Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GlaxoSmithKline (GSK) Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age



Status:Completed
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:12/27/2018
Start Date:January 16, 2017
End Date:May 24, 2018

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Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GSK Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age

The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals'
HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age

The study will evaluate the impact of HZ/su vaccination on the QoL, 400 adults ≥ 50 years of
age (YOA). Subjects will be asked to respond to a series of SF-36 and EQ-5D questionnaires
before and after vaccination following a 2 month schedule. To estimate the impact of
reactogenicity on an individual's physical functioning (PF) and QoL, the study will compare
subject questionnaire responses made during two periods, i.e., pre-vaccination and
post-vaccination. The difference will be considered to be the effect of vaccination and
reactogenicity on the PF and QoL. To characterize the study population and determine if
frailty may influence reactogenicity and consequently the impact on QoL scores, the subjects'
frailty status will be assessed at the first inclusion visit. In addition to the SF-36 and
EQ-5D questionnaires, a more complete characterization of the reactogenicity of the vaccine
will be made by including a detailed collection of the use of healthcare resources and the
occurrence of symptoms through diary card data collection. Impact on days of work loss, both
for the subject or for a caregiver, as applicable, will also be assessed.

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 questionnaires and diary cards).

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

- A male or female aged ≥ 50 YOA at the time of consent.

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

- For this study population, non-childbearing potential is defined as 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.

Exclusion Criteria:

- Any condition which, in the judgment of the investigator, would make intramuscular
(IM) injection unsafe.

- Use or planned use of any investigational or non-registered product (drug or vaccine)
other than the study vaccine or current participation or planned concurrent
participation in another clinical study, in which the subject has been or will be
exposed to an investigational or a non-investigational product (pharmaceutical product
or device) during the period starting 30 days before the first dose of study vaccine
and the study end.

- Use or anticipated use of immunosuppressants or other immune-modifying drugs during
the period starting 180 days prior to study start and during the whole study period.
This includes chronic administration of corticosteroids (> 14 consecutive days of
prednisone at a dose of ≥ 20 mg/day [or equivalent]), long-acting immune-modifying
agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications
used during cancer chemotherapy, organ transplantation or to treat autoimmune
disorders). Inhaled, topical and intra-articular corticosteroids are allowed.

- 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 in the period starting 90
days preceding the first dose of study vaccine or planned administration during the
study period.

- Administration or planned administration of a live vaccine in the period starting 30
days before the first dose of study vaccine and ending 30 days after the last dose of
study vaccine, or, administration or planned administration of a non-replicating
vaccine in the period starting 15 days prior to and ending 14 days after either dose
of study vaccine.

- Previous or planned administration of a vaccine against HZ (including an
investigational or non-registered vaccine) other than the study vaccine, during the
entire study period.

- History of HZ.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- Pregnant or lactating female.

- Significant underlying illness requiring medications that might confound the
evaluation of general/ local AEs, or in the opinion of the investigator, would be
expected to prevent completion of the study.

- Any other condition that, in the opinion of the investigator, might interfere with the
evaluations required by the study.
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Kansas City, Missouri 64128
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Corvallis, Oregon 97330
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Durham, North Carolina 27705
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Norfolk, Virginia 23502
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Oakland, California 94611
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Spartanburg, South Carolina 29303
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Uniontown, Pennsylvania 15401
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