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OpenTrials
Completed

NCT Number: NCT00412555

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Coquitlam, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oseltamivir [Tamiflu]

Drug

30-75mg po daily for 6 weeks

Primary outcomes

  1. AEs, laboratory parameters, vital signs.

    Time frame: Throughout study

  2. Percentage of patients with laboratory confirmed clinical influenza

    Time frame: Throughout study

Secondary outcomes

  1. Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 18, 2006
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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