臨床研究等提出・公開システム

Scientific Title	A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity of a Booster Dose of S-268019 or COMIRNATY (COVID-19)
Public Title	A Booster Study of S-268019 in Japan (COVID-19)

Contact for Scientific Queries	Name	Nagata Tsutae
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp
Contact for Public Queries	Name	- Corporate Communications Department
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 06, 2021
Actual date of first enrollment		Dec. 03, 2021
Target sample size		204
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Participant must be >= 20 years of age inclusive, at the time of signing the informed consent. Participant who have received 2 doses of COMIRNATY and at least 6 months post second dose.
	Exclusion Criteria	Positive SARS-CoV-2 antigen test result at Screening. A known history of SARS-CoV-2 infection as determined by medical interview before study intervention. Participant has a contraindication to IM injections or blood draws.
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of COVID-19
Intervention(s)		S-268019 or COMIRNATY (intramuscular injection)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		SARS-CoV-2 neutralizing antibody titer on Day 29
Secondary Outcome(s)

Primary Sponsor	Shionogi & Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Ministry of Health, Labour and Welfare
Secondary Sponsor	Not applicable

Name of Certified Review Board	Institutional Review Board of Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
Address	3-22, Higashioi 6-chome, Shinagawa-ku, Tokyo
Telephone	+81-3-3764-0511
E-Mail	ueda.satsuki@neues.co.jp
Approval Status	Approval
Date of approval	Nov. 24, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history