A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.
1 other identifier
interventional
52
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2006
Shorter than P25 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedAugust 18, 2020
August 1, 2020
5 months
December 15, 2006
August 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
AEs, laboratory parameters, vital signs.
Throughout study
Percentage of patients with laboratory confirmed clinical influenza
Throughout study
Secondary Outcomes (1)
Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- males or females, 1-12 years of age;
- candidate for seasonal prophylaxis;
- negative rapid diagnostic test for influenza at baseline.
You may not qualify if:
- symptoms suggestive of influenza-like illness;
- positive rapid diagnostic test for influenza;
- antiviral treatment for influenza in 2 weeks prior to randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
West Palm Beach, Florida, 33409, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Jackson, Tennessee, 38305, United States
Unknown Facility
El Paso, Texas, 79925, United States
Unknown Facility
Coquitlam, British Columbia, V3K 3P4, Canada
Unknown Facility
Aalborg, 9000, Denmark
Related Publications (1)
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.
PMID: 22520945DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 18, 2006
Study Start
December 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
August 18, 2020
Record last verified: 2020-08