A Phase 3 Study of CS-8958 (Prophylaxis for children)

A Phase 3 Study of CS-8958 (Prophylaxis for children) - A randomized, double-blind, placebo-controlled study to evaluate the efficacy for the prevention of influenza virus infection in children under 10 years-

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222627

Enrollment

300

Registered

2014-10-16

Start date

2014-11-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postexposure prophylaxis of influenza A or B virus infection

Interventions

investigational material(s) Generic name etc : CS-8958 INN of investigational material : laninamivir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
safety efficacy confirmatory Proportion of subjects with laboratory-confirmed influenza virus infection and influenza symptoms	—

Secondary

Measure	Time frame
safety efficacy Proportion of subjects with laboratory-confirmed influenza virus infection	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026