Last updated: 12/02/2020 14:20:09
A study to assess frailty of subjects during ZOSTER-006 and ZOSTER-022
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects by frailty status, at baseline
Timeframe: At Baseline (Month 0)
Secondary outcomes:
Distribution of Short Form 36 (SF-36) Questionnaire scale scores, by country
Timeframe: At Month 0, 14, 26 and 38
Distribution of EuroQol (EQ)-5D Questionnaire scale scores, by country
Timeframe: At Month 0, 14, 26 and 38
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)
Herpes Zoster burden of illness score, by frailty status
Timeframe: 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
Timeframe: Within 7 days (Days 0-6) after each vaccination
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
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
Number of subjects with Any and Related serious adverse events (SAEs), by frailty status
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38
Interventions:
Other: Encoding of data collected in Zoster 006 and Zoster 022 studies
Enrollment:
26976
Observational study model:
Other
Primary completion date:
2019-30-04
Time perspective:
Retrospective
Clinical publications:
Desmond Curran, Joon Hyung Kim, Sean Matthews, Christophe Dessart, Myron J. Levin, Lidia Oostvogels, Megan E. Riley, Kenneth E. Schmader, Anthony L. Cunningham, Shelly A. McNeil, Anne E. Schuind, Melissa K. Andrew. Recombinant Zoster Vaccine is Efficacious and Safe in Frail Individuals. 2020. J Am Geriatr Soc. doi: 10.1111/jgs.16917.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
June 2018 to April 2019
Type
Observational
Phase
3
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
All subjects who participated in the Zoster 006 and Zoster 022 trials.
Exclusion criteria:
- 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).
Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER-022. This will include any subject eliminated following deviations from GCP compliance.
Trial location(s)
Location
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Status
Study Complete
Location
GSK Investigational Site
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Cary, North Carolina, United States, 27518
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45355
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64114
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
La Roca del Valles (Barcelona), Spain, 08430
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23554
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Maroubra, New South Wales, Australia, 2035
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, North Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85018
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85020
Status
Study Complete
Location
GSK Investigational Site
Pleasant Hills, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Rednitzhembach, Bayern, Germany, 91126
Status
Study Complete
Location
GSK Investigational Site
Renton, Washington, United States, 98057
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04023-900
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04266-010
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 05403-000
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72074
Status
Study Complete
Location
GSK Investigational Site
Umina, New South Wales, Australia, 2257
Status
Study Complete
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3M9
Status
Study Complete
Location
GSK Investigational Site
Wangen, Baden-Wuerttemberg, Germany, 88239
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Winchester, Virginia, United States, 22601
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
Status
Study Complete
Location
GSK Investigational Site
Wollongong, New South Wales, Australia, 2522
Status
Study Complete
Location
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2019-30-04
Actual study completion date
2019-30-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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Access to clinical trial data by researchers
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