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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2016-04-11
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
Completed
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
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