Trial Information

Summary: 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 Design / Study Details:

• Purpose: Prevention
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

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: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 3:09:44 PM