Trial information
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
Status: Completed
Protocol number: NV20236
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label multi-center trial of oseltamivir for the seasonal prophylaxis of influenza in children.
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. Target sample size is
50.
Study phase: IV
Study type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Influenza
Intervention type: Drug
Intervention name: oseltamivir [Tamiflu]
Primary outcome: 1. AEs, laboratory parameters, vital signs. Time frame: Throughout study
2. Percentage of patients with laboratory confirmed clinical influenza Time frame: Throughout study
Key secondary outcomes: 1. Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 1 year Years Max: 12 Years
Accepts healthy volunteers: No
Trial registration date: 12/18/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Canada
United States
- West Palm Beach, FL
- Pittsburgh, PA
- Jackson, TN
