Sofia RSV FIA Field Study



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:March 2012
End Date:December 2012

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The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA
with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of
age.


Inclusion Criteria:

1. Male or Female

2. Children less than nineteen (19) years of age can participate (assuming appropriate
consent is obtained).

3. Must currently be exhibiting symptoms characteristic of respiratory syncytial virus
(RSV) illness.

4. Subjects must present with one or more of the following to be eligible for
enrollment:

- Fever, ≥ 37.8º C (100º F) at present or within past 24 hours

- Moderate to severe runny nose*

- Moderate to severe congestion*

- Decreased appetite

- Coughing

- Sneezing*

- Wheezing

- Irritability

- Decreased activity

- Labored breathing

Exclusion Criteria:

1. Subjects nineteen years of age or older.

2. The parent or legal guardian is unable to understand and consent to participation.

3. Current or prior treatment during this infection with anti-RSV Synagis®.
We found this trial at
17
sites
Vienna, Virginia 22180
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Vienna, VA
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Belton, Texas 76513
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from
Belton, TX
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Boynton Beach, Florida 33435
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from
Boynton Beach, FL
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Boynton Beach, Florida 33435
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from
Boynton Beach, FL
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Delray Beach, Florida 33483
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from
Delray Beach, FL
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Lake Worth, Florida 33460
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from
Lake Worth, FL
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Miami, Florida 33173
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from
Miami, FL
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Morris Plains, New Jersey 07950
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from
Morris Plains, NJ
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Panorama City, California 91402
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from
Panorama City, CA
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Pensacola, Florida 32504
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Pensacola, FL
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Phoenix, Arizona 85042
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from
Phoenix, AZ
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Rochester, New York 14618
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from
Rochester, NY
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St. Petersburg, Florida 33702
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from
St. Petersburg, FL
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St. Petersburg, Florida 33710
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from
St. Petersburg, FL
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Tampa, Florida 33613
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from
Tampa, FL
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West Palm Beach, Florida 33415
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from
West Palm Beach, FL
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West Palm Beach, Florida 33406
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from
West Palm Beach, FL
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