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Активно (без набиране) Фаза 3 NCT05371080

A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults

Фаза 3 – широко изпитване преди одобрение
Заболявания: Herpes Zoster

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * Participants and participant's caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol. * Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure. * Medically stable participants as established by medical history and clinical examination before entering into the study. * Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies). Exclusion Criteria: Medical conditions * Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy * Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period. * Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than HZ/su administered in studies ZOSTER-006/022 or ZOSTER-049). Prior/Concurrent clinical study experience * Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV.
Места на провеждане 18
Австралия (1)
GSK Investigational Site
Warrawong , New South Wales
Бразилия (1)
GSK Investigational Site
Belo Horizonte , Minas Gerais
Канада (1)
GSK Investigational Site
Vancouver , British Columbia
Чехия (1)
GSK Investigational Site
Brno
Estonia (1)
GSK Investigational Site
Tallinn
Финландия (1)
GSK Investigational Site
Espoo
Франция (1)
GSK Investigational Site
Angers
Германия (1)
GSK Investigational Site
Wangen , Baden-Wurttemberg
Hong Kong (1)
GSK Investigational Site
Shatin
Италия (1)
GSK Investigational Site
Genoa , Liguria
Япония (1)
GSK Investigational Site
Fukuoka
Mexico (1)
GSK Investigational Site
Durango
Южна Корея (1)
GSK Investigational Site
Ansan
Испания (1)
GSK Investigational Site
Balenyà (Barcelona)
Швеция (1)
GSK Investigational Site
Borås
Taiwan (1)
GSK Investigational Site
Taichung
Великобритания (1)
GSK Investigational Site
Buckshaw Village, Chorley , Lancashire
САЩ (1)
GSK Investigational Site
Phoenix , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
50 Years
Здрави доброволци
Не
Начална дата
10.08.2022
Крайна дата
23.08.2027
Регистрационен номер
NCT05371080
Източник
anzctr
Запитване за медицински туризъм

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