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Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01610414
First Posted: June 4, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Herpes Zoster Biological: Herpes Zoster vaccine GSK1437173A Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with confirmed Herpes Zoster (HZ) episode [ Time Frame: From Month 0 until study end (4 years approximately) ]

    A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings* suggestive of VZV infection in the absence of characteristic HZ or VZV rash.

    A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.



Secondary Outcome Measures:
  • Duration of 'worst' HZ-associated pain [ Time Frame: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period ]
    Duration of HZ-associated pain rated as 3 or greater on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ; presented as T (day) [=the sum of follow-up period (for subjects without severe worst pain T is 1, for subjects with severe worst pain T is the duration of severe worst pain) expressed in days].

  • Number of subjects with confirmed HZ-associated complications [ Time Frame: From Month 0 up until study end (4 years approximately) ]
    This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.

  • Number of subjects with Postherpetic Neuralgia (PHN) [ Time Frame: From Month 0 until study end (4 years approximately) ]
    This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.

  • Antigen-glycoprotein E (gE) antibody concentrations in a sub-cohort of subjects [ Time Frame: At Months 0, 1, 2, 13 and 25 ]
    Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU/mL.

  • Number of subjects with any and Grade 3 solicited local symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  • Number of subjects with any, Grade 3 and related solicited general symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary/tympanic temperature equal to or above 37.5 degrees Celsius (°C) or rectal temperature equal to or above 38.0 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs) [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of subjects with any and related potential Immune Mediated Diseases (pIMDs) [ Time Frame: From Month 0 up to Month 13 ]
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  • Number of subjects with any relapse [ Time Frame: From Month 0 until study end (4 years, approximately) ]
    Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken.

  • Number of subjects with any and related Serious Adverse Events (SAEs) [ Time Frame: From Month 0 until study end (4 years approximately) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. This enpoint also presents SAES related to the GSK study vaccine/placebo.

  • Number of subjects with fatal and related SAEs [ Time Frame: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (4 years approximately) ]
    This endpoint presents fatal SAEs and SAEs related to study participation or to a concurrent GSK medication/vaccine.


Enrollment: 1877
Actual Study Start Date: July 13, 2012
Study Completion Date: February 1, 2017
Primary Completion Date: November 4, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1437173A Group
Subjects received 2 doses of the candidate HZ vaccine GSK 1437173A, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.
Biological: Herpes Zoster vaccine GSK1437173A
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm
Placebo Comparator: Placebo Group
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.
Biological: Placebo
2 doses administered IM in deltoid region of non-dominant arm

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Study entry (enrollment) occurs at the Pre-vaccination visit.

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • A male or female aged 18 years or older at the time of study entry.
  • Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs.
  • Female subjects of non-childbearing potential may be enrolled in the study. For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 12 months after completion of the vaccination series (i.e., until Month 13).

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/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.
  • Planned administration during the study of a HZ vaccine other than the study vaccine.
  • Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
  • Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV) expected to last more than 6 months after transplantation.
  • Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo.
  • HIV infection by clinical history.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610414


  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Duarte, California, United States, 91010
GSK Investigational Site
San Francisco, California, United States, 94143
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
United States, Kansas
GSK Investigational Site
Westwood, Kansas, United States, 66205
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02111
GSK Investigational Site
Boston, Massachusetts, United States, 02114
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
GSK Investigational Site
Minnesota, Minnesota, United States, 55455
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, New Jersey
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Durham, North Carolina, United States, 27705
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98108
GSK Investigational Site
Seattle, Washington, United States, 98109-1024
United States, Wisconsin
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Australia, New South Wales
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
GSK Investigational Site
Waratah, New South Wales, Australia, 2298
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, South Australia
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Australia, Tasmania
GSK Investigational Site
Hobart, Tasmania, Australia, 7000
Australia, Victoria
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
GSK Investigational Site
Heidelberg, Victoria, Australia, 3084
GSK Investigational Site
Parkville, Victoria, Australia, 3050
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2060
GSK Investigational Site
Brugge, Belgium, 8000
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Hasselt, Belgium, 3500
GSK Investigational Site
Jette, Belgium, 1090
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liege, Belgium, 4000
Bulgaria
GSK Investigational Site
Sofia, Bulgaria, 1756
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, New Brunswick
GSK Investigational Site
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4M1
GSK Investigational Site
Quebec City, Quebec, Canada, G1J 1Z4
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 4H4
Czechia
GSK Investigational Site
Hradec Kralove, Czechia
GSK Investigational Site
Olomouc, Czechia, 775 20
GSK Investigational Site
Praha 10, Czechia, 100 34
GSK Investigational Site
Praha 2, Czechia, 128 08
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
Finland
GSK Investigational Site
Helsinki, Finland, 00029
GSK Investigational Site
Tampere, Finland, 33520
GSK Investigational Site
Turku, Finland, 20520
France
GSK Investigational Site
Clermont-Ferrand Cedex 1, France, 63003
GSK Investigational Site
Créteil cedex, France, 94010
GSK Investigational Site
Grenoble cedex 9, France, 38043
GSK Investigational Site
Marseille cedex 9, France, 13273
GSK Investigational Site
Montpellier cedex 5, France, 34295
GSK Investigational Site
Pessac cedex, France, 33604
GSK Investigational Site
Rouen cedex 1, France, 76038
Germany
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Bayreuth, Bayern, Germany, 95445
GSK Investigational Site
Muenchen, Bayern, Germany, 81545
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97080
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53127
GSK Investigational Site
Eschweiler, Nordrhein-Westfalen, Germany, 52249
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 12200
GSK Investigational Site
Berlin, Germany, 12351
Greece
GSK Investigational Site
Athens, Greece, 106 76
GSK Investigational Site
Athens, Greece, 115 27
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Athens, Greece, 151 23
GSK Investigational Site
Thessaloniki, Greece, 57010
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Tuen Mun, Hong Kong
Israel
GSK Investigational Site
Hafia, Israel, 31096
GSK Investigational Site
Jerusalem, Israel, 91120
Italy
GSK Investigational Site
Cona (FE), Emilia-Romagna, Italy, 44124
GSK Investigational Site
Meldola (FC), Emilia-Romagna, Italy, 47014
GSK Investigational Site
Ravenna, Emilia-Romagna, Italy
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
GSK Investigational Site
Aviano (PN), Friuli-Venezia-Giulia, Italy, 33081
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
GSK Investigational Site
Rozzano (MI), Lombardia, Italy, 20089
GSK Investigational Site
Novara, Piemonte, Italy, 28100
Japan
GSK Investigational Site
Fukuoka, Japan, 811-1395
GSK Investigational Site
Gunma, Japan, 377-0280
GSK Investigational Site
Hiroshima, Japan, 737-0023
GSK Investigational Site
Hiroshima, Japan, 739-0651
GSK Investigational Site
Hyogo, Japan, 650-0047
GSK Investigational Site
Kumamoto, Japan, 860-0008
GSK Investigational Site
Nagasaki, Japan, 856-8562
GSK Investigational Site
Niigata, Japan, 951-8566
GSK Investigational Site
Okayama, Japan, 700-8558
GSK Investigational Site
Okayama, Japan, 701-1192
GSK Investigational Site
Shizuoka, Japan, 411-8777
GSK Investigational Site
Tokyo, Japan, 113-8677
Korea, Republic of
GSK Investigational Site
Daegu, Korea, Republic of, 700-721
GSK Investigational Site
Incheon, Korea, Republic of, 405-760
GSK Investigational Site
Jellanamdo, Korea, Republic of, 519-809
GSK Investigational Site
Jeonju, Korea, Republic of, 561-712
GSK Investigational Site
Kyunggi-do, Korea, Republic of, 410-769
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
Malaysia
GSK Investigational Site
Kuala Lumpur, Malaysia, 56000
GSK Investigational Site
Selangor, Malaysia, 68000 Ampang
Netherlands
GSK Investigational Site
Leiden, Netherlands, 2333 ZA
New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8011
GSK Investigational Site
Grafton, New Zealand, 1003
GSK Investigational Site
Wellington, New Zealand, 6021
Panama
GSK Investigational Site
Panama, Panama
Poland
GSK Investigational Site
Gliwice, Poland, 44-101
GSK Investigational Site
Krakow, Poland, 30510
GSK Investigational Site
Warszawa, Poland, 02-776
Romania
GSK Investigational Site
Bucharest, Romania, 022328
GSK Investigational Site
Bucharest, Romania, 030171
GSK Investigational Site
Tirgu Mures, Romania, 540042
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105 229
GSK Investigational Site
Moscow, Russian Federation, 125101
GSK Investigational Site
Novosibirsk, Russian Federation, 630099
GSK Investigational Site
Petrozavodsk, Russian Federation, 185019
GSK Investigational Site
St'Petersburg, Russian Federation, 191024
GSK Investigational Site
St.-Petersburg, Russian Federation, 194291
GSK Investigational Site
St.Petersburg, Russian Federation, 197110
South Africa
GSK Investigational Site
Parktown, Gauteng, South Africa, 2193
GSK Investigational Site
Plumstead, Western Province, South Africa
GSK Investigational Site
Groenkloof, South Africa, 0181
GSK Investigational Site
Moreleta Park, Pretoria, South Africa, 0001
Spain
GSK Investigational Site
Badalona/Barcelona, Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
León, Spain, 24008
GSK Investigational Site
Madrid, Spain, 28009
GSK Investigational Site
Madrid, Spain, 28033
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Madrid, Spain, 28050
GSK Investigational Site
Madrid, Spain, 28911
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Majadahonda (Madrid), Spain, 28222
GSK Investigational Site
Malaga, Spain, 29010
GSK Investigational Site
Murcia (El Palmar), Spain, 30120
GSK Investigational Site
Murcia, Spain, 30008
GSK Investigational Site
Oviedo, Spain, 33006
GSK Investigational Site
Pozuelo De Alarcón/Madrid, Spain, 28223
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
Santander, Spain, 39008
GSK Investigational Site
Valencia, Spain, 46010
GSK Investigational Site
Valencia, Spain, 46026
Taiwan
GSK Investigational Site
Kaohsiung, Taiwan, 833
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Taichung, Taiwan, 40705
GSK Investigational Site
Taoyuan Hsien, Taiwan, 333
Turkey
GSK Investigational Site
Ankara, Turkey, 06100
GSK Investigational Site
Ankara, Turkey, 06500
GSK Investigational Site
Ankara, Turkey
GSK Investigational Site
Istanbul, Turkey, 34481
GSK Investigational Site
Izmir, Turkey
United Kingdom
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
GSK Investigational Site
Swindon, Wiltshire, United Kingdom, SN3 6BB
GSK Investigational Site
Bournemouth, United Kingdom, BH7 7DW
GSK Investigational Site
Cottingham, United Kingdom, HU16 5JQ
GSK Investigational Site
Headington, Oxford, United Kingdom, OX3 7LE
GSK Investigational Site
Leeds, United Kingdom, LS9 7TF
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01610414     History of Changes
Other Study ID Numbers: 115523
2012-000138-20 ( EudraCT Number )
First Submitted: May 31, 2012
First Posted: June 4, 2012
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
Observer-blind
Efficacy
Immunogenicity
Vaccination
Safety
Adult autologous haematopoietic cell transplant recipients
Herpes Zoster

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs