Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years



Status:Completed
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:1/11/2019
Start Date:January 12, 2009
End Date:July 2, 2010

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Immunogenicity and Safety Study of Different Formulations of GSK Biologicals' Herpes Zoster Vaccine 1437173A When Administered Twice in Adults Aged 50 Years and Older

The goal of this randomized observer-blind trial is to further refine the formulation of
vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune
responses and the safety profiles of the different formulations.


Inclusion Criteria:

- A male or female 50 years of age or above at the time of the first vaccination;

- Written informed consent obtained from the subject;

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study;

- If the subject is female, she must be of non-childbearing potential, or if she is of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions 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 vaccine(s) 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 three months prior to the
first vaccine dose.

- Planned administration/ administration of a vaccine not foreseen by the study protocol
within one month before the first study vaccination or scheduled within 30 days after
study vaccination;

- Previous vaccination against HZ;

- Previous vaccination against varicella;

- History of HZ;

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine;

- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
from disease or immunosuppressive/cytotoxic therapy;

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

- Acute disease at the time of enrolment.

- Any other condition that, in the opinion of the investigator, might interfere with the
evaluations required by the study;

- History of or current drug and/or alcohol abuse;

- Pregnant or lactating female;

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