A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.

Roche

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Drug: oseltamivir [Tamiflu]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412555

NV20236

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

1

Experimental group

Treatment:

Drug: oseltamivir [Tamiflu]