Last updated: 12/02/2020 14:20:09

A study to assess frailty of subjects during ZOSTER-006 and ZOSTER-022

GSK study ID
204878
See study documents
Clinicaltrials.gov ID
NCT03563183
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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 purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects by frailty status, at baseline

Timeframe: At Baseline (Month 0)

Secondary outcomes:

Distribution of Short Form 36 (SF-36) Questionnaire scale scores, by country

Timeframe: At Month 0, 14, 26 and 38

Distribution of EuroQol (EQ)-5D Questionnaire scale scores, by country

Timeframe: At Month 0, 14, 26 and 38

Incidence rate (per 1000 person-years) of confirmed Herpes zoster (HZ) cases, by frailty status

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Herpes Zoster burden of illness score, by frailty status

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with Any and Grade 3 Solicited Local Symptoms, by frailty status

Timeframe: Within 7 days (Days 0-6) after each vaccination

Number of subjects with Any, Grade 3 and Related Solicited General Symptoms, by frailty status

Timeframe: Within 7 days (Days 0-6) after each vaccination

Number of subjects with Any, Grade 3 and Related Unsolicited adverse events (AEs), by frailty status

Timeframe: Within 30 days (Days 0 - 29) after each vaccination

Number of subjects with Any and Related serious adverse events (SAEs), by frailty status

Timeframe: From Month 0 to Month 14

Number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine, by frailty status

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with any Fatal serious adverse events (SAEs), by frailty status

Timeframe: 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

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Anti-glycoprotein E (Anti-gE) Antibody (Ab) concentrations, by frailty status, in a subset of subjects

Timeframe: Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38

Anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) concentrations, by frailty status, in a subset of subjects

Timeframe: Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38

Interventions:
  • Other: Encoding of data collected in Zoster 006 and Zoster 022 studies
    • Enrollment:
    26976
    Primary completion date:
    2019-30-04
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Desmond Curran, Joon Hyung Kim, Sean Matthews, Christophe Dessart, Myron J. Levin, Lidia Oostvogels, Megan E. Riley, Kenneth E. Schmader, Anthony L. Cunningham, Shelly A. McNeil, Anne E. Schuind, Melissa K. Andrew. Recombinant Zoster Vaccine is Efficacious and Safe in Frail Individuals. 2020. J Am Geriatr Soc. doi: 10.1111/jgs.16917.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    June 2018 to April 2019
    Type
    Observational
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • 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.
    • 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).
    Inclusion and exclusion 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Alcover( Tarragona), Spain, 43460
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Angers, France, 49000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Angers, France, 49100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Atherstone, Warwickshire, United Kingdom, CV9 1EU
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    BORÃ…S, Sweden, SE-506 30
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Balenyà (Barcelona), Spain, 08550
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 165 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2019-30-04
    Actual study completion date
    2019-30-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website