Last updated: 07/17/2024 16:46:37

Study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster subunit (HZ/su) vaccine in adults aged 18 years and older with blood cancers

GSK study ID
116428
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: Study to evaluate safety and immunogenicity of GSK Biologicals' Herpes Zoster vaccine GSK1437173A in adults aged 18 years and older with haematologic malignancies
Trial description: The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals’ vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Vaccine response rates (VRR) for anti-glycoprotein E (anti-gE) antibody concentrations

Timeframe: At Month 2

Adjusted geometric mean concentration of anti-gE antibodies

Timeframe: At Month 2

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 days with solicited local symptoms

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

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 days with solicited general symptoms

Timeframe: Withing the 7-day (Day 0-6) post-vaccination period

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

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

Number of subjects with serious adverse events (SAEs)

Timeframe: From first vaccination up to 30 days post last vaccination

Number of subjects reporting any and related potential immune-mediated diseases (pIMDs)

Timeframe: From first vaccination up to 30 days post last vaccination

Secondary outcomes:

Vaccine response rate (VRR) for anti-gE antibody concentrations

Timeframe: At Month 2

Anti-gE antibody concentrations

Timeframe: At Month 2

Time to occurrence of any confirmed HZ case

Timeframe: From Month 0 until study end (Month 13)

Anti-gE antibody concentrations

Timeframe: At Months 0, 1, 2 and 13

Vaccine response rate (VRR) for anti-gE antibody concentrations

Timeframe: At Months 1, 2 and 13

Frequency of gE -specific cluster of differentiation 4 (CD4) [2+] T-cells expressing at least 2 activation markers

Timeframe: At Months 0, 1, 2 and 13

Vaccine response rates (VRR) for gE-specific CD4 [2+] T-cells, expressing at least 2 activation markers

Timeframe: At Months 1, 2 and 13

Number of subjects with serious adverse events (SAEs)

Timeframe: From first vaccination at Month 0 up to study end at Month 13

Number of subjects reporting any potential immune-mediated diseases (pIMDs)

Timeframe: From first vaccination at Month 0 up to study end at Month 13

Geometric mean concentrations (GMCs) of anti-gE antibodies

Timeframe: At Months 0 and 2

Mean Geometric Increase (MGI) of anti-gE antibody ELISA concentrations

Timeframe: At Month 2

Interventions:
  • Biological/vaccine: Herpes zoster vaccine (GSK 1437173A)
  • Drug: Placebo
  • Enrollment:
    567
    Primary completion date:
    2016-07-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Dagnew AF et al. (2019) Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 19(9):988-1000.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    March 2013 to January 2017
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Subjects who the investigator believes can and will comply with the requirements of the protocol.
    • Written informed consent obtained from the subject.
    • Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled).
    • Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy.

    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, 06500
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ankara, Turkey, 06590
    Status
    Study Complete
    Location
    GSK Investigational Site
    Antwerpen, Belgium, 2060
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08035
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bournemouth, United Kingdom, BH7 7DW
    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
    Busan, South Korea, 614-735
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60637
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chorzow, Poland, 41-500
    Status
    Study Complete
    Location
    GSK Investigational Site
    Christchurch, New Zealand, 8011
    Status
    Study Complete
    Location
    GSK Investigational Site
    Coburg, Victoria, Australia, 3058
    Status
    Study Complete
    Location
    GSK Investigational Site
    Daegu, South Korea, 700-721
    Status
    Study Complete
    Location
    GSK Investigational Site
    Darlinghurst, New South Wales, Australia, 2010
    Status
    Study Complete
    Location
    GSK Investigational Site
    ESKILSTUNA, Sweden, SE-631 88
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ekaterinburg, Russia, 620102
    Status
    Study Complete
    Location
    GSK Investigational Site
    Halifax, Nova Scotia, Canada, B3K 6R8
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hamilton, New Zealand, 3240
    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
    Helsinki, Finland, 00029
    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
    Incheon, South Korea, 405-760
    Status
    Study Complete
    Location
    GSK Investigational Site
    Inverness, Florida, United States, 34452
    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
    KARLSKRONA, Sweden, SE-371 41
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kaohsiung, Taiwan, 833
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kyunggi-do, South Korea, 410-769
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lahore, Pakistan
    Status
    Study Complete
    Location
    GSK Investigational Site
    London, United Kingdom, SE13 6LH
    Status
    Study Complete
    Location
    GSK Investigational Site
    MALMÖ, Sweden, SE-205 02
    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, 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
    Majadahonda (Madrid), Spain, 28222
    Status
    Study Complete
    Location
    GSK Investigational Site
    Meldola (FC), Emilia-Romagna, Italy, 47014
    Status
    Study Complete
    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55455
    Status
    Study Complete
    Location
    GSK Investigational Site
    Montpellier cedex 5, France, 34295
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mulhouse, France, 68070
    Status
    Study Complete
    Location
    GSK Investigational Site
    Multan, Pakistan
    Status
    Study Complete
    Location
    GSK Investigational Site
    Móstoles, Madrid, Spain, 28933
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nantes cedex 1, France, 44093
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nizhniy Novgorod, Russia, 603126
    Status
    Study Complete
    Location
    GSK Investigational Site
    Novara, Piemonte, Italy, 28100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Opole, Poland, 45-372
    Status
    Study Complete
    Location
    GSK Investigational Site
    Orpington, Kent, United Kingdom, BR6 8ND
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oshawa, Ontario, Canada, L1G 2B9
    Status
    Study Complete
    Location
    GSK Investigational Site
    Panama, Panama
    Status
    Study Complete
    Location
    GSK Investigational Site
    Petrozavodsk, Russia, 185019
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pozuelo de Alarcón/Madrid, Spain, 28223
    Status
    Study Complete
    Location
    GSK Investigational Site
    Praha 2, Czech Republic, 128 08
    Status
    Study Complete
    Location
    GSK Investigational Site
    Périgueux cedex, France, 24019
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rouen cedex 1, France, 76038
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint John, New Brunswick, Canada, E2L 4L2
    Status
    Study Complete
    Location
    GSK Investigational Site
    Santander, Spain, 39008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98108
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seoul, South Korea, 135-710
    Status
    Study Complete
    Location
    GSK Investigational Site
    Singapore, Singapore, 169608
    Status
    Study Complete
    Location
    GSK Investigational Site
    Slupsk, Poland, 76-200
    Status
    Study Complete
    Location
    GSK Investigational Site
    St'Petersburg, Russia, 191024
    Status
    Study Complete
    Location
    GSK Investigational Site
    St-Petersburg, Russia, 197758
    Status
    Study Complete
    Location
    GSK Investigational Site
    St. Petersburg, Russia, 197 089
    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
    Taipei, Taiwan, 112
    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
    Toronto, Ontario, Canada, M4C 3E7
    Status
    Study Complete
    Location
    GSK Investigational Site
    UPPSALA, Sweden, SE-751 85
    Status
    Study Complete
    Location
    GSK Investigational Site
    Udine, Friuli-Venezia-Giulia, Italy, 33100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wodonga, Victoria, Australia, 3690
    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
    2016-07-01
    Actual study completion date
    2017-06-01

    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
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    Access to clinical trial data by researchers
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