Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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