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.
2 other identifiers
interventional
8,687
17 countries
183
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Typical duration for phase_3
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2016
CompletedFirst Posted
Study publicly available on registry
February 24, 2016
CompletedStudy Start
First participant enrolled
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedResults Posted
Study results publicly available
March 12, 2020
CompletedMarch 4, 2021
February 1, 2021
3 years
February 16, 2016
February 26, 2020
February 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
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)
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 Outcomes (1)
Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s)
From Month 0 until study end (Month 14, i.e. 12 months post dose 2)
Study Arms (1)
HZ/su Group
EXPERIMENTALSubjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (195)
GSK Investigational Site
Mesa, Arizona, 85213, United States
GSK Investigational Site
Phoenix, Arizona, 85018, United States
GSK Investigational Site
Phoenix, Arizona, 85020, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Spring Valley, California, 91978, United States
GSK Investigational Site
Clearwater, Florida, 33761, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
West Palm Beach, Florida, 33409, United States
GSK Investigational Site
Meridian, Idaho, 83642, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Columbia, Maryland, 21045, United States
GSK Investigational Site
Elkridge, Maryland, 21075, United States
GSK Investigational Site
Kansas City, Missouri, 64114, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Somers Point, New Jersey, 08244, United States
GSK Investigational Site
Cary, North Carolina, 27518, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cleveland, Ohio, 44122, United States
GSK Investigational Site
Wadsworth, Ohio, 44281, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Murray, Utah, 84123, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Winchester, Virginia, 22601, United States
GSK Investigational Site
Renton, Washington, 98057, United States
GSK Investigational Site
Maroubra, New South Wales, 2035, Australia
GSK Investigational Site
Umina, New South Wales, 2257, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Wollongong, New South Wales, 2522, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Geelong, Victoria, 3220, Australia
GSK Investigational Site
Ivanhoe, Victoria, 3079, Australia
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30150-221, Brazil
GSK Investigational Site
Curitiba, Paraná, 80810-050, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035003, Brazil
GSK Investigational Site
Curitiba/PR, 80240-280, Brazil
GSK Investigational Site
São Paulo, 04023-900, Brazil
GSK Investigational Site
São Paulo, 04266-010, Brazil
GSK Investigational Site
São Paulo, 05403-000, Brazil
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
GSK Investigational Site
Victoria, British Columbia, V8V 3M9, Canada
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Toronto, Ontario, M4S 1Y2, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Woodstock, Ontario, N4S 5P5, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Mirabel, Quebec, J7J 2K8, Canada
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
GSK Investigational Site
Québec, Quebec, G1E 7G9, Canada
GSK Investigational Site
Québec, Quebec, G1W 4R4, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 2G2, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Brno, 662 10, Czechia
GSK Investigational Site
České Budějovice, 370 04, Czechia
GSK Investigational Site
Hradec Králové, Czechia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tartu, 50106, Estonia
GSK Investigational Site
Espoo, 02230, Finland
GSK Investigational Site
Helsinki, 00100, Finland
GSK Investigational Site
Helsinki, 00930, Finland
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Kokkola, 67100, Finland
GSK Investigational Site
Oulu, 90220, Finland
GSK Investigational Site
Pori, 28100, Finland
GSK Investigational Site
Seinäjoki, 60100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Angers, 49000, France
GSK Investigational Site
Angers, 49100, France
GSK Investigational Site
Château-Gontier, 53200, France
GSK Investigational Site
Clermont-Ferrand, 63003, France
GSK Investigational Site
Laval, 53000, France
GSK Investigational Site
Montrevault, 49110, France
GSK Investigational Site
Muret, 31600, France
GSK Investigational Site
Mûrs-Erigné, 49610, France
GSK Investigational Site
Nantes, 44300, France
GSK Investigational Site
Rosiers-d'Égletons, 19300, France
GSK Investigational Site
Saint-Cyr-sur-Loire, 37540, France
GSK Investigational Site
Segré, 49500, France
GSK Investigational Site
Tours, 37100, France
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326, Germany
GSK Investigational Site
Güglingen, Baden-Wurttemberg, 74363, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72074, Germany
GSK Investigational Site
Wangen, Baden-Wurttemberg, 88239, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Dachau, Bavaria, 85221, Germany
GSK Investigational Site
Künzing, Bavaria, 94550, Germany
GSK Investigational Site
Munich, Bavaria, 80339, Germany
GSK Investigational Site
Rednitzhembach, Bavaria, 91126, Germany
GSK Investigational Site
Wallerfing, Bavaria, 94574, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Flörsheim, Hesse, 65439, Germany
GSK Investigational Site
Duelmen, Lower Saxony, 48249, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Dresden, Saxony, 01097, Germany
GSK Investigational Site
Freiberg, Saxony, 09599, Germany
GSK Investigational Site
Leipzig, Saxony, 04315, Germany
GSK Investigational Site
Köthen, Saxony-Anhalt, 06366, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23554, Germany
GSK Investigational Site
Berlin, 10629, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 13347, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, 22143, Germany
GSK Investigational Site
Hamburg, 22415, Germany
GSK Investigational Site
Magdeburg, 39120, Germany
GSK Investigational Site
Kwun Tong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Chieti, Abruzzo, 66013, Italy
GSK Investigational Site
Pescara, Abruzzo, 65100, Italy
GSK Investigational Site
Rome, Lazio, 00163, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Monza, Lombardy, 20900, Italy
GSK Investigational Site
Cuneo, Piedmont, 12100, Italy
GSK Investigational Site
Sassari, Sardinia, 07100, Italy
GSK Investigational Site
Ragusa (RG), Sicily, 97100, Italy
GSK Investigational Site
Fukuoka, 810-0021, Japan
GSK Investigational Site
Fukuoka, 812-0025, Japan
GSK Investigational Site
Fukuoka, 813-8588, Japan
GSK Investigational Site
Fukuoka, 816-0864, Japan
GSK Investigational Site
Kanagawa, 224-8503, Japan
GSK Investigational Site
Kanagawa, 247-8533, Japan
GSK Investigational Site
Tokyo, 142-0054, Japan
GSK Investigational Site
Tokyo, 142-8666, Japan
GSK Investigational Site
Tokyo, 154-0024, Japan
GSK Investigational Site
Zapopan, Jalisco, Jalisco, 45190, Mexico
GSK Investigational Site
Jojutla, Morelos, 62900, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64710, Mexico
GSK Investigational Site
Durango, 34000, Mexico
GSK Investigational Site
Ansan, 425-707, South Korea
GSK Investigational Site
Bucheon-si, 420-767, South Korea
GSK Investigational Site
Incheon, 400-711, South Korea
GSK Investigational Site
Kangnam-gu, Seoul, South Korea
GSK Investigational Site
Kangwon-do, 220-701, South Korea
GSK Investigational Site
Seoul, 135-710, South Korea
GSK Investigational Site
Seoul, 150-950, South Korea
GSK Investigational Site
Seoul, 152-703, South Korea
GSK Investigational Site
Alcover( Tarragona), 43460, Spain
GSK Investigational Site
Balenyà (Barcelona), 08550, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Centelles (Barcelona), 08540, Spain
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Majadahonda( Madrid, 28222, Spain
GSK Investigational Site
Peralada( Girona), 17491, Spain
GSK Investigational Site
Valencia, 46020, Spain
GSK Investigational Site
Vic, 28500, Spain
GSK Investigational Site
Borås, SE-506 30, Sweden
GSK Investigational Site
Eskilstuna, SE-631 88, Sweden
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Jönköping, SE-551 85, Sweden
GSK Investigational Site
Karlskrona, SE-371 41, Sweden
GSK Investigational Site
Linköping, SE-581 85, Sweden
GSK Investigational Site
Malmo, SE-211 52, Sweden
GSK Investigational Site
Örebro, SE-703 62, Sweden
GSK Investigational Site
Skövde, SE-541 50, Sweden
GSK Investigational Site
Stockholm, 11446, Sweden
GSK Investigational Site
Uppsala, SE-751 85, Sweden
GSK Investigational Site
Vällingby, SE-162 68, Sweden
GSK Investigational Site
Taichung, 40447, Taiwan
GSK Investigational Site
Taipei, 112, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Taoyuan District, 333, Taiwan
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, PR7 7NA, United Kingdom
GSK Investigational Site
Atherstone, Warwickshire, CV9 1EU, United Kingdom
GSK Investigational Site
Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom
GSK Investigational Site
Bangor, BT19 1NB, United Kingdom
GSK Investigational Site
Belfast, BT7 2EB, United Kingdom
GSK Investigational Site
Broughshane, BT42 4JP, United Kingdom
GSK Investigational Site
Liverpool, L22 0LG, United Kingdom
GSK Investigational Site
Newtonabbey, BT37 9QW, United Kingdom
Related Publications (1)
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.
PMID: 33277059BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2016
First Posted
February 24, 2016
Study Start
March 16, 2016
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
March 4, 2021
Results First Posted
March 12, 2020
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
- 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 for this study is available via the Clinical Study Data Request site.