Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:65 - Any
Updated:5/27/2018
Start Date:February 17, 2009
End Date:October 15, 2009

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Evaluation of GSK Biologicals' Boostrix® Vaccine When Compared With Decavac™ in Adults Aged 65 Years or Older.

This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK
Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.


Inclusion Criteria:

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

- Males or females 65 years of age and older at the time of study entry.

- Free of an acute aggravation of the health status as established by medical history
and medical history and clinical examination before entering into the study.

- Written informed consent from all subjects.

Exclusion Criteria:

- Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.

- Administration of a Tdap vaccine at any time prior to study entry.

- History of diphtheria and/or tetanus and/or pertussis disease.

- Use of any investigational or non-registered drug or vaccine other than the study
vaccines within 30 days preceding vaccination, or planned use during the entire study
period.

- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to enrolment in this study, with the exception of
influenza, vaccine, which may be administered at any time up to or during the study
period, including the day of study vaccination.

- Planned administration of any vaccine not foreseen by the study protocol up to 30 days
following vaccination, with the exception of influenza, vaccine, which may be
administered at any time up to or during the study period, including the day of study
vaccination. Pneumococcal and zoster vaccines can be administered at the discretion of
the investigator when the subject comes back at Visit 2.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to vaccination or planned administration during the study period.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.

- History of serious allergic reaction following any other tetanus toxoid, diphtheria
toxoid or pertussis-containing vaccine or any component of the study vaccines.

- History of encephalopathy within seven days of administration of a previous booster
dose of pertussis vaccine that is not attributable to another identifiable cause.

- Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy:
pertussis vaccine should not be administered to individuals with these conditions
until a treatment regimen has been established and the condition has stabilized.

- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by clinical evaluation or pre-existing
laboratory screening tests.

- Acute disease at the time of vaccination.

- Administration of immunoglobulins and/or any blood products within the three months
preceding vaccination, or planned administration during the study period.

- Any medical condition that, in the opinion of the investigator, might interfere with
the evaluations required by the study.
We found this trial at
24
sites
DeLand, Florida 32720
2177
mi
from 91732
DeLand, FL
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Bristol, Tennessee 37620
2015
mi
from 91732
Bristol, TN
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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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Elkridge, Maryland 21075
2296
mi
from 91732
Elkridge, MD
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Fort Worth, Texas 76104
1195
mi
from 91732
Fort Worth, TX
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High Point, North Carolina 27262
2138
mi
from 91732
High Point, NC
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Indianapolis, Indiana 46202
1793
mi
from 91732
Indianapolis, IN
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Lexington, Kentucky 40504
1879
mi
from 91732
Lexington, KY
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Los Angeles, California 90025
24
mi
from 91732
Los Angeles, CA
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Metairie, Louisiana 70006
1647
mi
from 91732
Metairie, LA
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Milford, Massachusetts 01757
2555
mi
from 91732
Milford, MA
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Mogadore, Ohio 44260
2046
mi
from 91732
Mogadore, OH
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Mount Pleasant, South Carolina 29464
2188
mi
from 91732
Mount Pleasant, SC
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Pratt, Kansas 67124
1105
mi
from 91732
Pratt, KS
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Stevensville, Michigan 49127
1787
mi
from 91732
Stevensville, MI
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Stockbridge, Georgia 30281
1930
mi
from 91732
Stockbridge, GA
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Tucson, Arizona 85724
427
mi
from 91732
Tucson, AZ
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Wadsworth, Ohio 44281
2029
mi
from 91732
Wadsworth, OH
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Wenatchee, Washington 98801
930
mi
from 91732
Wenatchee, WA
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West Jordan, Utah 84088
559
mi
from 91732
West Jordan, UT
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West Palm Beach, Florida 33409
2301
mi
from 91732
West Palm Beach, FL
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Williamsburg, Virginia 23185
2310
mi
from 91732
Williamsburg, VA
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Wilmington, North Carolina 28405
2282
mi
from 91732
Wilmington, NC
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