AzTrials
AzTrials

Herpes ZosterPhase 3NCT01610414

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

A Phase 3 study testing Herpes Zoster vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 178 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Herpes Zoster
What is being tested?
Herpes Zoster vaccine GSK1437173A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,877 participants
Where
178 sitesin 28 countries
Study dates
13 Jul 2012to 1 Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 10Show fewer
  • 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).

Trial locations and contacts

178 sites in 28 countries.

178 sites in 28 countries

Spain24 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Badalona/Barcelona, 08916

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    León, 24008

  • GSK Investigational Site

    Madrid, 28009

  • GSK Investigational Site

    Madrid, 28033

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Madrid, 28911

  • GSK Investigational Site

    Madrid

  • GSK Investigational Site

    Majadahonda (Madrid), 28222

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Murcia, 30008

  • GSK Investigational Site

    Murcia (El Palmar), 30120

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Valencia, 46026

Other trials in Spain

United States23 sites

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Boston, Massachusetts, 02111

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Duarte, California, 91010

  • GSK Investigational Site

    Durham, North Carolina, 27705

  • GSK Investigational Site

    Hackensack, New Jersey, 07601

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Minneota, Minnesota, 55455

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    San Francisco, California, 94143

  • GSK Investigational Site

    Seattle, Washington, 98108

  • GSK Investigational Site

    Seattle, Washington, 98109-1024

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Westwood, Kansas, 66205

Other trials in United States

Germany13 sites

  • GSK Investigational Site

    Bayreuth, Bavaria, 95445

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 12200

  • GSK Investigational Site

    Berlin, 12351

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • GSK Investigational Site

    Eschweiler, North Rhine-Westphalia, 52249

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Munich, Bavaria, 81545

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • GSK Investigational Site

    Velbert, North Rhine-Westphalia, 42551

  • GSK Investigational Site

    Würzburg, Bavaria, 97080

Other trials in Germany

Japan12 sites

  • GSK Investigational Site

    Fukuoka, 811-1395

  • GSK Investigational Site

    Gunma, 377-0280

  • GSK Investigational Site

    Hiroshima, 737-0023

  • GSK Investigational Site

    Hiroshima, 739-0651

  • GSK Investigational Site

    Hyōgo, 650-0047

  • GSK Investigational Site

    Kumamoto, 860-0008

  • GSK Investigational Site

    Nagasaki, 856-8562

  • GSK Investigational Site

    Niigata, 951-8566

  • GSK Investigational Site

    Okayama, 700-8558

  • GSK Investigational Site

    Okayama, 701-1192

  • GSK Investigational Site

    Shizuoka, 411-8777

  • GSK Investigational Site

    Tokyo, 113-8677

Other trials in Japan

Australia9 sites

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010

  • GSK Investigational Site

    East Melbourne, Victoria, 3002

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Hobart, Tasmania, 7000

  • GSK Investigational Site

    Parkville, Victoria, 3050

  • GSK Investigational Site

    Waratah, New South Wales, 2298

  • GSK Investigational Site

    Westmead, New South Wales, 2145

  • GSK Investigational Site

    Woodville, South Australia, 5011

Other trials in Australia

South Korea9 sites

  • GSK Investigational Site

    Daegu, 700-721

  • GSK Investigational Site

    Incheon, 405-760

  • GSK Investigational Site

    Jellanamdo, 519-809

  • GSK Investigational Site

    Jeonju, 561-712

  • GSK Investigational Site

    Kyunggi-do, 410-769

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 137-701

Other trials in South Korea

Belgium8 sites

  • GSK Investigational Site

    Antwerp, 2060

  • GSK Investigational Site

    Bruges, 8000

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Hasselt, 3500

  • GSK Investigational Site

    Jette, 1090

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

Italy8 sites

  • GSK Investigational Site

    Aviano (PN), Friuli Venezia Giulia, 33081

  • GSK Investigational Site

    Cona (FE), Emilia-Romagna, 44124

  • GSK Investigational Site

    Meldola (FC), Emilia-Romagna, 47014

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Ravenna, Emilia-Romagna

  • GSK Investigational Site

    Rimini, Emilia-Romagna, 47900

  • GSK Investigational Site

    Rozzano (MI), Lombardy, 20089

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

United Kingdom8 sites

  • GSK Investigational Site

    Airdrie, Lanarkshire, ML6 0JS

  • GSK Investigational Site

    Bournemouth, BH7 7DW

  • GSK Investigational Site

    Cottingham, HU16 5JQ

  • GSK Investigational Site

    Headington, Oxford, OX3 7LE

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    Manchester, M13 9WL

  • GSK Investigational Site

    Manchester, M20 4BX

  • GSK Investigational Site

    Swindon, Wiltshire, SN3 6BB

Other trials in United Kingdom

France7 sites

  • GSK Investigational Site

    Clermont-Ferrand, 63003

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    Marseille, 13273

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Rouen, 76038

Other trials in France

Russia7 sites

  • GSK Investigational Site

    Moscow, 105 229

  • GSK Investigational Site

    Moscow, 125101

  • GSK Investigational Site

    Novosibirsk, 630099

  • GSK Investigational Site

    Petrozavodsk, 185019

  • GSK Investigational Site

    Saint Petersburg, 194291

  • GSK Investigational Site

    Saint Petersburg, 197110

  • GSK Investigational Site

    St'Petersburg, 191024

Other trials in Russia

Canada6 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Québec, Quebec, G1J 1Z4

  • GSK Investigational Site

    Saint John, New Brunswick, E2L 4L2

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7N 4H4

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Greece5 sites

  • GSK Investigational Site

    Athens, 106 76

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Athens, 151 23

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Turkey (Türkiye)5 sites

  • GSK Investigational Site

    Ankara, 06100

  • GSK Investigational Site

    Ankara, 06500

  • GSK Investigational Site

    Ankara

  • GSK Investigational Site

    Istanbul, 34481

  • GSK Investigational Site

    Izmir

Other trials in Turkey (Türkiye)

Czechia4 sites

  • GSK Investigational Site

    Hradec Králové

  • GSK Investigational Site

    Olomouc, 775 20

  • GSK Investigational Site

    Prague, 100 34

  • GSK Investigational Site

    Prague, 128 08

Other trials in Czechia

South Africa4 sites

  • GSK Investigational Site

    Groenkloof, 0181

  • GSK Investigational Site

    Moreleta Park, Pretoria, 0001

  • GSK Investigational Site

    Parktown, Gauteng, 2193

  • GSK Investigational Site

    Plumstead, Western Province

Other trials in South Africa

Taiwan4 sites

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taichung, 40705

  • GSK Investigational Site

    Taoyuan Hsien, 333

Other trials in Taiwan

Finland3 sites

  • GSK Investigational Site

    Helsinki, 00029

  • GSK Investigational Site

    Tampere, 33520

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

New Zealand3 sites

  • GSK Investigational Site

    Christchurch, 8011

  • GSK Investigational Site

    Grafton, 1003

  • GSK Investigational Site

    Wellington, 6021

Other trials in New Zealand

Poland3 sites

  • GSK Investigational Site

    Gliwice, 44-101

  • GSK Investigational Site

    Krakow, 30510

  • GSK Investigational Site

    Warsaw, 02-776

Other trials in Poland

Romania3 sites

  • GSK Investigational Site

    Bucharest, 022328

  • GSK Investigational Site

    Bucharest, 030171

  • GSK Investigational Site

    Târgu Mureş, 540042

Other trials in Romania

Hong Kong2 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Tuenmen

Other trials in Hong Kong

Israel2 sites

  • GSK Investigational Site

    Hafia, 31096

  • GSK Investigational Site

    Jerusalem, 91120

Other trials in Israel

Malaysia2 sites

  • GSK Investigational Site

    Kuala Lumpur, 56000

  • GSK Investigational Site

    Kuala Selangor, 68000 Ampang

Other trials in Malaysia

Bulgaria1 site

  • GSK Investigational Site

    Sofia

Other trials in Bulgaria

Estonia1 site

  • GSK Investigational Site

    Tallinn, 13419

Other trials in Estonia

Netherlands1 site

  • GSK Investigational Site

    Leiden, 2333 ZA

Other trials in Netherlands

Panama1 site

  • GSK Investigational Site

    Panama City

Other trials in Panama

About this study

Official title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

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.

Conditions
Herpes Zoster
Being tested
Herpes Zoster vaccine GSK1437173A, Placebo
Keywords
Observer-blind, Efficacy, Immunogenicity, Vaccination, Safety, Adult autologous haematopoietic cell transplant recipients, Herpes Zoster
Medical subject headings
Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Herpes Zoster vaccine GSK1437173ABiological

    2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm

  • PlaceboBiological

    2 doses administered IM in deltoid region of non-dominant arm

Study groups in NCT01610414
Study groupRoleWhat they receive
GSK1437173A GroupExperimentalSubjects 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.
Receives: Biological: Herpes Zoster vaccine GSK1437173A
Placebo GroupPlacebo comparatorSubjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Confirmed Herpes Zoster (HZ) Episode

    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.

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

Secondary outcomes (11)

  1. Duration of 'Worst' HZ-associated Pain

    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].

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

  2. Number of Subjects With Confirmed HZ-associated Complications

    This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.

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

  3. Number of Subjects With Postherpetic Neuralgia (PHN)

    This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.

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

  4. Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects

    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.

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

  5. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    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.

    Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    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.

    Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

  7. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    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.

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

  8. Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)

    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.

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

  9. Number of Subjects With Any Relapse

    Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken.

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

  10. Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This enpoint also presents SAES related to the GSK study vaccine/placebo.

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

  11. Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This endpoint presents fatal SAEs and SAEs related to study participation or to a concurrent GSK medication/vaccine.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2012 (estimated)
  2. Study start13 Jul 2012
  3. Primary completion4 Nov 2016
  4. Study completion1 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,877 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01610414
Sponsor's protocol ID
115523
Other IDs
2012-000138-20
Status last verified
Dec 2017
First submitted
31 May 2012
Last updated
23 Jan 2018

Publications

  • Matthews S, Curran D, Sabater Cabrera E, Boutry C, Lecrenier N, Cunningham AL, Schmader K. An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies. Clin J Pain. 2023 Aug 1;39(8):386-393. doi: 10.1097/AJP.0000000000001129.

    PubMed 37166199

  • Kim JH, Johnson R, Kovac M, Cunningham AL, Amakrane M, Sullivan KM, Dagnew AF, Curran D, Schuind A. Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials. Pain. 2023 Apr 1;164(4):741-748. doi: 10.1097/j.pain.0000000000002760. Epub 2022 Aug 19.

    PubMed 36066965

  • Curran D, Matthews S, Rowley SD, Young JH, Bastidas A, Anagnostopoulos A, Barista I, Chandrasekar PH, Dickinson M, El Idrissi M, Heras I, Milliken ST, Monserrat Coll J, Navarro Matilla MB, Oostvogels L, Piatkowska-Jakubas B, Quiel D, Sabry W, Schwartz S, Selleslag DLD, Sullivan KM, Theunissen K, Yegin ZA, Yeh SP, Zaja F, Szer J; ZOE-HSCT Study group collaborators. Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT). Biol Blood Marrow Transplant. 2019 Dec;25(12):2474-2481. doi: 10.1016/j.bbmt.2019.07.036. Epub 2019 Aug 5.

    PubMed 31394276

  • Bastidas A, de la Serna J, El Idrissi M, Oostvogels L, Quittet P, Lopez-Jimenez J, Vural F, Pohlreich D, Zuckerman T, Issa NC, Gaidano G, Lee JJ, Abhyankar S, Solano C, Perez de Oteyza J, Satlin MJ, Schwartz S, Campins M, Rocci A, Vallejo Llamas C, Lee DG, Tan SM, Johnston AM, Grigg A, Boeckh MJ, Campora L, Lopez-Fauqued M, Heineman TC, Stadtmauer EA, Sullivan KM; ZOE-HSCT Study Group Collaborators. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):123-133. doi: 10.1001/jama.2019.9053.

    PubMed 31287523

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Herpes Zoster vaccine GSK1437173A in people with Herpes Zoster, run by GlaxoSmithKline at 178 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in Spain, United States, Germany, Japan, Australia and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Confirmed Herpes Zoster (HZ) Episode (time frame: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01610414, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in