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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: oseltamivir [Tamiflu] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

AEs, laboratory parameters, vital signs.

Percentage of patients with laboratory confirmed clinical influenza

Secondary outcome: Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.

Eligibility

Minimum age: 1 Year. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Aalborg 9000, Denmark

Coquitlam, British Columbia V3K 3P4, Canada

West Palm Beach, Florida 33409, United States

Pittsburgh, Pennsylvania 15241, United States

Jackson, Tennessee 38305, United States

El Paso, Texas 79925, United States

Additional Information

Starting date: December 2006
Last updated: August 17, 2015

Page last updated: August 23, 2015

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