臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 13, 2022
Last modified on	July. 14, 2022
Trial ID	jRCT2051210151

Scientific Title	A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Compare the Immunogenicity against COVID-19, of S-268019 to the ChAdOx1 nCoV-19 vaccine (COVID-19)
Public Title	A Phase 3 Study to Compare the Immunogenicity against COVID-19, of S-268019 to the ChAdOx1 nCoV-19 vaccine (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		Jan. 17, 2022
Actual date of first enrollment		Jan. 17, 2022
Target sample size		1000
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 >= 18 years of age, at the time of signing the informed consent form (ICF). Male and female Capable of giving signed ICF which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
	Exclusion Criteria	Current or history of a laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19. Unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation. Immunosuppression (immunodeficiency, acquired immunodeficiency syndrome [AIDS], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy). Individuals considered to have hypersensitivity to any of the study interventions,or components thereof, or drug or other allergy that, in the opinion of the investigator or subinvestigator, contraindicates participation in the study (except for pollinosis and atopic dermatitis). Participant has a contraindication to intramuscular(IM) injections or blood draws.
	Age Minimum	18age 0month old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of COVID-19
Intervention(s)		S-268019-b or ChAdOx1 nCoV-19 vaccine (intramuscular injection) Only the participants who agree to receive the third vaccination will be given a booster vaccination of S-268019-b.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Primary Vaccination Part SARS-CoV-2 neutralizing antibody titer at 28 days following the second vaccination Booster Vaccination Part SARS-CoV-2 neutralizing antibody titer at 28 days following the booster vaccination
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	Medical corporation Takahashi clinic clinical trial examination committee
Address	Medical Hat, 1st floor, 1-31, Iwayakitamachi, Nada-ku, Kobe-shi, Hyogo
Telephone	+81-78-882-6432
E-Mail	kishimoto.satoshi@neues.co.jp
Approval Status	Approval
Date of approval	Dec. 22, 2021

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	July. 14, 2022	(this page)	Changes
2	Feb. 05, 2022	Detail	Changes
1	Jan. 13, 2022	Detail

List of change history