A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:1 - 12
Updated:8/3/2016
Start Date:December 2006
End Date:May 2008

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An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.

This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in
children during the flu season. Children who would benefit from influenza prophylaxis when
influenza is circulating in the community will receive treatment with Tamiflu syrup (or
capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and
influenza symptoms will be recorded throughout the study. The anticipated time on study
treatment is <3 months, and the target sample size is <100 individuals.


Inclusion Criteria:

- males or females, 1-12 years of age;

- candidate for seasonal prophylaxis;

- negative rapid diagnostic test for influenza at baseline.

Exclusion Criteria:

- symptoms suggestive of influenza-like illness;

- positive rapid diagnostic test for influenza;

- antiviral treatment for influenza in 2 weeks prior to randomization.
We found this trial at
5
sites
?
mi
from
Jackson, TN
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mi
from
Coquitlam,
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mi
from
El Paso, TX
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mi
from
Pittsburgh, PA
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mi
from
West Palm Beach, FL
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