Clinical trial NCT03563183: A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Zoster
Keywords: immunogenicity
Herpes Zoster
efficacy
safety
frailty
Shingles vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 26976
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects enrolled in the Zoster 006 and Zoster 022 studies

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Subjects by Frailty Status, at Baseline
timeFrame: At Baseline (Month 0)
Secondary outcomes:
measure: Distribution of Short Form 36 (SF-36) Questionnaire Scale Scores, by Country
timeFrame: At Month 0, 14, 26 and 38
measure: Distribution of EuroQol (EQ)-5D Questionnaire Scale Scores, by Country
timeFrame: At Month 0, 14, 26 and 38
measure: Incidence Rate (Per 1000 Person-years) of Confirmed Herpes Zoster (HZ) Cases, by Frailty Status
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Herpes Zoster Burden of Illness Score, by Frailty Status
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Frailty Status
timeFrame: Within 7 days (Days 0-6) after each vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Frailty Status
timeFrame: Within 7 days (Days 0-6) after each vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs), by Frailty Status
timeFrame: Within 30 days (Days 0 - 29) after each vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs), by Frailty Status
timeFrame: From Month 0 to Month 14
measure: Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine, by Frailty Status
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Any Fatal Serious Adverse Events (SAEs), by Frailty Status
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs), by Frailty Status
timeFrame: During the entire study period (3 to 5 year period following Day 0)
measure: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects
timeFrame: Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38
measure: Anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects
timeFrame: Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38
Other outcomes:
Locations:
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Spring Valley
country: United States
facility: GSK Investigational Site
state: California
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: DeLand
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Meridian
country: United States
facility: GSK Investigational Site
state: Idaho
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Cary
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: GSK Investigational Site
state: Ohio
city: Wadsworth
country: United States
facility: GSK Investigational Site
state: Ohio
city: Pleasant Hills
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Murray
country: United States
facility: GSK Investigational Site
state: Utah
city: Newport News
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Winchester
country: United States
facility: GSK Investigational Site
state: Virginia
city: Renton
country: United States
facility: GSK Investigational Site
state: Washington
city: Maroubra
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Umina
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Sherwood
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
city: Curitiba
country: Brazil
facility: GSK Investigational Site
state: Paraná
city: Curitiba/PR
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Bay Roberts
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Woodstock
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Gatineau
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Tampereen Yliopisto
country: Finland
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Cherbourg
country: France
facility: GSK Investigational Site
city: Château Gontier
country: France
facility: GSK Investigational Site
city: Clermont-Ferrand
country: France
facility: GSK Investigational Site
city: Laval
country: France
facility: GSK Investigational Site
city: Montrevault
country: France
facility: GSK Investigational Site
city: Muret
country: France
facility: GSK Investigational Site
city: Murs-Erigne
country: France
facility: GSK Investigational Site
city: Nantes cedex 2
country: France
facility: GSK Investigational Site
city: Rosiers-d'Egletons
country: France
facility: GSK Investigational Site
city: Saint Cyr sur Loire
country: France
facility: GSK Investigational Site
city: Segré
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Deggingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Gueglingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wangen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Dachau
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kuenzing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Rednitzhembach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Floersheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Duelmen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freiberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Magdeburg
country: Germany
facility: GSK Investigational Site
city: Kwun Tong
country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Chieti
country: Italy
facility: GSK Investigational Site
state: Abruzzo
city: Pescara
country: Italy
facility: GSK Investigational Site
state: Abruzzo
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Monza
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Cuneo
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Gangwon-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Zapopan, Jalisco
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Alcover( Tarragona)
country: Spain
facility: GSK Investigational Site
city: Balenyà (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Centelles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: La Roca Del Valles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda( Madrid
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
city: Peralada( Girona)
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vic/ Barcelona
country: Spain
facility: GSK Investigational Site
city: Borås
country: Sweden
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Jönköping
country: Sweden
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Vällingby
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan County
country: Taiwan
facility: GSK Investigational Site
city: Atherstone
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Bradford on Avon
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Bangor
country: United Kingdom
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Broughshane
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Newtonabbey
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.