Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03563183
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment
Herpes Zoster 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.


Layout table for study information
Study Type : Observational
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : January 3, 2010
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Group/Cohort Intervention/treatment
Zoster-064 GSK1437173A Group
Subjects who have received herpes zoster subunit vaccine (gE/AS01B vaccine) in the ZOSTER-006 and Zoster-022 studies. SF-36 and EQ-5D questionnaires will be encoded to evaluate frailty Thereafter, efficacy/safety / immune responses will be assessed by frailty status.
Other: Encoding of data collected in Zoster 006 and Zoster 022 studies
Not applicable (disease epidemiology study)

Zoster-064 Placebo Group
Subjects who have received saline solution (NaCl solution) as control in the ZOSTER-006 and Zoster-022 studies. SF-36 and EQ-5D questionnaires will be encoded to evaluate frailty Thereafter, efficacy/safety / immune responses will be assessed by frailty status.
Other: Encoding of data collected in Zoster 006 and Zoster 022 studies
Not applicable (disease epidemiology study)




Primary Outcome Measures :
  1. Number of subjects with frailty status at baseline [ Time Frame: At Baseline (Month 0) ]
    Frailty Status prior to vaccination, is defined by responses to components of the SF-36 and EQ-5D questionnaire and the subjects coded medical history, from Zoster-006 and Zoster-022 studies


Secondary Outcome Measures :
  1. Number of subjects with Short Form 36 Questionnaire (SF-36) scale scores [ Time Frame: At Baseline (Month 0) ]
    The SF-36 is a multi-purpose health survey with 36 questions. It yields an 8-scale profile of scores (physical functioning, role physical, bodily pain, general health perceptions, vitality, social functioning, role emotional, and mental health) as well as a reported health transition score.

  2. Number of subjects with EuroQol (EQ)-5D scale scores [ Time Frame: At Baseline (Month 0) ]
    The EQ-5D is a generic multi-attribute health classification system. The EQ-5D uses a 5-dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) descriptive system, with each consisting of 3 response options (no problems, moderate problems or extreme problems/inability to perform).

  3. Number of subjects with confirmed Herpes zoster (HZ) cases, by frailty status [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Incidence of HZ cases during ZOSTER-006 and ZOSTER-022 for subjects in the modified Total Vaccinated Cohort (mTVC).

  4. Number of subjects with Herpes Zoster burden of illness score, by frailty status [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    HZ Burden of Illness score for subjects in both ZOSTER-006 and ZOSTER-022 is calculated from the Zoster Brief Pain Inventory (ZBPI), for each subject responding with "worst pain". HZ burden-of-illness score, is defined as the area under the curve (AUC) of 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.

  5. Number of subjects with any local and general symptoms, by frailty status [ Time Frame: Within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; ]
    Solicited local and general symptoms from ZOSTER-006 and-022. Assessed solicited local symptoms were pain, redness and swelling. 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.

  6. Number of subjects with any unsolicited adverse events (AEs) from ZOSTER-006 and ZOSTER-022 studies, by frailty status [ Time Frame: Within 30 days (Days 0 - 29) after each vaccination ]
    An unsolicited AE covers 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, excluding events reported in a solicited manner.

  7. Number of subjects with serious adverse events (AEs) from ZOSTER-006 and ZOSTER-022 studies [ Time Frame: Up to 1 year post dose 2 ]
    Serious adverse events (SAEs) assessed include medical occurrences that are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  8. Number of subjects reporting any potential immune-mediated diseases (pIMDs) by frailty status in ZOSTER-006 and ZOSTER-022 studies [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    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

  9. Anti-glycoprotein E (Anti-gE) and anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) concentrations, by frailty status [ Time Frame: At Months 0, 3, 14, 26 and 38. ]
    Anti-gE and anti-VZV Ab concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), in a subset of subjects

  10. Number of subjects with fatal SAEs [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Fatal SAEs assessed include medical occurrences that result in death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects enrolled in the Zoster 006 and Zoster 022 studies
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563183


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85213
GSK Investigational Site
Phoenix, Arizona, United States, 85018
GSK Investigational Site
Phoenix, Arizona, United States, 85020
United States, California
GSK Investigational Site
Spring Valley, California, United States, 91978
United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33761
GSK Investigational Site
DeLand, Florida, United States, 32720
GSK Investigational Site
Jacksonville, Florida, United States, 32205
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Idaho
GSK Investigational Site
Meridian, Idaho, United States, 83642
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64114
United States, North Carolina
GSK Investigational Site
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
United States, Ohio
GSK Investigational Site
Beachwood, Ohio, United States, 44122
GSK Investigational Site
Wadsworth, Ohio, United States, 44281
United States, Pennsylvania
GSK Investigational Site
Pleasant Hills, Pennsylvania, United States, 15236
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
GSK Investigational Site
Murray, Utah, United States, 84123
United States, Virginia
GSK Investigational Site
Newport News, Virginia, United States, 23606
GSK Investigational Site
Richmond, Virginia, United States, 23294
GSK Investigational Site
Winchester, Virginia, United States, 22601
United States, Washington
GSK Investigational Site
Renton, Washington, United States, 98057
Australia, New South Wales
GSK Investigational Site
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
Australia, Queensland
GSK Investigational Site
Sherwood, Queensland, Australia, 4075
Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
GSK Investigational Site
Curitiba, Paraná, Brazil, 80810-050
GSK Investigational Site
Curitiba/PR, Brazil, 80240-280
GSK Investigational Site
São Paulo, Brazil, 04023-900
GSK Investigational Site
São Paulo, Brazil, 04266-010
GSK Investigational Site
São Paulo, Brazil, 05403-000
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3M9
Canada, Newfoundland and Labrador
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M4S 1Y2
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
GSK Investigational Site
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
GSK Investigational Site
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
Canada
GSK Investigational Site
Quebec, Canada, G1W 4R4
Czechia
GSK Investigational Site
Hradec Kralove, Czechia
Estonia
GSK Investigational Site
Tallinn, Estonia, 13619
GSK Investigational Site
Tartu, Estonia, 50106
Finland
GSK Investigational Site
Tampereen Yliopisto, Finland, 33014
France
GSK Investigational Site
Angers, France, 49000
GSK Investigational Site
Angers, France, 49100
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
Germany
GSK Investigational Site
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
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
Floersheim, Hessen, Germany, 65439
GSK Investigational Site
Frankfurt, Hessen, Germany, 60389
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
GSK Investigational Site
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
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
GSK Investigational Site
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
Luebeck, Schleswig-Holstein, Germany, 23554
GSK Investigational Site
Berlin, Germany, 10629
GSK Investigational Site
Berlin, Germany, 10717
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 12157
GSK Investigational Site
Berlin, Germany, 13347
GSK Investigational Site
Hamburg, Germany, 20251
GSK Investigational Site
Hamburg, Germany, 22143
GSK Investigational Site
Hamburg, Germany, 22415
GSK Investigational Site
Magdeburg, Germany, 39120
Hong Kong
GSK Investigational Site
Kwun Tong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Italy
GSK Investigational Site
Chieti, Abruzzo, Italy, 66013
GSK Investigational Site
Pescara, Abruzzo, Italy, 65100
GSK Investigational Site
Roma, Lazio, Italy, 00133
GSK Investigational Site
Roma, Lazio, Italy, 00163
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Monza, Lombardia, Italy, 20900
GSK Investigational Site
Cuneo, Piemonte, Italy, 12100
Japan
GSK Investigational Site
Fukuoka, Japan, 810-0021
GSK Investigational Site
Fukuoka, Japan, 812-0025
GSK Investigational Site
Fukuoka, Japan, 813-8588
GSK Investigational Site
Kanagawa, Japan, 224-8503
GSK Investigational Site
Tokyo, Japan, 141-0001
GSK Investigational Site
Tokyo, Japan, 142-8666
GSK Investigational Site
Tokyo, Japan, 154-0024
Korea, Republic of
GSK Investigational Site
Gangwon-do, Korea, Republic of, 26426
GSK Investigational Site
Gyeonggi-do, Korea, Republic of, 14584
GSK Investigational Site
Gyeonggi-do, Korea, Republic of, 15355
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Seoul, Korea, Republic of, 06273
GSK Investigational Site
Seoul, Korea, Republic of, 06351
GSK Investigational Site
Seoul, Korea, Republic of, 07441
GSK Investigational Site
Seoul, Korea, Republic of, 08308
Mexico
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
GSK Investigational Site
Durango, Mexico, 34000
Spain
GSK Investigational Site
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
Sweden
GSK Investigational Site
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
Taiwan
GSK Investigational Site
Taichung, Taiwan, 40447
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Taoyuan County, Taiwan, 333
United Kingdom
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU
GSK Investigational Site
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03563183     History of Changes
Other Study ID Numbers: 204878
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by GlaxoSmithKline:
immunogenicity
Herpes Zoster
efficacy
safety
frailty
Shingles vaccine

Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Herpes Zoster
Pathologic Processes
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases