Seasonal prophylaxis of influenza in immunocompromised subjects MedDRA version: 8.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Trade Name: Tamiflu
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: oseltamivir phosphate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration
Sponsors
F.Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males or females 1 to 12 years of age; females must be pre-menarchal • Subject is a candidate for seasonal prophylaxis in the opinion of the Principal investigator • Negative rapid diagnostic test for influenza at baseline • Parent/guardian willing and able to comply with study requirements and give consent • Subject able to comply with study requirements and willing to give assent, as appropriate Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Symptoms suggestive of influenza-like illness, including but not limited to, fever, cough, or nasal congestion • Positive rapid diagnostic test for influenza • Creatinine clearance < 30 ml/min/1.73M2 • Females of child-bearing potential • Uncontrolled renal, vascular, neurologic, metabolic, or pulmonary disease or known chronic renal failure, hepatitis or cirrhosis. Uncontrolled is defined as disease requiring change of therapy or hospitalization within 4 weeks preceding the first dose of study medication. Change of therapy is defined as dose increase or change of medication. • Allergy to the test medication • Hereditary fructose intolerance (for subjects who will be taking the liquid formulation) • Malignancy at the time of randomization excluding adequately treated skin carcinoma (basal or squamous cell) • Participation in a clinical trial with an investigational drug in the 4 weeks prior to randomization. Patients enrolled in this study can not be enrolled in another study for either research, diagnostic or treatment purposes. • Antiviral treatment (example: amantadine, rimantadine, zanamavir, oseltamivir and ribavirin) for influenza in the 2 weeks prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •to evaluate the safety of 6 weeks of seasonal prophylaxis of influenza in children •to evaluate the effect of oseltamivir in preventing laboratory confirmed clinical influenza in children ;Secondary Objective: ;Primary end point(s): The efficacy end points in the study are: 1. Proportion of subjects with laboratory confirmed clinical influenza. 2. Proportion of subjects with laboratory confirmed influenza. 3. Proportion of subjects with asymptomatic influenza. 4. Proportion of subjects with an influenza-like illness not caused by influenza virus infection. | — |
Countries
Denmark, Germany
Outcome results
None listed