Herpes Zoster Clinical Trial
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
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.
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.
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