Back to resultsA Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
oseltamivir [Tamiflu]
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
AEs, laboratory parameters, vital signs.
Percentage of patients with laboratory confirmed clinical influenza
Secondary Outcome Measures
Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00412555
Brief Title
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
Official Title
An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oseltamivir [Tamiflu]
Intervention Description
30-75mg po daily for 6 weeks
Primary Outcome Measure Information:
Title
AEs, laboratory parameters, vital signs.
Time Frame
Throughout study
Title
Percentage of patients with laboratory confirmed clinical influenza
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22520945
Citation
Reisinger K, Shu D, Cupelli L, Marcadis I, Dutkowski R. Safety and tolerability of a 6-week course of oseltamivir prophylaxis for seasonal influenza in children. Influenza Other Respir Viruses. 2013 Jan;7(1):11-3. doi: 10.1111/j.1750-2659.2012.00367.x. Epub 2012 Apr 23.
Results Reference
derived
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A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
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