Last updated: 07/18/2020 12:12:21

Study to evaluate efficacy, safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A in adults aged 70 years and older

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GSK study ID
113077
See study documents
Clinicaltrials.gov ID
NCT01165229
See results summary
EudraCT ID
2009-015791-94
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 70 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 ≥ 70 years.
Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be 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. This protocol posting also deals with the outcome measures related to the pooled analysis.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with any episodes of herpes zoster (HZ)

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

Outcome measure for the pooled analysis of combined data from studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of subjects with post-herpetic neuralgia (PHN)

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

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with confirmed HZ

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

Secondary outcomes:

Number of subjects with post-herpetic neuralgia (PHN)

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 overall mortality and HZ-related mortality

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 HZ related complications

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

Number of subjects receiving pain medication associated with HZ

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

Number of days with 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: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

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

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)

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

Number of subjects with any and related serious adverse events (SAEs)

Timeframe: From Month 0 to Month 14

Number of subjects with fatal serious adverse events (SAEs)

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

Number of subjects with SAEs related to study participation or concomitant GSK medication

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)

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

Number of subjects with any and related Medically attended visits

Timeframe: From Month 0 to Month 8 post-vaccination

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall number of subjects with PHN in subjects ≥ 50 YOA

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

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with a reduction of PHN incidence in subjects ≥ 50 YOA with confirmed HZ

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

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with at least one day of severe ‘worst’ HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ.

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

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of severe ‘worst’ HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ.

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

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any,grade 3 and related unsolicited AEs in subjects ≥ 70 YOA

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

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any and related SAEs

Timeframe: From Month 0 to Month 14

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with fatal SAEs

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

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any and related pIMDs

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

Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any and related medically attended visits

Timeframe: From Month 0 to Month 8 post-vaccination

Interventions:
  • Biological/vaccine: Herpes Zoster Vaccine GSK1437173A
  • Biological/vaccine: Placebo
    • Enrollment:
    14819
    Primary completion date:
    2015-24-07
    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.
    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
    70+ 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.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes will comply with the requirements of the protocol.

      • Written informed consent obtained from the subject.
      • A male or female aged 70 years or older at the time of the first vaccination.
    Exclusion criteria:

      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.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy History of HZ.
      • Previous vaccination against varicella or HZ.
      • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation.
      • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
      • Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period.
      • Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
      • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
      • Acute disease and/or fever at the time of enrolment.
      • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Alcover( Tarragona), Spain, 43460
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Angers, France, 49000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ansan, South Korea, 425-707
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arlington, Virginia, United States, 22203
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Atherstone, Warwickshire, United Kingdom, CV9 1EU
    Status
    Study Complete
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    Location
    GSK Investigational Site
    BORÅS, Sweden, SE-506 30
    Status
    Study Complete
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    Showing 1 - 6 of 210 Results

    Study documents

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

    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
    2015-24-07
    Actual study completion date
    2015-24-07

    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

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    Additional information
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