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

Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster; Herpes Zoster Vaccine
• Intervention / Treatment: Biological: Herpes Zoster Vaccine GSK1437173A

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 7539
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • GSK Investigational Site
    • Wollongong, New South Wales, Australia, 2522
      • GSK Investigational Site
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • GSK Investigational Site
• Brazil
  • Belo Horizonte, Brazil, 30150-320
    • GSK Investigational Site
  • Curitiba, Brazil, 80069-900
    • GSK Investigational Site
  • CuritibaPR, Brazil, 80240-000
    • GSK Investigational Site
  • São Paulo, Brazil, 04266-010
    • GSK Investigational Site
  • São Paulo, Brazil, 04312903
    • GSK Investigational Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • GSK Investigational Site
    • Victoria, British Columbia, Canada, V8V 3M9
      • GSK Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • GSK Investigational Site
    • Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site
  • Ontario
    • Toronto, Ontario, Canada, M9W 4L6
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M4S 1Y2
      • GSK Investigational Site
    • Woodstock, Ontario, Canada, N4V 0E1
      • GSK Investigational Site
  • Quebec
    • Gatineau, Quebec, Canada, J8Y1W2
      • GSK Investigational Site
    • Montreal, Quebec, Canada, J7J 2K8
      • GSK Investigational Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • GSK Investigational Site
    • Québec, Quebec, Canada, G1W 4R4
      • GSK Investigational Site
    • Québec, Quebec, Canada, G1E 7G9
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1J 2G2
      • GSK Investigational Site
• Czechia
  • Brno, Czechia, 612 00
    • GSK Investigational Site
  • Hradec Králové, Czechia, 500 05
    • GSK Investigational Site
  • České Budějovice, Czechia, 370 05
    • GSK Investigational Site
• Estonia
  • Tallinn, Estonia, 13619
    • GSK Investigational Site
  • Tartu, Estonia, 50106
    • GSK Investigational Site
• Finland
  • Espoo, Finland, 02230
    • GSK Investigational Site
  • Helsinki, Finland, 00100
    • GSK Investigational Site
  • Helsinki, Finland, 00930
    • GSK Investigational Site
  • Järvenpää, Finland, 04400
    • GSK Investigational Site
  • Kokkola, Finland, 67100
    • GSK Investigational Site
  • Oulu, Finland, 90220
    • GSK Investigational Site
  • Pori, Finland, 28100
    • GSK Investigational Site
  • Seinäjoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• France
  • Angers, France, 49100
    • GSK Investigational Site
  • Angers, France, 49000
    • GSK Investigational Site
  • Château-Gontier, France, 53200
    • GSK Investigational Site
  • Clermont-Ferrand, France, 63003
    • GSK Investigational Site
  • Laval, France, 53000
    • GSK Investigational Site
  • Montrevault, France, 49110
    • GSK Investigational Site
  • Muret, France, 31600
    • GSK Investigational Site
  • Mûrs-Erigné, France, 49610
    • GSK Investigational Site
  • Nantes, France, 44300
    • GSK Investigational Site
  • Rosiers-d'Égletons, France, 19300
    • GSK Investigational Site
  • Segré, France, 49500
    • GSK Investigational Site
  • Tours, France, 37100
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10629
    • GSK Investigational Site
  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Berlin, Germany, 13347
    • GSK Investigational Site
  • Cologne, Germany, 51069
    • GSK Investigational Site
  • Dachau, Germany, 85221
    • GSK Investigational Site
  • Dresden, Germany, 01097
    • GSK Investigational Site
  • Essen, Germany, 45355
    • GSK Investigational Site
  • Essen, Germany, 45359
    • GSK Investigational Site
  • Flörsheim, Germany, 65439
    • GSK Investigational Site
  • Freiberg, Germany, 09599
    • GSK Investigational Site
  • Goch, Germany, 47574
    • GSK Investigational Site
  • Güglingen, Germany, 74363
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Hamburg, Germany, 22415
    • GSK Investigational Site
  • Hamburg, Germany, 20251
    • GSK Investigational Site
  • Köthen, Germany, 06366
    • GSK Investigational Site
  • Künzing, Germany, 94550
    • GSK Investigational Site
  • Leipzig, Germany, 04315
    • GSK Investigational Site
  • Lübeck, Germany, 23554
    • GSK Investigational Site
  • Magdeburg, Germany, 39112
    • GSK Investigational Site
  • Mainz, Germany, 55116
    • GSK Investigational Site
  • Mannheim, Germany, 68161
    • GSK Investigational Site
  • München, Germany, 80339
    • GSK Investigational Site
  • Rednitzhembach, Germany, 91126
    • GSK Investigational Site
  • Rhaunen, Germany, 55624
    • GSK Investigational Site
  • Tübingen, Germany, 72074
    • GSK Investigational Site
  • Wallerfing, Germany, 94574
    • GSK Investigational Site
  • Wangen, Germany, 88239
    • GSK Investigational Site
  • Weinheim, Germany, 69469
    • GSK Investigational Site
  • Witten, Germany, 58455
    • GSK Investigational Site
  • Würzburg, Germany, 97070
    • GSK Investigational Site
• Hong Kong
  • Kwun Tong Kowloon, Hong Kong
    • GSK Investigational Site
  • Shatin, Hong Kong, 000000
    • GSK Investigational Site
• Italy
  • Chieti, Italy, 66013
    • GSK Investigational Site
  • Genova, Italy, 16132
    • GSK Investigational Site
  • Monza MB, Italy, 20900
    • GSK Investigational Site
  • Roma, Italy, 00163
    • GSK Investigational Site
  • Sassari, Italy, 07100
    • GSK Investigational Site
• Japan
  • Fukuoka, Japan, 812-0025
    • GSK Investigational Site
  • Fukuoka, Japan, 810-0021
    • GSK Investigational Site
  • Fukuoka, Japan, 813-8588
    • GSK Investigational Site
  • Fukuoka, Japan, 816-0864
    • GSK Investigational Site
  • Kanagawa, Japan, 224-8503
    • GSK Investigational Site
  • Kanagawa, Japan, 247-8533
    • GSK Investigational Site
  • Tokyo, Japan, 142-0054
    • GSK Investigational Site
  • Tokyo, Japan, 142-8666
    • GSK Investigational Site
  • Tokyo, Japan, 154-0024
    • GSK Investigational Site
• Mexico
  • Durango, Mexico, 34000
    • GSK Investigational Site
  • Zapopan Jalisco, Mexico, 45190
    • GSK Investigational Site
• South Korea
  • Ansan, South Korea, 425-707
    • GSK Investigational Site
  • Bucheon-si Kyunggi-do 14584, South Korea, 420-767
    • GSK Investigational Site
  • Incheon, South Korea, 400-711
    • GSK Investigational Site
  • Kangwon-do, South Korea, 220-701
    • GSK Investigational Site
  • Seoul, South Korea, 152-703
    • GSK Investigational Site
  • Seoul, South Korea, 150-950
    • GSK Investigational Site
• Spain
  • Alcover Tarragona, Spain, 43460
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Barcelona, Spain, 08540
    • GSK Investigational Site
  • Barcelona, Spain, 08430
    • GSK Investigational Site
  • Barcelona, Spain, 28500
    • GSK Investigational Site
  • Hostalets de Balenya Ba, Spain, 08550
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Madrid, Spain, 28222
    • GSK Investigational Site
  • Peralada Girona, Spain, 17491
    • GSK Investigational Site
  • Valencia, Spain, 46020
    • GSK Investigational Site
• Sweden
  • Borås, Sweden, SE-506 30
    • GSK Investigational Site
  • Eskilstuna, Sweden, SE-631 88
    • GSK Investigational Site
  • Gothenburg, Sweden, SE-413 45
    • GSK Investigational Site
  • Jönköping, Sweden, SE-551 85
    • GSK Investigational Site
  • Karlskrona, Sweden, SE-371 79
    • GSK Investigational Site
  • Linköping, Sweden, SE-58758
    • GSK Investigational Site
  • Malmo, Sweden, SE-211 52
    • GSK Investigational Site
  • Stockholm, Sweden, 11446
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
  • Vällingby, Sweden, SE-194 61
    • GSK Investigational Site
  • Örebro, Sweden, SE-703 62
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taipei, Taiwan, 112
    • GSK Investigational Site
  • Taipei, Taiwan, 10002
    • GSK Investigational Site
  • Tau-Yuan, Taiwan, 333
    • GSK Investigational Site
• United Kingdom
  • Atherstone Warwickshire, United Kingdom, CV9 1EU
    • GSK Investigational Site
  • Belfast, United Kingdom, BT7 2EB
    • GSK Investigational Site
  • Bradford on Avon Wiltsh, United Kingdom, BA15 1DQ
    • GSK Investigational Site
  • Broughshane, United Kingdom, BT42 4JP
    • GSK Investigational Site
  • Chorley, United Kingdom, PR7 7NA
    • GSK Investigational Site
  • Liverpool, United Kingdom, L22 0LG
    • GSK Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85018
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85306
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 29651
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 84123
      • GSK Investigational Site
  • California
    • Spring Valley, California, United States, 91978
      • GSK Investigational Site
  • Florida
    • Hallandale, Florida, United States, 85213
      • GSK Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83712
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
  • Maryland
    • Columbia, Maryland, United States, 21045
      • GSK Investigational Site
    • Elkridge, Maryland, United States, 21075
      • GSK Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28209
      • GSK Investigational Site
    • Hickory, North Carolina, United States, 28601
      • GSK Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28412
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • GSK Investigational Site
    • Wadsworth, Ohio, United States, 44281
      • GSK Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • GSK Investigational Site
    • Uniontown, Pennsylvania, United States, 15401
      • GSK Investigational Site
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, availability for follow-up contacts).
• Written informed consent obtained from the subject prior to performance of any study specific procedure.
• Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of HZ/su vaccine.

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.

  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

• Female subjects of childbearing potential may be enrolled in this study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Use of any investigational or non-registered product (pharmaceutical product or device) at the time of enrolment or planned use during the study period.
• Previous vaccination against Varicella Zoster Virus (VZV) or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than the HZ/su vaccine administered in studies ZOSTER-006/022).
• Chronic administration (defined as ≥ 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
• Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab) within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
• Administration of immunoglobulins and/or any blood products within 3 months prior to Visit Month 0 of study ZOSTER-049 or planned administration during the study period.
• Prolonged use (> 14 consecutive days) of oral and/or parenteral antiviral agents that are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be used during the study period for an indication other than to treat suspected or confirmed HZ or an HZ-related complication (topical use of these antiviral agents is allowed).
• Important underlying illness that in the opinion of the investigator would be expected to interfere significantly during the study.

Additional exclusion criteria for the 1-Additional Dose Revaccination and Control groups, only:

• Subjects who experienced an SAE from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049 that was considered related to study vaccine by either the investigator or the sponsor.
• Subjects with a new onset of a pIMD or exacerbation of a pIMD from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049.
• Use of any investigational or non-registered product (pharmaceutical product or device) within 30 days preceding the first dose of study vaccine or planned use during the study period.
• Administration or planned administration of any other immunizations within 30 days before the first study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex-gloves, syringes, etc.). Please note, the vaccine and vials in this study do not contain latex.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential).
• Previous episode/history of HZ.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Biological: Herpes Zoster Vaccine GSK1437173A; Intramuscular injection
Experimental: 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.	Biological: Herpes Zoster Vaccine GSK1437173A; Intramuscular injection
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: due to the high VE observed in ZOSTER-006/022 studies, recipients of placebo in both studies were offered cross-vaccination with HZ/su. Since there was no placebo group in this study, historic controls were used for VE assessment. Incidence rates estimations on Historical Control group were done by utilizing Poisson regression model using placebo data from ZOSTER-006/022 studies to obtain the coefficients by age ranges.; the participants in Control group were a subset of LTFU group that were randomized to serve as control for those who were vaccinated in this study, otherwise they were treated similarly as LTFU group, hence LTFU and Control groups were combined.	During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2016
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimated): March 30, 2016

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Adults; Immunogenicity; Herpes zoster
• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster
• Other Study ID Numbers: 201190; 2015-001778-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No