臨床研究等提出・公開システム

Date of registration	Mar. 05, 2025
Last modified on	April. 10, 2025
Trial ID	jRCT2031240717

Scientific Title	A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Investigate the Immunogenicity of a Booster Dose of S-268024 Compared with NUVAXOVID (COVID-19)
Public Title	A Booster Study of S-268024 (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		Mar. 12, 2025
Target sample size		730
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 18 years or older, at the time of sigining the informed consent form. -Participants who have passed 90 days or more after completing the primary or booster vaccination with an approved SARS-CoV-2 vaccine (excluding approved SARS-CoV-2 vaccines for JN.1 variant). -Participants with no infection history of SARS-CoV-2, or participants with infection history of SARS-CoV-2 who have not been infected since October 2023. -Male and female.
	Exclusion Criteria	-Participants who have previously received an approved SARS-CoV-2 vaccines for JN.1 variant. -Participants who tested positive for anti-SARS-CoV-2 N-protein antibody at the screening. -Participants who tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Visit 1 (before administration).
	Age Minimum	18age 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-268024 or NUVAXOVID intramuscular injection (JN.1 variant)
Primary Outcome(s)		SARS-CoV-2 neutralizing antibody titer on day 29 (JN.1 variant) -GMT -Seroresponse rate

Primary Sponsor	Shionogi & Co., Ltd.

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	Feb. 27, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 10, 2025	(this page)	Changes
1	Mar. 05, 2025	Detail

List of change history