Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.

February 11, 2021 updated by: GlaxoSmithKline

Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies

The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since the HZ/su vaccine has not yet been licensed and marketed, this study is being conducted to enable potentially eligible subjects who previously received placebo in ZOSTER-006 (NCT01165177) or ZOSTER-022 (NCT01165229) to receive the HZ/su vaccine.

Study ZOSTER-056 is an open-label, multi-centric and single arm study to cross-vaccinate and collect safety data in terms of of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and pIMD from subjects >= 50 YOA who previously received placebo.

Study Type

Interventional

Enrollment (Actual)

8687

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Maroubra, New South Wales, Australia, 2035
        • GSK Investigational Site
      • Umina, New South Wales, Australia, 2257
        • GSK Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • GSK Investigational Site
      • Wollongong, New South Wales, Australia, 2522
        • GSK Investigational Site
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • GSK Investigational Site
      • Ivanhoe, Victoria, Australia, 3079
        • GSK Investigational Site
  • Brazil
      • Curitiba/PR, Brazil, 80240-280
        • GSK Investigational Site
      • São Paulo, Brazil, 04266-010
        • GSK Investigational Site
      • São Paulo, Brazil, 05403-000
        • GSK Investigational Site
      • São Paulo, Brazil, 04023-900
        • GSK Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • GSK Investigational Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80810-050
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
        • GSK Investigational Site
  • Canada
      • Quebec, Canada, G1W 4R4
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
      • Victoria, British Columbia, Canada, V8V 3M9
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4S 1Y2
        • GSK Investigational Site
      • Woodstock, Ontario, Canada, N4S 5P5
        • GSK Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S8
        • GSK Investigational Site
      • Mirabel, Quebec, Canada, J7J 2K8
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • GSK Investigational Site
      • Québec City, Quebec, Canada, G1E 7G9
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 2G2
        • GSK Investigational Site
      • Trois-Rivieres, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
  • Czechia
      • Brno, Czechia, 662 10
        • GSK Investigational Site
      • Ceske Budejovice, Czechia, 370 04
        • GSK Investigational Site
      • Hradec Kralove, Czechia
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia
        • GSK Investigational Site
      • Tartu, Estonia, 50106
        • GSK Investigational Site
  • Finland
      • Espoo, Finland, 02230
        • GSK Investigational Site
      • Helsinki, Finland, 00100
        • GSK Investigational Site
      • Helsinki, Finland, 00930
        • GSK Investigational Site
      • Jarvenpaa, Finland, 04400
        • GSK Investigational Site
      • Kokkola, Finland, 67100
        • GSK Investigational Site
      • Oulu, Finland, 90220
        • GSK Investigational Site
      • Pori, Finland, 28100
        • GSK Investigational Site
      • Seinajoki, Finland, 60100
        • GSK Investigational Site
      • Tampere, Finland, 33100
        • GSK Investigational Site
      • Turku, Finland, 20520
        • GSK Investigational Site
  • France
      • Angers, France, 49100
        • GSK Investigational Site
      • Angers, France, 49000
        • GSK Investigational Site
      • Château Gontier, France, 53200
        • GSK Investigational Site
      • Clermont-Ferrand, France, 63003
        • GSK Investigational Site
      • Laval, France, 53000
        • GSK Investigational Site
      • Montrevault, France, 49110
        • GSK Investigational Site
      • Muret, France, 31600
        • GSK Investigational Site
      • Murs-Erigne, France, 49610
        • GSK Investigational Site
      • Nantes, France, 44300
        • GSK Investigational Site
      • Rosiers d'Egletons, France, 19300
        • GSK Investigational Site
      • Saint Cyr sur Loire, France, 37540
        • GSK Investigational Site
      • Segré, France, 49500
        • GSK Investigational Site
      • Tours, France, 37100
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10717
        • GSK Investigational Site
      • Berlin, Germany, 10629
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Berlin, Germany, 13347
        • GSK Investigational Site
      • Hamburg, Germany, 22143
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 22415
        • GSK Investigational Site
      • Magdeburg, Germany, 39120
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Deggingen, Baden-Wuerttemberg, Germany, 73326
        • GSK Investigational Site
      • Gueglingen, Baden-Wuerttemberg, Germany, 74363
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68161
        • GSK Investigational Site
      • Tuebingen, Baden-Wuerttemberg, Germany, 72074
        • GSK Investigational Site
      • Wangen, Baden-Wuerttemberg, Germany, 88239
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • GSK Investigational Site
    • Bayern
      • Dachau, Bayern, Germany, 85221
        • GSK Investigational Site
      • Kuenzing, Bayern, Germany, 94550
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80339
        • GSK Investigational Site
      • Rednitzhembach, Bayern, Germany, 91126
        • GSK Investigational Site
      • Wallerfing, Bayern, Germany, 94574
        • GSK Investigational Site
      • Wuerzburg, Bayern, Germany, 97070
        • GSK Investigational Site
    • Hessen
      • Floersheim, Hessen, Germany, 65439
        • GSK Investigational Site
    • Niedersachsen
      • Duelmen, Niedersachsen, Germany, 48249
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45355
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
      • Witten, Nordrhein-Westfalen, Germany, 58455
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • GSK Investigational Site
      • Rhaunen, Rheinland-Pfalz, Germany, 55624
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01097
        • GSK Investigational Site
      • Freiberg, Sachsen, Germany, 09599
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04315
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Koethen, Sachsen-Anhalt, Germany, 06366
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23554
        • GSK Investigational Site
  • Hong Kong
      • Kwun Tong, Hong Kong
        • GSK Investigational Site
      • Shatin, Hong Kong
        • GSK Investigational Site
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
        • GSK Investigational Site
      • Pescara, Abruzzo, Italy, 65100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00163
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • GSK Investigational Site
    • Piemonte
      • Cuneo, Piemonte, Italy, 12100
        • GSK Investigational Site
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • GSK Investigational Site
    • Sicilia
      • Ragusa (RG), Sicilia, Italy, 97100
        • GSK Investigational Site
  • Japan
      • Fukuoka, Japan, 812-0025
        • GSK Investigational Site
      • Fukuoka, Japan, 810-0021
        • GSK Investigational Site
      • Fukuoka, Japan, 813-8588
        • GSK Investigational Site
      • Fukuoka, Japan, 816-0864
        • GSK Investigational Site
      • Kanagawa, Japan, 224-8503
        • GSK Investigational Site
      • Kanagawa, Japan, 247-8533
        • GSK Investigational Site
      • Tokyo, Japan, 142-0054
        • GSK Investigational Site
      • Tokyo, Japan, 142-8666
        • GSK Investigational Site
      • Tokyo, Japan, 154-0024
        • GSK Investigational Site
  • Korea, Republic of
      • Ansan, Korea, Republic of, 425-707
        • GSK Investigational Site
      • Bucheon-si,, Korea, Republic of, 420-767
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 400-711
        • GSK Investigational Site
      • Kangnam-gu, Seoul, Korea, Republic of
        • GSK Investigational Site
      • Kangwon-do, Korea, Republic of, 220-701
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 150-950
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • GSK Investigational Site
  • Mexico
      • Durango, Mexico, 34000
        • GSK Investigational Site
    • Jalisco
      • Zapopan, Jalisco, Jalisco, Mexico, 45190
        • GSK Investigational Site
    • Morelos
      • Jojutla, Morelos, Mexico, 62900
        • GSK Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64710
        • GSK Investigational Site
  • Spain
      • Alcover( Tarragona), Spain, 43460
        • GSK Investigational Site
      • Balenyà (Barcelona), Spain, 08550
        • GSK Investigational Site
      • Barcelona, Spain, 08025
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Centelles (Barcelona), Spain, 08540
        • GSK Investigational Site
      • La Roca Del Valles (Barcelona), Spain, 08430
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Majadahonda( Madrid, Spain, 28222
        • GSK Investigational Site
      • Peralada( Girona), Spain, 17491
        • GSK Investigational Site
      • Valencia, Spain, 46020
        • GSK Investigational Site
      • Vic, Spain, 28500
        • GSK Investigational Site
  • Sweden
      • Borås, Sweden, SE-506 30
        • GSK Investigational Site
      • Eskilstuna, Sweden, SE-631 88
        • GSK Investigational Site
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Jönköping, Sweden, SE-551 85
        • GSK Investigational Site
      • Karlskrona, Sweden, SE-371 41
        • GSK Investigational Site
      • Linköping, Sweden, SE-581 85
        • GSK Investigational Site
      • Malmö, Sweden, SE-211 52
        • GSK Investigational Site
      • Skövde, Sweden, SE-541 50
        • GSK Investigational Site
      • Stockholm, Sweden, 11446
        • GSK Investigational Site
      • Uppsala, Sweden, SE-751 85
        • GSK Investigational Site
      • Vällingby, Sweden, SE-162 68
        • GSK Investigational Site
      • Örebro, Sweden, SE-703 62
        • GSK Investigational Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • GSK Investigational Site
      • Taipei, Taiwan, 112
        • GSK Investigational Site
      • Taipei, Taiwan
        • GSK Investigational Site
      • Taoyuan, Taiwan, 333
        • GSK Investigational Site
  • United Kingdom
      • Bangor, United Kingdom, BT19 1NB
        • GSK Investigational Site
      • Belfast, United Kingdom, BT7 2EB
        • GSK Investigational Site
      • Broughshane, United Kingdom, BT42 4JP
        • GSK Investigational Site
      • Liverpool, United Kingdom, L22 0LG
        • GSK Investigational Site
      • Newtonabbey, United Kingdom, BT37 9QW
        • GSK Investigational Site
    • Lancashire
      • Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
        • GSK Investigational Site
    • Warwickshire
      • Atherstone, Warwickshire, United Kingdom, CV9 1EU
        • GSK Investigational Site
    • Wiltshire
      • Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
        • GSK Investigational Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85213
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85020
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85018
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85712
        • GSK Investigational Site
    • California
      • Spring Valley, California, United States, 91978
        • GSK Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • GSK Investigational Site
      • DeLand, Florida, United States, 32720
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32205
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • GSK Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • GSK Investigational Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • GSK Investigational Site
      • Elkridge, Maryland, United States, 21075
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • GSK Investigational Site
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • GSK Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
      • Hickory, North Carolina, United States, 28601
        • GSK Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • GSK Investigational Site
      • Wadsworth, Ohio, United States, 44281
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • GSK Investigational Site
      • Uniontown, Pennsylvania, United States, 15401
        • GSK Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Utah
      • Murray, Utah, United States, 84123
        • GSK Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
      • Winchester, Virginia, United States, 22601
        • GSK Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, follow-up contacts). Or subjects' Legally Acceptable Representative(s) [LAR(s)]/caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, vaccination visits, availability for follow-up contacts).
  • Written informed consent obtained from the subject/Legally Acceptable representative(s) [LAR(s)] of the subject prior to performing any study specific procedure. If the subjects is not capable of giving consent, his/her assent to participate should be obtained to the extent possible.
  • Subject who previously participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of placebo.

  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, 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 2 months after completion of the vaccination series.

      • treatment period refers to vaccination days and the interval between them.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use up to 30 days post Dose 2.
  • Previous vaccination against Varicella Zoster virus (VZV) or HZ.
  • Planned administration of VZV or HZ vaccination during the study (including an investigational or non-registered vaccine), with the exception of the study vaccine.
  • Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant for seasonal or pandemic flus). These may be administered up to 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose and up to 30 days post Dose 2. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. Inhaled, topical and intra-articular corticosteroids are allowed.
  • Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab) within six months prior to the first vaccine dose up to 30 days post Dose 2.
  • Concurrently participating in another clinical study, at the time of enrolment or planned participation up to the 30 days post second dose, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, Human Immunodeficiency Virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Active HZ infection at the time of enrolment (i.e. HZ lesions not completely crusted over).
  • Pregnant or lactating female.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  • Any condition which in the judgment of the investigator would make intramuscular injection unsafe.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HZ/su Group
Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm
Biological: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Other Names:
  • HZ/su

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time Frame: During 30 days (Days 0-29) after any vaccination (across doses)
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. 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.
During 30 days (Days 0-29) after any vaccination (across doses)
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Time Frame: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related=SAE assessed by the investigator as related to the vaccination.
From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Time Frame: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
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. Related pIMDs=pIMDs assessed by the investigator as related to the vaccination.
From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s)
Time Frame: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

A suspected case of HZ was defined as a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations).

Clinically confirmed HZ episode is suspected HZ episode confirmed by the Investigator/Delegate.
From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2016

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

March 15, 2019

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 204486
  • 2015-000965-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD for this study is available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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