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Active (not recruiting) Phase 3 NCT05371080

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

Phase 3 – large-scale trial before approval
Conditions: Herpes Zoster

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 18
Australia (1)
GSK Investigational Site
Warrawong , New South Wales
Brazil (1)
GSK Investigational Site
Belo Horizonte , Minas Gerais
Canada (1)
GSK Investigational Site
Vancouver , British Columbia
Czech Republic (1)
GSK Investigational Site
Brno
Estonia (1)
GSK Investigational Site
Tallinn
Finland (1)
GSK Investigational Site
Espoo
France (1)
GSK Investigational Site
Angers
Germany (1)
GSK Investigational Site
Wangen , Baden-Wurttemberg
Hong Kong (1)
GSK Investigational Site
Shatin
Italy (1)
GSK Investigational Site
Genoa , Liguria
Japan (1)
GSK Investigational Site
Fukuoka
Mexico (1)
GSK Investigational Site
Durango
South Korea (1)
GSK Investigational Site
Ansan
Spain (1)
GSK Investigational Site
Balenyà (Barcelona)
Sweden (1)
GSK Investigational Site
Borås
Taiwan (1)
GSK Investigational Site
Taichung
United Kingdom (1)
GSK Investigational Site
Buckshaw Village, Chorley , Lancashire
United States (1)
GSK Investigational Site
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
50 Years
Healthy volunteers
No
Start date
10.08.2022
Completion date
23.08.2027
Registry ID
NCT05371080
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.