Herpes Zoster Clinical Trial
Official title:
Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GSK Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age
The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals' HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age
The study will evaluate the impact of HZ/su vaccination on the QoL, 400 adults ≥ 50 years of
age (YOA). Subjects will be asked to respond to a series of SF-36 and EQ-5D questionnaires
before and after vaccination following a 2 month schedule. To estimate the impact of
reactogenicity on an individual's physical functioning (PF) and QoL, the study will compare
subject questionnaire responses made during two periods, i.e., pre-vaccination and
post-vaccination. The difference will be considered to be the effect of vaccination and
reactogenicity on the PF and QoL. To characterize the study population and determine if
frailty may influence reactogenicity and consequently the impact on QoL scores, the subjects'
frailty status will be assessed at the first inclusion visit. In addition to the SF-36 and
EQ-5D questionnaires, a more complete characterization of the reactogenicity of the vaccine
will be made by including a detailed collection of the use of healthcare resources and the
occurrence of symptoms through diary card data collection. Impact on days of work loss, both
for the subject or for a caregiver, as applicable, will also be assessed.
Note that as a result of internal change in data standards terminology, the study data
collected was converted to cDISC and the statistical analysis plan was amended accordingly.
"Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by
"Day n+1". Thus, the timeframes (Day 0, Day n) of Outcome Measures described in this study
record are different to that denoted in the full protocol document posted.
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