A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00412555

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 IV

MedlinePlus related topics: Flu

Drug Information available for: Oseltamivir Tamiflu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Multi-Center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.

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 Completion Date:	March 2007

Arms	Assigned Interventions
1: Experimental	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, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV20236
Study First Received:	December 15, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00412555
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Orthomyxoviridae Infections
Oseltamivir

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009