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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.

Primary Purpose

Herpes Zoster

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Herpes Zoster Vaccine GSK1437173A

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring Herpes Zoster, Safety, Adults, Cross-vaccination

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HZ/su Group

Arm Description

Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm

Outcomes

Primary Outcome Measures

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. 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 Serious Adverse Events (SAEs)

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.

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

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.

Secondary Outcome Measures

Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s)

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.

Full Information

NCT ID

NCT02690207

First Posted

February 16, 2016

Last Updated

February 11, 2021

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02690207

Brief Title

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.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

March 16, 2016 (Actual)

Primary Completion Date

March 15, 2019 (Actual)

Study Completion Date

March 15, 2019 (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 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).

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.

6. Conditions and Keywords

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

Herpes Zoster

Keywords

Herpes Zoster, Safety, Adults, Cross-vaccination

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8687 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HZ/su Group

Arm Type

Experimental

Arm Description

Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm

Intervention Type

Biological

Intervention Name(s)

Herpes Zoster Vaccine GSK1437173A

Other Intervention Name(s)

HZ/su

Intervention Description

Intramuscular injection

Primary Outcome Measure Information:

Title

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

Description

Time Frame

During 30 days (Days 0-29) after any vaccination (across doses)

Title

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

Description

Time Frame

From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Title

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

Description

Time Frame

From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Secondary Outcome Measure Information:

Title

Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s)

Description

Time Frame

From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Mesa

State/Province

Arizona

ZIP/Postal Code

85213

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

GSK Investigational Site

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

GSK Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

GSK Investigational Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

GSK Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

GSK Investigational Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21045

Country

United States

Facility Name

GSK Investigational Site

City

Elkridge

State/Province

Maryland

ZIP/Postal Code

21075

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

Facility Name

GSK Investigational Site

City

Somers Point

State/Province

New Jersey

ZIP/Postal Code

08244

Country

United States

Facility Name

GSK Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

GSK Investigational Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

GSK Investigational Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

GSK Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

GSK Investigational Site

City

Wadsworth

State/Province

Ohio

ZIP/Postal Code

44281

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

GSK Investigational Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

GSK Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

GSK Investigational Site

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

GSK Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

GSK Investigational Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

GSK Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

GSK Investigational Site

City

Winchester

State/Province

Virginia

ZIP/Postal Code

22601

Country

United States

Facility Name

GSK Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

GSK Investigational Site

City

Maroubra

State/Province

New South Wales

ZIP/Postal Code

2035

Country

Australia

Facility Name

GSK Investigational Site

City

Umina

State/Province

New South Wales

ZIP/Postal Code

2257

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

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2522

Country

Australia

Facility Name

GSK Investigational Site

City

Kippa Ring

State/Province

Queensland

ZIP/Postal Code

4021

Country

Australia

Facility Name

GSK Investigational Site

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

GSK Investigational Site

City

Ivanhoe

State/Province

Victoria

ZIP/Postal Code

3079

Country

Australia

Facility Name

GSK Investigational Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30150-221

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80810-050

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035003

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba/PR

ZIP/Postal Code

80240-280

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04023-900

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04266-010

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

GSK Investigational Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3M9

Country

Canada

Facility Name

GSK Investigational Site

City

Bay Roberts

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A0A 1G0

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

GSK Investigational Site

City

Truro

State/Province

Nova Scotia

ZIP/Postal Code

B2N 1L2

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y2

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

GSK Investigational Site

City

Woodstock

State/Province

Ontario

ZIP/Postal Code

N4S 5P5

Country

Canada

Facility Name

GSK Investigational Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S8

Country

Canada

Facility Name

GSK Investigational Site

City

Mirabel

State/Province

Quebec

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

GSK Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

GSK Investigational Site

City

Québec City

State/Province

Quebec

ZIP/Postal Code

G1E 7G9

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 2G2

Country

Canada

Facility Name

GSK Investigational Site

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

662 10

Country

Czechia

Facility Name

GSK Investigational Site

City

Ceske Budejovice

ZIP/Postal Code

370 04

Country

Czechia

Facility Name

GSK Investigational Site

City

Hradec Kralove

Country

Czechia

Facility Name

GSK Investigational Site

City

Tallinn

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50106

Country

Estonia

Facility Name

GSK Investigational Site

City

Espoo

ZIP/Postal Code

02230

Country

Finland

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

GSK Investigational Site

City

Jarvenpaa

ZIP/Postal Code

04400

Country

Finland

Facility Name

GSK Investigational Site

City

Kokkola

ZIP/Postal Code

67100

Country

Finland

Facility Name

GSK Investigational Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

GSK Investigational Site

City

Pori

ZIP/Postal Code

28100

Country

Finland

Facility Name

GSK Investigational Site

City

Seinajoki

ZIP/Postal Code

60100

Country

Finland

Facility Name

GSK Investigational Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

GSK Investigational Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

GSK Investigational Site

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

GSK Investigational Site

City

Angers

ZIP/Postal Code

49100

Country

France

Facility Name

GSK Investigational Site

City

Château Gontier

ZIP/Postal Code

53200

Country

France

Facility Name

GSK Investigational Site

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

GSK Investigational Site

City

Laval

ZIP/Postal Code

53000

Country

France

Facility Name

GSK Investigational Site

City

Montrevault

ZIP/Postal Code

49110

Country

France

Facility Name

GSK Investigational Site

City

Muret

ZIP/Postal Code

31600

Country

France

Facility Name

GSK Investigational Site

City

Murs-Erigne

ZIP/Postal Code

49610

Country

France

Facility Name

GSK Investigational Site

City

Nantes

ZIP/Postal Code

44300

Country

France

Facility Name

GSK Investigational Site

City

Rosiers d'Egletons

ZIP/Postal Code

19300

Country

France

Facility Name

GSK Investigational Site

City

Saint Cyr sur Loire

ZIP/Postal Code

37540

Country

France

Facility Name

GSK Investigational Site

City

Segré

ZIP/Postal Code

49500

Country

France

Facility Name

GSK Investigational Site

City

Tours

ZIP/Postal Code

37100

Country

France

Facility Name

GSK Investigational Site

City

Deggingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73326

Country

Germany

Facility Name

GSK Investigational Site

City

Gueglingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

74363

Country

Germany

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68161

Country

Germany

Facility Name

GSK Investigational Site

City

Tuebingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72074

Country

Germany

Facility Name

GSK Investigational Site

City

Wangen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

88239

Country

Germany

Facility Name

GSK Investigational Site

City

Weinheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69469

Country

Germany

Facility Name

GSK Investigational Site

City

Dachau

State/Province

Bayern

ZIP/Postal Code

85221

Country

Germany

Facility Name

GSK Investigational Site

City

Kuenzing

State/Province

Bayern

ZIP/Postal Code

94550

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80339

Country

Germany

Facility Name

GSK Investigational Site

City

Rednitzhembach

State/Province

Bayern

ZIP/Postal Code

91126

Country

Germany

Facility Name

GSK Investigational Site

City

Wallerfing

State/Province

Bayern

ZIP/Postal Code

94574

Country

Germany

Facility Name

GSK Investigational Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97070

Country

Germany

Facility Name

GSK Investigational Site

City

Floersheim

State/Province

Hessen

ZIP/Postal Code

65439

Country

Germany

Facility Name

GSK Investigational Site

City

Duelmen

State/Province

Niedersachsen

ZIP/Postal Code

48249

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45355

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45359

Country

Germany

Facility Name

GSK Investigational Site

City

Goch

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47574

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51069

Country

Germany

Facility Name

GSK Investigational Site

City

Witten

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

58455

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55116

Country

Germany

Facility Name

GSK Investigational Site

City

Rhaunen

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55624

Country

Germany

Facility Name

GSK Investigational Site

City

Koethen

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06366

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01097

Country

Germany

Facility Name

GSK Investigational Site

City

Freiberg

State/Province

Sachsen

ZIP/Postal Code

09599

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04315

Country

Germany

Facility Name

GSK Investigational Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23554

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

GSK Investigational Site

City

Kwun Tong

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Shatin

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Chieti

State/Province

Abruzzo

ZIP/Postal Code

66013

Country

Italy

Facility Name

GSK Investigational Site

City

Pescara

State/Province

Abruzzo

ZIP/Postal Code

65100

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00163

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20900

Country

Italy

Facility Name

GSK Investigational Site

City

Cuneo

State/Province

Piemonte

ZIP/Postal Code

12100

Country

Italy

Facility Name

GSK Investigational Site

City

Sassari

State/Province

Sardegna

ZIP/Postal Code

07100

Country

Italy

Facility Name

GSK Investigational Site

City

Ragusa (RG)

State/Province

Sicilia

ZIP/Postal Code

97100

Country

Italy

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

810-0021

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

812-0025

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

813-8588

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

816-0864

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

224-8503

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

142-0054

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

154-0024

Country

Japan

Facility Name

GSK Investigational Site

City

Ansan

ZIP/Postal Code

425-707

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Bucheon-si,

ZIP/Postal Code

420-767

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kangnam-gu, Seoul

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kangwon-do

ZIP/Postal Code

220-701

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

150-950

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Zapopan, Jalisco

State/Province

Jalisco

ZIP/Postal Code

45190

Country

Mexico

Facility Name

GSK Investigational Site

City

Jojutla

State/Province

Morelos

ZIP/Postal Code

62900

Country

Mexico

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64710

Country

Mexico

Facility Name

GSK Investigational Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

GSK Investigational Site

City

Alcover( Tarragona)

ZIP/Postal Code

43460

Country

Spain

Facility Name

GSK Investigational Site

City

Balenyà (Barcelona)

ZIP/Postal Code

08550

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

Centelles (Barcelona)

ZIP/Postal Code

08540

Country

Spain

Facility Name

GSK Investigational Site

City

La Roca Del Valles (Barcelona)

ZIP/Postal Code

08430

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

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Majadahonda( Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

GSK Investigational Site

City

Peralada( Girona)

ZIP/Postal Code

17491

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46020

Country

Spain

Facility Name

GSK Investigational Site

City

Vic

ZIP/Postal Code

28500

Country

Spain

Facility Name

GSK Investigational Site

City

Borås

ZIP/Postal Code

SE-506 30

Country

Sweden

Facility Name

GSK Investigational Site

City

Eskilstuna

ZIP/Postal Code

SE-631 88

Country

Sweden

Facility Name

GSK Investigational Site

City

Göteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

GSK Investigational Site

City

Jönköping

ZIP/Postal Code

SE-551 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Karlskrona

ZIP/Postal Code

SE-371 41

Country

Sweden

Facility Name

GSK Investigational Site

City

Linköping

ZIP/Postal Code

SE-581 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Malmö

ZIP/Postal Code

SE-211 52

Country

Sweden

Facility Name

GSK Investigational Site

City

Skövde

ZIP/Postal Code

SE-541 50

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

11446

Country

Sweden

Facility Name

GSK Investigational Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Vällingby

ZIP/Postal Code

SE-162 68

Country

Sweden

Facility Name

GSK Investigational Site

City

Örebro

ZIP/Postal Code

SE-703 62

Country

Sweden

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

GSK Investigational Site

City

Buckshaw Village, Chorley

State/Province

Lancashire

ZIP/Postal Code

PR7 7NA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Atherstone

State/Province

Warwickshire

ZIP/Postal Code

CV9 1EU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bradford on Avon

State/Province

Wiltshire

ZIP/Postal Code

BA15 1DQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bangor

ZIP/Postal Code

BT19 1NB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Belfast

ZIP/Postal Code

BT7 2EB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Broughshane

ZIP/Postal Code

BT42 4JP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Liverpool

ZIP/Postal Code

L22 0LG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newtonabbey

ZIP/Postal Code

BT37 9QW

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://clinicalstudydatarequest.com/Posting.aspx?ID=20772

Citations:

PubMed Identifier

33277059

Citation

Ocran-Appiah J, Boutry C, Herve C, Soni J, Schuind A; ZOSTER-056 Study Group. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients. Vaccine. 2021 Jan 3;39(1):6-10. doi: 10.1016/j.vaccine.2020.10.029. Epub 2020 Dec 1.

Results Reference

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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.

Herpes Zoster

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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