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 range50 Years
SexALL
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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…
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)