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

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ClinicalTrials.gov Identifier: NCT00412555
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Influenza Drug: oseltamivir [Tamiflu] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.
Study Start Date : December 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 1 Drug: oseltamivir [Tamiflu]
30-75mg po daily for 6 weeks




Primary Outcome Measures :
  1. AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]
  2. Percentage of patients with laboratory confirmed clinical influenza [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness. [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412555


Locations
United States, Florida
West Palm Beach, Florida, United States, 33409
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, Tennessee
Jackson, Tennessee, United States, 38305
United States, Texas
El Paso, Texas, United States, 79925
Canada, British Columbia
Coquitlam, British Columbia, Canada, V3K 3P4
Denmark
Aalborg, Denmark, 9000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00412555     History of Changes
Other Study ID Numbers: NV20236
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action