CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26,976 enrolled
Drug / intervention
Encoding of data collected in Zoster 006 and Zoster 022 studiesother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03563183
NCT03563183N/ACompleted
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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

GlaxoSmithKline·observational·Posted Jun 20, 2018·Updated Apr 30, 2020

In Brief

An observational study evaluating Encoding of data collected in Zoster 006 and Zoster 022 studies for Herpes Zoster. Completed, enrolled 26,976 participants across 169 sites in 18 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
CountriesAustralia, Brazil, Canada, Czechia, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Mexico, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 20, 2018
Enrollment StartJun 5, 2018
Primary CompletionApr 30, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.0 years ago

Interventions

Encoding of data collected in Zoster 006 and Zoster 022 studiesother

Not applicable (disease epidemiology study)