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

Primary Purpose

Herpes Zoster

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Herpes Zoster vaccine GSK1437173A

Placebo

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring Observer-blind, Efficacy, Immunogenicity, Vaccination, Safety, Adult autologous haematopoietic cell transplant recipients, Herpes Zoster

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GSK1437173A Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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].

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.

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.

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.

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.

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.

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.

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.

Number of Subjects With Any Relapse

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

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.

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.

Full Information

NCT ID

NCT01610414

First Posted

May 31, 2012

Last Updated

December 20, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01610414

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

July 13, 2012 (Actual)

Primary Completion Date

November 4, 2016 (Actual)

Study Completion Date

February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Zoster

Keywords

Observer-blind, Efficacy, Immunogenicity, Vaccination, Safety, Adult autologous haematopoietic cell transplant recipients, Herpes Zoster

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1877 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1437173A Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Herpes Zoster vaccine GSK1437173A

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Subjects With Confirmed Herpes Zoster (HZ) Episode

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Duration of 'Worst' HZ-associated Pain

Description

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

Title

Number of Subjects With Confirmed HZ-associated Complications

Description

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

Time Frame

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

Title

Number of Subjects With Postherpetic Neuralgia (PHN)

Description

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

Time Frame

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

Title

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

Description

Time Frame

At Months 0, 1, 2, 13 and 25

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

From Month 0 up to 365 days post last vaccination

Title

Number of Subjects With Any Relapse

Description

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

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

GSK Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

GSK Investigational Site

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

GSK Investigational Site

City

Minnesota

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

GSK Investigational Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

GSK Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

GSK Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109-1024

Country

United States

Facility Name

GSK Investigational Site

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Facility Name

GSK Investigational Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

GSK Investigational Site

City

Waratah

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Facility Name

GSK Investigational Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

GSK Investigational Site

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

GSK Investigational Site

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

GSK Investigational Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

GSK Investigational Site

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

GSK Investigational Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

GSK Investigational Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

GSK Investigational Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

GSK Investigational Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

GSK Investigational Site

City

Jette

ZIP/Postal Code

1090

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Sofia

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

GSK Investigational Site

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

GSK Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

GSK Investigational Site

City

Hradec Kralove

Country

Czechia

Facility Name

GSK Investigational Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

GSK Investigational Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

GSK Investigational Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

GSK Investigational Site

City

Clermont-Ferrand Cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

GSK Investigational Site

City

Créteil cedex

ZIP/Postal Code

94010

Country

France

Facility Name

GSK Investigational Site

City

Grenoble cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

GSK Investigational Site

City

Marseille cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

GSK Investigational Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

GSK Investigational Site

City

Pessac cedex

ZIP/Postal Code

33604

Country

France

Facility Name

GSK Investigational Site

City

Rouen cedex 1

ZIP/Postal Code

76038

Country

France

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68167

Country

Germany

Facility Name

GSK Investigational Site

City

Bayreuth

State/Province

Bayern

ZIP/Postal Code

95445

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81545

Country

Germany

Facility Name

GSK Investigational Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97080

Country

Germany

Facility Name

GSK Investigational Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

GSK Investigational Site

City

Eschweiler

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

52249

Country

Germany

Facility Name

GSK Investigational Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

GSK Investigational Site

City

Velbert

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

42551

Country

Germany

Facility Name

GSK Investigational Site

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

106 76

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

151 23

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

GSK Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Tuen Mun

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Hafia

ZIP/Postal Code

31096

Country

Israel

Facility Name

GSK Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

GSK Investigational Site

City

Cona (FE)

State/Province

Emilia-Romagna

ZIP/Postal Code

44124

Country

Italy

Facility Name

GSK Investigational Site

City

Meldola (FC)

State/Province

Emilia-Romagna

ZIP/Postal Code

47014

Country

Italy

Facility Name

GSK Investigational Site

City

Ravenna

State/Province

Emilia-Romagna

Country

Italy

Facility Name

GSK Investigational Site

City

Rimini

State/Province

Emilia-Romagna

ZIP/Postal Code

47900

Country

Italy

Facility Name

GSK Investigational Site

City

Aviano (PN)

State/Province

Friuli-Venezia-Giulia

ZIP/Postal Code

33081

Country

Italy

Facility Name

GSK Investigational Site

City

Udine

State/Province

Friuli-Venezia-Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

GSK Investigational Site

City

Rozzano (MI)

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Name

GSK Investigational Site

City

Novara

State/Province

Piemonte

ZIP/Postal Code

28100

Country

Italy

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

GSK Investigational Site

City

Gunma

ZIP/Postal Code

377-0280

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

737-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

739-0651

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

GSK Investigational Site

City

Kumamoto

ZIP/Postal Code

860-0008

Country

Japan

Facility Name

GSK Investigational Site

City

Nagasaki

ZIP/Postal Code

856-8562

Country

Japan

Facility Name

GSK Investigational Site

City

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

701-1192

Country

Japan

Facility Name

GSK Investigational Site

City

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

113-8677

Country

Japan

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Jellanamdo

ZIP/Postal Code

519-809

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Jeonju

ZIP/Postal Code

561-712

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kyunggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

Facility Name

GSK Investigational Site

City

Selangor

ZIP/Postal Code

68000 Ampang

Country

Malaysia

Facility Name

GSK Investigational Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

GSK Investigational Site

City

Grafton

ZIP/Postal Code

1003

Country

New Zealand

Facility Name

GSK Investigational Site

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

GSK Investigational Site

City

Panama

Country

Panama

Facility Name

GSK Investigational Site

City

Gliwice

ZIP/Postal Code

44-101

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

30510

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

030171

Country

Romania

Facility Name

GSK Investigational Site

City

Tirgu Mures

ZIP/Postal Code

540042

Country

Romania

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

105 229

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

125101

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St'Petersburg

ZIP/Postal Code

191024

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St.-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St.Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Parktown

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

GSK Investigational Site

City

Plumstead

State/Province

Western Province

Country

South Africa

Facility Name

GSK Investigational Site

City

Groenkloof

ZIP/Postal Code

0181

Country

South Africa

Facility Name

GSK Investigational Site

City

Moreleta Park, Pretoria

ZIP/Postal Code

0001

Country

South Africa

Facility Name

GSK Investigational Site

City

Badalona/Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

León

ZIP/Postal Code

24008

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28911

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

Country

Spain

Facility Name

GSK Investigational Site

City

Majadahonda (Madrid)

ZIP/Postal Code

28222

Country

Spain

Facility Name

GSK Investigational Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

GSK Investigational Site

City

Murcia (El Palmar)

ZIP/Postal Code

30120

Country

Spain

Facility Name

GSK Investigational Site

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

GSK Investigational Site

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

GSK Investigational Site

City

Pozuelo De Alarcón/Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

GSK Investigational Site

City

San Sebastián

ZIP/Postal Code

20014

Country

Spain

Facility Name

GSK Investigational Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taoyuan Hsien

ZIP/Postal Code

333

Country

Taiwan

Facility Name

GSK Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

GSK Investigational Site

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

GSK Investigational Site

City

Ankara

Country

Turkey

Facility Name

GSK Investigational Site

City

Istanbul

ZIP/Postal Code

34481

Country

Turkey

Facility Name

GSK Investigational Site

City

Izmir

Country

Turkey

Facility Name

GSK Investigational Site

City

Airdrie

State/Province

Lanarkshire

ZIP/Postal Code

ML6 0JS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Swindon

State/Province

Wiltshire

ZIP/Postal Code

SN3 6BB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cottingham

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Headington, Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31394276

Citation

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.

Results Reference

derived

PubMed Identifier

31287523

Citation

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. Erratum In: JAMA. 2019 Aug 27;322(8):785.

Results Reference

derived

Learn more about this trial

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

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

Herpes Zoster

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial