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
Tucson, Arizona 85724
427
mi
from 91732
Tucson, AZ
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Arlington, Virginia 22205
2275
mi
from 91732
Arlington, VA
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Baltimore, Maryland 21201
2301
mi
from 91732
Baltimore, MD
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Bristol, Tennessee 37620
2015
mi
from 91732
Bristol, TN
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Carnegie, Pennsylvania 15106
2114
mi
from 91732
Carnegie, PA
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Cary, North Carolina 27518
2211
mi
from 91732
Cary, NC
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Charlotte, North Carolina 28203
2100
mi
from 91732
Charlotte, NC
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Clearwater, Florida 33759
2122
mi
from 91732
Clearwater, FL
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Cleveland, Ohio 44195
2036
mi
from 91732
Cleveland, OH
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Columbia, Maryland 21044
2287
mi
from 91732
Columbia, MD
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DeLand, Florida 32720
2177
mi
from 91732
DeLand, FL
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Edison, New Jersey
2412
mi
from 91732
Edison, NJ
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Glebe, New South Wales 2037
7515
mi
from 91732
Glebe,
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Greer, South Carolina 29651
2027
mi
from 91732
Greer, SC
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Hickory, North Carolina 28601
2068
mi
from 91732
Hickory, NC
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Jacksonville, Florida 32207
2131
mi
from 91732
Jacksonville, FL
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Kansas City, Missouri 64128
1343
mi
from 91732
Kansas City, MO
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Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
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Meridian, Idaho 83642
664
mi
from 91732
Meridian, ID
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Mesa, Arizona 85206
365
mi
from 91732
Mesa, AZ
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Mount Pleasant, South Carolina 29464
2188
mi
from 91732
Mount Pleasant, SC
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Murray, Utah 84107
565
mi
from 91732
Murray, UT
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Norfolk, Virginia 23502
2341
mi
from 91732
Norfolk, VA
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Overland Park, Kansas 66210
1333
mi
from 91732
Overland Park, KS
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Phoenix, Arizona 85012
343
mi
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Phoenix, AZ
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Pleasant Hills, Pennsylvania 15236
2121
mi
from 91732
Pleasant Hills, PA
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Renton, Washington 98057
952
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from 91732
Renton, WA
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Richmond, Virginia 23298
2269
mi
from 91732
Richmond, VA
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Salisbury, North Carolina 28114
2051
mi
from 91732
Salisbury, NC
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San Antonio, Texas 78258
1184
mi
from 91732
San Antonio, TX
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Somers Point, New Jersey 08244
2409
mi
from 91732
Somers Point, NJ
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Spring Valley, California 91978
324
mi
from 91732
Spring Valley, CA
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Uniontown, Pennsylvania 15401
2134
mi
from 91732
Uniontown, PA
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Vista, California 92083
74
mi
from 91732
Vista, CA
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Wadsworth, Ohio 44281
2029
mi
from 91732
Wadsworth, OH
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West Palm Beach, Florida 33409
2301
mi
from 91732
West Palm Beach, FL
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Wichita, Kansas 67207
1186
mi
from 91732
Wichita, KS
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Wilmington, North Carolina 28405
2282
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from 91732
Wilmington, NC
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Winchester, Virginia 22601
2219
mi
from 91732
Winchester, VA
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Winston-Salem, North Carolina 27103
2122
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from 91732
Winston-Salem, NC
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