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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690207
• Other study ID #: 204486
• Secondary ID: 2015-000965-30
• Status: Completed
• Phase: Phase 3
• Start date: March 16, 2016
• Est. completion date: March 15, 2019

Study information

• Verified date: February 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8687
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• Herpes Zoster Vaccine GSK1437173A
Intramuscular injection

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Geelong	Victoria
Australia	GSK Investigational Site	Ivanhoe	Victoria
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	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
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Curitiba	Paraná
Brazil	GSK Investigational Site	Curitiba/PR
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	São Paulo
Canada	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Gatineau	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Mirabel	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Québec City	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois-Rivieres	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Woodstock	Ontario
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Ceske Budejovice
Czechia	GSK Investigational Site	Hradec Kralove
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Kokkola
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
France	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	GSK Investigational Site	Montrevault
France	GSK Investigational Site	Muret
France	GSK Investigational Site	Murs-Erigne
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Rosiers d'Egletons
France	GSK Investigational Site	Saint Cyr sur Loire
France	GSK Investigational Site	Segré
France	GSK Investigational Site	Tours
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dachau	Bayern
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Duelmen	Niedersachsen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Floersheim	Hessen
Germany	GSK Investigational Site	Freiberg	Sachsen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koethen	Sachsen-Anhalt
Germany	GSK Investigational Site	Kuenzing	Bayern
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Magdeburg
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Rednitzhembach	Bayern
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wallerfing	Bayern
Germany	GSK Investigational Site	Wangen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Hong Kong	GSK Investigational Site	Kwun Tong
Hong Kong	GSK Investigational Site	Shatin
Italy	GSK Investigational Site	Chieti	Abruzzo
Italy	GSK Investigational Site	Cuneo	Piemonte
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Monza	Lombardia
Italy	GSK Investigational Site	Pescara	Abruzzo
Italy	GSK Investigational Site	Ragusa (RG)	Sicilia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sassari	Sardegna
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Ansan
Korea, Republic of	GSK Investigational Site	Bucheon-si,
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Kangnam-gu, Seoul
Korea, Republic of	GSK Investigational Site	Kangwon-do
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Jojutla	Morelos
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Mexico	GSK Investigational Site	Zapopan, Jalisco	Jalisco
Spain	GSK Investigational Site	Alcover( Tarragona)
Spain	GSK Investigational Site	Balenyà (Barcelona)
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Centelles (Barcelona)
Spain	GSK Investigational Site	La Roca Del Valles (Barcelona)
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda( Madrid
Spain	GSK Investigational Site	Peralada( Girona)
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vic
Sweden	GSK Investigational Site	Borås
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Jönköping
Sweden	GSK Investigational Site	Karlskrona
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Örebro
Sweden	GSK Investigational Site	Skövde
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uppsala
Sweden	GSK Investigational Site	Vällingby
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan
United Kingdom	GSK Investigational Site	Atherstone	Warwickshire
United Kingdom	GSK Investigational Site	Bangor
United Kingdom	GSK Investigational Site	Belfast
United Kingdom	GSK Investigational Site	Bradford on Avon	Wiltshire
United Kingdom	GSK Investigational Site	Broughshane
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	Newtonabbey
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Columbia	Maryland
United States	GSK Investigational Site	DeLand	Florida
United States	GSK Investigational Site	Elkridge	Maryland
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Meridian	Idaho
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	Newport News	Virginia
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	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Renton	Washington
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Somers Point	New Jersey
United States	GSK Investigational Site	Spring Valley	California
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	Wadsworth	Ohio
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winchester	Virginia
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

References & Publications (1)

Ocran-Appiah J, Boutry C, Hervé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During 30 days (Days 0-29) after any vaccination (across doses)
Primary	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.	From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Primary	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.	From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Secondary	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.	From Month 0 until study end (Month 14, i.e. 12 months post dose 2)