臨床研究等提出・公開システム

Scientific Title	A Phase 3, Open-label Study to Evaluate Safety of a Booster Dose of S-268019 in Adults and Older Adults Who Have Completed COVID-19 Vaccine as a Primary Series (COVID-19)
Public Title	A Booster Study of S-268019 in Japan-2 (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	- -
	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		Feb. 28, 2022
Actual date of first enrollment		Feb. 28, 2022
Target sample size		150
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. Participant who have received 2 doses of SARS-CoV-2 vaccine (Adults:only SPIKEVAX, Older adults: COMIRNATY or SPIKEVAX) and 6 months or more and 8 months or less after 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)		One dose of S-268019 via intramuscular injection. Participants who provided informed consent for the second booster dose will receive one dose of S-268019 again via intramuscular injection.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety
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	P-One Clinic, Keikokai Medical Corporation IRB
Address	View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo
Telephone	+81-42-625-5216
E-Mail	irbjimukyoku@p1-clinic.or.jp
Approval Status	Approval
Date of approval	Feb. 14, 2022

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