Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.



Status:Active, not recruiting
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:10/5/2018
Start Date:March 16, 2016
End Date:April 15, 2019

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Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies

The purpose of this study is to cross-vaccinate and collect safety data in terms of
unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated
Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in
ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).

Since the HZ/su vaccine has not yet been licensed and marketed, this study is being conducted
to enable potentially eligible subjects who previously received placebo in ZOSTER-006
(NCT01165177) or ZOSTER-022 (NCT01165229) to receive the HZ/su vaccine.

Study ZOSTER-056 is an open-label, multi-centric and single arm study to cross-vaccinate and
collect safety data in terms of of unsolicited Adverse Events (AEs), Serious Adverse Events
(SAEs) and pIMD from subjects >= 50 YOA who previously received placebo.

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, 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/Legally Acceptable
representative(s) [LAR(s)] of the subject prior to performing any study specific
procedure. If the subjects 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.

- 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.

Exclusion Criteria:

- 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 Varicella Zoster virus (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 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 autoimmune 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.
We found this trial at
35
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Kansas City, Missouri 64128
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Bristol, Tennessee 37620
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Cary, North Carolina 27518
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Charlotte, North Carolina 28203
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Clearwater, Florida 33759
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Cleveland, Ohio 44195
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Columbia, Maryland 21044
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DeLand, Florida 32720
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Elkridge, Maryland 21075
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Greer, South Carolina 29651
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Hickory, North Carolina 28601
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Jacksonville, Florida 32207
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Las Vegas, Nevada 89102
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Maroubra, New South Wales 2035
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Meridian, Idaho 83642
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Mesa, Arizona 85206
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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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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15213
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Renton, Washington 98057
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Richmond, Virginia 23298
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Salisbury, North Carolina 28114
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San Antonio, Texas 78258
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Somers Point, New Jersey 08244
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Spring Valley, California 91978
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Tucson, Arizona 85724
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Uniontown, Pennsylvania 15401
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Wadsworth, Ohio 44281
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West Palm Beach, Florida 33409
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Wichita, Kansas 67207
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Wilmington, North Carolina 28405
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Winchester, Virginia 22601
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Winston-Salem, North Carolina 27103
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