A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults



Status:Active, not recruiting
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:9/19/2018
Start Date:April 16, 2016
End Date:July 28, 2023

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Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults

The purpose of this study is a long-term follow-up of the two studies 110390 and 113077
(ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK
Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2
additional doses in two subgroups of older adults.

This is the long-term follow-up study (ZOE-LTFU) of studies 110390 and 113077
(ZOSTER-006/022) to assess the prophylactic efficacy, safety, and immunogenicity persistence
of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1
or 2 additional doses on a 0 or 0, 2-month schedule in two subgroups of older adults.

Inclusion Criteria:

- 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, return for
follow-up visits, ability to have scheduled contacts to allow evaluation during the
study). Or subjects with a 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, availability for follow-up contacts).

- Written informed consent obtained from the subject prior to performance of any study
specific procedure.

- Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one
dose of HZ/su vaccine.

Additional inclusion criteria for the 1-Additional Dose Revaccination and Control groups,
ONLY:

- Female subjects of non-childbearing potential may be enrolled in this study.

- Non-childbearing potential is defined as pre-menarche, current tubal ligation,
hysterectomy, ovariectomy or post-menopause.

- Female subjects of childbearing potential may be enrolled in this 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.

Exclusion Criteria:

- Use of any investigational or non-registered product (pharmaceutical product or
device) at the time of enrolment or planned use during the study period.

- Previous vaccination against Varicella Zoster Virus (VZV) or HZ and/or planned
administration during the study of a VZV or HZ vaccine (including an investigational
or non-registered vaccine other than the HZ/su vaccine administered in studies
ZOSTER-006/022).

- Chronic administration (defined as ≥ 14 consecutive days in total) of
immunosuppressants or other immune-modifying drugs during the period starting six
months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any
time during the study period. For corticosteroids, this will mean prednisone ≥ 20
mg/day or equivalent. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical
and intra-articular corticosteroids are allowed.

- Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab)
within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration
at any time during the study period.

- 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 autoimmune disorders).

- Administration of immunoglobulins and/or any blood products within 3 months prior to
Visit Month 0 of study ZOSTER-049 or planned administration during the study period.

- Prolonged use (> 14 consecutive days) of oral and/or parenteral antiviral agents that
are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be
used during the study period for an indication other than to treat suspected or
confirmed HZ or an HZ-related complication (topical use of these antiviral agents is
allowed).

- Important underlying illness that in the opinion of the investigator would be expected
to interfere significantly during the study.

Additional exclusion criteria for the 1-Additional Dose Revaccination and Control groups,
only:

- Subjects who experienced an SAE from first vaccination in the previous ZOSTER-006/022
studies to enrolment in study ZOSTER-049 that was considered related to study vaccine
by either the investigator or the sponsor.

- Subjects with a new onset of a pIMD or exacerbation of a pIMD from first vaccination
in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049.

- Use of any investigational or non-registered product (pharmaceutical product or
device) within 30 days preceding the first dose of study vaccine or planned use during
the study period.

- Administration or planned administration of any other immunizations within 30 days
before the first study vaccination or scheduled within 30 days after study
vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit
vaccines, including inactivated and subunit influenza vaccines for seasonal or
pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each
dose and/or at least 14 days after any dose of study vaccine.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine. Additionally, consider allergic reactions to other material or equipment
related to study participation (such as materials that may possibly contain
latex-gloves, syringes, etc.). Please note, the vaccine and vials in this study do not
contain latex.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions (if of childbearing potential).

- Previous episode/history of HZ.
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Mount Pleasant, South Carolina 29464
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Murray, Utah 84107
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Newport News, Virginia 23606
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Winston-Salem, North Carolina 27103
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