CTIS2023-505255-51-00
Active, not recruiting
Phase 1
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. - 217917
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 3,571
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
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.
Investigators
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