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NCT03563183 · ClinicalTrials.gov registry record
A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022
A clinical trial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 26,976
- Enrollment target
NCT03563183: Completed study, sponsored by GlaxoSmithKline.
NCT03563183 is a clinical trial that has completed, run by GlaxoSmithKline. The registered enrollment target is 26,976 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03563183 has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 26,976 participants
- Enrollment target
Study 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.
Primary Outcome
Frailty status was measured in relation to the accumulation of deficits using a Frailty Index (FI) adapted from the model proposed by Mitnitski et al. \[Mitnitski, 2001\]. The different aspects of frailty composing the FI were assessed through the medical history and components of the Short Form 36 Questionnaire (SF-36) and EuroQol (EQ)-5D questionnaires recorded pre-vaccination Dose 1 (in the study ZOSTER-006\[NCT01165177\] and ZOSTER-022\[NCT01165229\]). If the FI was less than or equal to 0.
Interventions
- OTHER Encoding of data collected in Zoster 006 and Zoster 022 studies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26,976 participants |
| Start Date | 2018-06-05 |
| Est. Completion | 2019-04-30 |
What the finished NCT03563183 record still lists
NCT03563183 is an observational study that tracks outcomes without assigning an intervention. Its 26,976 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Encoding of data collected in Zoster 006 and Zoster 022 studies is the first listed.
NCT03563183 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03563183 about?
NCT03563183 is a clinical study titled "A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022". 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 purpo...
What is the current status of trial NCT03563183?
This trial is currently completed. The enrollment target is 26,976 participants. The study started on 2018-06-05. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT03563183?
The interventions under investigation include: Encoding of data collected in Zoster 006 and Zoster 022 studies (OTHER).
Who is sponsoring clinical trial NCT03563183?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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