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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26,976
- 试验地点
- 1
- 主要终点
- Number of Subjects by Frailty Status, at Baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER-
- •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).
结局指标
主要结局
Number of Subjects by Frailty Status, at Baseline
时间窗: At Baseline (Month 0)
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 0.08, the subject was classified as Non-Frail. If the score was greater than 0.08 but less than or equal to 0.25, the subject was classified as pre-frail. If the score was greater than 0.25, the subject was classified as Frail. Subjects without a FI score were classified as unknown.
次要结局
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Frailty Status(Within 7 days (Days 0-6) after each vaccination)
- Number of Subjects With Any Fatal Serious Adverse Events (SAEs), by Frailty Status(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Frailty Status(Within 7 days (Days 0-6) after each vaccination)
- Anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects(Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38)
- Distribution of Short Form 36 (SF-36) Questionnaire Scale Scores, by Country(At Month 0, 14, 26 and 38)
- Herpes Zoster Burden of Illness Score, by Frailty Status(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Any and Related Serious Adverse Events (SAEs), by Frailty Status(From Month 0 to Month 14)
- Incidence Rate (Per 1000 Person-years) of Confirmed Herpes Zoster (HZ) Cases, by Frailty Status(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine, by Frailty Status(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs), by Frailty Status(During the entire study period (3 to 5 year period following Day 0))
- Distribution of EuroQol (EQ)-5D Questionnaire Scale Scores, by Country(At Month 0, 14, 26 and 38)
- Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects(Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs), by Frailty Status(Within 30 days (Days 0 - 29) after each vaccination)