臨床研究等提出・公開システム

Japanese

Date of registration	May. 17, 2022
Last modified on	Dec. 25, 2022
Trial ID	jRCT2031220063

Scientific Title	A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity and Safety of S-268019 in Participants Aged 12 to 19 Years (COVID-19)
Public Title	A Phase 2/3 Study of S-268019 in Participants Aged 12 to 19 Years(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		May. 14, 2022
Actual date of first enrollment
Target sample size		350
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 aged 12 to 19 years, at the time of signing the informed consent form (ICF). Male and female Capable of giving signed ICF from participants, minor participants and parent(s) or legal guardian as stated in the protcol, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
	Exclusion Criteria	Tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening. Determined in the interview prior to the study intervention to have a history of SARS-CoV-2 infection. Current history of poorly controlled 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. Immunosuppressed (immunocompromised, having acquired immunodeficiency syndrome [AIDS], having received steroids and having received systemic immunosuppressants within 6 months prior to the first dose of study intervention, being treated for malignant tumors, being on 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	12age 0month 0week old over
	Age Maximum	20age 0month 0week old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of COVID-19
Intervention(s)		S-268019 or COMIRNATY (intramuscular injection)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Priming vaccination part SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the second vaccination Booster vaccination part SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the third 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	Nihonbashi Sakura Clinic IRB
Address	5F, Inamura Building, 1-9-2, Nihonbashikayabacho, Chuo-ku, Tokyo
Telephone	+81-3-6661-9061
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
2	Dec. 25, 2022	(this page)	Changes
1	May. 17, 2022	Detail

List of change history