NCT03563183

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26,976 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
OTHER	Encoding of data collected in Zoster 006 and Zoster 022 studies	Not applicable (disease epidemiology study)

Timeline

• Start date: 2018-06-05
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2018-06-20
• Last updated: 2020-04-30
• Results posted: 2020-04-30

Locations

169 sites across 18 countries: United States, Australia, Brazil, Canada, Czechia, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Mexico, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study