Influenza Clinical Trial
Official title:
An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.
NCT number | NCT00412555 |
Other study ID # | NV20236 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2006 |
Est. completion date | May 2007 |
Verified date | August 2020 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 12 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Canada, Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AEs, laboratory parameters, vital signs. | Throughout study | ||
Primary | Percentage of patients with laboratory confirmed clinical influenza | Throughout study | ||
Secondary | Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness. | Throughout study |
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