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A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults
Sponsor: GlaxoSmithKline
Summary
The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.
Official title: A Phase 3b, Open-label, Multi-country, Multi-centre, Long-term Follow-up Study of ZOSTER-049 (Follow-up of ZOSTER-006/022 Studies) to Assess the Prophylactic Efficacy, Safety and Persistence of Immune Response of a Herpes Zoster Subunit Vaccine and Assessment of Persistence of Immune Response and Safety of 1 or 2 Additional Doses Administered in ZOSTER-049 in 2 Subgroups of Older Adults
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3038
Start Date
2022-08-10
Completion Date
2027-08-23
Last Updated
2024-01-18
Healthy Volunteers
No
Conditions
Interventions
HZ/su vaccine
No study intervention is administered in this extension study. Participants received the HZ/su vaccine administered in the ZOSTER-049 (NCT02723773), ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies. In order to assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment. In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR)
Locations (107)
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Elkridge, Maryland, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Pittsburgh, Pennsylvania, United States
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Bristol, Tennessee, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Warrawong, New South Wales, Australia
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Westmead, New South Wales, Australia
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Geelong, Victoria, Australia
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Truro, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Mirabel, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Brno, Czechia
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České Budějovice, Czechia
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Hradec Králové, Czechia
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Tallinn, Estonia
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Tartu, Estonia
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Espoo, Finland
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Helsinki, Finland
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Helsinki, Finland
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Jarvenpaa, Finland
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Kokkola, Finland
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Oulu, Finland
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Pori, Finland
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Seinäjoki, Finland
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Tampere, Finland
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Turku, Finland
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Angers, France
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Clermont-Ferrand, France
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Laval, France
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Mûrs-Erigné, France
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Rosiers-d'Égletons, France
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Wangen, Baden-Wurttemberg, Germany
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Weinheim, Baden-Wurttemberg, Germany
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Rednitzhembach, Bavaria, Germany
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Wallerfing, Bavaria, Germany
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Flörsheim, Hesse, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Goch, North Rhine-Westphalia, Germany
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Witten, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Dresden, Saxony, Germany
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Freiberg, Saxony, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Berlin, Germany
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Hamburg, Germany
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Hamburg, Germany
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Shatin, Hong Kong
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Genoa, Liguria, Italy
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Milan, Lombardy, 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
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Kanagawa, Japan
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Tokyo, Japan
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Durango, Mexico
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Ansan, South Korea
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Bucheon-si, South Korea
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Incheon, South Korea
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Kangwon-do, South Korea
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Seoul, South Korea
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Seoul, South Korea
GSK Investigational Site
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 Vallès, Spain
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Madrid, Spain
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Majadahonda( Madrid, Spain
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Marid, Spain
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Peralada( Girona), Spain
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Valencia, Spain
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Vic, Spain
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Borås, Sweden
GSK Investigational Site
Gothenburg, Sweden
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Karlskrona, Sweden
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Linköping, Sweden
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Malmo, Sweden
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Örebro, Sweden
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Stockholm, Sweden
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Upplands Vasby, Sweden
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Uppsala, Sweden
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Taichung, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
GSK Investigational Site
Taoyuan, Taiwan
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom
GSK Investigational Site
Bradford-on-Avon, Wiltshire, United Kingdom
GSK Investigational Site
Belfast, United Kingdom
GSK Investigational Site
Broughshane, United Kingdom
GSK Investigational Site
Liverpool, United Kingdom