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

Hoffmann-La Roche52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Influenza

Interventions

oseltamivir [Tamiflu]DRUG

30-75mg po daily for 6 weeks

Eligibility

Sex: ALLMin age: 1 YearMax age: 12 Years

Medical Language ↔ Plain English

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 (6)

Unnamed facility

West Palm Beach, Florida, United States

Unnamed facility

Pittsburgh, Pennsylvania, United States

Unnamed facility

Jackson, Tennessee, United States

Unnamed facility

El Paso, Texas, United States

Outcomes

Primary Outcomes

AEs, laboratory parameters, vital signs.

Time frame: Throughout study

Percentage of patients with laboratory confirmed clinical influenza

Time frame: Throughout study

Secondary Outcomes

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

Time frame: Throughout study

Data from ClinicalTrials.gov

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