Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older



Status:Completed
Conditions:Shingles, Vaccines, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:70 - Any
Updated:7/14/2018
Start Date:August 2, 2010
End Date:July 24, 2015

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Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 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 ≥ 70
years.

Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be 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. This
protocol posting 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. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022
(NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy
(HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)
separately.

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 70 years or older at the time of the first vaccination.

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 enrolment.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose.
We found this trial at
40
sites
Baltimore, Maryland 21201
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Baltimore, MD
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Arlington, Virginia 22205
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Arlington, VA
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Bristol, Tennessee 37620
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Bristol, TN
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Carnegie, Pennsylvania 15106
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Carnegie, PA
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Cary, North Carolina 27518
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Cary, NC
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Charlotte, North Carolina 28203
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Charlotte, NC
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Clearwater, Florida 33759
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Clearwater, FL
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Cleveland, Ohio 44195
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Cleveland, OH
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Columbia, Maryland 21044
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Columbia, MD
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DeLand, Florida 32720
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DeLand, FL
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Edison, New Jersey
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Edison, NJ
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Glebe, New South Wales 2037
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Glebe,
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Greer, South Carolina 29651
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Greer, SC
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Hickory, North Carolina 28601
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Hickory, NC
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Jacksonville, Florida 32207
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Jacksonville, FL
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Kansas City, Missouri 64128
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Kansas City, MO
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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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Mesa, Arizona 85206
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Mesa, AZ
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Murray, Utah 84107
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Murray, UT
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Norfolk, Virginia 23502
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Norfolk, VA
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Overland Park, Kansas 66210
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Overland Park, KS
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Phoenix, Arizona 85012
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Phoenix, AZ
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Pleasant Hills, Pennsylvania 15236
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Renton, Washington 98057
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Renton, WA
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Richmond, Virginia 23298
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Richmond, VA
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Salisbury, North Carolina 28114
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Salisbury, NC
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San Antonio, Texas 78258
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Somers Point, New Jersey 08244
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Somers Point, NJ
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Spring Valley, California 91978
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Spring Valley, CA
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Tucson, Arizona 85724
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Uniontown, Pennsylvania 15401
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Uniontown, PA
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Vista, California 92083
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Vista, CA
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Wadsworth, Ohio 44281
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Wadsworth, OH
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West Palm Beach, Florida 33409
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Wichita, Kansas 67207
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Wichita, KS
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Wilmington, North Carolina 28405
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Wilmington, NC
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Winchester, Virginia 22601
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Winchester, VA
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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