臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 20, 2021
Last modified on	May. 19, 2022
Trial ID	jRCT2031210383

Scientific Title	An Open-Label Phase 2/3 Study of S-268019 (COVID-19)
Public Title	A Phase 2/3 Study of S-268019 (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		Oct. 20, 2021
Actual date of first enrollment		Oct. 20, 2021
Target sample size		3100
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single 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. Male and female Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
	Exclusion Criteria	Positive SARS-CoV-2 antigen test result at Screening. Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacy Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs within 6 months prior to the first dose of study intervention, being treated for malignancy or receiving other immunosuppressive therapy]. Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis). Participant has a contraindication to IM injections or blood draws. et, al.
	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 0.5 mL, intramuscular injection in the upper arm for a total of two doses. S-268019 0.5 mL is injected intramuscularly once to the participants who wish to receive the third vaccination.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		The incidence of adverse events/adverse reactions/serious adverse events/solicited adverse events/medically attended adverse events/adverse event of special interest. SARS-CoV-2 neutralizing antibody titer on Day 239
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	Adachi Kyousai Hospital Institutional Review Board
Address	1-36-8 Yanagihara, Adachi-ku, 120-0022 JAPAN, Tokyo
Telephone	+81-3-3881-6116
E-Mail	c-irb_ug@neues.co.jp
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
3	May. 19, 2022	(this page)	Changes
2	Nov. 17, 2021	Detail	Changes
1	Oct. 20, 2021	Detail

List of change history