Herpes Zoster

To evaluate the safety, in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAE) and potential Immune Mediated Disease (pIMD) in all subjects, following administration of each dose of the HZ/su vaccine.

HZ/su

VZV gE antigen +AS01B adjuvant

Injection

0.5ml

Primary
 Occurrence of unsolicited AEs.
 Occurrence, intensity and relationship to vaccination
of unsolicited AEs during 30 days (Days 0-29) after
each vaccination, according to the Medical Dictionary
for Regulatory Activities (MedDRA) classification.
 Occurrence of SAEs.
 Occurrence and relationship to vaccination of all SAEs
from Month 0 until study end (Month 14, i.e. 12
months post dose 2).
 Occurrence of AEs of special interest.
 Occurrence of any pIMDs from Month 0 until study
end (Month 14, i.e. 12 months post dose 2).
Secondary (Amended 17 December 2015)
 Occurrence of suspected HZ cases.
 Occurrence of suspected HZ cases from Month 0 to
study end.

Inclusion criteria for enrolment
Deviations from inclusion criteria are not allowed because they can potentially jeopardize
the scientific integrity of the study, regulatory acceptability or subject safety. Therefore,
adherence to the criteria as specified in the protocol is essential.
All subjects must satisfy ALL the following criteria at study entry:
 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, vaccination visits,
follow-up contacts). Or subjects’ Legally Acceptable Representative(s)
[LAR(s)]/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, vaccination
visits, availability for follow-up contacts).
 Written informed consent obtained from the subject/LAR(s) of the subject prior to
performing any study specific procedure. If the subject is not capable of giving
consent, his/her assent to participate should be obtained to the extent possible.
 Subject who previously participated in ZOSTER-006 or ZOSTER-022 studies and
received at least one dose of placebo.
 Female subjects of non-childbearing potential may be enrolled in the study.
 Non-childbearing potential is defined as pre-menarche, current tubal ligation,
hysterectomy, ovariectomy or post-menopause.
Please refer to the glossary of terms for the definition of menarche and 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 during the entire treatment
period* and for 2 months after completion of the vaccination series.
*treatment period refers to vaccination days and the interval between them.
Please refer to the glossary of terms for the definition of adequate contraception.

Exclusion criteria for enrolment
Deviations from exclusion criteria are not allowed because they can potentially
jeopardize the scientific integrity of the study, regulatory acceptability or subject safety.
Therefore, adherence to the criteria as specified in the protocol is essential.
The following criteria should be checked at the time of study entry. If ANY exclusion
criterion applies, the subject must not be included in the study:
 Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine during the period starting 30 days before the first dose of study vaccine
(Day -29 to Day 0), or planned use up to 30 days post Dose 2.
 Previous vaccination against VZV or HZ.
 Planned administration of VZV or HZ vaccination during the study (including an
investigational or non-registered vaccine), with the exception of the study vaccine.
 Planned administration/administration of a vaccine/product not foreseen by the study
protocol in the period starting 30 days before the first dose and ending 30 days after
the last dose of vaccine administration, with the exception of licensed non-replicating
vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit
influenza vaccines, with or without adjuvant for seasonal or pandemic flus). These
vaccines may be administered up to 8 days prior to dose 1 and/or dose 2 and/or at
least 14 days after any dose of study vaccine.
 Chronic administration (defined as more than 14 days in total) of
immunosuppressants or other immune-modifying drugs during the period starting six
months prior to the first vaccine dose and up to 30 days post Dose 2. For
corticosteroids, this will mean prednisone  20 mg/day or equivalent. Inhaled, topical
and intra-articular corticosteroids are allowed.
 Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab)
within six months prior to the first vaccine dose up to 30 days post Dose 2.
 Concurrently participating in another clinical study, at the time of enrolment or
planned participation up to the 30 days post second dose, in which the subject has
been or will be exposed to an investigational or a non-investigational vaccine/product
(pharmaceutical product or device).
 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 autoimmugne disorders).
 History of any reaction or hypersensitivity likely to be exacerbated by any
component of the vaccine.
 Active HZ infection at the time of enrolment (i.e. HZ lesions not completely crusted
over).
 Pregnant or lactating female.
 Any condition which, in the opinion of the investigator, prevents the subject from
participating in the study.
 Any condition which in the judgment of the investigator would make intramuscular
injection unsafe.