Eligibility Details:
Inclusion Criteria:
- Inclusion criteria for enrolment
- Subjects who, in the opinion of the investigator, can and will comply with the
requirements of the protocol or/and subjects' Legally Acceptable
Representative(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/LAR(s) of the subject prior to
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 allograft
rejection for a minimum of one month prior to the first revaccination.
- Subjects without an episode of allograft rejection within 90 days prior to the
first revaccination visit.
- Female subjects of non-childbearing potential may be revaccinated.
Non-childbearing potential is defined as pre-menarche, current bilateral tubal
ligation 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 the
revaccination series.
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 expected
to prevent completion of the study.
- Any other condition that, in the opinion of the investigator, would interfere with the
evaluations required by the study.
Prior/Concurrent clinical study experience
• Concurrently participating in another interventional vaccine or immunosuppressive
clinical study, at any time during the study period, in which the subject has been or will
be exposed to an investigational or a non-investigational vaccine/product (drug).
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 immunodeficient condition.
- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine.
- Any other condition that, in the opinion of the investigator, would interfere with the
evaluations required by the study or make vaccination unsafe.
Prior/Concomitant therapy
- Administration or planned administration of immunoglobulins and/or any blood products
or plasma derivatives during the period starting 3 months before the first
revaccination 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/or
therapeutic immunosuppressive therapy for the prevention of allograft rejection within
9 months of first revaccination dose of study vaccine.
- Evidence or high suspicion, in the opinion of the investigator, of noncompliance or
nonadherence to use of maintenance immunosuppressive therapies.
- Planned administration/administration of a live vaccine in the period starting 30 days
before the first dose and ending 30 days after the last dose of study vaccine
administration.
- Planned administration/administration of a non-replicating or subunit vaccine, not
foreseen by the study protocol, in the period starting 8 days before and ending 30
days after each dose of study vaccine.
Other exclusion criteria for revaccination
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive
precautions up to 2 months post-revaccination Dose 2.
- Any condition which, in the judgment of the investigator, would make intramuscular
injection unsafe.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
