Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older



Status:Completed
Conditions:Shingles, Vaccines, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:7/13/2018
Start Date:August 1, 2010
End Date:July 27, 2015

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Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

The purpose of this observer-blind study is to evaluate the efficacy, safety and
immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50
years.

Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted
concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both
studies combined will be conducted contingent on each study achieving its objectives. The
protocol posting of study ZOSTER-022 also deals with the outcome measures related to the
pooled analysis.

This protocol summary has been updated following Protocol Amendment 4 changes to study
objectives and endpoints and the analyses of the objectives in 2 steps.

Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ
VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all
objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at
step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step
1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006
(NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA,
and other pre-specified endpoints will be analyzed.

Inclusion Criteria:

- Subjects who the investigator believes will comply with the requirements of the
protocol;

- Written informed consent obtained from the subject;

- A male or female aged 50 years or older at the time of the first vaccination;

- 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.

OR 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
urine 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 other than the study vaccine
within 30 days preceding the first dose of study vaccine, or planned use 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 product;

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

- History of HZ;

- Previous vaccination against varicella or HZ;

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine. Additionally, consider allergic reactions to other material or equipment
related to study participation;

- Significant underlying illness that in the opinion of the investigator would be
expected to prevent completion of the study;

- Receipt of immunoglobulins and/or any blood products within the 90 days preceding the
first dose of study vaccine or planned administration during the study period;

- Administration or planned administration of any other immunizations within 30 days
before the first or second study vaccination or scheduled within 30 days after study
vaccination. However, licensed non-replicating vaccines may be administered up to 8
days prior to each dose and/or at least 14 days after any dose of study vaccine;

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

- Acute disease and/or fever at the time of enrollment;

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose.

- Pregnant or lactating female;

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.
We found this trial at
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Phoenix, Arizona 85012
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Arlington, Virginia 22205
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Baltimore, Maryland 21201
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Bristol, Tennessee 37620
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Carnegie, Pennsylvania 15106
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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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Edison, New Jersey
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Glebe, New South Wales 2037
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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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Kansas City, Missouri 64128
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Las Vegas, Nevada 89102
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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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Norfolk, Virginia 23502
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Overland Park, Kansas 66210
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Pleasant Hills, Pennsylvania 15236
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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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Vista, California 92083
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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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Winston-Salem, NC
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