Last updated: 07/17/2024 15:46:36

Study to evaluate efficacy, safety, and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster vaccine GSK1437173A

GSK study ID
115523
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: Observer-blind study to evaluate efficacy, safety, and immunogenicity of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A
Trial description: The purpose of this study is to evaluate the efficacy of GSK Biologicals’ vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.
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) episode

Timeframe: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)

Secondary outcomes:

Duration of ‘worst’ HZ-associated pain

Timeframe: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period

Number of subjects with confirmed HZ-associated complications

Timeframe: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)

Number of subjects with Postherpetic Neuralgia (PHN)

Timeframe: From Month 0 until study end (21 months median follow-up)

Antigen-glycoprotein E (gE) antibody concentrations in a sub-cohort of subjects

Timeframe: At Months 0, 1, 2, 13 and 25

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During 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: During 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: During the 30-day (Days 0-29) post-vaccination period

Number of subjects with any and related potential Immune Mediated Diseases (pIMDs)

Timeframe: From Month 0 up to 365 days post last vaccination

Number of subjects with any relapse

Timeframe: From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)

Number of subjects with any Serious Adverse Events (SAEs) and Related SAEs to GSK study vaccine/placebo

Timeframe: From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)

Number of subjects with fatal SAEs and SAEs related to study participation or to a GSK concomitant medication or vaccination

Timeframe: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years)

Interventions:
  • Biological/vaccine: Herpes Zoster vaccine GSK1437173A
  • Biological/vaccine: Placebo
  • Enrollment:
    1877
    Primary completion date:
    2016-04-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bastidas A et al. (2019) Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 322(2):123-133.
    Edward A. Stadtmauer et al for the ZOE-HSCT study group collaborators. Adjuvanted recombinant zoster vaccine in adult autologous stem cell transplant recipients: polyfunctional immune responses and lessons for clinical practice. Hum Vaccin Immunother. 2021;epub(epub):epub. DOI: http://dx.doi.org/ 10.1080/21645515.2021.1953346
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    July 2012 to February 2017
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Study entry (enrollment) occurs at the Pre-vaccination visit.
    • Subjects who the investigator believes can and will comply with the requirements of the protocol.
    • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered or non-registered product to treat the subject’s underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed.
    • Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Airdrie, Lanarkshire, United Kingdom, ML6 0JS
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ankara, Turkey, 6100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Antwerpen, Belgium, 2060
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 106 76
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 115 27
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 151 23
    Status
    Study Complete
    Location
    GSK Investigational Site
    Aurora, Colorado, United States, 80045
    Status
    Study Complete
    Location
    GSK Investigational Site
    Aviano (PN), Friuli-Venezia-Giulia, Italy, 33081
    Status
    Study Complete
    Location
    GSK Investigational Site
    Badalona/Barcelona, Spain, 08916
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08025
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08035
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08036
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bayreuth, Bayern, Germany, 95445
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10117
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12200
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12351
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bonn, Nordrhein-Westfalen, Germany, 53127
    Status
    Study Complete
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02111
    Status
    Study Complete
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02114
    Status
    Study Complete
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02115
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bournemouth, United Kingdom, BH7 7DW
    Status
    Study Complete
    Location
    GSK Investigational Site
    Box Hill, Victoria, Australia, 3128
    Status
    Study Complete
    Location
    GSK Investigational Site
    Brugge, Belgium, 8000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bruxelles, Belgium, 1000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27599
    Status
    Study Complete
    Location
    GSK Investigational Site
    Clermont-Ferrand Cedex 1, France, 63003
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44195
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cona (FE), Emilia-Romagna, Italy, 44124
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cottingham, United Kingdom, HU16 5JQ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Créteil cedex, France, 94010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Daegu, South Korea, 700-721
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75246
    Status
    Study Complete
    Location
    GSK Investigational Site
    Darlinghurst, New South Wales, Australia, 2010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48201
    Status
    Study Complete
    Location
    GSK Investigational Site
    Duarte, California, United States, 91010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27705
    Status
    Study Complete
    Location
    GSK Investigational Site
    East Melbourne, Victoria, Australia, 3002
    Status
    Study Complete
    Location
    GSK Investigational Site
    Eschweiler, Nordrhein-Westfalen, Germany, 52249
    Status
    Study Complete
    Location
    GSK Investigational Site
    Fukuoka, Japan, 811-1395
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gliwice, Poland, 44-101
    Status
    Study Complete
    Location
    GSK Investigational Site
    Grafton, New Zealand, 1003
    Status
    Study Complete
    Location
    GSK Investigational Site
    Grenoble cedex 9, France, 38043
    Status
    Study Complete
    Location
    GSK Investigational Site
    Groenkloof, South Africa, 0181
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gunma, Japan, 377-0280
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hackensack, New Jersey, United States, 07601
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hafia, Israel, 31096
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hasselt, Belgium, 3500
    Status
    Study Complete
    Location
    GSK Investigational Site
    Headington, Oxford, United Kingdom, OX3 7LE
    Status
    Study Complete
    Location
    GSK Investigational Site
    Heidelberg, Victoria, Australia, 3084
    Status
    Study Complete
    Location
    GSK Investigational Site
    Heidelberg, Baden-Wuerttemberg, Germany, 69120
    Status
    Study Complete
    Location
    GSK Investigational Site
    Helsinki, Finland, 00029
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hiroshima, Japan, 737-0023
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hiroshima, Japan, 739-0651
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hobart, Tasmania, Australia, 7000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hong Kong, Hong Kong
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hradec Kralove, Czech Republic, 500 05
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hyogo, Japan, 650-0047
    Status
    Study Complete
    Location
    GSK Investigational Site
    Incheon, South Korea, 405-760
    Status
    Study Complete
    Location
    GSK Investigational Site
    Izmir, Turkey, 35100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jellanamdo, South Korea, 519-809
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jeonju, South Korea, 561-712
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jerusalem, Israel, 91120
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jette, Belgium, 1090
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kaohsiung, Taiwan, 833
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kiel, Schleswig-Holstein, Germany, 24105
    Status
    Study Complete
    Location
    GSK Investigational Site
    Krakow, Poland, 30510
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kuala Lumpur, Malaysia, 56000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kumamoto, Japan, 860-0008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kyunggi-do, South Korea, 410-769
    Status
    Study Complete
    Location
    GSK Investigational Site
    LEIDEN, Netherlands, 2333 ZA
    Status
    Study Complete
    Location
    GSK Investigational Site
    Leeds, United Kingdom, LS9 7TF
    Status
    Study Complete
    Location
    GSK Investigational Site
    Leuven, Belgium, 3000
    Status
    Study Complete
    Location
    GSK Investigational Site
    León, Spain, 24008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Liege, Belgium, 4000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28009
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28033
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28034
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28040
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28041
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28050
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28911
    Status
    Study Complete
    Location
    GSK Investigational Site
    Majadahonda (Madrid), Spain, 28222
    Status
    Study Complete
    Location
    GSK Investigational Site
    Malaga, Spain, 29010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Manchester, United Kingdom, M13 9WL
    Status
    Study Complete
    Location
    GSK Investigational Site
    Manchester, United Kingdom, M20 4BX
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mannheim, Baden-Wuerttemberg, Germany, 68167
    Status
    Study Complete
    Location
    GSK Investigational Site
    Marseille cedex 9, France, 13273
    Status
    Study Complete
    Location
    GSK Investigational Site
    Marshfield, Wisconsin, United States, 54449
    Status
    Study Complete
    Location
    GSK Investigational Site
    Meldola (FC), Emilia-Romagna, Italy, 47014
    Status
    Study Complete
    Location
    GSK Investigational Site
    Minnesota, Minnesota, United States, 55455
    Status
    Study Complete
    Location
    GSK Investigational Site
    Montpellier cedex 5, France, 34295
    Status
    Study Complete
    Location
    GSK Investigational Site
    Montréal, Québec, Canada, H2X 3E4
    Status
    Study Complete
    Location
    GSK Investigational Site
    Moreleta Park, Pretoria, South Africa, 0001
    Status
    Study Complete
    Location
    GSK Investigational Site
    Moscow, Russia, 105 229
    Status
    Study Complete
    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 81545
    Status
    Study Complete
    Location
    GSK Investigational Site
    Muenster, Nordrhein-Westfalen, Germany, 48149
    Status
    Study Complete
    Location
    GSK Investigational Site
    Murcia, Spain, 30008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Murcia (El Palmar), Spain, 30120
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nagasaki, Japan, 856-8562
    Status
    Study Complete
    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
    Location
    GSK Investigational Site
    Niigata, Japan, 951-8566
    Status
    Study Complete
    Location
    GSK Investigational Site
    Novara, Piemonte, Italy, 28100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Novosibirsk, Russia, 630099
    Status
    Study Complete
    Location
    GSK Investigational Site
    Okayama, Japan, 700-8558
    Status
    Study Complete
    Location
    GSK Investigational Site
    Okayama, Japan, 701-1192
    Status
    Study Complete
    Location
    GSK Investigational Site
    Olomouc, Czech Republic, 775 20
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oviedo, Spain, 33006
    Status
    Study Complete
    Location
    GSK Investigational Site
    Panama, Panama
    Status
    Study Complete
    Location
    GSK Investigational Site
    Parktown, Gauteng, South Africa, 2193
    Status
    Study Complete
    Location
    GSK Investigational Site
    Parkville, Victoria, Australia, 3050
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pessac cedex, France, 33604
    Status
    Study Complete
    Location
    GSK Investigational Site
    Petrozavodsk, Russia, 185019
    Status
    Study Complete
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Study Complete
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Study Complete
    Location
    GSK Investigational Site
    Plumstead, Western Province, South Africa, 7800
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pozuelo de Alarcón/Madrid, Spain, 28223
    Status
    Study Complete
    Location
    GSK Investigational Site
    Praha 10, Czech Republic, 100 34
    Status
    Study Complete
    Location
    GSK Investigational Site
    Praha 2, Czech Republic, 128 08
    Status
    Study Complete
    Location
    GSK Investigational Site
    Quebec City, Québec, Canada, G1J 1Z4
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ravenna, Emilia-Romagna, Italy, 48123
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rimini, Emilia-Romagna, Italy, 47900
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rochester, Minnesota, United States, 55905
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rouen cedex 1, France, 76038
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rozzano (MI), Lombardia, Italy, 20089
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint John, New Brunswick, Canada, E2L 4L2
    Status
    Study Complete
    Location
    GSK Investigational Site
    San Francisco, California, United States, 94143
    Status
    Study Complete
    Location
    GSK Investigational Site
    San Sebastián, Spain, 20014
    Status
    Study Complete
    Location
    GSK Investigational Site
    Santander, Spain, 39008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saskatoon, Saskatchewan, Canada, S7N 4H4
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98108
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98109-1024
    Status
    Study Complete
    Location
    GSK Investigational Site
    Selangor, Malaysia, 68000 Ampang
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seoul, South Korea, 110-744
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shizuoka, Japan, 411-8777
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sofia, Bulgaria, 1000
    Status
    Study Complete
    Location
    GSK Investigational Site
    St'Petersburg, Russia, 191024
    Status
    Study Complete
    Location
    GSK Investigational Site
    St.-Petersburg, Russia, 194291
    Status
    Study Complete
    Location
    GSK Investigational Site
    St.Petersburg, Russia, 197110
    Status
    Study Complete
    Location
    GSK Investigational Site
    Swindon, Wiltshire, United Kingdom, SN3 6BB
    Status
    Study Complete
    Location
    GSK Investigational Site
    Taichung, Taiwan, 404
    Status
    Study Complete
    Location
    GSK Investigational Site
    Taichung, Taiwan, 40705
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tallinn, Estonia, 13419
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tampere, Finland, 33520
    Status
    Study Complete
    Location
    GSK Investigational Site
    Taoyuan Hsien, Taiwan, 333
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thessaloniki, Greece, 57010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tirgu Mures, Romania, 540042
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tokyo, Japan, 113-8677
    Status
    Study Complete
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M5G 2M9
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tuen Mun, Hong Kong
    Status
    Study Complete
    Location
    GSK Investigational Site
    Turku, Finland, 20520
    Status
    Study Complete
    Location
    GSK Investigational Site
    Udine, Friuli-Venezia-Giulia, Italy, 33100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valencia, Spain, 46010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valencia, Spain, 46026
    Status
    Study Complete
    Location
    GSK Investigational Site
    Vancouver, British Columbia, Canada, V5Z 1M9
    Status
    Study Complete
    Location
    GSK Investigational Site
    Velbert, Nordrhein-Westfalen, Germany, 42551
    Status
    Study Complete
    Location
    GSK Investigational Site
    Warszawa, Poland, 02-776
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wellington, New Zealand, 6021
    Status
    Study Complete
    Location
    GSK Investigational Site
    Westmead, New South Wales, Australia, 2145
    Status
    Study Complete
    Location
    GSK Investigational Site
    Westwood, Kansas, United States, 66205
    Status
    Study Complete
    Location
    GSK Investigational Site
    Woodville, South Australia, Australia, 5011
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wuerzburg, Bayern, Germany, 97080
    Status
    Study Complete

    Study documents

    Clinical study report
    Available language(s): English
    Protocol
    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
    2016-04-11
    Actual study completion date
    2017-01-02

    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

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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