A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
- Registration Number
- NCT00412555
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 oseltamivir [Tamiflu] -
- Primary Outcome Measures
Name Time Method AEs, laboratory parameters, vital signs. Throughout study Percentage of patients with laboratory confirmed clinical influenza Throughout study
- Secondary Outcome Measures
Name Time Method Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness. Throughout study