A long-term follow-up study (ZOE-LTFU) of two studies 110390 (ZOSTER- 006) and 113077 (ZOSTER-022) to assess the efficacy, safety, andimmunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and assessment of 1 or 2 additional doses in two subgroups of older adults.
- Conditions
- Vaccination against HZ and its related complications in adults older than 50 years (at the time of primary vaccination)MedDRA version: 20.0Level: LLTClassification code 10019982Term: Herpes zoster NOSSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-001778-17-IT
- Lead Sponsor
- GLAXOSMITHKLINE BIOLOGICALS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 8581
•Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to
allow evaluation during the study). Or subjects 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 diary cards,
availability for follow-up contacts);
•Witten informed consent obtained from the subject prior to performance of any study specific procedure;
•Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of HZ/su vaccine.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1716
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6865
•Use of any investigational or non-registered product (pharmaceutical product or device) at the time of enrolment or 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 the HZ/su vaccine administered in studies ZOSTER-006/022);
•Chronic administration (defined as > 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. For corticosteroids, this will mean prednisone = 20 mg/day or equivalent. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intraarticular corticosteroids are allowed;
•Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab) within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study
period;
•Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders);
•Administration of immunoglobulins and/or any blood products within 3 months prior to Visit Month 0 of study ZOSTER-049 or planned administration during the study period;
•Prolonged use (> 14 consecutive days) of oral and/or par-enteral antiviral agents that are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be used during the study period for an indication other than to treat suspected or confirmed HZ or an HZ related complication (topical use of these antiviral agents is allowed).
•Important underlying illness that in the opinion of the investigator would be expected to interfere significantly during the study;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method