Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older



Status:Completed
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:4/26/2018
Start Date:February 7, 2014
End Date:April 21, 2016

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Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Boostrix® in Adults Aged 50 Years and Older

The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK
Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine
in adults aged 50 years or older compared to administration of vaccines separately.


Inclusion Criteria:

- Subjects who, in the opinion of the investigator, can and will comply with the
requirements of the protocol.

- A male or female aged 50 years or older at the time of the first vaccination with the
study vaccine(s).

- Written informed consent obtained from the subject.

- 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.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccines within 30 days preceding the first dose of study vaccine, or planned
use during the study period.

- Chronic administration (defined as more than 14 consecutive days) of
immunosuppressants or other immune-modifying drugs within six months prior to the
first vaccine dose (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 or planned administration of a vaccine not foreseen by the study
protocol within the period starting 30 days before the first dose of study vaccine(s)
and ending 30 days after the last dose of study vaccine. This includes any type of
vaccine such as (but not limited to) live, inactivated and subunit vaccines (e.g.,
inactivated and subunit influenza vaccines).

- Administration of long-acting immune-modifying drugs (e.g. infliximab) within six
months prior to the first vaccine dose or expected administration at any time during
the study period.

- Concurrently participating in another 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 (pharmaceutical product or device).

- Previous vaccination against VZV or HZ and/or planned administration during the study
of an HZ or VZV vaccine (including an investigational or non-registered vaccine) other
than the study vaccine.

- History of HZ.

- Vaccination against diphtheria, or tetanus in the last five years or planned
vaccination against diphtheria or tetanus during the study period, other than the
study vaccine(s).

- Administration of a combined tetanus, diphtheria and pertussis (Tdap) vaccine at any
time prior to study entry.

- 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 vaccines including prior severe allergic reaction following tetanus-toxoid,
diphtheria-toxoid or pertussis-containing vaccine.

- Hypersensitivity to latex. Note: The investigational HZ/su vaccine does not contain
latex.

- Acute disease and/or fever at the time of enrolment.

- Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred
route for recording temperature in this study will be oral.

- Subjects with a minor illness (such as mild diarrhea, mild upper respiratory
infection) without fever may, be enrolled at the discretion of the investigator.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions before 2 months after the last dose of study vaccine.

- 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
(IM) injection unsafe.

- Encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) not
attributable to an identifiable cause within 7 days of administration of a previous
pertussis antigen-containing vaccine.

- Progressive or unstable neurologic disorder.

- History of Arthus-type hypersensitivity reaction following a prior dose of a
tetanus-toxoid containing vaccine within the last 10 years.

- History of Guillain-Barré syndrome within 6 weeks of receipt of a prior vaccine
containing tetanus toxoid.
We found this trial at
12
sites
Lewiston, Maine 04240
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Lewiston, ME
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Charlotte, North Carolina 28203
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Charlotte, NC
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Greer, South Carolina 29651
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Greer, SC
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Meridian, Idaho 83642
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Meridian, ID
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Richmond, Virginia 23298
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from
Richmond, VA
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Salisbury, North Carolina 28114
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from
Salisbury, NC
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San Diego, California 92111
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from
San Diego, CA
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Stockbridge, Georgia 30281
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Stockbridge, GA
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Tucson, Arizona 85724
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Tucson, AZ
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Uniontown, Pennsylvania 15401
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Uniontown, PA
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Warwick, Rhode Island 02888
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from
Warwick, RI
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