Last updated: 03/16/2021 13:40:05

Cross-vaccination study of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies.

GSK study ID
204486
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: Cross-vaccination study of GSK Biologicals’ Lyophilized formulation of the Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) in subjects who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies
Trial description: The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects with Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Timeframe: During 30 days (Days 0-29) after any vaccination (across doses)

Number of subjects with Any and Related Serious Adverse Events (SAEs)

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Number of subjects with Any and Related Potential Immune Mediated Diseases (pIMDs)

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Secondary outcomes:

Number of subjects with at least one suspected Herpes Zoster (HZ) case(s)

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Interventions:
  • Biological/vaccine: Herpes Zoster Vaccine GSK1437173A
  • Enrollment:
    8687
    Primary completion date:
    2019-15-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Josephine Ocran-Appiah, Céline Boutry, Caroline Hervé, Jyoti Soni, Anne Schuind on behalf of the Z-056 Study Group. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label Study in previous ZOE-50 and ZOE-70 placebo recipients. Vaccine. 2020. 39(1):6-10.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    March 2016 to March 2019
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    Yes
    • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, follow-up contacts). Or subjects' Legally Acceptable Representative(s) [LAR(s)]/caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, availability for follow-up contacts).
    • Written informed consent obtained from the subject/Legally Acceptable representative(s) [LAR(s)] of the subject prior to performing any study specific procedure. If the subjects is not capable of giving consent, his/her assent to participate should be obtained to the extent possible.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use up to 30 days post Dose 2.
    • Previous vaccination against Varicella Zoster virus (VZV) or HZ.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Alcover( Tarragona), Spain, 43460
    Status
    Study Complete
    Location
    GSK Investigational Site
    Angers, France, 49000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Angers, France, 49100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ansan, South Korea, 425-707
    Status
    Study Complete
    Location
    GSK Investigational Site
    Atherstone, Warwickshire, United Kingdom, CV9 1EU
    Status
    Study Complete
    Location
    GSK Investigational Site
    BORÅS, Sweden, SE-506 30
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Protocol
    Available language(s): English
    Statistical analysis plan
    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
    2019-15-03
    Actual study completion date
    2019-15-03

    Plain language summaries

    Summary of results in plain language
    Available language(s): English, Czech, German, Spanish (Mexico), Spanish, Estonian, Finnish, French (Canadian), French, Italian, Japanese, Korean, Portuguese, Russian, Swedish (Finland), Swedish, Chinese (Hong Kong), Chinese (Taiwan)

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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