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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

oseltamivir [Tamiflu]

Intervention Type DRUG

30-75mg po daily for 6 weeks

Interventions

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oseltamivir [Tamiflu]

30-75mg po daily for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No