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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00412555
First received: December 15, 2006
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention Phase
Influenza
 Drug: oseltamivir [Tamiflu]
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients with laboratory confirmed clinical influenza [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: oseltamivir [Tamiflu]
30-75mg po daily for 6 weeks

  Eligibility

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Hoffmann-La Roche

Additional 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
Study First Received: December 15, 2006
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013