Influenza
Conditions
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.
Interventions
30-75mg po daily for 6 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs, laboratory parameters, vital signs. | Throughout study |
| Percentage of patients with laboratory confirmed clinical influenza | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness. | Throughout study |
Countries
Canada, Denmark, United States
Outcome results
None listed