Phase
Condition
Shingles
Chickenpox (Varicella Zoster Infection)
Herpes Simplex Infections
Treatment
HZ/su vaccine (GSK1437173A)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Inclusion criteria for enrolment
Subjects who, in the opinion of the investigator, can and will comply with therequirements of the protocol or/and subjects' Legally AcceptableRepresentative(s) [LAR(s)] who, in the opinion of the investigator, can andwill comply, with the requirements of the protocol.
Written informed consent obtained from the subject/LAR(s) of the subject priorto performance of any study-specific procedure.
Subjects who previously participated in study ZOSTER-041 and completed the full 2 dose HZ/su primary vaccination course.
Inclusion criteria for revaccination
Subjects receiving maintenance CIS therapy for the prevention of allograftrejection for a minimum of one month prior to the first revaccination.
Subjects without an episode of allograft rejection within 90 days prior to thefirst revaccination visit.
Female subjects of non-childbearing potential may be revaccinated.Non-childbearing potential is defined as pre-menarche, current bilateral tuballigation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
Female subjects of childbearing potential may be revaccinated, if the subject:
has practiced adequate contraception for 30 days prior to revaccination, and
has a negative pregnancy test on the day of revaccination, and
has agreed to continue adequate contraception up to 2 months after completion of therevaccination series.
Exclusion
Exclusion Criteria:
Exclusion criteria for enrolment Medical conditions
Vaccination against HZ since completion of study ZOSTER-041.
Significant underlying illness that, in the opinion of the investigator, is expectedto prevent completion of the study.
Any other condition that, in the opinion of the investigator, would interfere withthe evaluations required by the study.
Prior/Concurrent clinical study experience
• Concurrently participating in another interventional vaccine or immunosuppressive clinical study, in which the subject is exposed to an investigational or a non-investigational vaccine/product (drug) at any time during the ZOSTER-073 study.
Exclusion criteria for revaccination Medical conditions
History of confirmed HZ within one year before revaccination visit (Visit 3).
More than one organ transplanted.
Any additional confirmed or suspected immunosuppressive or immunodeficientcondition.
History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the vaccine.
Any other condition that, in the opinion of the investigator, would interfere withthe evaluations required by the study or make vaccination unsafe.
Prior/Concomitant therapy
Administration or planned administration of immunoglobulins and/or any bloodproducts or plasma derivatives during the period starting 3 months before the firstrevaccination dose of study vaccine and ending at Visit 5 (Month 26).
Use of anti-CD20 or other B-cell monoclonal antibody agents as maintenance and/ortherapeutic immunosuppressive therapy for the prevention of allograft rejectionwithin 9 months of first revaccination dose of study vaccine.
Evidence or high suspicion, in the opinion of the investigator, of noncompliance ornonadherence to use of maintenance immunosuppressive therapies.
Planned administration/administration of a live vaccine in the period starting 30days before the first dose and ending 30 days after the last dose of study vaccineadministration.
Planned administration/administration of a non-replicating or subunit vaccine, notforeseen by the study protocol, in the period starting 8 days before and ending 30days after each dose of study vaccine.
Other exclusion criteria for revaccination
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptiveprecautions up to 2 months post-revaccination Dose 2.
Any condition which, in the judgment of the investigator, would make intramuscularinjection unsafe.
Study Design
Connect with a study center
GSK Investigational Site
Brussel, 1090
BelgiumSite Not Available
GSK Investigational Site
Bruxelles, 1090
BelgiumSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 2N2
CanadaSite Not Available
GSK Investigational Site
Helsinki, 00029
FinlandSite Not Available
GSK Investigational Site
Seoul, 06351
Korea, Republic ofSite Not Available
GSK Investigational Site
Panama, 1001
PanamaSite Not Available
GSK Investigational Site
Panama City, 1001
PanamaSite Not Available
GSK Investigational Site
Barcelona, 08035
SpainSite Not Available
GSK Investigational Site
Hospitalet de Llobregat, 08907
SpainSite Not Available
GSK Investigational Site
Madrid, 28040
SpainSite Not Available
GSK Investigational Site
Santander, 39008
SpainSite Not Available
GSK Investigational Site
Sevilla, 41013
SpainSite Not Available
GSK Investigational Site
Taoyuan, 333
TaiwanSite Not Available
GSK Investigational Site
Tau-Yuan, 333
TaiwanSite Not Available
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