N/A N=26,976

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

Herpes Zoster

Bottom Line

View on ClinicalTrials.gov: NCT03563183 ↗

Enrolled (actual)

26,976

Serious AEs

13.2%

Results posted

Apr 2020

Primary outcome: Primary: Number of Subjects by Frailty Status, at Baseline — 11518; 12290; 3037; 131 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Encoding of data collected in Zoster 006 and Zoster 022 studies (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects by Frailty Status, at Baseline	11518; 12290; 3037; 131	—
SECONDARY Distribution of Short Form 36 (SF-36) Questionnaire Scale Scores, by Country	75.50; 80.43; 74.49; 76.15; 67.58; 91.11	—
SECONDARY Distribution of EuroQol (EQ)-5D Questionnaire Scale Scores, by Country	0.8072; 85.43; 0.7671; 81.48; 0.7582; 81.24	—
SECONDARY Incidence Rate (Per 1000 Person-years) of Confirmed Herpes Zoster (HZ) Cases, by Frailty Status	0.4; 8.8; 0.8; 8.6; 1.0; 9.9	<0.0001 sig
SECONDARY Herpes Zoster Burden of Illness Score, by Frailty Status	0.017; 1.173; 0.108; 1.475; 0.345; 2.330	—
SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Frailty Status	1655; 209; 1494; 211; 322; 51	—
SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Frailty Status	951; 301; 848; 339; 164; 96	—
SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs), by Frailty Status	2984; 1696; 3019; 2034; 754; 520	—
SECONDARY Number of Subjects With Any and Related Serious Adverse Events (SAEs), by Frailty Status	357; 328; 697; 751; 293; 332	—
SECONDARY Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine, by Frailty Status	14; 16; 55; 49; 24; 31	—
SECONDARY Number of Subjects With Any Fatal Serious Adverse Events (SAEs), by Frailty Status	124; 109; 299; 343; 174; 182	—
SECONDARY Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs), by Frailty Status	74; 69; 76; 90; 15; 27	—
SECONDARY Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects	1251.6; 1389.1; 1363.0; 1325.4; 1450.8; 1457.7	—
SECONDARY Anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects	966.9; 1053.3; 992.9; 1036.9; 996.6; 1054.7	—

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.

Eligibility Criteria

Inclusion Criteria

All subjects who participated in the Zoster 006 and Zoster 022 trials.
Subjects who died or were lost to follow-up during ZOSTER-006 and ZOSTER-022 will be considered for enrolment in ZOSTER-064 and their data/questionnaires up to that point will be used.

Exclusion Criteria

Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER-022. This will include any subject eliminated following deviations from GCP compliance.
Subjects who developed a suspected HZ case during ZOSTER-006 and ZOSTER-022 (since their QoL questionnaires were encoded in the eCRF for ZOSTER-006 and ZOSTER-022).

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Data sourced from ClinicalTrials.gov (NCT03563183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.