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: July 7, 2014
Last verified: July 2014
  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 inf luenza prophylaxis when influenza is circulating in the community will receive t reatment with Tamiflu syrup (or capsules) 30mg-75mg once daily (dependent on bod y weight) for 6 weeks. Safety data and influenza symptoms will be recorded throu ghout the study. The anticipated time on study treatment is <3 months, and the t arget 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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 7, 2014
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 July 24, 2014