Last updated: 01/26/2021 12:10:27

Study to evaluate efficacy, safety and immunogenicity of GSK Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A in adults aged 50 years and older

GSK study ID
110390
Clinicaltrials.gov ID
EudraCT ID
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: Efficacy, safety, and immunogenicity study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged 50 years or older
Trial description: The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals’ candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.
Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with confirmed Herpes zoster (HZ) cases

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

Secondary outcomes:

Number of subjects with any episodes of Post-Herpetic Neuralgia (PHN)

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

Number of subjects with a reduction of duration of severe ‘worst’ HZ-associated pain

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

Number of subjects with confirmed HZ episode related mortality

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

Number of subjects with HZ related complications

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

Number of subjects with confirmed HZ episode related hospitalizations

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

Number of subjects with a confirmed HZ episode having a reduction of duration of pain medication associated with HZ

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

Number of subjects with a confirmed HZ episode taking pain medication associated with HZ

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

Number of days with severe ‘worst’ HZ-associated pain.

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

Number of subjects with confirmed HZ episode related mortality and hospitalizations

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

Number of subjects with HZ related complications, by complication type

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

Distribution of pain medication associated with HZ

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

Number of days of pain medication associated with HZ

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

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Number of subjects with any, grade 3 and related solicited general symptoms

Timeframe: Within the 7-day (Days 0-6) post-vaccination period

Number of subjects with any and Grade 3 symptoms (solicited and unsolicited)

Timeframe: Within the 7-day (Days 0-6) post-vaccination period

Number of subjects with any and related potential Immune mediated diseases (pIMDs)

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

Number of subjects with AEs with any and related medically attended visit

Timeframe: From Month 0 to Month 8 post-vaccination

Number of subjects with unsolicited adverse events (AEs)

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

Number of subjects with serious adverse events (SAEs)

Timeframe: Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)

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

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

Number of subjects with fatal SAEs

Timeframe: During the entire study period (3 to 5 years following day 0)

Interventions:
  • Biological/vaccine: Herpes Zoster Vaccine GSK1437173A
  • Biological/vaccine: Placebo
  • Enrollment:
    16165
    Primary completion date:
    2014-09-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Cunningham AL et al (2016) Efficacy of the Herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 375(11):1019-1032.
    Cunningham AL et al. (2018) Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older.J Infect Dis. 217(11):1750-1760.
    Cunningham AL et al. (2018) Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in adults aged 50 years or older. J Infect Dis. 217(11):1750-1760.
    Ikematsu H et al. (2018) Efficacy, safety and immunogenicity of new adjuvanted herpes zoster subunit vaccine for Japanese over 50 years old and over 70 years old. Kansenshogaku Zasshi. 92(2):103-114.
    Kovac M et al (2018) Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 36(12):1537-1541.
    Lal H et al. (2015) Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 372(22):2087-2096.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    August 2010 to July 2015
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes will comply with the requirements of the protocol;
    • Written informed consent obtained from the subject;
    • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period;
    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product;

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Geelong, Victoria, Australia, 3220
    Status
    Study Complete
    Location
    GSK Investigational Site
    Renton, Washington, United States, 98057
    Status
    Study Complete
    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33761
    Status
    Study Complete
    Location
    GSK Investigational Site
    KARLSKRONA, Sweden, SE-371 41
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cary, North Carolina, United States, 27518
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tartu, Estonia, 50106
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-09-05
    Actual study completion date
    2015-27-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    IPD for this study will be made available via the Clinical Study Data Request site.
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