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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03563183




Registration number
NCT03563183
Ethics application status
Date submitted
4/06/2018
Date registered
20/06/2018
Date last updated
30/04/2020

Titles & IDs
Public title
A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022
Scientific title
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
Secondary ID [1] 0 0
204878
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Encoding of data collected in Zoster 006 and Zoster 022 studies

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 interventions: Encoding of data collected in Zoster 006 and Zoster 022 studies
Not applicable (disease epidemiology study)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects by Frailty Status, at Baseline
Timepoint [1] 0 0
At Baseline (Month 0)
Secondary outcome [1] 0 0
Distribution of Short Form 36 (SF-36) Questionnaire Scale Scores, by Country
Timepoint [1] 0 0
At Month 0, 14, 26 and 38
Secondary outcome [2] 0 0
Distribution of EuroQol (EQ)-5D Questionnaire Scale Scores, by Country
Timepoint [2] 0 0
At Month 0, 14, 26 and 38
Secondary outcome [3] 0 0
Incidence Rate (Per 1000 Person-years) of Confirmed Herpes Zoster (HZ) Cases, by Frailty Status
Timepoint [3] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [4] 0 0
Herpes Zoster Burden of Illness Score, by Frailty Status
Timepoint [4] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [5] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Frailty Status
Timepoint [5] 0 0
Within 7 days (Days 0-6) after each vaccination
Secondary outcome [6] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Frailty Status
Timepoint [6] 0 0
Within 7 days (Days 0-6) after each vaccination
Secondary outcome [7] 0 0
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs), by Frailty Status
Timepoint [7] 0 0
Within 30 days (Days 0 - 29) after each vaccination
Secondary outcome [8] 0 0
Number of Subjects With Any and Related Serious Adverse Events (SAEs), by Frailty Status
Timepoint [8] 0 0
From Month 0 to Month 14
Secondary outcome [9] 0 0
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine, by Frailty Status
Timepoint [9] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [10] 0 0
Number of Subjects With Any Fatal Serious Adverse Events (SAEs), by Frailty Status
Timepoint [10] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [11] 0 0
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs), by Frailty Status
Timepoint [11] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [12] 0 0
Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects
Timepoint [12] 0 0
Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38
Secondary outcome [13] 0 0
Anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects
Timepoint [13] 0 0
Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2019
Sample size
Target
Accrual to date
Final
26976
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Maroubra
Recruitment hospital [2] 0 0
GSK Investigational Site - Umina
Recruitment hospital [3] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [4] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [5] 0 0
GSK Investigational Site - Sherwood
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2257 - Umina
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
2522 - Wollongong
Recruitment postcode(s) [5] 0 0
4075 - Sherwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Brazil
State/province [16] 0 0
Minas Gerais
Country [17] 0 0
Brazil
State/province [17] 0 0
Paraná
Country [18] 0 0
Brazil
State/province [18] 0 0
Curitiba/PR
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Newfoundland and Labrador
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Czechia
State/province [25] 0 0
Hradec Kralove
Country [26] 0 0
Estonia
State/province [26] 0 0
Tallinn
Country [27] 0 0
Estonia
State/province [27] 0 0
Tartu
Country [28] 0 0
Finland
State/province [28] 0 0
Tampereen Yliopisto
Country [29] 0 0
France
State/province [29] 0 0
Angers
Country [30] 0 0
France
State/province [30] 0 0
Cherbourg
Country [31] 0 0
France
State/province [31] 0 0
Château Gontier
Country [32] 0 0
France
State/province [32] 0 0
Clermont-Ferrand
Country [33] 0 0
France
State/province [33] 0 0
Laval
Country [34] 0 0
France
State/province [34] 0 0
Montrevault
Country [35] 0 0
France
State/province [35] 0 0
Muret
Country [36] 0 0
France
State/province [36] 0 0
Murs-Erigne
Country [37] 0 0
France
State/province [37] 0 0
Nantes cedex 2
Country [38] 0 0
France
State/province [38] 0 0
Rosiers-d'Egletons
Country [39] 0 0
France
State/province [39] 0 0
Saint Cyr sur Loire
Country [40] 0 0
France
State/province [40] 0 0
Segré
Country [41] 0 0
France
State/province [41] 0 0
Tours
Country [42] 0 0
Germany
State/province [42] 0 0
Baden-Wuerttemberg
Country [43] 0 0
Germany
State/province [43] 0 0
Bayern
Country [44] 0 0
Germany
State/province [44] 0 0
Hessen
Country [45] 0 0
Germany
State/province [45] 0 0
Niedersachsen
Country [46] 0 0
Germany
State/province [46] 0 0
Nordrhein-Westfalen
Country [47] 0 0
Germany
State/province [47] 0 0
Rheinland-Pfalz
Country [48] 0 0
Germany
State/province [48] 0 0
Sachsen
Country [49] 0 0
Germany
State/province [49] 0 0
Schleswig-Holstein
Country [50] 0 0
Germany
State/province [50] 0 0
Berlin
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Germany
State/province [52] 0 0
Magdeburg
Country [53] 0 0
Hong Kong
State/province [53] 0 0
Kwun Tong
Country [54] 0 0
Hong Kong
State/province [54] 0 0
Shatin
Country [55] 0 0
Italy
State/province [55] 0 0
Abruzzo
Country [56] 0 0
Italy
State/province [56] 0 0
Lazio
Country [57] 0 0
Italy
State/province [57] 0 0
Liguria
Country [58] 0 0
Italy
State/province [58] 0 0
Lombardia
Country [59] 0 0
Italy
State/province [59] 0 0
Piemonte
Country [60] 0 0
Japan
State/province [60] 0 0
Fukuoka
Country [61] 0 0
Japan
State/province [61] 0 0
Kanagawa
Country [62] 0 0
Japan
State/province [62] 0 0
Tokyo
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Gangwon-do
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Gyeonggi-do
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Incheon
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Seoul
Country [67] 0 0
Mexico
State/province [67] 0 0
Jalisco
Country [68] 0 0
Mexico
State/province [68] 0 0
Durango
Country [69] 0 0
Spain
State/province [69] 0 0
Alcover( Tarragona)
Country [70] 0 0
Spain
State/province [70] 0 0
Balenyà (Barcelona)
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
Country [72] 0 0
Spain
State/province [72] 0 0
Centelles (Barcelona)
Country [73] 0 0
Spain
State/province [73] 0 0
La Roca Del Valles (Barcelona)
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
Country [75] 0 0
Spain
State/province [75] 0 0
Majadahonda( Madrid
Country [76] 0 0
Spain
State/province [76] 0 0
Marid
Country [77] 0 0
Spain
State/province [77] 0 0
Peralada( Girona)
Country [78] 0 0
Spain
State/province [78] 0 0
Valencia
Country [79] 0 0
Spain
State/province [79] 0 0
Vic/ Barcelona
Country [80] 0 0
Sweden
State/province [80] 0 0
Borås
Country [81] 0 0
Sweden
State/province [81] 0 0
Eskilstuna
Country [82] 0 0
Sweden
State/province [82] 0 0
Göteborg
Country [83] 0 0
Sweden
State/province [83] 0 0
Jönköping
Country [84] 0 0
Sweden
State/province [84] 0 0
Karlskrona
Country [85] 0 0
Sweden
State/province [85] 0 0
Linköping
Country [86] 0 0
Sweden
State/province [86] 0 0
Malmö
Country [87] 0 0
Sweden
State/province [87] 0 0
Uppsala
Country [88] 0 0
Sweden
State/province [88] 0 0
Vällingby
Country [89] 0 0
Sweden
State/province [89] 0 0
Örebro
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taichung
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taipei
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taoyuan County
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Warwickshire
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Wiltshire
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Bangor
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Belfast
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Broughshane
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Liverpool
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Newtonabbey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03563183
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03563183