臨床研究等提出・公開システム

Scientific Title	A Clinical Study To investigate Incidence Rate of Seasonal Influenza
Public Title	A Clinical Study To investigate Incidence Rate of Seasonal Influenza

Contact for Scientific Queries	Name	Inoguchi Akihiro
	Affiliation	Daiichi Sankyo Co., Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial_jp@daiichisankyo.com
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	Daiichi Sankyo Co., Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial_jp@daiichisankyo.com

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 28, 2025
Actual date of first enrollment
Target sample size		6000
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Has provided written consent to research participation by the participant or via the legal representative. 2) Is not willing to receive a seasonal influenza vaccine after the date of consent until the end of research observation period. 3) Is able to visit the research institution upon report and undergo the tests specified in the protocol when seasonal influenza-like symptoms are observed during the research observation period (report by a legal representative is also acceptable).
	Exclusion Criteria	1) Is received a seasonal influenza vaccine from 6 months before the start of resarch observation period to the date of consent in each season. 2) Has a medical history of a seasonal influenza from 6 months before the start of resarch observation period to the date of consent in each season.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Seasonal influenza
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		1) The proportion of participants reporting seasonal influenza cases 2) Strains of influenza virus in participants reporting seasonal influenza cases
Secondary Outcome(s)

Primary Sponsor	Daiichi Sankyo Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nihonbashi Sakura Clinic Ethics Review Committee
Address	1-9-2 Nihonbashikayabacho, Chuo-ku, Tokyo
Telephone	+81-3-6661-9061
E-Mail
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none