臨床研究等提出・公開システム

Scientific Title	A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Investigate the Immunogenicity of a Booster Dose of S-268023 compared with COMIRNATY (COVID-19)
Public Title	A Booster Study of S-268023 (COVID-19)

Contact for Scientific Queries	Name	Gomez Juan Carlos
	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. 16, 2023
Actual date of first enrollment		Dec. 16, 2023
Target sample size		600
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	-Participants aged 20 years or older, at the time of sigining the informed consent form. -Participants who have passed 90 days or more after completing the primary vaccination or booster vaccination with an approved SARS-CoV-2 vaccine (excluding an approved monovalent XBB.1.5 SARS-CoV-2 vaccine). -Participants with no infection history of SARS-CoV-2, or participants with infection history of SARS-CoV-2 who have not been infected since March 2023. -Male and female.
	Exclusion Criteria	-Participants who have previously received an approved monovalent XBB.1.5 SARS-CoV-2 vaccines. -Participants who tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of COVID-19
Intervention(s)		Intramuscular injection of S-268023 or COMIRNATY RTU intramuscular injection (XBB.1.5 variant)
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 (XBB.1.5 variant) -GMT -Seroresponse rate
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	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5213-0028
E-Mail	secretariat@hurecs.org
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 26, 2024	(this page)	Changes
1	Dec. 11, 2023	Detail

List of change history