU+Control >=70 YOA Group | Participants >=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049:EXT 006-022 study. |
| OG005 | Historical Control >=50 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants >=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG006 | Historical Control 50-59 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 50 and 59 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG007 | Historical Control 60-69 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants between 60 and 69 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG008 | Historical Control >=60 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants >=60 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
| OG009 | Historical Control >=70 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants >=70 YOA (at time of primary vaccination in ZOSTER-006/022 studies). |
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| OG001 |
| HZ/su 50-59 YOA Group |
Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG002 | HZ/su 60-69 YOA Group | Participants between 60 to 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG003 | HZ/su >=60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG004 | HZ/su >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies, among which participants who did not enroll in the current ZOSTER-049:EXT 006-022 study only contributed to data for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start. |
| OG005 | Placebo/Historical Control >= 50 YOA Group | Participants >=50 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG006 | Placebo/Historical Control 50-59 YOA Group | Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG007 | Placebo/Historical Control 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG008 | Placebo/Historical Control >= 60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
| OG009 | Placebo/Historical Control >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) from the Placebo groups in the ZOSTER-006/022 primary studies for Year 1 through Year 4 preceding the ZOSTER-049 EXT:006-022 study start and from the hypothetical Historical control group in the current ZOSTER-049:EXT 006-022 study for Year 6 and onwards were combined into this group. |
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| OG002 | LTFU 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study. |
| OG003 | LTFU >=60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study. |
| OG004 | LTFU >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study. |
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|
Participants between 50 and 59 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study.
| OG002 | LTFU 60-69 YOA Group | Participants between 60 and 69 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study. |
| OG003 | LTFU >=60 YOA Group | Participants >=60 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study. |
| OG004 | LTFU >=70 YOA Group | Participants >=70 YOA (at the time of primary vaccination in ZOSTER-006/022 studies) who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study. |
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| Counts |
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| Participants |
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| Control Group |
Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
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| OG002 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
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| OG002 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
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| OG002 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
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Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study.
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| OG002 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
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| OG002 |
| Revaccination Group |
Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study. |
| OG003 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
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| OG002 | Control Group | Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group). |
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