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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03563183
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date June 4, 2018
First Posted Date June 20, 2018
Last Update Posted Date June 3, 2019
Actual Study Start Date January 3, 2010
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2018)
Number of subjects with frailty status at baseline [ Time Frame: At Baseline (Month 0) ]
Frailty Status prior to vaccination, is defined by responses to components of the SF-36 and EQ-5D questionnaire and the subjects coded medical history, from Zoster-006 and Zoster-022 studies
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03563183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 19, 2018)
  • Number of subjects with Short Form 36 Questionnaire (SF-36) scale scores [ Time Frame: At Baseline (Month 0) ]
    The SF-36 is a multi-purpose health survey with 36 questions. It yields an 8-scale profile of scores (physical functioning, role physical, bodily pain, general health perceptions, vitality, social functioning, role emotional, and mental health) as well as a reported health transition score.
  • Number of subjects with EuroQol (EQ)-5D scale scores [ Time Frame: At Baseline (Month 0) ]
    The EQ-5D is a generic multi-attribute health classification system. The EQ-5D uses a 5-dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) descriptive system, with each consisting of 3 response options (no problems, moderate problems or extreme problems/inability to perform).
  • Number of subjects with confirmed Herpes zoster (HZ) cases, by frailty status [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Incidence of HZ cases during ZOSTER-006 and ZOSTER-022 for subjects in the modified Total Vaccinated Cohort (mTVC).
  • Number of subjects with Herpes Zoster burden of illness score, by frailty status [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    HZ Burden of Illness score for subjects in both ZOSTER-006 and ZOSTER-022 is calculated from the Zoster Brief Pain Inventory (ZBPI), for each subject responding with "worst pain". HZ burden-of-illness score, is defined as the area under the curve (AUC) of HZ-associated pain plotted against time during the 182-day period after the onset of the case. Subjects who developed HZ presented "burden-of-illness" scores ranging from 0 up to, theoretically, 1820. A score of 0 is recorded for subjects in whom HZ did not develop during the study period.
  • Number of subjects with any local and general symptoms, by frailty status [ Time Frame: Within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; ]
    Solicited local and general symptoms from ZOSTER-006 and-022. Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and gastro-intestinal (GI) symptoms: nausea, vomiting, diarrhoea and/or abdominal pain.
  • Number of subjects with any unsolicited adverse events (AEs) from ZOSTER-006 and ZOSTER-022 studies, by frailty status [ Time Frame: Within 30 days (Days 0 - 29) after each vaccination ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported, excluding events reported in a solicited manner.
  • Number of subjects with serious adverse events (AEs) from ZOSTER-006 and ZOSTER-022 studies [ Time Frame: Up to 1 year post dose 2 ]
    Serious adverse events (SAEs) assessed include medical occurrences that are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of subjects reporting any potential immune-mediated diseases (pIMDs) by frailty status in ZOSTER-006 and ZOSTER-022 studies [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
  • Anti-glycoprotein E (Anti-gE) and anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) concentrations, by frailty status [ Time Frame: At Months 0, 3, 14, 26 and 38. ]
    Anti-gE and anti-VZV Ab concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), in a subset of subjects
  • Number of subjects with fatal SAEs [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]
    Fatal SAEs assessed include medical occurrences that result in death.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022
Official Title 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
Brief 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All subjects enrolled in the Zoster 006 and Zoster 022 studies
Condition Herpes Zoster
Intervention Other: Encoding of data collected in Zoster 006 and Zoster 022 studies
Not applicable (disease epidemiology study)
Study Groups/Cohorts
  • Zoster-064 GSK1437173A Group
    Subjects who have received herpes zoster subunit vaccine (gE/AS01B vaccine) in the ZOSTER-006 and Zoster-022 studies. SF-36 and EQ-5D questionnaires will be encoded to evaluate frailty Thereafter, efficacy/safety / immune responses will be assessed by frailty status.
    Intervention: Other: Encoding of data collected in Zoster 006 and Zoster 022 studies
  • Zoster-064 Placebo Group
    Subjects who have received saline solution (NaCl solution) as control in the ZOSTER-006 and Zoster-022 studies. SF-36 and EQ-5D questionnaires will be encoded to evaluate frailty Thereafter, efficacy/safety / immune responses will be assessed by frailty status.
    Intervention: Other: Encoding of data collected in Zoster 006 and Zoster 022 studies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Estimated Enrollment
 (submitted: June 19, 2018)
25000
Actual Study Completion Date April 30, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Brazil,   Canada,   Czechia,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Mexico,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03563183
Other Study ID Numbers 204878
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2019