Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When G… (NCT04091451) | Clinical Trial Compass
CompletedPhase 3
Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster
Russia1,430 participantsStarted 2019-09-17
Plain-language summary
The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
* Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure.
* A male or female ≥ 50 YOA at the time of the first vaccination.
* Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:
* Clinically diagnosed HZ:
OR Laboratory diagnosed HZ: OR
* HZ diagnosed by an adjudication committee: Female subjects of non-childbearing potential may be enrolled in the study.
* Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination, and
* has agreed to continue adequate contraception for 2 months after completion of the vaccination series.
Exclusion Criteria:
* Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
* Use of any investigational or non-regis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
Timeframe: From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)