Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older



Status:Completed
Conditions:Influenza, Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:5/4/2018
Start Date:October 3, 2013
End Date:March 20, 2015

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Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A 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 FLU-D-QIV 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 (e.g. completion of the diary cards, return for follow-up
visits).

- 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)
(HZ/su and/or FLU-D-QIV vaccines) and ending 30 days after the last dose of HZ/su
vaccine.

- Administration of an influenza vaccine during the six months preceding entry into the
study or planned administration up to the last blood sampling with the exception of
the FLU-D-QIV vaccine given during this study.

- 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 a VZV or HZ vaccine (including an investigational or non-registered vaccine) other
than the study vaccine.

- History of HZ.

- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
from disease (e.g., malignancy, 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.

- History of Guillain Barré syndrome.

- Hypersensitivity to latex.

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

- Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic
route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording
temperature in this study will be oral.

- Subjects with a minor illness (such as mild diarrhoea, 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
injection unsafe.
We found this trial at
4
sites
Carnegie, Pennsylvania 15106
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Carnegie, PA
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Brampton, Ontario
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Brampton,
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Erie, Pennsylvania 16507
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Erie, PA
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Phoenix, Arizona 85012
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Phoenix, AZ
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