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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-

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

343

Most of the index cases were children <=15 years of age, and subjects were mostly siblings of the index case. Of all index cases, 333 (98%; 165 [97%] and 168 [99%] cases of household contacts in the CS-8958 20 mg group and in the placebo group, respectively) were infected with influenza A(H3N2) virus. Among all subjects, 140 (41%) had received the 2014/2015 seasonal influenza vaccination.

A total of 343 subjects (172 subjects in the CS-8958 20 mg group and 171 subjects in the placebo group) were enrolled into the study. 341 subjects completed the study (171 subjects in the CS-8958 20 mg group and 170 subjects in the placebo group).

In the safety analysis set (341 subjects), the incidence of adverse events was 15% (25/171) in the CS-8958 20 mg group and 13% (22/170) in the placebo group. All adverse events were considered mild or moderate. No deaths, serious adverse events, or abnormal behavior were reported.

The proportion of subjects with clinical influenza were 11% (18/171) and 19% (33/170) in the CS-8958 20 mg group and placebo group, respectively (P = .02). The relative risk reduction was 45.8% (95% CI, 7.5% to 68.2%)

The proportion of subjects with symptomatic influenza was 15% (26/171) in the CS-8958 20 mg group and 27% (45/170) in the placebo group (P = .01).

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.

Nov. 02, 2016

https://pediatrics.aappublications.org/content/138/6/e20160109.long

Yes

Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ Supporting Documents: - Study Protocol - Statistical Analysis Plan - Clinical Study Report Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO CO., LTD.

dsclinicaltrial@daiichisankyo.co.jp

completed

Nov. 17, 2014

Interventional

Multicenter, randomized, double-blind, 2-parallel-group, placebo-controlled

prevention purpose

3

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

Both

Postexposure prophylaxis of influenza A or B virus infection

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 material : Single inhaled administration of CS-8958 20 mg

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Inhalation of placebo

safety
efficacy
confirmatory
Proportion of subjects with laboratory-confirmed influenza virus infection and influenza symptoms

safety
efficacy
Proportion of subjects with laboratory-confirmed influenza virus infection

-

Sept. 11, 2014