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Sofia RSV FIA Field Study | Clinical Trials | Clareo Health

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COMPLETEDNCT01734668

Sofia RSV FIA Field Study

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.

Lead sponsor: Quidel Corporation•17 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Quidel Corporation

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

No

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®.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 7, 2013Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment2,468

Start dateMar 2012

Last updatedFeb 7, 2013

Condition

Respiratory Syncytial Virus

Locations shown

Best Medical Group

Phoenix, Arizona

Santo Nino Medical Clinic

Panorama City, California

Genesis Community Health

Boynton Beach, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2013Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions