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
Vista, California 92083
1942
mi
from 43215
Vista, CA
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Arlington, Virginia 22205
322
mi
from 43215
Arlington, VA
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Baltimore, Maryland 21201
343
mi
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Baltimore, MD
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Bristol, Tennessee 37620
237
mi
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Bristol, TN
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Carnegie, Pennsylvania 15106
158
mi
from 43215
Carnegie, PA
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Cary, North Carolina 27518
373
mi
from 43215
Cary, NC
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Charlotte, North Carolina 28203
348
mi
from 43215
Charlotte, NC
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Clearwater, Florida 33759
828
mi
from 43215
Clearwater, FL
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Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
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Columbia, Maryland 21044
331
mi
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Columbia, MD
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DeLand, Florida 32720
761
mi
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DeLand, FL
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Edison, New Jersey
455
mi
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Edison, NJ
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Glebe, New South Wales 2037
9458
mi
from 43215
Glebe,
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Greer, South Carolina 29651
350
mi
from 43215
Greer, SC
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Hickory, North Carolina 28601
306
mi
from 43215
Hickory, NC
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Jacksonville, Florida 32207
672
mi
from 43215
Jacksonville, FL
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Kansas City, Missouri 64128
616
mi
from 43215
Kansas City, MO
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Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
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Meridian, Idaho 83642
1725
mi
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Meridian, ID
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Mesa, Arizona 85206
1644
mi
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Mesa, AZ
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Mount Pleasant, South Carolina 29464
525
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from 43215
Mount Pleasant, SC
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Murray, Utah 84107
1514
mi
from 43215
Murray, UT
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Norfolk, Virginia 23502
426
mi
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Norfolk, VA
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Overland Park, Kansas 66210
626
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Overland Park, KS
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Phoenix, Arizona 85012
1660
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Phoenix, AZ
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Pleasant Hills, Pennsylvania 15236
163
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Pleasant Hills, PA
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Renton, Washington 98057
2001
mi
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Renton, WA
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Richmond, Virginia 23298
344
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Richmond, VA
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Salisbury, North Carolina 28114
334
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Salisbury, NC
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San Antonio, Texas 78258
1126
mi
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San Antonio, TX
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Somers Point, New Jersey 08244
450
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Somers Point, NJ
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Spring Valley, California 91978
2014
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Spring Valley, CA
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Tucson, Arizona 85724
1639
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Tucson, AZ
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Uniontown, Pennsylvania 15401
175
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Uniontown, PA
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Wadsworth, Ohio 44281
99
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Wadsworth, OH
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West Palm Beach, Florida 33409
930
mi
from 43215
West Palm Beach, FL
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Wichita, Kansas 67207
780
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Wichita, KS
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Wilmington, North Carolina 28405
488
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Wilmington, NC
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Winchester, Virginia 22601
264
mi
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Winchester, VA
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Winston-Salem, North Carolina 27103
307
mi
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Winston-Salem, NC
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