"Zoster-064 Study to assess frailty of subjects in Zoster 006 and 022"
Research type
Research Study
Full 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
IRAS ID
247229
Contact name
Huda Alobaidi
Contact email
Sponsor organisation
GSK Biologicals SA
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
Herpes Zoster (Shingles) is an infection caused by the same virus that causes chickenpox. After getting chickenpox during childhood, the virus remains dormant in the body. Shingles occurs when the virus becomes active again after many years, mostly when people are older than 50 years. The chance of getting shingles is higher as people get older.
This is a retrospective study of subjects enrolled in two previous vaccine studies, ZOSTER-006 and ZOSTER-022. There will be no new subjects enrolled in this study.
During the ZOSTER-006 and ZOSTER-022 studies, each subject enrolled was asked, at four timepoints during the study, to complete two quality of life (QoL) questionnaires. These questionnaires were encoded into the study databases only for subjects who developed suspected shingles during the study (approx. 1000 subjects from 30,000 subjects enrolled worldwide). This was done to assess the QoL of subjects who developed suspected shingles in the vaccine group and the placebo group. Questionnaires completed by subjects who did not develop suspected shingles were not encoded or analysed as part of the previous studies.
This study, funded by GlaxoSmithKline (GSK), will allow for the encoding and analysis of all questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the frailty, at the start of the study, of subjects enrolled in ZOSTER-006 and ZOSTER-022 and to investigate the representativeness of the study population to the general older adult population.
In the UK, 1251 subjects from 7 GP/independent sites will be involved in this study, which is expected to start in August 2018, with encoding of questionnaires completed in approx. 7 months. (April 2019).
No new informed consent will be collected as consent provided by the subjects when participating in the earlier studies included completion of QoL questionnaires and allowed for their encoding and analysis.REC name
West of Scotland REC 4
REC reference
18/WS/0115
Date of REC Opinion
17 Jul 2018
REC opinion
Further Information Favourable Opinion