A Phase 3 Study of CS-8958 (Prophylaxis for children)
- Conditions
- Postexposure prophylaxis of influenza A or B virus infection
- Registration Number
- JPRN-jRCT2080222627
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Single 20-mg dose of inhaled CS-8958 20 mg was effective as post-exposure prophylaxis to protect against influenza in pediatric (<10 years of age) household members of index cases for prophylaxis of influenza. Adverse events in CS-8958 20 mg single-dose group did not differ significantly from those in the placebo-group. No abnormal behaviors were observed, and there were no other major safety issues.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 343
Household contact of a patient with influenza virus infection
Body temperature (axillary) at informed consent =< 36.9 degrees C
No influenza symptoms
Be capable of inhaling drug judged by investigator
Persons who are unable to cohabit with an index patient
Persons who cannot start study treatment within 48 hours after the initial onset of any influenza symptom in the index patient
Persons receiving corticosteroids or immunosuppressants
Persons who have a history of hypersensitivity to a neuraminidase inhibitor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method