A study on the long-term efficacy, safety and persistence of immune response of a vaccine against Herpes Zoster in older adults.

Phase 1

• Conditions: Herpes Zoster; Therapeutic area: Diseases [C] - Virus Diseases [C02]; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-505255-51-00
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-15
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3571

Inclusion Criteria

Participants, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol (e.g. completion of the HZ-specific diary cards/QoL questionnaires, return for follow-up visits and ability to have scheduled contacts to allow evaluation during the study) or participants with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the HZ-specific diary cards, availability for follow-up contacts)., 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

Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study., Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or 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)., 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the VE of HZ/su in preventing HZ.;Secondary Objective: To evaluate the VE of HZ/su in preventing HZ from 1- month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study., To evaluate persistence of the humoral immune response to HZ/su., To evaluate persistence of the cell-mediated immune response to HZ/su., To evaluate vaccine safety of HZ/su.;Primary end point(s): Confirmed HZ cases during the total duration of the ZOSTER-101 study (Day 1 through Month 48).