Status:
ACTIVE_NOT_RECRUITING
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Zoster
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 23 2027
Estimated Enrollment :
3038 Patients enrolled
Trial Details
Trial ID
NCT05371080
Start Date
August 10 2022
End Date
August 23 2027
Last Update
January 18 2024
Active Locations (107)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85020
2
GSK Investigational Site
Elkridge, Maryland, United States, 21075
3
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
4
GSK Investigational Site
Hickory, North Carolina, United States, 28601