A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022

Observational Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022 and HZ Efficacy, Immunogenicity and Safety of HZ/su by Frailty Status

As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study.

The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Other: Encoding of data collected in Zoster 006 and Zoster 022 studies

Detailed Description

As part of the study procedure, each subject enrolled in studies Zoster-006 and Zoster-022 was asked to complete two quality of life (QoL) questionnaires named respectively SF-36 and EQ-5D at predefined study time points. These questionnaires were to provide relevant information about the quality of life (functional status, ability to socialize, mental health, etc.) of subjects before they develop shingles Extracting some elements of the Quality of Life questionnaires (QoL), EQ-5D and SF-36, completed by all study subjects at baseline, and combining them with other medical history data allows attributing of frailty scores.

Analyses pertaining to efficacy, safety and immunogenicity as per frailty score might be performed according to the methodology used in the ZOSTER-006 and ZOSTER-022 studies.

Additionally, the data collected can be used to assess if some physical, physiological and/or psychological characteristics reported by the subjects before the onset of HZ would be predictive of HZ.

• Study Type: Observational
• Enrollment (Actual): 26976

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Maroubra, New South Wales, Australia, 2035
      • GSK Investigational Site
    • Umina, New South Wales, Australia, 2257
      • GSK Investigational Site
    • Westmead, New South Wales, Australia, 2145
      • GSK Investigational Site
    • Wollongong, New South Wales, Australia, 2522
      • GSK Investigational Site
  • Queensland
    • Sherwood, Queensland, Australia, 4075
      • GSK Investigational Site
• Brazil
  • Curitiba/PR, Brazil, 80240-280
    • GSK Investigational Site
  • São Paulo, Brazil, 04266-010
    • GSK Investigational Site
  • São Paulo, Brazil, 05403-000
    • GSK Investigational Site
  • São Paulo, Brazil, 04023-900
    • GSK Investigational Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • GSK Investigational Site
  • Paraná
    • Curitiba, Paraná, Brazil, 80810-050
      • GSK Investigational Site
• Canada
  • Quebec, Canada, G1W 4R4
    • GSK Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • GSK Investigational Site
    • Victoria, British Columbia, Canada, V8V 3M9
      • GSK Investigational Site
  • Newfoundland and Labrador
    • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
      • 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, N4S 5P5
      • GSK Investigational Site
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 6S8
      • GSK Investigational Site
    • Mirabel, Quebec, Canada, J7J 2K8
      • GSK Investigational Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • GSK Investigational Site
    • Québec City, Quebec, Canada, G1E 7G9
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 2G2
      • GSK Investigational Site
• Czechia
  • Hradec Kralove, Czechia
    • GSK Investigational Site
• Estonia
  • Tallinn, Estonia, 13619
    • GSK Investigational Site
  • Tartu, Estonia, 50106
    • GSK Investigational Site
• Finland
  • Tampereen Yliopisto, Finland, 33014
    • GSK Investigational Site
• France
  • Angers, France, 49100
    • GSK Investigational Site
  • Angers, France, 49000
    • GSK Investigational Site
  • Cherbourg, France, 50100
    • 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
  • Murs-Erigne, France, 49610
    • GSK Investigational Site
  • Nantes cedex 2, France, 44277
    • GSK Investigational Site
  • Rosiers-d'Egletons, France, 19300
    • GSK Investigational Site
  • Saint Cyr sur Loire, France, 37540
    • GSK Investigational Site
  • Segré, France, 49500
    • GSK Investigational Site
  • Tours, France, 37100
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10717
    • GSK Investigational Site
  • Berlin, Germany, 10629
    • GSK Investigational Site
  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Berlin, Germany, 13347
    • GSK Investigational Site
  • Berlin, Germany, 12157
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Hamburg, Germany, 22415
    • GSK Investigational Site
  • Hamburg, Germany, 20251
    • GSK Investigational Site
  • Magdeburg, Germany, 39120
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Deggingen, Baden-Wuerttemberg, Germany, 73326
      • GSK Investigational Site
    • Gueglingen, Baden-Wuerttemberg, Germany, 74363
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68161
      • GSK Investigational Site
    • Tuebingen, Baden-Wuerttemberg, Germany, 72074
      • GSK Investigational Site
    • Wangen, Baden-Wuerttemberg, Germany, 88239
      • GSK Investigational Site
    • Weinheim, Baden-Wuerttemberg, Germany, 69469
      • GSK Investigational Site
  • Bayern
    • Dachau, Bayern, Germany, 85221
      • GSK Investigational Site
    • Kuenzing, Bayern, Germany, 94550
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80339
      • GSK Investigational Site
    • Rednitzhembach, Bayern, Germany, 91126
      • GSK Investigational Site
    • Wallerfing, Bayern, Germany, 94574
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site
  • Hessen
    • Floersheim, Hessen, Germany, 65439
      • GSK Investigational Site
    • Frankfurt, Hessen, Germany, 60389
      • GSK Investigational Site
  • Niedersachsen
    • Duelmen, Niedersachsen, Germany, 48249
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45355
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45359
      • GSK Investigational Site
    • Goch, Nordrhein-Westfalen, Germany, 47574
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 51069
      • GSK Investigational Site
    • Witten, Nordrhein-Westfalen, Germany, 58455
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site
    • Rhaunen, Rheinland-Pfalz, Germany, 55624
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01097
      • GSK Investigational Site
    • Freiberg, Sachsen, Germany, 09599
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04315
      • GSK Investigational Site
    • Pirna, Sachsen, Germany, 01796
      • GSK Investigational Site
  • Schleswig-Holstein
    • Luebeck, Schleswig-Holstein, Germany, 23554
      • GSK Investigational Site
• Hong Kong
  • Kwun Tong, Hong Kong
    • GSK Investigational Site
  • Shatin, Hong Kong
    • GSK Investigational Site
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66013
      • GSK Investigational Site
    • Pescara, Abruzzo, Italy, 65100
      • GSK Investigational Site
  • Lazio
    • Roma, Lazio, Italy, 00163
      • GSK Investigational Site
    • Roma, Lazio, Italy, 00133
      • GSK Investigational Site
  • Liguria
    • Genova, Liguria, Italy, 16132
      • GSK Investigational Site
  • Lombardia
    • Monza, Lombardia, Italy, 20900
      • GSK Investigational Site
  • Piemonte
    • Cuneo, Piemonte, Italy, 12100
      • 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
  • Kanagawa, Japan, 224-8503
    • GSK Investigational Site
  • Tokyo, Japan, 142-8666
    • GSK Investigational Site
  • Tokyo, Japan, 154-0024
    • GSK Investigational Site
  • Tokyo, Japan, 141-0001
    • GSK Investigational Site
• Korea, Republic of
  • Gangwon-do, Korea, Republic of, 26426
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of, 15355
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of, 14584
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 400-711
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 06351
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 06273
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 08308
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 07441
    • GSK Investigational Site
• Mexico
  • Durango, Mexico, 34000
    • GSK Investigational Site
  • Jalisco
    • Zapopan, Jalisco, Jalisco, Mexico, 45190
      • GSK Investigational Site
• Spain
  • Alcover( Tarragona), Spain, 43460
    • GSK Investigational Site
  • Balenyà (Barcelona), Spain, 08550
    • GSK Investigational Site
  • Barcelona, Spain, 08025
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Centelles (Barcelona), Spain, 08540
    • GSK Investigational Site
  • La Roca Del Valles (Barcelona), Spain, 08430
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Majadahonda( Madrid, Spain, 28222
    • GSK Investigational Site
  • Marid, Spain, 28040
    • GSK Investigational Site
  • Peralada( Girona), Spain, 17491
    • GSK Investigational Site
  • Valencia, Spain, 46020
    • GSK Investigational Site
  • Vic/ Barcelona, Spain, 08500
    • GSK Investigational Site
• Sweden
  • Borås, Sweden, SE-506 30
    • GSK Investigational Site
  • Eskilstuna, Sweden, SE-631 88
    • GSK Investigational Site
  • Göteborg, Sweden, SE-413 45
    • GSK Investigational Site
  • Jönköping, Sweden, SE-551 85
    • GSK Investigational Site
  • Karlskrona, Sweden, SE-371 41
    • GSK Investigational Site
  • Linköping, Sweden, SE-581 85
    • GSK Investigational Site
  • Malmö, Sweden, SE-211 52
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
  • Vällingby, Sweden, SE-162 68
    • GSK Investigational Site
  • Örebro, Sweden, SE-703 62
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taipei, Taiwan, 100
    • GSK Investigational Site
  • Taipei, Taiwan, 112
    • GSK Investigational Site
  • Taoyuan County, Taiwan, 333
    • GSK Investigational Site
• United Kingdom
  • Bangor, United Kingdom, BT19 1NB
    • GSK Investigational Site
  • Belfast, United Kingdom, BT7 2EB
    • GSK Investigational Site
  • Broughshane, United Kingdom, BT42 4JP
    • GSK Investigational Site
  • Liverpool, United Kingdom, L22 0LG
    • GSK Investigational Site
  • Newtonabbey, United Kingdom, BT37 9QW
    • GSK Investigational Site
  • Warwickshire
    • Atherstone, Warwickshire, United Kingdom, CV9 1EU
      • GSK Investigational Site
  • Wiltshire
    • Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
      • GSK Investigational Site
• United States
  • Arizona
    • Mesa, Arizona, United States, 85213
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85020
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85018
      • GSK Investigational Site
  • California
    • Spring Valley, California, United States, 91978
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33761
      • GSK Investigational Site
    • DeLand, Florida, United States, 32720
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32216
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32205
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • GSK Investigational Site
  • Idaho
    • Meridian, Idaho, United States, 83642
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • 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
    • Mount Pleasant, North Carolina, United States, 29464
      • GSK Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • GSK Investigational Site
    • Wadsworth, Ohio, United States, 44281
      • GSK Investigational Site
  • Pennsylvania
    • Pleasant Hills, Pennsylvania, United States, 15236
      • GSK Investigational Site
    • Uniontown, Pennsylvania, United States, 15401
      • GSK Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
  • Utah
    • Murray, Utah, United States, 84123
      • GSK Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23294
      • GSK Investigational Site
    • Winchester, Virginia, United States, 22601
      • GSK Investigational Site
  • Washington
    • Renton, Washington, United States, 98057
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All subjects enrolled in the Zoster 006 and Zoster 022 studies

Description

Inclusion Criteria:

• All subjects who participated in the Zoster 006 and Zoster 022 trials.
• Subjects who died or were lost to follow-up during ZOSTER-006 and ZOSTER-022 will be considered for enrolment in ZOSTER-064 and their data/questionnaires up to that point will be used.

Exclusion Criteria:

• Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER-022. This will include any subject eliminated following deviations from GCP compliance.
• Subjects who developed a suspected HZ case during ZOSTER-006 and ZOSTER-022 (since their QoL questionnaires were encoded in the eCRF for ZOSTER-006 and ZOSTER-022).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Overall Group; Adults aged ≥50 years of age in the Zoster-064 TVC who received herpes zoster subunit (HZ/su) vaccine or Placebo in Zoster-006/022 study	Other: Encoding of data collected in Zoster 006 and Zoster 022 studies; Not applicable (disease epidemiology study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects by Frailty Status, at Baseline	Frailty status was measured in relation to the accumulation of deficits using a Frailty Index (FI) adapted from the model proposed by Mitnitski et al. [Mitnitski, 2001]. The different aspects of frailty composing the FI were assessed through the medical history and components of the Short Form 36 Questionnaire (SF-36) and EuroQol (EQ)-5D questionnaires recorded pre-vaccination Dose 1 (in the study ZOSTER-006[NCT01165177] and ZOSTER-022[NCT01165229]). If the FI was less than or equal to 0.08, the subject was classified as Non-Frail. If the score was greater than 0.08 but less than or equal to 0.25, the subject was classified as pre-frail. If the score was greater than 0.25, the subject was classified as Frail. Subjects without a FI score were classified as unknown.	At Baseline (Month 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Short Form 36 (SF-36) Questionnaire Scale Scores, by Country	The mean and standard deviation of the SF-36 Questionnaire scale scores are presented for each time point. The SF-36 is a multi-purpose health survey with 36 questions underlying the construction of 8 scales [Ware, 2001]: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH). All but one of the 36 items (self-reported health transition) are used to score the eight SF-36 scales. Each item is used in scoring only one scale. Scale scores are constructed following the summated ratings and standardized SF-36 scoring algorithms. The SF-36 scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life.	At Month 0, 14, 26 and 38
Distribution of EuroQol (EQ)-5D Questionnaire Scale Scores, by Country	The EQ-5D questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 possible responses (No symptoms, Moderate symptoms, Extreme symptoms). The 5 items are then combined to generate health profiles that are subsequently converted to a continuous single index utility score using a one to one matching. Country or region-specific value sets are used for the score conversion. The scores range from less than 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility. The EQ-5D also contains a visual analogue scale (VAS). The VAS records the respondent's self-rated health on a vertical scale, ranging from 0(worst imaginable health state) to 100(best imaginable health state).	At Month 0, 14, 26 and 38
Incidence Rate (Per 1000 Person-years) of Confirmed Herpes Zoster (HZ) Cases, by Frailty Status	Incidence rate (IR) of confirmed Herpes zoster (HZ) cases with 95% Confidence Interval (CI) calculated as the number of cases per 1000 person-years : numerator = number of confirmed HZ cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first confirmed HZ cases or occurrence of treatment for relapse. A suspected HZ case defined as (1) new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) clinical presentation and specific laboratory findings suggestive of VZV infection in the absence of HZ or VZV rash. A suspected case of HZ was confirmed either by PCR or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.	During the entire study period (3 to 5 year period following Day 0)
Herpes Zoster Burden of Illness Score, by Frailty Status	Zoster Brief Pain Inventory (ZBPI) Burden of Illness (BOI) score was calculated as the sum of the ZBPI worst pain scores for all subjects in the group divided by the total follow-up time (Person-years). HZ Burden of Illness score for subjects was calculated from the Zoster Brief Pain Inventory (ZBPI), for each confirmed HZ cases responding to the "worst pain" question in both ZOSTER-006 and ZOSTER-022, and defined as the area under the curve of confirmed HZ-associated pain plotted against time during the 182-day period after the onset of the case. Subjects who developed HZ presented "burden-of-illness" scores ranging from 0 up to, theoretically, 1820. A score of 0 is recorded for subjects in whom HZ did not develop during the study period. Subjects who had a confirmed Zoster episode but who did not have at least 1 ZBPI assessment were excluded from the analysis.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Frailty Status	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. 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 (Days 0-6) after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Frailty Status	Assessed solicited general symptoms were, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and gastro-intestinal (GI) symptoms(nausea, vomiting, diarrhoea and/or abdominal pain) Any = occurrence of the symptom regardless of intensity grade. 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 (Days 0-6) after each vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs), by Frailty Status	An unsolicited AE covered 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	Within 30 days (Days 0 - 29) after each vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs), by Frailty Status	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs were those considered vaccine-related by the investigator.	From Month 0 to Month 14
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine, by Frailty Status	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs throughout the entire study period by frailty status were reported for SAEs considered related to study participation or to a concurrent GSK medication/vaccine.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Any Fatal Serious Adverse Events (SAEs), by Frailty Status	Serious adverse events (SAEs) assessed include medical occurrences that result in death.	During the entire study period (3 to 5 year period following Day 0)
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs), by Frailty Status	Potential immune-mediated diseases (pIMDs) are 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. Related = pIMDs assessed by the investigator as related to the vaccination.	During the entire study period (3 to 5 year period following Day 0)
Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects	Anti-gE Ab concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), in a subset of subjects. The assay cut-off is 97 milli-international units (mIU)/mL.	Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38
Anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects	Anti-VZV Ab concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), in a subset of subjects. The assay cut-off is 25 mIU/mL.	Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Curran D, Kim JH, Matthews S, Dessart C, Levin MJ, Oostvogels L, Riley ME, Schmader KE, Cunningham AL, McNeil SA, Schuind AE, Andrew MK; Zoster-064 Study Group. Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals. J Am Geriatr Soc. 2021 Mar;69(3):744-752. doi: 10.1111/jgs.16917. Epub 2020 Nov 16.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: safety; frailty; efficacy; immunogenicity; Herpes Zoster; Shingles vaccine
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Frailty; Herpes Zoster
• Other Study ID Numbers: 204878

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes