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.

NCT ID: NCT02690207

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8687 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-16
• Study Completion Date: 2019-03-15

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HZ/su Group

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

Group Type: EXPERIMENTAL

Herpes Zoster Vaccine GSK1437173A

Intervention Type: BIOLOGICAL

Intramuscular injection

Interventions

Herpes Zoster Vaccine GSK1437173A

Intramuscular injection

Intervention Type: BIOLOGICAL

Other Intervention Names

HZ/su

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Spring Valley, California, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

DeLand, Florida, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Meridian, Idaho, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Columbia, Maryland, United States

GSK Investigational Site

Elkridge, Maryland, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Somers Point, New Jersey, United States

GSK Investigational Site

Cary, North Carolina, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Hickory, North Carolina, United States

GSK Investigational Site

Salisbury, North Carolina, United States

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Wilmington, North Carolina, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Wadsworth, Ohio, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Uniontown, Pennsylvania, United States

GSK Investigational Site

Greer, South Carolina, United States

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Murray, Utah, United States

GSK Investigational Site

Newport News, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Winchester, Virginia, United States

GSK Investigational Site

Renton, Washington, United States

GSK Investigational Site

Maroubra, New South Wales, Australia

GSK Investigational Site

Umina, New South Wales, Australia

GSK Investigational Site

Westmead, New South Wales, Australia

GSK Investigational Site

Wollongong, New South Wales, Australia

GSK Investigational Site

Kippa-Ring, Queensland, Australia

GSK Investigational Site

Geelong, Victoria, Australia

GSK Investigational Site

Ivanhoe, Victoria, Australia

GSK Investigational Site

Belo Horizonte, Minas Gerais, Brazil

GSK Investigational Site

Curitiba, Paraná, Brazil

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

Curitiba/PR, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

Victoria, British Columbia, Canada

GSK Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Woodstock, Ontario, Canada

GSK Investigational Site

Gatineau, Quebec, Canada

GSK Investigational Site

Mirabel, Quebec, Canada

GSK Investigational Site

Pointe-Claire, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Trois-Rivières, Quebec, Canada

GSK Investigational Site

Brno, , Czechia

GSK Investigational Site

České Budějovice, , Czechia

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

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Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Kokkola, , Finland

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Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Angers, , France

GSK Investigational Site

Angers, , France

GSK Investigational Site

Château-Gontier, , France

GSK Investigational Site

Clermont-Ferrand, , France

GSK Investigational Site

Laval, , France

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Montrevault, , France

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Muret, , France

GSK Investigational Site

Mûrs-Erigné, , France

GSK Investigational Site

Nantes, , France

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Rosiers-d'Égletons, , France

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Saint-Cyr-sur-Loire, , France

GSK Investigational Site

Segré, , France

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Tours, , France

GSK Investigational Site

Deggingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Güglingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Wangen, Baden-Wurttemberg, Germany

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Dachau, Bavaria, Germany

GSK Investigational Site

Künzing, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Rednitzhembach, Bavaria, Germany

GSK Investigational Site

Wallerfing, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Flörsheim, Hesse, Germany

GSK Investigational Site

Duelmen, Lower Saxony, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Witten, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Freiberg, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Köthen, Saxony-Anhalt, Germany

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Lübeck, Schleswig-Holstein, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

GSK Investigational Site

Magdeburg, , Germany

GSK Investigational Site

Kwun Tong, , Hong Kong

GSK Investigational Site

Shatin, , Hong Kong

GSK Investigational Site

Chieti, Abruzzo, Italy

GSK Investigational Site

Pescara, Abruzzo, Italy

GSK Investigational Site

Rome, Lazio, Italy

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Genoa, Liguria, Italy

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Monza, Lombardy, Italy

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Cuneo, Piedmont, Italy

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Sassari, Sardinia, Italy

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Ragusa (RG), Sicily, Italy

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

GSK Investigational Site

Kanagawa, , Japan

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Kanagawa, , Japan

GSK Investigational Site

Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Zapopan, Jalisco, Jalisco, Mexico

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Jojutla, Morelos, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

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Durango, , Mexico

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Ansan, , South Korea

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Bucheon-si, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Kangnam-gu, Seoul, , South Korea

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Kangwon-do, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

GSK Investigational Site

Alcover( Tarragona), , Spain

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Balenyà (Barcelona), , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Centelles (Barcelona), , Spain

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La Roca Del Valles (Barcelona), , Spain

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Madrid, , Spain

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Madrid, , Spain

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Majadahonda( Madrid, , Spain

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Peralada( Girona), , Spain

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Valencia, , Spain

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Vic, , Spain

GSK Investigational Site

Borås, , Sweden

GSK Investigational Site

Eskilstuna, , Sweden

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Gothenburg, , Sweden

GSK Investigational Site

Jönköping, , Sweden

GSK Investigational Site

Karlskrona, , Sweden

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Linköping, , Sweden

GSK Investigational Site

Malmo, , Sweden

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Örebro, , Sweden

GSK Investigational Site

Skövde, , Sweden

GSK Investigational Site

Stockholm, , Sweden

GSK Investigational Site

Uppsala, , Sweden

GSK Investigational Site

Vällingby, , Sweden

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan District, , Taiwan

GSK Investigational Site

Buckshaw Village, Chorley, Lancashire, United Kingdom

GSK Investigational Site

Atherstone, Warwickshire, United Kingdom

GSK Investigational Site

Bradford-on-Avon, Wiltshire, United Kingdom

GSK Investigational Site

Bangor, , United Kingdom

GSK Investigational Site

Belfast, , United Kingdom

GSK Investigational Site

Broughshane, , United Kingdom

GSK Investigational Site

Liverpool, , United Kingdom

GSK Investigational Site

Newtonabbey, , United Kingdom

Countries

United States; Australia; Brazil; Canada; Czechia; Estonia; Finland; France; Germany; Hong Kong; Italy; Japan; Mexico; South Korea; Spain; Sweden; Taiwan; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 33277059 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-000965-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

204486

Identifier Type: -

Identifier Source: org_study_id